Voices in Bioethics

How does Generative AI Affect Patients' Rights?

2025-09-03T11:44:40+00:00

Photo by Igor Omilaev on Unsplash

Abstract

Healthcare systems are facing constant changes due to demographic modifications (a rapidly aging population), technological developments, global pandemics, and shifts in social paradigms. These changes are increasingly being analysed through the lens of patients’ rights, which are central in ethical and legal discussions in healthcare. A significant change in healthcare today is the growing use of generative artificial intelligence (AI) in clinical practice. This research analyses the potential risks of the use of generative AI systems to fundamental patients’ rights. With a mixed methodology combining literature review and semi-structured interviews with experts and stakeholders, the study identifies three main areas of risk, each one associated with fundamental values: the right to medical data protection (privacy), the right to equal access to healthcare (justice), and the right to informed consent (autonomy). The report concludes with a discussion of the findings and presents legal and ethical recommendations to promote the benefits of generative AI in healthcare.

1. Introduction

The increasing digitalization of healthcare is reshaping how healthcare professionals deal with clinical tasks and patient interactions. This technological shift is accelerated by systemic pressures that healthcare is facing today due to a double aging population and workforce shortages. Generative artificial intelligence (GenAI) has the capacity to help healthcare providers with clinical documentation, decision-making, and patient communication through automated processes. At the same time, the fast integration of GenAI models in healthcare raises ethical and legal concerns. For example, general-purpose AI models are already being used in clinical practice without being subject to high-risk regulatory requirements. This produces regulatory gaps that challenge the protection of fundamental patients’ rights in real-world clinical settings.

This report focuses on three main patients’ rights: the right to privacy, the right to equitable access, and the right to informed consent. These rights are represented in bioethical and legal frameworks for the protection of patients. The question guiding this study is the following: How does the use of generative AI in healthcare impact patients’ rights, particularly regarding privacy, justice, and autonomy? While the analysis is framed within the EU context, the concepts and findings remain relevant for broader global discussions. By identifying key risks, such as unauthorized access to health data, limitations of anonymization techniques, algorithmic bias, and digital informed consent, this study contributes to the growing body of research on AI in healthcare and the protection of patients’ rights.

2. Context

2.1. What is Generative AI?

Generative artificial intelligence (GenAI) is a broad category of AI that, in addition to recognizing and predicting patterns, can also generate new content such as text, images, and sound, based on input and training data.^[1] GenAI differs from traditional AI in two key ways: dynamic context and scale of use. While traditional AI is typically designed for specific contexts and predefined tasks, GenAI has a sort of “flexibility” and “creativity” that allows the model to learn new capabilities that it had never been explicitly trained for, allowing it to adapt to different contexts and uses.^[2] In this sense, GenAI is one single tool with multiple uses and applications.^[3]

Because of this high adaptability, it is harder to interpret the complex learning algorithms of GenAI, which leads to less transparency of the system. Ultimately, when asking a GenAI model to create an outcome, if asked the same thing twice, it will provide inconsistent outcomes due to its probabilistic nature.

A specific category of GenAI is large language models (LLMs), which are designed to generate human-like text. These models pertain to the class of natural language processing (NLP), the technology that allows computers to understand and process human language (an example would be Google Translate). LLMs are trained on enormous text datasets that allow the model to self-learn and create text on its own.^[4]

GenAI has gained significant attention since the release of ChatGPT, a chatbot made publicly available by the American organization OpenAI in 2019. Its ease and free accessibility reached widespread adoption^[5] also in healthcare settings.^[6]

2.2. Generative AI in Healthcare

In healthcare, traditional AI systems are used in several areas. For example, in radiology, they automate the detection and classification of medical images.^[7] In emergency departments and intensive care units (ICUs), AI is used as a decision support system. For example, the Pacmed Critical model at Leiden University Medical Centre (UMC) (Netherlands) is a machine learning model that predicts readmission or death after ICU discharge.^[8] AI is also used in patient monitoring to track physiological changes and provide predictive analytics: MS Sherpa is an application for multiple sclerosis that uses digital biomarkers to monitor symptom progression and disease activity.^[9]

GenAI offers new possibilities, mainly aimed at reducing administrative burdens, for instance, through automatically creating clinical documents like discharge letters, referral letters, and clinical notes.^[10] For example, the UMC Utrecht (Netherlands) has developed an application that uses General Pre-training Transformer (GPT) to generate draft discharge letters.^[11] GenAI is also being used to transcribe and summarize conversations between doctor and patient. “Autoscriber,” at Leiden UMC research department (Netherlands), is a digital scribe system that automatically records, transcribes, and summarizes the clinical encounter.^[12] Besides administrative tasks, GenAI can assist with clinical decision-making by creating diagnosis and treatment recommendations based on patient data.^[13] It also supports medical research activities like assisting in systematic reviews.^[14] GenAI is also used to automatically answer patients’ questions related to their care. For example, at the Elizabeth-Twee Steden Hospital (Netherlands), a chatbot called “Eliza” answers patients’ medical questions.^[15]

2.3. Current Use of Generative AI in Healthcare

The use of GenAI in healthcare is rapidly increasing, which is changing how healthcare providers manage clinical tasks and patient interactions. Recent empirical studies reveal that more than half of healthcare providers use ChatGPT, or similar general-purpose LLMs, to assist with clinical documentation, patient communication, clinical decision-making, research, and more.^[16] These studies also show that despite this widespread use of GenAI, most healthcare providers lack the required knowledge and awareness of the risks of using this tool in general, and specifically for clinical tasks.^[17] This lack of comprehension is probably because GenAI has only become popular and widespread recently, which makes it difficult to fully understand and assess the risks and scale of these technologies to society.

This gap in understanding GenAI’s risks is reflected in healthcare institutions. For example, a survey on AI use in Dutch hospitals found that GenAI was used in 57 percent of hospitals, with applications such as automatic transcriptions, document summarisation, and text generation.^[18] The same study showed critical issues: in only 29 percent of hospitals, it was clear on what frequency AI models are retested, trained, and calibrated to errors such as hallucinations^[19] and data drifting.^[20] In more than half of the hospitals (52 percent), it is unknown whether, and if so, in what frequency, such practices occur at all, and in 11 percent, AI models are never retrained. Moreover, only 30 percent of hospitals reported having an AI policy describing the frameworks, standards, and guidelines for the use of AI.^[21]

Another survey found that 76 percent of physicians reported using general-purpose LLMs, like ChatGPT, for clinical decision-making.^[22] More than 60 percent of primary care doctors reported using them to check drug interactions; while more than half use them for diagnosis support, nearly half for clinical documentation, and more than 40 percent for treatment planning. Additionally, 70 percent use general-purpose LLMs for patient education and literature search.

These findings show a mismatch between the growing use of GenAI in clinical practices and the governance needed to ensure its responsible use. While GenAI has the potential to enhance efficiency and accuracy in clinical tasks, if it is integrated without the necessary knowledge, governance, legal, and ethical oversight, it can lead to harmful consequences to patients, such as data protection violations, automation bias, unclear accountability, healthcare inequality, incorrect clinical decisions, and the spread of misinformation.^[23]

2.4. Regulatory Landscape

At the European Union (EU) level, efforts to regulate the safe use of AI in healthcare are currently fragmented. This means there is not one regulatory framework solely dedicated to governing the use of AI in healthcare. Instead, different laws cover different parts of the issue, including the European Union AI Act,^[24] the General Data Protection Regulation,^[25] and the Medical Devices Regulation.^[26]

2.4.1. The European Union AI Act

In August 2024, the Artificial Intelligence (AI) Act entered into force. The AI Act is an EU regulation that sets rules for the development, introduction to the market, and deployment of AI systems. It adopts a risk-based approach: depending on the application and use of the system, it will fall under low, middle, high, or impermissible risk. The higher the risk, the stricter the regulatory requirements (e.g., risk management, data governance, human oversight).^[27]

Medical devices like AI diagnostic tools are classified as high-risk systems due to their direct implications for health outcomes. On the contrary, the majority of GenAI systems, like ChatGPT, fall under the category of general-purpose AI systems, which means that they can be classified both as high-risk and low-risk, depending on their application.^[28] Therefore, the actual risk of the GenAI system depends on how and where it is used.^[29]

Large GenAI systems (like ChatGPT, Bard, DALL-E) are considered to pose systemic risks due to their widespread adoption; however, they are not always classified as high-risk applications.^[30] This means that, in practice (as previously shown), a healthcare provider can and does use these systems for clinical tasks without the systems being under the requirements of high-risk medical devices. While these tools are fast and have access to vast amounts of data, they are relatively new, freely available, and not specifically designed or trained for medical use. Without the appropriate oversight and awareness, it creates the potential for unacceptable risks to patient care.

Moreover, the AI Act is presented as a horizontal regulation, which means that it applies across all sectors and industries rather than focusing on the unique needs, risks, and ethical concerns of the healthcare sector.^[31] As argued later, the increasing use of digital healthcare presents new risks to patients’ rights, which will require additional and tailored protections.

2.4.2. Medical Device Regulation

The Medical Device Regulation (MDR) is an EU-binding document that governs the use of devices in clinical settings. It is also risk-based, depending on the intended purpose.

The MDR provides strict rules for GenAI systems intended for clear medical purposes, such as diagnosis. However, not all applications of GenAI are considered medical devices under the MDR, even when used for clinical tasks.^[32] For example, when GenAI is used for facilitating communication between patients and practitioners, summarizing clinical reports, or generating referral letters, it is not defined as a medical purpose; therefore, they do not fall under the MDR regulation. Consequently, if healthcare providers use GenAI for such “non-medical purposes,” there is no regulatory guidance on critical issues like patient privacy and legal responsibilities.^[33]

GenAI systems are highly adaptable and can be used for many different purposes. Because of this versatility, the MDR and similar regulations based on defined intended purposes face particular challenges. Many GenAI systems, such as ChatGPT, are not specifically designed for medical settings, although healthcare providers use them for clinical tasks. This leads to a regulatory gap: the technology is being used in practice but lacks adequate regulation. This lack of regulation does not ensure the trustworthiness of these tools in clinical settings and poses unacceptable risks to patients’ rights.

2.4.3. General Data Protection Regulation

The use of GenAI in healthcare settings often involves dealing with large volumes of sensitive data like medical records, scan images, and lab results. The management of this data is regulated by the General Data Protection Regulation (GDPR), an EU regulatory framework to protect data privacy. The GDPR classifies health data as a special category of sensitive information that requires additional protections. It grants data subjects with specific rights, including the right to informed consent, the right to access the data, the right to rectification, and the right to be forgotten.^[34] Patient data falls under this category, and the GDPR provides strong protections, enabling the reinforcement of the principle of medical confidentiality by limiting the use and amount of such data strictly to the purpose of direct care. In practice, this means that a hospital cannot use patient data for training an AI algorithm or share it with an external vendor without obtaining explicit informed consent or meeting a legal exemption.

While the GDPR is clear for GenAI systems that are developed by the healthcare organisation itself, it becomes challenging for general-purpose GenAI systems, like ChatGPT, where the influence of the GDPR is less powerful compared to models explicitly designed to process personal data.^[35] This creates a regulatory grey area for the use of general-purpose GenAI systems in healthcare settings regarding compliance with sensitive data protection standards.

3. Patients’ Rights

Healthcare systems are facing changes constantly (rapidly ageing population, scientific and technological developments, global pandemics, shifts in social paradigms, etc.). These changes are increasingly being analysed through the lens of patients’ rights.^[36]

A significant change in healthcare today is the growing use of AI in medical tasks. This technological shift is likely to change traditional patients’ rights into what may soon be recognized as digital patients’ rights.^[37]

The field of patients’ rights lies at the intersection of ethics and health law, bringing together moral imperatives and legal protections. Patients’ rights are a special category of human rights aimed at protecting the dignity of the individual who is in a vulnerable state of illness.^[38] Since nearly all humans become patients,^[39] and patients are among the most vulnerable groups in society,^[40] their rights are uniquely defined and crucially important.^[41]

The position of the patient is especially vulnerable because of their illness, which can cause insecurity and fear. Moreover, the patient is in an unbalanced position compared to the doctor, who is learned, skilled, and experienced in the topics in which the patient often knows little or nothing about, and still are extremely important for the patient, since their health may depend on them.^[42] Besides this information asymmetry, the interaction between patient-practitioner is of a critical and private nature, which leaves the patient to highly depend on the practitioner in order to obtain adequate assistance.^[43] This imbalance creates an easy potential for abuse of power (intentional or not) and shows why it is necessary to give special attention to protecting the patient.

3.1. Legal Protection for Patients’ Rights

Over the past decades, patients’ rights have been recognized in a variety of different documents (Declarations, Charters, Laws) at the international, regional, and national levels.^[44] Examples of these regulatory efforts include:

European Convention of Human Rights and Fundamental Freedoms (1950)
International Covenant on Civil and Political Rights (1966)
A declaration on the promotion of patients’ rights in Europe (WHO, 1994)
Declaration of Lisbon of the World Medical Association (1995)
Wet op de Geneeskundige Behandelingsovereenkomst (WGBO) (Medical Treatment Agreement Act) (1995)
Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Oviedo Convention) (1997)
European Charter of Patient Rights (2002)

These documents are crucial to provide a framework to protect the dignity, freedom, self-determination, and respect of patients. However, the fragmented nature of patients’ rights creates a complex landscape that can be challenging for both patients and healthcare providers to navigate. As Herranz notes,^[45] these documents are highly diverse and target different audiences; some are universal, others regional or national in scope. While this diversity reflects the growing importance of patients’ rights globally, it also creates a fragmented landscape. Both patients and healthcare providers may find it difficult to understand the specific rights and obligations that apply in their context due to the diverse and spread nature of these rights between jurisdictions.^[46]

4. Methodology

4.1. Study Design and Population

This qualitative study consisted of semi-structured interviews with key experts and stakeholders. Stakeholder mapping was conducted through a document desk review. This process identified five relevant stakeholder groups: (1) patients, (2) healthcare providers, (3) healthcare organizations, (4) AI & Data experts, and (5) Ethical & Legal experts.

Participants were selected based on the following criteria: being 18 years or older, having the capacity to give informed consent, being knowledgeable about the use of AI in healthcare (this criterion did not apply to patient participants), and the ability to communicate in English. Each interview began with a short case study to provide participants with a concrete scenario to consider while answering the questions. Presenting a case study enabled a more focused discussion and helped participants reflect on specific risks.^[47]

4.2. Tools

Member States of the European Union (EU) do not share a single binding document to protect patients’ rights. Instead, they are diversified in multiple pieces of legislation. Although these rights are widely recognized in the EU, each country applies its own medical regulations depending on its context and traditional norms.^[48] However, it is possible to identify a set of fundamental patients’ rights that are widely recognised across all EU Member States.^[49] This study focused on three of these fundamental patients’ rights to guide the development of interview questions. These rights were selected based on existing European frameworks (including the European Convention on Human Rights; the Charter of Fundamental Rights of the European Union; and the European Convention on Human Rights and Biomedicine, or the Oviedo Convention), as well as Dutch legislation (Burgerlijk Wetboek Boek). The selected rights include: (1) The right to autonomy & informed consent of the patient: Patients must be able to make informed decisions about their care,^[50] (2) The right to privacy & medical data protection: Personal health data must be kept secure and confidential,^[51] and (3) The right to access to healthcare & non-discrimination: Care must be accessible to all, regardless of background, and without unfair barriers.^[52]

This research also draws on the classic bioethical framework proposed by Tom Beauchamp and James Franklin Childress^[53] to identify ethical guidelines that can support the responsible use of AI in healthcare and help safeguard those patients’ rights. The principles include: (1) Principle of justice: In healthcare ethics, justice refers to the concept of distributive justice, where all patients must be treated equally. This means every patient should receive the same quality of care (offering a uniform standard of quality) regardless of who they are. Persons with greater levels of need should be entitled to greater healthcare services when there is no discernible direct injury to others with lesser levels of need. In the context of AI, this raises important questions: Is access to AI-driven healthcare tools equitable? Are certain groups being left behind due to cost, location, or bias in algorithms? Justice also requires rejecting discrimination and ensuring that health technologies are available to all who need them. This principle is also public and legislated; (2) Principle of non-maleficence: This principle means “do no harm.” It is rooted in the Hippocratic tradition and updated in modern medicine to include preventing harm from unnecessary medical interventions (quaternary prevention). When applied to AI, it asks: Could the use of AI lead to the misdiagnosis of a patient, reinforce bias, or erode trust in care? If AI tools cause harm through poor design, overreliance, or misuse they can breach this core ethical obligation. It is a principle of the public sphere and non-compliance is punishable by law; (3) Principle of autonomy: Respect for autonomy (“self-rule”) means allowing individuals to make informed decisions about their own care according to their own reasons, values, and motives (rationality). AI tools can either support or undermine this principle. For example, if patients don’t understand how an AI tool was trained (or if it is used without their consent), their autonomy could be undermined. Ensuring transparency and informed consent is crucial to respect this principle; and (4) Principle of beneficence: The duty to do what is in the best interest of the patient. In AI, this might mean improving diagnostic accuracy, supporting clinical decisions, or helping to personalize treatment. This principle is more private in nature; it is a moral obligation rather than a legal one. Still, it is a guiding value in evaluating whether AI truly enhances patient care.

If there is a conflict of ethical principles, for instance, when promoting autonomy might risk the harm of a patient, justice and non-maleficence (which are public and legal) are above those of beneficence and autonomy (which are located in the private level).^[54]

Interview questions were designed to explore how generative AI, such as LLM models used for documentation or decision support, may pose risks to these fundamental patients’ rights. Sample questions include: “What is your opinion on the use of generative AI to assist with clinical notes during patient consultations? How might this use impact patient privacy and informed consent?”; “How do you think this application of generative AI could change the doctor-patient relationship, especially regarding trust and transparency?”; “Do you think the use of generative AI in healthcare could impact equal access to care? If so, how?”; and “Who should be held accountable if the use of generative AI harms a patient?’’ For more information, see Appendix.

4.3. Participants & Recruitment

In total, 66 individuals and 12 organizations were invited to partake in this study; 35 did not respond, 17 had other priorities, and one lacked insight on AI in healthcare. 14 individuals participated: one patient, four healthcare professionals, four ethics & legal experts, five AI & data experts, one health attorney, and three medical students (see Table 1). Participants came from different professional backgrounds, as long as their work gave them insights into the use of AI in healthcare (this criterion did not apply to patient participants). Recruitment was done through email and LinkedIn networks. Follow-up reminders were sent seven days after the first invitation.

Table 1 – Participants’ characteristics

4.4. Data Collection

Interviews were conducted between March 5 and April 7, 2025. Five interviews were conducted face-to-face, and nine were conducted via video calls using Microsoft Teams. Potential bias between the two methods was considered minimal, as video calls also allow for face-to-face interaction and can promote trust.^[55]

Face-to-face interviews were conducted at a place chosen by participants to ensure comfort and confidentiality. All interviews were semi-structured, with a consistent set of core questions and the flexibility to ask follow-up questions when relevant. This allowed for flexibility, acknowledging that participants have diverse forms of expertise relevant to the research topic. All participants were provided with a case study, interview questions, a participant information sheet, and asked to sign an informed consent form before the interview was conducted. All interviews, with the exception of one, due to the wishes of the participant, were recorded. During the interviews, field notes were taken, capturing the mood, tone, and expressions of the respondents. Field notes also helped to develop follow-up questions. Interviews lasted from 22 to 86 minutes. Five interviews lasted less than 30 minutes (35.7 percent), four lasted between 30 and 45 minutes (28.6 percent), and five lasted more than 45 minutes (35.7 percent). While the same topics were covered in all interviews, the focus varied depending on the participants’ expertise.

4.5. Data Analysis

Interview data was analysed using Microsoft Excel. Audio recordings were transcribed manually, and field notes were included. Through the analysis of interviews, textual data was organized, cleaned, and manually coded. Data was classified into five main categories, according to the European Patients’ Rights framework and Bioethical Principles: (1) General Perspectives, (2) Privacy, (3) Autonomy, (4) Justice, and (5) Future Prospects. After coding the data into the general themes, subthemes were identified and coded manually. For example, the subcategories under (2) Privacy include: 2.1) Cloud Storage and Retraining Purposes, 2.2) Unauthorized Data Access, 2.3) Limits of Data Anonymization, and 2.4) Data Rights. Results were synthesised per code while remaining sensitive to links and patterns across the data. After the initial synthesis of results, all interviews were reviewed to identify any overlooked insights.

4.6. Ethical Considerations

Under Dutch law, this study did not require approval from an Ethics Review Board.^[56] However, the following steps were taken to safeguard ethical conduct: Data was de-identified and reported anonymously. Prior to participation in the study, participants were sent comprehensive information about the study's purpose and procedures via an information sheet and an informed consent form. Verbal informed consent was obtained at the start of the interview. All participants were above 18 years of age.

5. Results

This research aimed to identify which patients’ rights are at most risk when using GenAI systems in healthcare. Given the fast digitalization of healthcare, traditional patients’ rights may experience new (and unexpected) risks that must be safeguarded. The study revealed three main areas of risk, each one associated with corresponding fundamental values: medical data protection (privacy), equal access to healthcare (justice), and informed consent (autonomy). Results are organized into the following sections: general perspectives, medical data protection, equal access to healthcare, informed consent, and future perspectives.

5.1. General Perspectives

All participants (14/14) considered the use of GenAI for administrative tasks generally more beneficial than risky, pointing out that it would reduce the pressure of healthcare organisations regarding staff shortages and time constraints. While benefits were identified, participants also acknowledged specific concerns associated with this use. For instance, a healthcare provider (P3) mentioned that “AI can be helpful for storing and retrieving patient information quickly. However, there are critical concerns, including loss of human empathy, depersonalized care, vulnerability to cyberattacks, and malfunction.”

In contrast, when discussing the use of GenAI for clinical reasoning, such as diagnostics, participants considered patients’ rights to be at a greater risk. Eight participants expressed reluctance regarding this use due to the complexity and contextuality of clinical decisions. A healthcare provider (P2) explained: “A diagnosis is never based on one result, but on a combination of contextual factors, so I think AI cannot fully operate there.” Moreover, “AI will be fed with massive datasets and can be very accurate at specific tasks, but it might miss important details that a practitioner would see, since human minds are more varied and flexible,” an ethical and legal expert (P11) remarked.

As a result, participants considered patients’ rights to be at different levels of risk depending on the specific use of the GenAI, consistently mentioning clinical reasoning to be at the greatest risk.

5.2. The Right to Medical Data Protection (Privacy)

Most participants (12/14) identified the right to keep medical data private (confidentiality) as the most threatened patient right by the use of GenAI, both for administrative tasks and clinical reasoning. Four main problems were recognized: (1) cloud storage and retraining purposes, (2) unauthorized access to health data, (3) limits of anonymization techniques, and (4) patients’ awareness of data rights.

5.2.1. Cloud Storage and Retraining Purposes

GenAI systems require huge amounts of data to function, which are typically stored in massive datasets. Most participants (12/14) mentioned risks with health data being stored in a cloud that is not specifically made for healthcare purposes: “AI is cloud-based. If it’s developed by big American tech companies, they could use the data commercially. I’d rather have a Dutch or German system,” an ethical and AI expert (P8) shared.

Moreover, participants raised concerns about the use of health data to retrain the system without patients’ explicit consent, which could undermine patients’ trust and, in return, the quality of care. As an ethical and legal expert (P10) mentioned: “Medical confidentiality is necessary to create trust in the therapeutic relationship, which is private in nature […] From a human rights perspective, any health data is sensitive data and requires extra protection.”

5.2.2. Unauthorized Data Access

Ten participants raised concerns regarding unauthorized access to patients’ data. Participants viewed this issue as being at a greater risk when using GenAI systems developed by large tech companies from countries like the US or China, compared to European countries. This was based on increasing risks regarding the issue of using health data for commercial purposes (e.g., for insurance or advertising), data breaches, and secondary uses of data (e.g., research, software retraining). As an AI and data expert (P7) remarked, “AI technology is evolving, and so are hackers. If cyber-attacks are getting more sophisticated, privacy measures need to be enhanced along.” Or as a healthcare provider (P2) noted: “Sometimes healthcare providers use translation AI systems, like Google, for patient communication. Most people accept ’cookies’ and ’terms & conditions’, which raises privacy issues. When you pay for nothing, you pay with your data. In clinical settings, this is unacceptable.”

5.2.3. Data Anonymization

Five participants expressed skepticism about whether health data can be truly anonymized. They argued that even if health data is anonymised, it could easily be re-identified by cross-referencing with publicly available datasets such as Facebook, Reddit, or LinkedIn. Participants thereby raised issues of whether patients’ privacy could truly be protected. As an ethical and legal expert (P10) explains: “Anonymization of health data is not realistic, with few other points, re-identification can be easy. Moreover, once data is gathered, it can be revalued for different purposes.” Furthermore, inherent issues of GenAI systems complicate this further, as one ethical and legal expert (P11) mentions: “Due to medical confidentiality, it is mandatory to secure medical data, but due to the black-box nature of AI, this becomes a challenge.” Finally, a healthcare provider and AI and data expert (P4) highlighted that “When an AI model is being used, patients’ data needs not to be anonymized since it will need to be traceable for safety and auditing. Every action should be logged, and healthcare organizations need a clinical data strategy to decide what goes in the electronic medical record versus the broader data platform. These are clinical data strategies.”

5.2.4. Data Rights

Four participants highlighted that specific patient groups, such as the elderly, individuals from lower-income backgrounds, or those from developing countries, may experience more difficulties understanding their rights regarding health data protection. As an AI and data expert (P7) mentions: “Patients from developed nations are more aware of data rights than those in developing countries.”

5.3. The Right to Equal Access to Healthcare (Justice)

Participants raised four main concerns related to the value of justice: (1) human-in-the-loop, (2) biases, (3) quality of care, and (4) liability.

5.3.1. Human-in-the-loop

All participants except one (P1, healthcare provider) strongly advocated for maintaining human oversight in all uses of GenAI, mentioning that GenAI should function as a support tool, and not as a replacement for healthcare providers. The recurrent reason provided for this belief was the potential of GenAI to generate errors, which can have serious consequences in healthcare settings. An AI and data expert (P7) states: “No AI system can be 100% accurate, it will produce errors from time to time. We have to accept this fact. That’s why human intervention becomes primary in the healthcare context.”

However, one healthcare provider (P1) advocated for full automation in administrative tasks, arguing that requiring constant human oversight would undermine efficiency gains that GenAI systems are meant to provide.

5.3.2. Biases

All participants identified the risk of GenAI perpetuating biases against social minority groups, both in administrative and clinical uses. They stated that biased outputs could lead to technology working better for the generalized patient profile than for others. In healthcare settings, this would be an unacceptable risk for patients and could lead to harmful consequences such as misdiagnosis, delayed diagnosis, or inaccurate treatment recommendations, placing the right to non-discrimination at risk. “AI in public settings involves dealing with vulnerable and marginalized social groups, where algorithmic biases can lead to preventable misdiagnosis and delayed diagnoses,” said an ethical and legal expert (P10).

Moreover, eight participants expressed preoccupation about automation bias, meaning that healthcare providers might over-rely on GenAI’s outcomes without actually checking for accuracy: “Healthcare providers might develop a false sense of security by relying too much on AI. Even if regulation requires human intervention, healthcare providers may blindly trust it,” a medical student (P13) noted. An ethical and legal expert (P9) mentioned that: “Doctors can become lazy and, being used to the AI being right all the time, that they lose the capacity of critical thinking.”

5.3.3. Quality of Care

Ten participants raised concerns about GenAI hallucinations and how this could negatively impact patients’ quality of care. Eight participants also doubted whether these systems would be able to recognize psychosocial factors of a patient, which are often crucial to comprehensive patient assessments: “During a clinical visit, an AI system might not be capable of recognizing specific visible signs of a patient such as psychosocial details that are non-verbal and form part, not only of the health concern, but also of the human interaction, intimacy and trust between patient and doctor,” an ethical and legal expert (P10) explained. Additionally, patient comfort and trust were recurrently mentioned (8/14) as a major concern: “If patients feel uncomfortable with the use of AI systems in their care, they may withhold or limit the information they share with the practitioner. This, in turn, can negatively impact the quality of care they receive,” an ethical and legal expert (P9) noted.

5.3.4. Liability

Thirteen participants were asked who should be held accountable if the use of a GenAI results in patient harm. Views varied: most participants (7/13) said the healthcare provider should be held accountable, followed by the healthcare organization (4/13), the tech company (3/13), and one participant (P12, medical student) suggested shared responsibility between the healthcare provider and the patient (50/50), mentioning the patient’s responsibility to give informed consent.

5.4. The Right to Informed Consent (Autonomy)

Eleven participants mentioned challenges around obtaining patients’ informed consent for the use of GenAI in their care. Two main issues were raised: patients’ ability to understand information related to AI use, and the form and timing of obtaining consent.

5.4.1. Being Informed

Nine participants expressed concern about low levels of AI literacy among patients and healthcare providers. This knowledge gap can hinder valid consent. Some healthcare providers may not fully know how to inform patients of AI use, and patients may feel overwhelmed by the information required to give informed consent. As an AI and data expert (P6) expressed: “Patients might feel overwhelmed with all the information needed to give informed consent.”

5.4.2. Giving Consent

Eleven participants mentioned the requirement of obtaining consent before using GenAI in patient care. Eight of them mentioned that consent must be explicit, voluntary, and revocable (meaning patients should have a clear option to opt out). However, participants differed on when and how consent should be obtained: four recommended requesting consent at the start of the patient’s healthcare trajectory; three suggested obtaining consent before each use of GenAI; and two proposed a single consent form (e.g., policy brief) provided at the reception or in the electronic health data space.

5.5. Future Perspectives

At the end of each interview, participants were asked how they envision the use of AI in healthcare in the next 5 to 10 years. All participants agreed about increased automation, with some of them predicting healthcare to be largely automated within that time frame. “I hope AI can be integrated in a way that is minimally invasive for both patients and HCPs,” a healthcare provider (P2) said.

Six participants provided suggestions for future regulations and guidelines. A healthcare provider and AI and data expert (P4) mentioned the need for healthcare organizations to reflect on internal values and align them with the use of AI: “Apart from complying with legal requirements, healthcare organizations need to have internal discussions about their own values and how these shape the way they use AI. How can these values be translated into concrete action? What guidelines align with these values?” One healthcare provider (P1) called for ethical frameworks in addition to legal ones: “Besides the existing laws, there must be ethical guidelines for healthcare providers to guide them into the responsible use of AI.” An AI and data expert (P5) suggested that AI systems should be delivered using transparent explanations, similar to pharmaceutical leaflets, giving details about the system: “AI systems should come with a declaration explaining how they were trained, known anomalies, risks, potential biases, etc. Similar to the information leaflets included with medicines in the pharmaceutical sector.”

6. Discussion

This study found that using GenAI in healthcare could risk three fundamental patients’ rights: medical data protection, equal access to healthcare, and informed consent. While the fast digitalization of healthcare will present increased efficiency and accuracy, it also brings unforeseen and unacceptable risks to those patients’ rights and their corresponding values: privacy, justice, and autonomy. It is essential to critically reflect on these risks and take action so that technology helps protect patients’ rights instead of compromising them.

6.1. Systemic Pressures

An unexpected but recurring theme in the interviews was the growing pressure on healthcare systems, especially regarding staff shortages and time constraints. This, in return, affects both the quality of care patients receive and the well-being of healthcare providers. GenAI is often presented as the solution to reduce these pressures by automating administrative tasks. However, more time does not automatically mean better quality of care. In other words, increasing efficiency does not translate into increasing quality. This is particularly important in the healthcare context, where relational aspects of care, such as empathy, dignity, and trust, are essential. Therefore, the integration of GenAI should be guided by other values than just economic ones (efficiency), but also by relational values (empathy, compassion, trust). Healthcare is not a factory; it is a human right, and it is a human-centred practice based on relationship, trust, and dignity.^[57] If speed and automation are prioritized above everything else, there is a real risk of undermining the very foundation of care: empathy. The current and growing healthcare crisis must not blind us into implementing technologies in the name of efficiency without first asking whether they are truly necessary or whether there are more human, sustainable ways to solve these issues.

6.2. European AI Health

One concern frequently raised by participants was the origin and ownership of GenAI systems used in healthcare. Many argued that systems developed by large commercial tech companies may pose greater risks to patients’ rights, especially regarding data sovereignty and commercial use of health data. This shows that participants appreciate the value of privacy in the healthcare context and that they worry about GenAI undermining it. Moreover, it is important to note that, if a patient is harmed as a result of these systems, liability may be harder to pursue due to the difference in magnitude between an individual patient and a large tech company.^[58] On the contrary, it would be easier in terms of accessibility if the models were developed by healthcare institutions themselves. However, without governmental support, it is difficult for these institutions to develop healthcare-specific GenAI systems due to financial, technical, and regulatory complexities.^[59]

6.3. Human Oversight and Automation Bias

Another key finding was the need to maintain human oversight. All participants referred to the necessity of a human-in-the-loop model, mainly due to the risks of hallucinations, biased outcomes, and failing to recognize context-sensitive factors associated with GenAI. This aligns with the regulatory principles of the European Union AI Act, which requires human intervention in high-risk applications, such as healthcare.^[60] The fact that participants mentioned the need for human intervention to correct AI errors reflects their appreciation for the value of justice: AI medical interventions should not have negative effects on any patient.

Many participants raised concerns about automation bias. This is the risk that healthcare providers may develop a false sense of security and over-rely on AI outputs without critically revising them. Such scenarios pose the risk that the requirement of the human-in-the-loop model becomes symbolic instead of functional, leading to reduced critical thinking and potential harm to patients.

6.4. Recommendations

The study identified multiple challenges in protecting patients’ rights from the growing use of generative AI models in clinical practice. While there are diversified regulatory efforts at the EU level to protect these issues (such as the AI Act, GDPR, and MDR), there is no single binding EU document specifically dedicated to the use of AI in healthcare and the associated risks to patients’ rights. One potential solution would be the development of an EU Medical AI Act. This proposal has been defended by experts,^[61] and it would be more accurate in addressing the specific challenges raised by the use of AI in healthcare.

Moreover, these regulations still present grey areas when it comes to general-purpose models, such as ChatGPT. These models can be used for multiple purposes due to their “flexible” nature, which presents regulatory challenges when they are used in high-risk areas, like healthcare.

On another note, more discussion should be focused on the so-called “non-medical” applications of generative AI in healthcare, such as clinical documentation tools. These tools fall outside the scope of the MDR and are therefore subject to fewer regulatory requirements than those used for clinical decision-making. However, it can be argued that this distinction is not as clear, since the information included in medical records has a significant influence on future medical decision-making.

To conclude, I argue that in addition to top-down, macro-level legislation at the European or national level, “micro-level” governance could help address these challenges further. By “micro-level” governance, I refer to institutional requirements for healthcare organizations to develop internal agreements, binding rules, and policies to govern the use of AI in clinical practice. Every healthcare organization should make agreements and establish clear internal guidelines with its healthcare providers to ensure the responsible use of GenAI systems. These guidelines should explicitly define the appropriate use cases for GenAI tools, as well as identify the limits of its use. They must be aligned with existing legal frameworks and ethical standards, including patients’ rights to informed consent, medical data protection, and equal access to healthcare. Such internal governance would have multiple benefits: it would be implemented faster than EU or national legislation, necessary to keep the unprecedented pace of technological developments; it would lead to more engagement and awareness among healthcare professionals not only about legal aspects (what is permissible to do) but also ethical (what should be done); by having internal discussions, it would promote transparency and accountability, and therefore increase trust among healthcare providers and patients.

6.5. Limitations and Further Research

This research focused on general risks to patients’ rights but did not specifically analyse how generative AI systems affect the most vulnerable patient populations, such as minors, incompetent adults, the elderly, individuals with mental health conditions, or individuals with a lower socio-economic background. These population groups are more vulnerable to risks than others, due to their dependency or limited capacities to give informed consent. They are at greater risk of being harmed and should therefore be protected even more proactively. At the same time, they deserve equitable access to the potential benefits of these systems, in light of the right to non-discrimination. Future research should focus on how the use of GenAI impacts patients’ rights of social minority groups.

This research also did not differentiate between types of care. The risks to patients’ rights may differ depending on the type of healthcare context (e.g., primary and secondary care, long-term and curative care, or mental healthcare). Future research could analyse the nature and severity of right-related risks.

Additionally, the small sample size of participants (n = 14) is a limitation of this study. Although the qualitative insights provide depth, conducting broader studies with larger and more diverse participant groups would improve the generalisability of the findings and capture a wider range of perspectives. Expanding the sample size in future research could enhance the robustness and relevance of the results.

6.6. Conclusions

This study analysed the specific risks that generative AI models pose to patients’ rights in clinical practice: the right to medical data protection, the right to equal access to healthcare, and the right to informed consent. In order to benefit from the high potential of these tools, these risks must be addressed both ethically and legally, with the patient at the centre of decision-making. Depending on the efforts focused when developing, regulating, and using AI, it can either increase access and quality of care or exacerbate existing power imbalances and reduce healthcare to a dehumanized practice.

7. Annex

Table 2 - Excel table with detailed results and participants’ references.

[1] Tian, S., Jin, Q., Yeganova, L., Lai, P., Zhu, Q., Chen, X., Yang, Y., Chen, Q., Kim, W., Comeau, D. C., Islamaj, R., Kapoor, A., Gao, X., & Lu, Z. (2023). Opportunities and challenges for ChatGPT and large language models in biomedicine and health. Briefings in Bioinformatics, 25(1). https://doi.org/10.1093/bib/bbad493

[2] Helberger, N., & Diakopoulos, N. (2023). ChatGPT and the AI Act. Internet

Policy Review, 12(1). https://doi.org/10.14763/2023.1.1682

[3] Workum, J. D., van de Sande, D., Gommers, D., & van Genderen, M. E. (2025). Bridging the gap: A practical step-by-step approach to warrant safe implementation of large language models in healthcare. Frontiers in Artificial Intelligence, 8, 1504805. https://doi.org/10.3389/frai.2025.1504805

[4] Tian et al., 2023.

[5] ChatGPT reached 1 million users in just five days and by 2023 it had 100 million weekly users, according to OpenAI CEO Sam Altman. https://www.linkedin.com/news/story/chatgpt-hits-100m-weekly-users-5808204/

[6] Berg, S. (2024). Some doctors are using public generative AI tools like ChatGPT for clinical decisions. Is it safe? Fierce Healthcare. https://www.fiercehealthcare.com/special-reports/some-doctors-are-using-public generative-ai-tools-chatgpt-clinical-decisions-it; Blease, C. R., Locher, C., Gaab, J., Hägglund, M., & Mandl, K. D. (2024). Generative artificial intelligence in primary care: An online survey of UK general practitioners. BMJ Health Care Inform, 31(1), e101102. https://doi.org/10.1136/bmjhci 2024-101102; MedicalPHIT. (2024). AI monitor 2024: Verkenning van AI-toepassingen in de Nederlandse zorgsector. M&I/Partners. https://mxi.nl/uploads/files/publication/ai monitor-2024.pdf.

[7] Hosny, A., Parmar, C., Quackenbush, J., Schwartz, L. H., & Aerts, H. J. W. L. (2018). Artificial intelligence in radiology. Nature Reviews Cancer, 18(8), 500–510. https://doi.org/10.1038/s41568-018-0016-5

[8] de Hond, Anne A. H.; Kant, Ilse M. J.; Fornasa, Mattia; Cinà, Giovanni; Elbers, Paul W. G.; Thoral, Patrick J.; Sesmu Arbous, M.; Steyerberg, Ewout W. Predicting Readmission or Death After Discharge From the ICU: External Validation and Retraining of a Machine Learning Model. Critical Care Medicine 51(2):p 291-300, February 2023. DOI: 10.1097/CCM.0000000000005758

[9] Cloosterman, S., Wijnands, I., Huygens, S., Wester, V., Lam, K.-H., Strijbis, E., den Teuling, B., & Versteegh, M. (2021). The Potential Impact of Digital Biomarkers in Multiple Sclerosis in The Netherlands: An Early Health Technology Assessment of MS Sherpa. Brain Sciences, 11(10), 1305. https://doi.org/10.3390/brainsci11101305

[10] Buchem, M. M. van, et al. (2021). The digital scribe in clinical practice: A scoping review and research agenda. NPJ Digital Medicine, 4(1). https://doi.org/10.1038/s41746 021-00432-5; Jeblick, K., et al. (2024). ChatGPT makes medicine easy to swallow: An exploratory case study on simplified radiology reports. European Radiology, 34(5), 2817–2825. https://doi.org/10.1007/s00330-023-10213-1; Nguyen, J., & Pepping, C. A. (2023). The application of ChatGPT in healthcare progress notes: A commentary from a clinical and research perspective. Clinical and Translational Medicine, 13(7). https://doi.org/10.1002/ctm2.1324.

[11] de Hond, A. (2024). GPT pilot to write draft discharge letters at the UMC Utrecht. Utrecht University. https://www.uu.nl/en/news/gpt-pilot-to-write-draft-discharge-letters-at-the-umc-utrecht

[12] van Buchem M., Kant I., King L., Kazmaier J., Steyerberg E., Bauer M., (2024). Impact of a Digital Scribe System on Clinical Documentation Time and Quality: Usability Study; JMIR AI;3:e60020; URL: https://ai.jmir.org/2024/1/e60020, DOI: 10.2196/60020

[13] Sorin, V., Klang, E., Sklair-Levy, M., Cohen, I., Zippel, D. B., Lahat, N. B., Konen, E., & Barash, Y. (2023). Large language model (ChatGPT) as a support tool for breast tumor board. NPJ Breast Cancer, 9(1). https://doi.org/10.1038/s41523-023-00557 8

[14] Eppler, M., et al. (2023). Awareness and Use of CHATGPT and Large Language Models: A Prospective cross-sectional Global Survey in Urology. European Urology, 85(2), 146–153. https://doi.org/10.1016/j.eururo.2023.10.014.

[15] Visser, D. S. (2023). “Ik ben Elisa, de chatbot van het Elisabeth-TweeSteden Ziekenhuis.” Masterscriptie Communicatie- en Informatiewetenschappen, Tilburg School of Humanities and Digital Sciences, Tilburg University.

[16] Berg, 2024; Blease et al., 2024; MedicalHPIT, 2024.

[17] Berg, 2024; MedicalHPIT, 2024.

[18] The report does not specify whether these healthcare providers are using GenAI tools that are publicly available or ones developed internally by the hospital.

[19] Hallucinations are a particularly recurrent error in LLMs, referring to the generation of content that is irrelevant, made-up, or inconsistent with the input data. This problem leads to incorrect information.

[20] Data drift happens when the LLM becomes worse in its responses due to when the training data becomes less representative of the data the model encounters in real-world usage.

[21] Berg, 2024; MedicalHPIT, 2024.

[22] Berg, 2024.

[23] Sallam, M. (2023). ChatGPT utility in healthcare education, research, and practice: Systematic review on the promising perspectives and valid concerns. Healthcare, 11(6), 887. https://doi.org/10.3390/healthcare11060887

[24] European Parliament & Council of the European Union. (2024). Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence (Artificial Intelligence Act). Official Journal of the European Union, L 2024/1689, 12 July 2024. https://eur-lex.europa.eu/eli/reg/2024/1689/oj

[25] Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (2016) OJ L 119/1

[26] European Parliament & Council of the European Union. (2017). Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Medical Device Regulation, MDR). Official Journal of the European Union, L 117, 1–175, 5 May 2017. https://eur-lex.europa.eu/eli/reg/2017/745/oj

[27] van Kolfschooten, H., & van Oirschot, J. (2024). The EU Artificial Intelligence Act (2024): Implications for healthcare. https://doi.org/10.1016/j.healthpol.2024.105152

[28] van Kolfschooten & van Oirschot, 2024.

[29] MedicalHPIT, 2024.

[30] van Kolfschooten & van Oirschot, 2024.

[31] van Kolfschooten & van Oirschot, 2024.

[32] van Kolfschooten, H. (2025). Patients’ rights protection and artificial intelligence in the European Union [PhD, Universiteit van Amsterdam].

[33] Mennella, C., Maniscalco, U., De Pietro, G., & Esposito, M. (2024). Ethical and regulatory challenges of AI technologies in healthcare: A narrative review. Heliyon, 10(4), e26297. https://doi.org/10.1016/j.heliyon.2024.e26297

[34] Williamson, S. M., & Prybutok, V. (2024). Balancing privacy and progress: A review of privacy challenges, systemic oversight, and patient perceptions in AI-driven healthcare. Applied Sciences, 14(1), 675. https://doi.org/10.3390/app14020675

[35] MedicalHPIT, 2024.

[36] Palm, W., Nys, H., Townend, D., Shaw, D., Clemens, T., & Brand, H. (2020). Patients’ rights: From recognition to implementation. In Achieving Person-Centred Health Systems: Evidence, Strategies and Challenges (pp. 347–387). Cambridge University Press. https://doi.org/10.1017/9781108855464

[37] van Kolfschooten, H. (2025). Towards an EU Charter of Digital Patients’ Rights in the Age of Artificial Intelligence. Digital Society, 4(6). https://doi.org/10.1007/s44206 025-00159-w

[38] Herranz, G. (1998). Are patients' rights human rights? Humanities and Medical Ethics Unit, University of Navarra. https://en.unav.edu/web/humanities-and-medical ethics-unit/bioethics-material/conferencias-sobre-etica-medica-de-gonzalo-herranz/los derechos-del-paciente-son-derechos-humanos

[39] Olejarczyk, J. P., & Young, M. (2024). Patient rights and ethics. In StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK538279/

[40] Diwan, T., & Kanyal, D. (2024). Evaluate the awareness regarding the patient’s rights and responsibilities among the patient visiting hospitals. F1000Research, 13, 41. https://doi.org/10.12688/f1000research.139209.1

[41] Esmaeili, H., Rahdar, M., & Bandani, G. (2024). Enhancing patients' rights criteria in hospital accreditation standards by using artificial intelligence (Case study: Selected hospitals in Zahedan County). Journal of Hospital Practices and Research, 9(3). https://www.jhpr.ir/article_215242_3b8480f694ed49bee62746bb29d46071.pdf

[42] Olejarczyk & Young, 2024.

[43] Palm et al., 2020.

[44] Herranz, 1998.

[45] Herranz, 1998.

[46] Ministry of Health, Welfare and Sport. (2010). Patients' Rights (Care Sector) Act: A summary. https://cbhc.hetcak.nl/publish/pages/10816/patients_rights-care-sector_act a-summary.pdf

[47] Crowe, S., Cresswell, K., Robertson, A., Huby, G., Avery, A., & Sheikh, A. (2011). The case study approach. BMC medical research methodology, 11, 100. https://doi.org/10.1186/1471-2288-11-100

[48] van Kolfschooten, 2025.

[49] Townend, D., Clemens, T., Shaw, D., Brand, H., Nys, H., & Palm, W. (2018). Patients’ rights in the European Union: Mapping eXercise: Final report—Study. European Commission.

[50] Charter of Fundamental Rights of the European Union (CFR), Article 3(2), 2012/C 326/02. Official Journal of the European Union, C 326, 391–407 (2012). https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A12012P%2FTXT; Council of Europe. (1997). Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine (Oviedo Convention), ETS No. 164, Oviedo. https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164; Netherlands. (1992). Burgerlijk Wetboek Boek 7: Bijzondere overeenkomsten (BW) (Dutch Civil Code, Book 7: Special agreements), Articles 448 & 450. Staatsblad van het Koninkrijk der Nederlanden (Official Gazette).

[51] Council of Europe. (1950). Convention for the Protection of Human Rights and Fundamental Freedoms (European Convention on Human Rights, ECHR) (1950), ETS No. 5., art. 8, https://www.echr.coe.int/documents/convention_eng.pdf; European Union. (2012). Charter of Fundamental Rights of the European Union, 2012/C 326/02. Official Journal of the European Union, C 326, 391–407 (26 October 2012). Arts. 7-8. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A12012P%2FTXT; Article 10, Oviedo Convention; Article 7:457, BW.

[52] Articles 20-26, CFR; Article 3, Oviedo Convention.

[53] Beauchamp, T. L., & Childress, J. F. (2012). Principles of biomedical ethics (7th ed.). New York: Oxford University Press.

[54] Beauchamp & Childress, 2012.

[55] Diana, F., Juárez-Mora, O. E., Boekel, W., Hortensius, R., & Kret, M. E. (2023). How video calls affect mimicry and trust during interactions. Philosophical Transactions of the Royal Society B, 378, 20210484. https://doi.org/10.1098/rstb.2021.0484

[56] Netherlands. (1992). Wet medisch-wetenschappelijk onderzoek met mensen (WMO). BWBR0009408. https://wetten.overheid.nl/BWBR0009408/

[57] Beach, M.C., Inui, T. & the Relationship-Centered Care Research Network. Relationship-centered care. J GEN INTERN MED 21 (Suppl 1), 3–8 (2006). https://doi.org/10.1111/j.1525-1497.2006.00302.x

[58] Diver, L. (2021). [Review of Algorithmic Regulation, by K. Yeung & M. Lodge]. Prometheus, 37(4), 387–393. https://www.jstor.org/stable/48676457

[59] Abdul, N. S., Adeghe, N. E. P., Adegoke, N. B. O., Adegoke, N. a. A., & Udedeh, N. E. H. (2024). Public-private partnerships in health sector innovation: Lessons from around the world. Magna Scientia Advanced Biology and Pharmacy, 12(1), 045–059. https://doi.org/10.30574/msabp.2024.12.1.0032

[60] European Comission, 2024.

[61] van Kolfschooten, 2025.

Autonomy on Trial

2025-07-07T16:30:23+00:00

Photo by CHUTTERSNAP on Unsplash

Abstract

This paper critically examines how US bioethics and health law conceptualize patient autonomy, contrasting the rights-based, individualistic model dominant in American legal doctrine with relational, duty-oriented frameworks found in parts of Asia and Europe. Analyzing landmark US cases—Cruzan v. Director, Missouri Dept. of Health, In re A.C., and Addington v. Texas—alongside bioethics scholarship, the paper highlights both the strengths and limitations of a legalistic approach to medical decision making. Drawing on comparative literature from India, China, Singapore, and several European nations, it explores how familial, cultural, and institutional norms shape the exercise of autonomy abroad. The paper argues that the American focus on individual consent and procedural safeguards can undermine trust in clinical relationships and neglect the social dimensions of care. It ultimately advocates for a more pluralistic model that integrates legal protections with relational ethics and calls for reforms to capacity standards, consent processes, and advance directives that respect cultural values while upholding patient rights.

Introduction

Patient autonomy has long been regarded as a cornerstone of US medical ethics. It is enshrined in law and policy as the basic right of individuals to make decisions about their own health care. In practice, however, legal cases and bioethics debates reveal tension between a formal, rights-based notion of autonomy and the relational values that many patients and cultures embrace. This paper examines how US law and policy interpret and enforce patient autonomy in contrast to relational approaches found in much of Asia and Europe. By analyzing landmark US court decisions and bioethics scholarship, this paper shows how American law practice often treats autonomy as an individualistic, legalistic matter that can sometimes undermine trust in the doctor-patient relationship. By comparison, many Asian and some European models emphasize duties, family involvement, and communal values in decision making. Critics argue that the American approach can reduce patients to processors of information rather than complex persons with relationships and values. In practice, a legalistic checklist for informed consent may prevail, sometimes at the expense of trust and empathy.

In sum, US bioethics and law emphasize individual choice, formal consent, and evidentiary standards. The prevailing model assumes an atomistic patient who holds rights (and responsibilities) to demand or refuse treatment, shielded by due process. This approach certainly protects autonomy on paper, but it may neglect the social and cultural dimensions of decision making. Some bioethicists caution that we must ask whether “moral claims that ought to be made into legal rights” are better served by courts or by ethical dialogue.^[1] Before turning to alternative models, we should acknowledge both the value and limits of the current, rights-based framework. It clearly delineates patient entitlements and uses legal procedures to safeguard choices, but it may also narrow the focus to rules over relationships.

Autonomy in US Law and Bioethics

In US health law, patient autonomy is largely enforced through formal rules about informed consent and decision-making capacity. Under American jurisprudence, a competent adult generally has a constitutional right to refuse medical treatment.^[2] For example, in In re A.C., a DC court emphatically held that even a pregnant woman has “the right to refuse medical treatment for herself and the fetus.”^[3] If a patient is incapacitated, courts attempt to honor her wishes, for example, by substituted judgment or by appointing a surrogate decision maker in accordance with state law. They do not consistently defer to the state’s interest in preserving life. Similarly, Lane v. Candura affirmed that a competent elderly patient “has the right under the law to refuse to submit either to medical treatment or a surgical operation” — a decision that, though deemed unwise by her physicians, could not be overridden absent a finding of legal incompetence.^[4] Notably, however, conflicts still arise. In 2025, for example, a hospital in Georgia kept a brain-dead pregnant woman on life support for months to allow her fetus to develop, citing a strict state fetal-protection law^[5] – an outcome that shows the discrepancy between DC caselaw and the Georgia statute. ^[6] These cases illustrate an emphasis on informed consent: the patient’s decision (or presumed decision, if competent) must prevail unless clear evidence shows incapacity or a compelling state interest. Yet the Georgia case may indicate a trend toward failing to respect autonomy.

The US Supreme Court has reinforced respect for autonomy while also permitting robust state oversight in borderline cases. In Cruzan, the Court recognized a federal constitutional right to refuse unwanted life-sustaining treatment. However, it also held that states may require “clear and convincing” evidence of the patient’s wishes before allowing withdrawal of care. American law treats autonomy as a fundamental principle but subjects it to procedural safeguards. Likewise, in the involuntary commitment context, the Court balanced individual liberty against state interests by mandating a clear-and-convincing standard of proof for committing someone to a mental institution.^[7] In Addington v. Texas, the Court insisted that due process requires more than a mere preponderance of evidence before depriving a person of liberty for psychiatric care, yet it declined to impose the criminal “beyond a reasonable doubt” standard. These rulings demonstrate that American law approaches life-and-death health care decisions as matters to be resolved through formal legal procedures, applying rules of evidence and capacity assessments. This legal framing ensures a degree of rigor and consistency in protecting patients’ rights, but it also reflects the tendency to translate deeply personal and complex medical dilemmas into technical legal questions. Importantly, the point is not to dispute the right to refuse treatment; rather, patients have the tool of resorting to courts and invoking legal procedures to ensure their ability to exercise their rights and to investigate limitations on them. Clinicians and hospital systems also look to courts to resolve issues. Some scholars suggest that other, less adversarial approaches might equally protect patient choice while better addressing the human and ethical dimensions.

Observers have described this legalistic phenomenon as the “language of the law” infiltrating bioethics. “Americans today truly do resolve political — and moral — questions into judicial questions,”^[8] adopting trial-style reasoning and formal rights-talk even in intimate healthcare matters. One commentator warns that law’s technical discourse may be “inapt” for addressing ethical concerns, and that the legal process can distort the meaning of concepts like autonomy.^[9] Similarly, an influential framework for assessing decision-making capacity analyzes ability in strictly cognitive terms. Capacity is defined as the ability to (a) understand information, (b) appreciate its significance for oneself, (c) reason about treatment options, and (d) communicate a choice. These four domains, drawn from case law and psychology, form the threshold for valid consent or refusal. In the US model, a patient lacking capacity cannot make certain binding decisions; instead, a surrogate decision maker, often a family member, or, in some cases, a state-appointed guardian steps in. This rights-based framework has virtues of clarity and fairness, but as critics note, translating every serious medical decision into a legal checklist can overlook the human context of care.

International and Relational Perspectives on Autonomy

Across Asia and Europe, many healthcare systems cast autonomy in a more relational or duty-embedded light. Cultural traditions, legal norms, and ethical theories in these contexts often emphasize family, community, and physician responsibilities rather than treating the patient as a solitary rights-bearer. One scholar observes that the very “principle of respect for autonomy” originated in Western bioethics and may not fit seamlessly into other cultures. Indeed, many critics view individual autonomy as “only applicable in the West,” contrasting it with the family- and community-oriented decision making typical in Eastern societies.^[10] Informed consent itself is often seen as a Western import that requires cultural adaptation. One ethicist calls for “glocal” flexibility—an Aristotelian “Lesbian rule”—allowing bioethical principles to bend to local contexts. This perspective suggests that autonomy must be understood in light of social roles and trust networks, not assumed to be universal by US standards.

In India, for example, bioethicists tend to “reject the primacy of autonomy,” instead empowering courts to protect vulnerable patients even against the wishes of patients or families.^[11] In practice, families and physicians often make decisions collectively, and courts may override refusals of treatment in the name of preserving life. Notably, one study suggests the Indian model does not necessarily reflect grassroots values but is partly a product of colonial legacy and legal conservatism., The author of that study critiques a competing bioethics in which courts and clinicians frame social vulnerability as mere “sociomoral underdevelopment,” cautioning that paternalism can masquerade as protection.^[12]

Elsewhere in Asia, similar themes appear. In China, traditional Confucian ethics emphasize familial harmony and deference to authority. One survey of Chinese clinicians and ethicists reported widespread acceptance of “benevolent deception” — doctors withholding information from patients to avoid distress, with the family’s blessing.^[13] Likewise, a case study involving a Russian émigré patient in a US hospital illustrates how families from some non-Western cultures may ask doctors not to disclose a cancer diagnosis. The authors of that study advise clinicians to elicit patients’ own values first: in the case described, the patient chose to limit her own informational autonomy. This approach respects autonomy in a broader sense—allowing patients to defer to family norms—but it may seem counterintuitive under a strict Western model. In East Asia generally, the doctor–patient relationship is often understood as a partnership involving the family; autonomy is exercised through dialogue and trust among all parties rather than in isolation.

Even in highly Westernized Asian settings, relational norms persist. In Singapore, even relational autonomy has limits under Confucian influence. A 2015 study found that Singaporean patients and families generally expect doctors to lead decisions, and there is little appetite for fully independent choice. Attempts simply to graft Western shared-decision models have fallen short. Researchers argue that given the emphasis on familial duty, a more “authoritative welfare-based” decision-making approach (akin to a best-interest standard) may better reflect local values. In practice, Singaporean hospitals often view care as a communal responsibility.

Japan, though economically and institutionally similar to Western countries, shares many features with East Asian models of autonomy. Its legal framework upholds patient rights with important caveats. There is, for instance, no clear legal right in Japan to refuse life-sustaining treatment unless death is imminent. Courts have acknowledged a competent patient’s wish to refuse treatment on religious grounds (such as a Jehovah’s Witness’s refusal of blood transfusions) as a personal right that must be respected, yet in practice, hospitals typically require advance directives or agreements, and if a life-saving intervention is deemed absolutely necessary, they may proceed unless the patient arranges care elsewhere. In general, many Asian models integrate family consent as normative and expect physicians to occasionally act in a paternalistic manner. This can strengthen trust and preserve social harmony, though it may also sideline the patient’s explicit personal wishes.

European countries, while part of the broader Western bioethics tradition and recognizing informed consent and patient autonomy, still vary in how these principles are implemented. One analysis identifies at least three “voices” in Europe: (1) a deontological Southern model in which doctors are bound more by professional codes, and patient autonomy —while recognized— has often been secondary to physician judgement; (2) a liberal Western model (e.g. Germany, the Netherlands, the UK), resembling the Anglo-American approach, where patient refusal rights are strongly upheld and balanced with clinical judgement in cases of limited capacity; and (3) a Nordic welfare model, which prioritizes universal entitlements and assigns decision disputes to public bodies. For example, Southern European constitutions once obliged patients “to maximize his or her own health and to follow the doctor’s instructions,” whereas in Western Europe, patients retain the right to override medical opinion, and Scandinavian countries focus on broad social support rather than individual rights. Even within Europe, then, ideals of social solidarity influence the meaning of autonomy.

French medical ethics historically emphasized duty over rights—physicians had a legal obligation to treat and inform, but patients’ refusals were traditionally subject to scrutiny. French law once allowed doctors to determine medical futility without patient consent. After major public controversies (e.g. the Vincent Humbert case), France enshrined an explicit patient right to consent or refuse treatment in 2002 (the Loi Kouchner). Germany, too, blends individual rights with a strong welfare-state ethic: patients may refuse treatment, but there is also a cultural ideal of Dankbarkeit (“gratitude”) and high trust in physicians. In the Netherlands, patient autonomy is very robust — Dutch law and practice recognize advance directives and even permit physician-assisted dying — but the system also stresses open communication and mutual trust between doctors and patients. Overall, Europe tends toward a more communal approach in practice. As one analyst notes, even in the West, health care is seen as a social contract: medicine requires physicians to treat patients “with professional respect, delicacy and [ensuring they are] not marginalized.”^[14] This ethic of solidarity and respect suggests that autonomy cannot be fully separated from trust and professional duty.

In summary, non-American contexts tend to view patient autonomy not as an absolute individual right enforceable by courts, but as one value among others within a web of relationships. Family members often have formal or informal roles in decision making. Physicians are expected to act paternalistically at times, motivated by beneficence and social norms, which can strengthen the patient’s trust but may also sideline the patient’s explicit will. These models aim to preserve dignity and communal harmony, sometimes at the expense of individual self-determination.

For example, the United Kingdom’s approach can be seen as intermediate. British law strongly protects an adult patient’s right to decide, yet courts will intervene in certain circumstances to serve a patient’s best interests—especially for children or incapacitated patients. High-profile UK cases show both sides of this coin. In the Charlie Gard^[15] and Indi Gregory^[16] controversies, judges upheld doctors’ recommendations to withdraw life-sustaining treatment from a critically ill infant despite the parents’ objections, emphasizing the child’s welfare over parental autonomy. Conversely, in the matter of Ashya King (2014), the High Court affirmed that parents could pursue an alternative cancer treatment abroad for their child, stressing that the state “has no business interfering” with parental decisions absent a risk of significant harm.^[17] These examples demonstrate that while autonomy is respected in the UK, it is not unchecked — it is balanced against social welfare considerations.

Table: Comparison of Autonomy Frameworks

Critical Comparison of Frameworks

The US model has clear strengths. It highlights individual liberty as a central value, protecting patients (and physicians) from coercion or abuse. It treats all adult, competent patients as equally entitled to make decisions, regardless of age, background, or social context. This formal equality can empower marginalized individuals against domineering relatives or paternalistic doctors. Moreover, precise legal rules provide a clear framework for resolving disputes, allowing judges to interpret rights and duties. The American legal model offers clarity and strong safeguards for individual choice.

Nonetheless, this model has notable weaknesses. First, the legalistic approach can transform a moral dialogue into an adversarial process. Framing a medical decision as a legal battle may undermine the therapeutic relationship. While many patients experience clinicians as trusted partners, overly procedural interactions — particularly around consent and capacity — can make the encounter feel impersonal or even adversarial. For example, when a patient’s decision-making capacity becomes an issue, the standard criteria reduce the assessment to a checklist of cognitive abilities, which may ignore important personal factors like the patient’s trust in their doctor or their spiritual values. In sum, a rigid focus on procedures and evidence can strip away the empathetic, human element of clinical encounters.

Second, while meant to protect patients, high procedural and evidentiary standards can sometimes appear insensitive or even cruel. The insistence on “clear and convincing” proof of a patient’s wishes, though legally prudent, imposes a heavy burden on families already in crisis. In the Cruzan case, for example, Nancy Cruzan’s parents had to present formal evidence of their daughter’s desire to refuse life support despite their intimate knowledge of her beliefs. This protracted legal ordeal added to their suffering. Such strict requirements may inadvertently create a gap between what patients truly want and what the law will allow, delaying compassion and closure for families.

Third, an exclusive focus on individual rights can undercut communal support and narrow the physician’s role. When doctors are trained to prioritize autonomy above all, they might see themselves only as technical providers or expert witnesses, rather than as compassionate counselors or moral guides. Traditional notions of solidarity and a duty to care are sidelined. Some observers lament that an atomistic emphasis on choice can “abandon patients to their ‘rights’” meaning patients are left on their own to make harrowing decisions with minimal guidance or support.^[29] In the US, there have been concerns about clinicians strictly following the letter of the law when seeking informed consent and thereby failing to engage with patients in a humane, relational manner.^[30] The patient may technically have the right to choose, yet feel isolated or unsupported in exercising that right.

By contrast, duty-based and relational models emphasize trust, context, and mutual obligations. A key strength of these approaches is that they can foster a deeper sense of care. When families and doctors work together, patients often receive more comprehensive support and reassurance. The idea of doctors and nurses as moral guides rather than just service providers can build confidence. A truly patient-centered system means not simply upholding abstract rights but treating patients “with professional respect, delicacy and [ensuring they are] not marginalized.”^[31] This ethos recognizes that many patients prefer to share decision making with trusted clinicians or family members. Indeed, when patients feel cared for by a trustworthy team, they may be more satisfied and less likely to resort to legal action. Relational models also better accommodate cultural diversity, as they allow for scenarios such as an Indonesian or Chinese patient’s preference not to be told bad news directly, or the South Korean deference to elders in family decisions, without reflexively labeling these choices as violations of autonomy. A collectivistic interpretation of autonomy can thus “maximize beneficence and trust within the patient–doctor relationship,” as one scholar suggests.^[32] In public health crises or communal cultures, duty-based ethics may even help societies coordinate more effectively by stressing cooperation and communal well-being.

Yet duty-oriented models have downsides as well. Most notably, they risk paternalism and abuse. When the doctor’s or family’s duty is given primacy, patients may feel coerced or unheard. The acceptance of “benevolent deception” by some clinicians in East Asian contexts illustrates how easily trust can slide into withholding information: if doctors routinely decide not to tell patients the whole truth “for their own good,” who judges when that crosses the line into violating patient dignity? Similarly, requiring surrogate or family decision-making without clear patient input can lead to outcomes the patient herself would not have wanted, as one Indian ICU study showed.^[33]

Relational models also tend to assume harmonious family dynamics; in reality, families can have internal conflicts or even financial interests that sway decisions. Critics point out that an overemphasis on community can end up suppressing individual autonomy in harmful ways.

Another challenge is inconsistency. When autonomy is not firmly mandated by law, patients have less assurance of their rights. Relational approaches may rely on the goodwill of providers rather than enforceable standards, and practices can vary widely between hospitals or individual clinicians. The absence of clear rules means that ethical outcomes may become unpredictable and dependent on personalities. In multicultural societies, this can introduce inequities: if a doctor defers to a family’s wishes in one case, should she do so for every patient of that cultural background? Without some legal guidance, bias or paternalism might creep in under the guise of cultural sensitivity.

In summary, rights-based models prioritize individual choice and legal protection, but they risk alienating patients and fracturing trust. Duty-based models foster trust and communal good, but they risk overriding genuine patient preferences. The US approach tends to swing toward formal rights, while many Asian and some European systems emphasize duties and shared decision making. Each framework has its own internal logic and local strengths.

Counterarguments and Responses

Potential Erosion of Individual Rights

Critics might argue that embracing relational or duty-based approaches could erode patients’ hard-won autonomy rights. They worry that empowering families or communities in medical decisions might lead to overriding the individual’s own wishes. Indeed, examples from other jurisdictions are often cited as cautionary tales. In some countries, patients or parents have been overruled by authorities “for the patient’s good,” raising alarms about paternalism. Such cases fuel fears that a relational ethic could become a pretext for diminishing personal autonomy.

Response

The pluralistic model advocated here does not abandon individual rights; it aims to formalize and elevate patient-directed relational involvement. Legal safeguards would remain in place to protect core autonomy such as the right to refuse treatment, and any involvement of family or community would be guided by the patient’s own preferences. In practice, this means that if a patient wants her family to participate in decisions, that wish is honored; if not, that choice is equally respected. The intention is not to let others trump the patient’s voice, but to acknowledge that the patient’s voice may include others. This model goes beyond current informal practices by embedding relational preferences in policy and documentation, not leaving them to chance or ad hoc interpretation. The aim is a middle path where patient agency is preserved even as the decision-making process becomes more inclusive and trust driven. By explicitly affirming individual rights as a baseline, the model guards against their erosion. The US can learn from other systems’ mistakes and design intentional relational practices that complement self-determination.

Risk of Family Coercion or Cultural Pressure

Another concern is that greater deference to family or cultural norms could invite undue pressure on patients. If families gain more say, what stops an overbearing relative from coercing a vulnerable patient into a decision contrary to the patient’s true wishes? For example, skeptics point to scenarios where an elderly parent might feel obligated to continue burdensome treatment because her children insist, or a young woman might defer to her family’s expectations at the expense of her own preferences. In some contexts, strong patriarchal or hierarchical traditions could silence the patient’s voice entirely.

Response

These are legitimate worries, and any relational approach must build in protections against coercion. First, respecting family involvement is never meant to override a competent patient’s expressed choice. Protocols can require that providers seek confirmation of the patient’s wishes privately, without family present, whenever pressure is suspected. Ethics committees or patient advocates can be engaged early if familial coercion is a concern. Importantly, relational autonomy does not mean the patient loses autonomy to the family. It means the patient is supported by relationships of her choosing. A key part of implementation is training clinicians to distinguish voluntary family support from undue influence. Empirical studies suggest many patients welcome family input, but only to the extent that it aligns with their own values.^[34] The proposed model emphasizes that health professionals must remain alert to power imbalances. In short, families can be partners in care, but the clinical team must ensure that the patient’s authentic voice remains central. Policies might, for example, allow a patient to designate a specific family member as a “decision partner” while also providing an avenue to override family input if there is evidence of coercion or abuse. The goal is a culturally sensitive approach that enhances patient agency through trusted relationships, not one that lets family members hijack the decision-making process.

Practical Challenges to Implementation

Even those who agree with the philosophy of a trust-enhanced model may question its practicality. An already-burdened healthcare system may not leave clinicians with time and resources to foster deeper relationships and shared decision-making. Skeptics might also note that the US healthcare environment is highly litigious and protocol-driven; deviating from standard procedures to accommodate individual cultural or familial preferences could increase complexity or even legal risk.

Response

It’s worth noting that patient-centered care and shared decision making are already widely endorsed in principle and operationalized. Improvement can be incremental. For example, hospitals can introduce structured communication interventions (such as family conferences in critical care or trained mediators for end-of-life discussions) on a pilot basis and measure outcomes. Early adopters of shared decision-making tools have found that, over time, these practices can save time by reducing conflicts and clarifying goals of care. Training in cultural competence and empathy has been linked to improved patient satisfaction and even better adherence to treatment plans. Regulators and insurers are increasingly emphasizing quality metrics that include patient engagement, which creates incentives for providers to invest in trust-building. Admittedly, there will be a learning curve. Not every clinician will immediately excel at relational communication, and healthcare administrators must support these efforts (through staffing, time allowances, etc.). But medical culture can evolve: consider how palliative care, once niche, became standard practice, or how the very concept of informed consent grew from an idea into a norm. By aligning training and policy incentives with the value of trust, practical barriers can be overcome step by step. Moreover, legal frameworks can adapt, clarifying that accommodating a patient’s cultural or relational wishes is an acceptable, even encouraged, practice rather than a liability.

Position on Scholarly Debates

This proposal builds on prior scholarship but also departs from it in important ways. One critique of the US model holds that an overly legalistic approach to bioethics can’t capture the nuance of moral issues; law’s vocabulary and adversarial posture can indeed warp delicate clinical relationships.^[35] Unlike that critic, I maintain that law still has a vital role; our task is to humanize it, not abandon it. Similarly, the clear criteria for decision-making capacity articulated by Appelbaum and colleagues provide essential guidance.^[36] Yet I agree with their critics that these criteria should be enriched with context. Evaluating a patient’s understanding, for example, should include understanding how a decision fits into the patient’s life narrative and relationships. My recommendations extend Appelbaum’s framework rather than rejecting it.

Recommendations for US Law and Bioethics Reform

Drawing on international examples and critical scholarship, the US can reform both law and medical ethics to better balance autonomy with trust and relational care:

Embrace a Pluralistic View of Autonomy

Reformers should encourage recognition that autonomy need not be purely individualistic. Medical institutions can train clinicians to ask patients not just for a yes/no consent, but also for information about their values and how (if at all) they wish others to be involved in their care (as one clinical case study recommends).^[37] However, this inquiry must be approached with caution and safeguards. Patients might be hesitant to disclose such preferences in clinical settings, especially if they fear that doing so could later be used against them — for example, in conflicts over capacity, liability and family disagreements. Power dynamics, cultural norms, and prior experiences in healthcare system may all shape a patient’s willingness to speak candidly. To mitigate this, institutions should ensure that any inquiry about relational preferences is clearly framed as optional, confidential and revocable. Policies should allow patients to express a wish not to know certain information or to designate family decision-makers in advance if they so desire. For example, hospitals could adopt dual-option consent forms that explicitly accommodate a patient’s preference for family-mediated decision making. Courts and ethics committees might also reinforce that respecting autonomy includes respecting these relational choices. While patients can already designate surrogates or relay on default hierarchies, legislatures could likewise broaden advance directive statutes to include sections for relational preferences and explicitly reflect cultural preferences — such as shared family or elder-led decisions.

Strengthen Fiduciary and Trust-based Obligations

Legal reform can explicitly endorse the physician’s duty to build and maintain trust. Professional codes already stress beneficence and nonmaleficence and certification ensures competence, but statutes could go further by promoting trust-building behaviors — such as continuity, transparency and cultural respect as expected norms of practice. For instance, laws or regulations might require hospitals to implement communication-skills training, cultural competence programs, and conflict-resolution practices for their staff. (Would this matter legally? Consider that in malpractice or professional discipline cases, regulators could be empowered to consider not only whether the doctor disclosed the necessary information, but how it was disclosed, e.g. was it conveyed with appropriate sensitivity and respect?) American law already uses fiduciary language for the doctor–patient relationship; this could be expanded so that physicians are understood to owe patients a duty of “transparent respect” in communication. Of course, trust also hinges on core competencies and integrity: providing accurate diagnoses, practicing good science, and genuinely respecting the patient’s informed decisions are fundamental to being trustworthy. By combining technical excellence with improved communication and cultural humility, caregivers can better earn and retain patients’ trust. Healthcare institutions can further incentivize long-term doctor–patient relationships (for example, through continuity-of-care models or reimbursement bonuses), since trust often grows over time. In certain high-stakes areas (like end-of-life care or psychiatry), ethics committees or patient advocates could be brought in earlier as neutral facilitators to mediate between patient autonomy and family concerns, preventing disputes from escalating into adversarial legal battles.^[38]

Promote Shared Decision Making as a Best Practice

On the policy level, agencies like the Centers for Medicare & Medicaid Services (CMS) and state health departments can require or encourage hospitals to use shared decision-making tools that respect both autonomy and relationships. Decision aids, interdisciplinary care conferences, and family meetings should be standard offerings (available to every patient, though not forced on anyone who declines), with documentation showing that the patient’s perspective was fully explored. This aligns with evidence-based medicine: studies show that when patients and doctors truly collaborate, both satisfaction and health outcomes often improve. Medical school curricula and continuing education should teach clinicians about relational ethics (drawing on thinkers like feminist bioethicists) and cross-cultural communication skills. Ethics training can still highlight cases like In re A.C. to remind physicians of the legal duty to honor patient refusals, but it should also present narratives (like Banerjee’s ICU study) illustrating how a blind “checkbox” approach to autonomy can backfire.^[39] The aim is to ingrain a default mode of shared decision-making, where obtaining informed consent is not a mere checkbox but a conversation that takes the patient’s social world into account.

Respect Cultural Values without Sacrificing Rights

The US can learn from the pluralism of global bioethics. Laws might incorporate guidance on cultural flexibility—for example, explicitly allowing surrogate decision-making by a chosen family member if doing so is consistent with the patient’s known or likely values. In other words, if a patient from a cultural tradition explicitly defers to her family’s judgment, the legal system should recognize this deference as an exercise of autonomy rather than a violation of it. My contention is not that competent patients cannot delegate decisions — as they can already designate surrogates — but there should be a clearer and more flexible mechanism for real-time, voluntary deferral of decision-making that reflects cultural or relational values, without invoking capacity. In practice, competent patients can already seek advice from relatives and often do follow that advice; the difference here is providing formal legal recognition and guidelines for such voluntary delegation of decision-making authority. For instance, a competent adult could designate a trusted family elder to discuss options with doctors and even speak on the patient’s behalf during deliberations, if that is the patient’s preference. Courts could then acknowledge that when a culturally diverse patient explicitly entrusts decisions to family, this is itself an autonomous choice that should be respected (much like an advance directive, except activated by cultural values rather than incapacity). At the same time, safeguards must be in place to protect vulnerable patients from coercion or family overreach. Any reform in this direction should not be a one-way slide into paternalism, but rather a calibrated move toward dignity-preserving care that honors both the individual and her community ties.

In proposing these recommendations, the aim is to enrich American autonomy doctrine, not to abandon it. The goal is to preserve patients’ rights to make personal choices and to help patients feel they can trust and be understood by their caregivers. By integrating relational ethics into law – an approach one scholar has called “glocal bioethics” – the US can respect both individual will and the social fabric that gives patients meaning and support.^[40]

Conclusion

The debate over patient autonomy in American bioethics and law often pits the letter of individual rights against the spirit of relational care. The task for US policymakers and ethicists is to bridge these perspectives: to protect self-determination and to nurture trust. Specific reforms such as recognizing relational preferences in advance directives, adjusting burdens of proof, and emphasizing shared decision making can help reconcile the divide. By learning from Asia’s trust-centered approaches and from Europe’s ethos of solidarity,^[41] American law can deepen its humanity—broadening the ethical lens beyond individual rights while safeguarding them. Indeed, some aspects of the current regime have been criticized as inhumane – for example, the Cruzan family’s drawn-out court battle to remove Nancy’s feeding tube has been described as an ordeal that added unnecessary trauma. If we reform procedures to be more compassionate and flexible, we can alleviate such burdens without undermining individual rights. Patients should be neither left isolated against the machinery of the state nor subsumed entirely by social or familial dictates. Ultimately, the aim is to ensure that they are empowered within a trusted community of care. This balanced path would honor the letter of autonomy while embracing the relational realities of healing.

^[1] Carl E. Schneider, “Bioethics in the Language of the Law,” Hastings Center Report 24, no. 4 (1994): 16–22, 18 https://doi.org/10.2307/3562838

^[2] Cruzan v. Director, Missouri Department of Health, 497 U.S. 261 (1990) https://supreme.justia.com/cases/federal/us/497/261/

^[3] In re A.C., 573 A.2d 1235 (D.C. App. 1990) https://law.justia.com/cases/district-of-columbia/court-of-appeals/1990/87-609-4.html

^[4] Lane v. Candura, 6 Mass. App. Ct. 377 (1978) https://law.justia.com/cases/massachusetts/court-of-appeals/1978/6-mass-app-ct-377-1.html

^[5] Associated Press, “Pregnant US Woman Declared Brain Dead Is Being Kept Alive Under State Abortion Law,” The Guardian, May 15, 2025 https://www.theguardian.com/us-news/2025/may/15/pregnant-georgia-woman-brain-dead-abortion-law

^[6] In re A.C. (D.C. App. 1990) https://law.justia.com/cases/district-of-columbia/court-of-appeals/1987/87-609-0-0.html

^[7] Addington v. Texas, 441 U.S. 418 (1979) https://supreme.justia.com/cases/federal/us/441/418/

[8] Schneider, 1994.

^[9] Schneider, 1994.

^[10] Bhakuni H. Glocalization of bioethics. Glob Bioeth. 2022 Mar 19;33(1):65-77. doi:10.1080/11287462.2022.2052603.

^[11] Dwaipayan Banerjee, “Provincializing Bioethics: Dilemmas of End-of-Life Care in an Indian ICU,” American Ethnologist49, no. 3 (2022): 318–331 https://doi.org/10.1111/amet.13092

^[12] Banerjee, 2022.

^[13] Hao Zhang et al., “Patient Privacy and Autonomy: A Comparative Analysis of Cases of Ethical Dilemmas in China and the United States,” BMC Medical Ethics 22, no. 1 (2021): 8 http://www.ncbi.nlm.nih.gov/pubmed/33531011

^[14] Banerjee, 2022.

[15] High Court of Justice. Great Ormond Street Hospital v. Yates and Gard, EWHC 972 (Fam) (2017). https://www.judiciary.uk/wp-content/uploads/2017/07/gosh-v-gard-24072017.pdf

[16] High Court of Justice. Nottingham University Hospitals NHS Trust v. Gregory (Indi Gregory), [2023] EWHC 2992 (Fam). https://www.judiciary.uk/wp-content/uploads/2023/10/Nottingham-University-Hospitals-NHS-v-Gregory-judgment-121023.pdf

[17] Paris JJ, Ahluwalia J, Cummings BM, Moreland MP, Wilkinson DJ. The Charlie Gard case: British and American approaches to court resolution of disputes over medical decisions. J Perinatol. 2017 Dec;37(12):1268-1271. https://www.nature.com/articles/jp2017138

[18] Lane v. Candura (1978)

[19] Ho, A. (2008), Relational autonomy or undue pressure? Family’s role in medical decision-making. Scandinavian Journal of Caring Sciences, 22: 128-135. https://doi.org/10.1111/j.1471-6712.2007.00561.x

[20] Dickenson DL. Cross-cultural issues in European bioethics. Bioethics. 1999 Jul;13(3-4):249-55. doi: 10.1111/1467-8519.00153

[21] Zhang et al., 2021.

[22] Dickenson,

[23] Canterbury v. Spence, 464 F.2d 772 (D.C. Cir. 1972), https://law.justia.com/cases/federal/appellate-courts/cadc/22099/22099.html

[24] Tanaka, M., Kodama, S., Lee, I. et al. Forgoing life-sustaining treatment – a comparative analysis of regulations in Japan, Korea, Taiwan, and England. BMC Med Ethics 21, 99 (2020). https://doi.org/10.1186/s12910-020-00535-w

[25] Gaille M, Horn R. The role of 'accompagnement' in the end-of-life debate in France: from solidarity to autonomy. Theor Med Bioeth. 2016 Dec;37(6):473-487. doi: 10.1007/s11017-016-9389-1. PMID: 27915459; PMCID: PMC5167768.

[26] Bhakuni, 2022.

[27] Banerjee, 2022.

[28] Dickenson, 1999.

[29] Schneider, 1994.

[30] Schneider, 1994.

[31] Banerjee, 2022.

[32] Banerjee, 2022.

[33] Banerjee, 2022.

[34] Ho, “Relational Autonomy or Undue Pressure?” 2008

[35] Schneider, 1994.

[36] Appelbaum PS. Clinical practice. Assessment of patients' competence to consent to treatment. N Engl J Med. 2007 Nov 1;357(18):1834-40. doi: 10.1056/NEJMcp074045

[37] Kolmes S, Ha C, Potter J. Responding to Cultural Limitations on Patient Autonomy: A Clinical Ethics Case Study. HEC Forum. 2024 Mar;36(1):99-109. doi: 10.1007/s10730-022-09490-y

[38] In re A.C. (D.C. App. 1990)

[39] Banerjee, 2022

[40] Bhakuni, 2022.

[41] Dickenson, 1999.

Is "Gender-Affirming Medical Care" Any of These?

2025-08-29T14:03:39+00:00

Photo ID 41345107 © Feverpitched | Dreamstime.com

Abstract

This article examines the contested phrase “gender-affirming medical care,” now common in legislation, litigation, and clinical guidance. It analyzes the term’s three components — affirmation, medicine, and care — and asks what each requires in ordinary clinical practice, drawing on classical and contemporary philosophy-of-medicine frameworks. The article argues that the bundled expression often obscures more than it clarifies: “affirmation” is treated as will-realization rather than truth-recognition; “medical” is invoked where interventions compromise rather than restore bodily function; and “care” is reduced to consent-compliance rather than fiduciary beneficence. The analysis is conceptual, not prescriptive. Its aim is to disaggregate a rhetorically powerful composite into concrete clinical acts, monitoring obligations, and claimed benefits so that ethical and policy debates can proceed on clearer terms. By testing the phrase against its own parts, the article shows that it often fails to meet the minimal thresholds of each and calls for greater precision in medical language.

Introduction

Legislation, litigation, and professional guidelines increasingly turn on contested medical terminology, including what is commonly referred to as “gender-affirming medical care,” a term that now appears in state statutes, court opinions, and policy statements from leading medical associations. Yet it carries more than descriptive weight. The term embeds assumptions about truth, medicine, and beneficence that shape the debate from the start.^[1] Before law and policy can meaningfully engage the merits of such interventions, the terminology itself warrants examination, both for its legal implications and for the persuasive force it carries in public debate. The point is underscored by United States v. Skrmetti (2025), in which the US Supreme Court addressed state restrictions on pediatric gender-transition interventions.^[2] While this article does not engage the legal arguments of that case, the ruling illustrates how “gender-affirming medical care” (and similar formulations) has become pivotal not only in professional discourse but in constitutional adjudication.

Beyond its legal salience, this phrase now frames public and professional discussion of medical interventions. It is rhetorically potent: “affirming” suggests truthfulness, “medical” implies scientific legitimacy, and “care” evokes benevolence. Each term carries a weight of meaning that can, and should, be examined. This is not a mere semantic exercise; in bioethics, precise definitions are essential to consistent standards, equitable treatment, and informed policy. Without them, policy and clinical standards drift, at the patient’s expense.

The interventions covered by this expression range from puberty blockers and cross-sex hormones to surgeries that remove healthy organs or construct new anatomy.^[3] Even their most indisputable consequences are often little known outside clinical circles. Long-term hormone therapy can impair fertility^[4] and typically entails ongoing medical monitoring; after gonad removal, continued sex-steroid replacement is required indefinitely to avoid hypogonadism-related harms.^[5] Surgeries are irreversible and permanently eliminate the capacities of the organs they remove.^[6] In many cases, these interventions disable or alter normal bodily functions and commit the patient to long-term — often lifelong — medical follow-up.^[7]

The analysis treats each element of the term to show that it falters under both widely used, practice-oriented accounts in the contemporary philosophy of medicine and the more comprehensive classical philosophical account of the person as an integrated unity of body and soul. While the clearest ethical concerns involve pediatric care (including questions of consent), the conceptual thresholds implied by the phrase are often unmet even for adults. The three components overlap in practice: affirmation, medicine, and care are not completely separate domains. However, this article approaches them singly, allowing each to be tested against its own criteria before considering their interrelation.

Is It “Gender-Affirming”?

To “affirm” something is to recognize and confirm it as true. In clinical settings, affirmation may take the form of reassurance, validation, or support, but the underlying structure is the same: affirmation aligns with reality, not against it. If a patient with severe protein-calorie malnutrition insists “I am overweight,” treatment that affirms the claim is not an act of truth-telling but of collusion in error.

In the classical philosophical-anthropological tradition, the human person is understood as an integrated psychophysical unity — often described in that tradition as a unity of body and soul — and sex is not an accessory but a fundamental determination of that unity. To affirm someone as the opposite sex is to deny this integral wholeness. Contemporary realist accounts also underscore this point,^[8] arguing that gender is the lived form of a sexed body: the social reality of a body already determined as male or female, not a free-floating psychological construct detachable from the organism to which it belongs.^[9]

One recent account observes that our modern technological imagination quietly shifts the meaning of affirmation itself. Once, to affirm was simply to take the world and the body as given. Now the given is treated as raw material for the will, to be reshaped until it matches desire.^[10] By this logic, one affirms not by recognizing what is, but by bringing what is into conformity with what is wished. The word remains, but its meaning is inverted: what once denoted truth‑recognition now denotes will‑realization. This plays out in self-help and motivational literature.

Even bracketing these philosophical commitments, gender‑affirming falters under conceptually minimal analysis and ordinary clinical terms. Affirmation treats its object as true. In medicine, when a truth-apt clinical claim is at stake, warrant ordinarily rests on tests, examinations, and findings that stand apart from the patient’s own report. With gender identity, diagnostic standards rely on reported incongruence and associated distress over time rather than on objective tests or biomarkers.^[11] Yet medicine cannot operate on self‑report alone when reality is disputed: “I have a fracture” begins, not ends, inquiry.

The same point becomes evident when we shift from words to procedures. Performing a vaginoplasty on a healthy male body does not make it more like a healthy female body, although postoperatively, the two will superficially share the absence of a penis and testes. Rather, this simply disables the male; it does not confer female-specific reproductive anatomy, physiology, or function.^[12] The alteration is merely morphological. Such interventions are not only non-affirming but positively pathological on function-based accounts.

Counterarguments

Proponents may assert that the term affirmation reduces stigma and builds therapeutic alliance; respectful language matters. As noted above, however, in clinical practice, affirm ordinarily denotes truth-recognition rather than a presumption of correctness. Respect and alliance are compatible with assessment; they do not require presuming the truth of contested claims. If affirm is used only to describe an interpersonal demeanor, then it is distinct from the clinical question; by contrast, in policy and protocol contexts, gender-affirming often functions as an outcome-preferring label that tends to make identity-congruent interventions the default, although access is filtered by eligibility criteria.

Some have cited neurobiological studies to argue that transgender identity is grounded in biology, claiming that certain transgender individuals have brain structures more similar, on average, to the opposite sex.^[13] Yet even setting aside the methodological limitations of such studies,^[14] these findings concern group averages, not diagnostic markers. They are equally compatible with a simpler conclusion: male and female brains each span a range, and some individuals cluster toward one end without ceasing to be their biological sex. Because the distributions substantially overlap, average differences do not support individual-level classification or brains to be swapped across bodies; they only show that not all members of a sex are identical. Even if such correlations were consistent, they would not establish that gender can be defined apart from the sexed body.^[15]

Another counterargument is that in contemporary usage, gender simply means identity, so to affirm gender is to affirm self-identification.^[16] But that is a change in usage, not a refutation. If gender is defined to exclude the body, then of course affirmation need not track the body — but only by abandoning the term’s embodied referent. That shift is semantic, resolving the dispute by redefinition rather than by argument.

Is It “Medical”?

To call something medical is not merely to note that clinicians perform it or that it uses surgical or pharmaceutical techniques. In both classical and modern accounts, medicine is the art and science of restoring or preserving health. From Hippocrates to Aquinas^[17] to contemporary philosophers of medicine, the practice is directed toward diagnosing, preventing, and treating disease or injury to maintain or restore proper bodily functioning. Even accounts that present themselves as value-neutral rest on some conception of health as an objective good to which interventions must be answerable.^[18]

One influential biostatistical account defines health in terms of how well an organism’s parts function, relative to species-typical norms.^[19] Disease, in this framework, is a measurable departure from those norms that lowers the odds of survival or reproduction. On this view, interventions that damage or remove organs in sound working order — such as sterilizing gonads or amputating breasts without pathological cause — produce disease.

In contrast, a widely discussed normativist account defines health as the ability to achieve one’s vital goals in standard circumstances.^[20] A desire to occupy the social role of the opposite sex is intelligible as a psychological phenomenon. Lacking the bodily sex-specific characteristics of that role, however, does not constitute a pathology; nor does the normative account require medicine to pursue any self-reported goal that conflicts with actual capacities.^[21]

Medicine rightly encompasses not only curative and preventive aims but also palliation and the relief of suffering. Analgesia, hospice care, and psychiatric interventions are part of medicine’s vocation, even when they do not restore lost functions. But even here, proportionality and evidentiary standards apply: the greater the irreversibility and loss of baseline functions, the stronger the justification required that benefits are durable and outweigh foreseeable harms.

Gender-transition procedures are generally not aimed at curing or preventing disease. They alter healthy bodies to fit a self‑reported identity, often by disabling or removing normally functioning organs. The resulting loss of fertility, sexual function, and other capacities is often integral to the desired phenotype, not an incidental side effect.^[22] This differs from most accepted interventions, where impairment is an unfortunate trade-off for treating pathology. Given their aims and effects, whether such procedures can rightly be considered medicine in the ordinary sense is doubtful. Medicine typically resists altering or removing healthy organs in conditions such as body dysmorphic disorder or body integrity identity disorder, where the problem lies not in the organ but in perception or identification. The therapeutic aim is to address the discordance, not to make the body match the disordered image. This is not to equate gender dysphoria with either condition; the narrower point is that in all such cases the bodily structure is not diseased, and the mismatch lies between body and self‑concept. Historically, medicine has sought to resolve such mismatches by addressing the self‑concept, not by impairing healthy anatomy.

These philosophical concerns find a practical counterpart in recent independent evidence reviews. The UK’s National Institute for Health and Care Excellence (NICE) has examined puberty blockers and cross-sex hormones,^[23] and the Cass Review, incorporating and extending those reviews, has independently evaluated gender identity services for children and young people.^[24] All concluded that the research base for pediatric gender-transition interventions is of very low quality and insufficient to establish safety or long-term benefit.^[25] Against that backdrop, a procedure does not become medical by virtue of who performs it or how skillfully; it becomes medical by what it aims at and what it accomplishes. Where the aim is not the restoration of healthy functioning, and the accomplishment is to compromise it, the description as medical does not hold, and the practices fall outside what medicine, in its ordinary sense, is understood to encompass.

Counterarguments

Some treat the recognition and endorsement of gender-affirming medical care terminology by professional associations as dispositive. Once major bodies use the label, the classification of the relevant interventions as medical is deemed settled. For advocates, such endorsements may appear to decisively buttress claims of safety and long-term benefit. But the value of such appeals to authority turns on independence, representativeness, and transparent methods; policy statements, often issued by small committees and subject to advocacy influence, falter under this standard. By conventional criteria, such statements are generally accorded less evidentiary weight than reviews that spell out how they searched, what they included, and how they judged the strength of evidence.^[26] Policy statements can standardize vocabulary, but labels alone do not legitimize the term. Similarly, even where it exists, consensus may follow evidence but does not raise its quality.

Some will point to cosmetic surgery to show we accept non-restorative alterations as medicine. Yet cosmetic surgery already sits somewhat uneasily in the medical tent. Some of it is reconstructive, but much is ornamental, tolerated more as a cultural concession than as part of medicine’s central art. Yet cosmetic surgery does not ordinarily ablate sex-specific reproductive structures or impose lifelong medical dependence. Even when medicine sacrifices healthy tissue, the loss is accepted for the sake of preserving health. Gender-transition surgery is different: it effectively treats the sacrifice itself (fertility, sexual function, intact organs) as the remedy. Medicine can accept loss for health’s sake; it cannot redefine loss as a cure. If elective cosmetic surgery is near the border of medicine, transition procedures are well past it. In such cases, the Hippocratic imperative to avoid harm remains a vital ethical boundary that preserves the good of the whole human being in the integrity of body and person.^[27] The point is not to withhold care, but to ensure that interventions genuinely promote patient health and well-being by standards that medicine applies to all patients, regardless of the condition.

Others may argue that experiencing one’s sexed body as incongruent can precipitate depression or anxiety, and that relieving suffering is a medical aim; they may contend that psychiatric diagnosis often relies in part on patient reporting. But diagnosis does not dictate proportional treatment. Self-reported distress can warrant psychosocial and psychiatric care. Supportive families, schools, and clinics may ease that distress. But that is distinct from the causal claim that transition-related interventions improve long-term, hard outcomes — and, absent strong evidence of durable benefit, such distress is a weak justification for irreversible procedures that disable healthy function absent strong evidence of durable benefit. Concerns about diagnostic expansion and medicalization only heighten the need not to let a label do the justificatory work.

Is It “Care”?

Even if gender-transition interventions could be classed as medical, a further question remains: do they meet the moral obligations that make medicine an act of care? Medicine, at its best, is not merely a technical service but a fiduciary relationship ordered toward the patient’s good. In clinical ethics, care implies technical competence, fidelity to the patient’s welfare, prudence amid uncertainty, and a commitment to avoid harm.

The duty of care^[28] also includes proportionality: the scale and irreversibility of the intervention should bear a reasonable relationship to the certainty and magnitude of the expected benefit. When interventions remove healthy organs, impair fertility, or carry significant lifelong medical burdens, this proportionality threshold rises. In other domains of medicine, life-altering interventions with no return path are reserved for conditions that pose a clear and present danger to life or long-term health, anchored in strong evidence of benefit.^[29] Under low-certainty evidence, best interests favor least-restrictive means first, with irreversible options reserved for clearer indications.

Within the classical tradition, care is a moral orientation toward the patient’s good, not merely the execution of a chosen procedure. Modern philosophy of medicine retains this orientation in, for example, an emphasis on beneficence within a covenantal relationship^[30] and an account of medicine as a moral community.^[31] Both approaches resist reducing care to technical provision or choice.

A further component of care is safeguarding against transient cultural pressures or institutional ideologies that may not align with patient welfare. The fiduciary role obliges clinicians to distinguish the patient’s interests from those of third parties and to resist conflating affirmation of a stated identity with the pursuit of the patient’s objective good. In gender-transition interventions, this includes recognizing that rapidly shifting cultural narratives, peer influence, or institutional commitments that do not necessarily track long-term clinical benefit may shape demand. Recent increases in referral rates and changing patient demographics in multiple countries underscore this.^[32] Agreement with a self-description does not, by itself, justify irreversible alterations to intact anatomy.

To provide care is not merely to comply with a request or endorse a belief, but to act in ways proportioned to benefit over a life. Where evidence is weak, risks are high, and alternatives exist, proceeding is better described as service provision than as care in the richer ethical sense.

Counterarguments

Some argue care consists in respecting patient autonomy and that honoring requests is itself care. Informed consent is necessary but not sufficient; agreement alone does not make an act one of care. Valid consent requires understanding benefits and risks, key uncertainties, and available alternatives, including nonmedical options. In the context of gender-transition procedures, especially for minors, these conditions are often contested, and independent reviews have judged the evidence base low-certainty.^[33] Where the evidentiary basis is uncertain, proceeding is not automatically an act of care simply because the patient or guardian agrees.

Reducing the essence of care to compliance with patient wishes treats care as though it were commerce, where the transaction is complete when the request is met, regardless of the long-term cost to the buyer. Autonomy, while essential, is not the sum of clinical ethics; it is bounded by non-maleficence, beneficence, and professional standards. Patients might request what is not in their interest, and clinicians have no ethical duty to comply simply because of a request. In fact, refusing foreseeably harmful interventions can be an exercise of respect for autonomy rightly understood — in fiduciary terms, the autonomy of the whole person over the course of a life, not the immediate choice of a moment. Respect for autonomy also includes protecting patients from choices that outstrip the evidence base for risks. This is neither refusal of care nor paternalism, but fidelity to the patient’s long-term good under uncertainty.

Others will appeal to measures of patient satisfaction, noting that some individuals report relief or happiness after intervention. Yet satisfaction is not identical to welfare; by itself, it cannot establish that the intervention was in the patient’s long-term interest. Patient-reported outcomes and lived experience are important for follow-up and for understanding subjective well-being, but they do not replace evidentiary or proportionality standards when risks are substantial or losses are nonrecoverable. In other domains of medicine, satisfaction is weighed against objective outcomes and foreseeable harms.

Conclusion

The label gender-affirming medical care subsumes three claims at once: that the interventions affirm what is true, are medical in aim and effect, and constitute care. Where those claims cannot be shown, the label obscures more than it clarifies and risks confusion in clinical decision-making.

Having tested the phrase by its own terms, the inconsistency that emerges is not merely semantic but practical. In medicine, language is part of practice. Terms shape what clinicians look for and how patients understand themselves. They also narrow which actions seem reasonable or obligatory. Bundling the three terms tends to insulate each part from scrutiny. The result is a narrowing of moral and clinical imagination at precisely the point where medicine most needs openness: in conditions of profound personal distress, contested evidence, and high-stakes intervention.

These are questions of language, ethics, and the goods of medicine. The deeper need is to recover the habit of speaking about clinical acts truthfully, describing what they actually do in the body and in the life, before judging whether they are wise or good. This is not a call for linguistic purity or moralizing diagnosis. It is an appeal to the precision without which neither trust nor care can survive.

In the classical tradition, medicine’s authority derived not from fulfilling wishes but from its orientation toward the patient’s good as a whole human being — a standard that persists in contemporary philosophy of medicine, which holds that interventions must answer to truth and to good: truth in description, and good in judgment. Language that dodges this twofold test is not just out of step with tradition. It fails the patient.

There should be common ground enough to insist that medicine name its acts accurately, justify them by their ends, and give care the dignity of meaning something more than acquiescence. Where such an agreement holds, disputes over what counts as gender-affirming become less a matter of identity politics and more a question of clinical and moral truth, a shift that can only help the patients and families who have most at stake in the answer.

The argument here has been limited to the conceptual and philosophical analysis of the phrase gender-affirming medical care. The analysis applies beyond this phrase, however. Any composite, putatively medical term that bundles empirical claims with contested moral judgments should be disaggregated and tested in this way, lest language foreclose clinical and ethical reasoning. When words are made to bear what is not true, speaker and patient alike suffer the consequences.

[1] Many clinicians and guideline authors have adopted “gender-affirming” terminology to reduce stigma, to align with depathologizing frameworks, and to standardize communications for clinical pathways, reimbursement, and policy. Those aims are intelligible. The present analysis is narrower: terms used in statutes and clinical standards should not, by definition alone, pre-decide the evidentiary and proportionality thresholds that ordinarily govern high-risk, irreversible interventions.

[2] United States v. Skrmetti, No. 23‑477, 605 U.S. ___ (June 18, 2025), slip op., https://www.supremecourt.gov/opinions/24pdf/23-477_2cp3.pdf.

[3] E. Coleman et al., “Standards of Care for the Health of Transgender and Gender Diverse People, Version 8,” International Journal of Transgender Health 23, suppl. 1 (2022): S1–S259, https://doi.org/10.1080/26895269.2022.2100644. SOC-8 lists surgical procedures including chest masculinization (mastectomy), hysterectomy with salpingo-oophorectomy, orchiectomy, vaginoplasty/vulvoplasty, metoidioplasty, penectomy, and phalloplasty, which alter primary and/or secondary sex characteristics.

[4] Katharina Feil et al., “Fertility, Contraception, and Fertility Preservation in Trans Individuals,” Deutsches Ärzteblatt International 120, no. 14 (2023): 243–50 (cross-sex hormone therapy can impair fertility; counseling on preservation recommended prior to treatment), https://doi.org/10.3238/arztebl.m2023.0026; Wylie C. Hembree et al., “Endocrine Treatment of Gender-Dysphoric/Gender-Incongruent Persons: An Endocrine Society Clinical Practice Guideline,” Journal of Clinical Endocrinology & Metabolism 102, no. 11 (2017): 3869–3903 (guideline discussion of fertility effects and pre-treatment fertility-preservation counseling for patients initiating cross-sex hormone therapy), https://doi.org/10.1210/jc.2017-01658.

[5] Hembree et al., “Endocrine Treatment.” The guideline recommends regular clinical and laboratory monitoring during sex-steroid therapy. It also states that adult regimens restore physiologic sex-hormone levels using the principles of hormone-replacement therapy for hypogonadal patients; after gonadectomy, ongoing replacement is indicated, and stopping hormones increases bone-loss risk (with bone mineral density monitoring advised if therapy ceases).

[6] Coleman et al., “Standards of Care, Version 8,” (classifies surgical interventions as irreversible; enumerates among others mastectomy, hysterectomy with salpingo-oophorectomy, and orchiectomy, each entailing permanent loss of the removed organ’s functions); Hembree et al., “Endocrine Treatment,” sec. 4.4; sec. 5.0 (post-gonadectomy, loss of endogenous sex-steroid production and need for replacement; permanent loss of gonadal reproductive function).

[7] Representative protocols describe regular dilation after vaginoplasty to prevent a surgically created canal from narrowing or closing, with maintenance often advised indefinitely; phalloplasty is commonly staged and may involve additional operations and prolonged recovery. See Joseph J. Pariser and Nicholas Kim, “Transgender Vaginoplasty: Techniques and Outcomes,” Translational Andrology and Urology 8, no. 3 (2019): 241–47 (postoperative dilation/maintenance), https://doi.org/10.21037/tau.2019.06.03; Devin Coon et al., “Gender-Affirming Vaginoplasty: A Comparison of Algorithms, Surgical Techniques and Management Practices across 17 High-Volume Centers in North America and Europe,” Plastic and Reconstructive Surgery – Global Open 11, no. 5 (2023): e5033 (technique variation; management practices), https://pmc.ncbi.nlm.nih.gov/articles/PMC10226616/; Annie M. Q. Wang et al., “Outcomes Following Gender-Affirming Phalloplasty: A Systematic Review and Meta-Analysis,” Sexual Medicine Reviews 10, no. 4 (2022): 499–512 (complication and revision rates; staged procedures and recovery profiles), https://doi.org/10.1016/j.sxmr.2022.03.002.

[8] Carrie Hull, The Ontology of Sex: A Critical Inquiry into the Deconstruction and Reconstruction of Categories (New York: Routledge, 2006), https://doi.org/10.4324/9780203007785. Note that the existence of intersex conditions does not undermine this point. Intersex diagnoses involve atypical chromosomal, gonadal, or anatomical development and are matters of biological variation within human sex dimorphism, not evidence of a third sex or of disembodied gender identity. Leonard Sax’s widely cited analysis, “How Common Is Intersex? A Response to Anne Fausto-Sterling,” Journal of Sex Research 39, no. 3 (2002): 174–78, https://doi.org/10.1080/00224490209552139, has been critiqued on definitional grounds, but even if one accepts higher prevalence estimates, these conditions remain rare and present distinct clinical management needs. They are qualitatively different from gender dysphoria in otherwise typical male or female bodies, and their existence does not establish that gender can be detached from sexed embodiment, as Hull also observes.

[9] Alternative anthropological accounts — especially certain social-constructionist frameworks — treat gender as independent from biological sex. While these perspectives fall outside the classical view, they require their own justification for using “affirmation” in a clinical sense, given that the detachment from the body changes what “truth” in affirmation could mean.

[10] Michael Hanby, “Transgender Theory and Post-Political Order,” Humanum Review, U.S. v. Skrmetti Special Issue, May 25, 2025, “From the scientific and biotechnical point of view, ‘nature’ is simply whatever happens or can be made to happen. It measures truth, what things are, by our power, what we can do.” https://humanumreview.com/articles/transgender-theory-and-post-political-order.

[11] American Psychiatric Association, Diagnostic and Statistical Manual of Mental Disorders, 5th ed., text rev. (DSM-5-TR) (Washington, DC: American Psychiatric Association, 2022), https://psychiatryonline.org/doi/book/10.1176/appi.books.9780890425787; see also APA, “What Is Gender Dysphoria?” (criteria summary for adolescents/adults and children), https://www.psychiatry.org/patients-families/gender-dysphoria/what-is-gender-dysphoria.

[12] Daniel Kodsi and John Maier, “Philosophical Malpractice,” The Philosophers’ Magazine, July 20, 2025, https://philosophersmag.com/philosophical-malpractice/.

[13] Representative neuroimaging reports include J.-N. Zhou et al., “A Sex Difference in the Human Brain and Its Relation to Transsexuality,” Nature 378, no. 6552 (1995): 68–70, https://doi.org/10.1038/378068a0; F. P. M. Kruijver et al., “Male-to-Female Transsexuals Have Female Neuron Numbers in a Limbic Nucleus,” Journal of Clinical Endocrinology & Metabolism 85, no. 5 (2000): 2034–41, https://doi.org/10.1210/jcem.85.5.6564; Giuseppina Rametti et al., “White Matter Microstructure in Female to Male Transsexuals before Cross-Sex Hormonal Treatment: A Diffusion Tensor Imaging Study,” Journal of Psychiatric Research 45, no. 2 (2011): 199–204, https://doi.org/10.1016/j.jpsychires.2010.05.006.

[14] Alberto Frigerio, Lucia Ballerini, and Maria Valdés Hernández, “Structural, Functional, and Metabolic Brain Differences as a Function of Gender Identity or Sexual Orientation: A Systematic Review of the Human Neuroimaging Literature,” Archives of Sexual Behavior (advance online publication, May 6, 2021) (noting small samples, cross-sectional designs, analytic heterogeneity, and potential confounding by sexual orientation and prior hormone exposure), https://doi.org/10.1007/s10508-021-02005-9.

[15] On why group differences do not by themselves support individual diagnostic classification (especially under broad distributional overlap) and the need for validated predictive biomarkers, see Eva Loth et al., “The Meaning of Significant Mean Group Differences for Biomarker Discovery,” Molecular Psychiatry 26 (2021): 1426–34, https://pmc.ncbi.nlm.nih.gov/articles/PMC8601419/. For a general statistical caution against inferring individual status from aggregate signals, see S. V. Subramanian, Kelvyn Jones, and Carole Brown, “Revisiting Robinson: The Perils of Individualistic and Ecological Fallacy,” International Journal of Epidemiology 38, no. 2 (2009): 342–60, https://pmc.ncbi.nlm.nih.gov/articles/PMC2663721/.

[16] Some societies have recognized culturally specific categories or roles outside contemporary Western male/female norms (e.g., hijras in South Asia; fa’afafine in Samoa; various Native American roles often discussed under “Two-Spirit”; and rabbinic categories such as androgynos and tumtum relating to bodily ambiguity). These examples are diverse and context bound; they do not establish that gender, in a clinical sense, can be defined apart from sexed embodiment. For representative discussions, see Serena Nanda, Neither Man nor Woman: The Hijras of India, 2nd ed. (Belmont, CA: Wadsworth Publishing Company, 1999), https://search.worldcat.org/oclc/39678474; Johanna Schmidt, Migrating Genders: Westernisation, Migration, and Samoan Fa‘afafine (London: Routledge, 2016), https://doi.org/10.4324/9781315595276; Sue-Ellen Jacobs, Wesley Thomas, and Sabine Lang, eds., Two-Spirit People: Native American Gender Identity, Sexuality, and Spirituality (Urbana: University of Illinois Press, 1997), https://www.press.uillinois.edu/books/?id=p066450; and Encyclopaedia Judaica, 2nd ed., ed. Michael Berenbaum and Fred Skolnik (Detroit: Macmillan Reference USA, 2007), vol. 2, s.v. “Androgynos,” https://www.encyclopedia.com/religion/encyclopedias-almanacs-transcripts-and-maps/androgynos.

[17] Hippocrates, “On the Art,” in Hippocrates, vol. II, Loeb Classical Library 148, trans. W. H. S. Jones (Cambridge, MA: Harvard University Press, 1923), 191–95, at 193: “to do away with the sufferings of the sick, to lessen the violence of their diseases …,” https://archive.org/details/hippocrates02hippuoft. See also Hippocrates, “Oath,” in Hippocrates, vol. I (Loeb 147), trans. W. H. S. Jones (1923), 298–301, https://archive.org/details/hippocrates01hippuoft. Thomas Aquinas, Summa theologiae, II–II, q. 1, a. 1 (respondeo), trans. Fathers of the English Dominican Province (New York: Benziger Brothers, 1947): “the object of the medical art is health, for it considers nothing save in relation to health” (obiectum medicinae est sanitas, quia nihil medicina considerat nisi in ordine ad sanitatem), https://www.newadvent.org/summa/3001.htm (English); https://www.corpusthomisticum.org/sth3001.html (Latin).

[18] Christopher Boorse, “Health as a Theoretical Concept,” Philosophy of Science 44, no. 4 (1977): 542–73, https://doi.org/10.1086/288768; Lennart Nordenfelt, “The Concepts of Health and Illness Revisited,” Medicine, Health Care and Philosophy 10, no. 1 (2007): 5–10, https://doi.org/10.1007/s11019-006-9017-3; and Edmund D. Pellegrino and David C. Thomasma, A Philosophical Basis of Medical Practice (New York: Oxford University Press, 1981), 58–118, https://archive.org/details/philosophicalbas00pell.

[19] Boorse, “Health as a Theoretical Concept.”

[20] Nordenfelt, “The Concepts of Health and Illness Revisited.”

[21] Still other contemporary frameworks in the philosophy of medicine, including Jerome Wakefield’s harmful-dysfunction analysis and K. W. M. Fulford’s account of medicine as essentially evaluative, likewise treat judgments about health and intervention as answerable to more than preference alone — combining empirical warrant with publicly defensible reasons about value. Applied here, such accounts do not confer “medical” status by label: they require, at a minimum, either a demonstrated dysfunction in the relevant internal mechanisms (for Wakefield) or explicit value-reasoning proportionate to the foreseeable loss of function and open to reasonable scrutiny (for Fulford). Jerome C. Wakefield, “The Concept of Mental Disorder: On the Boundary Between Biological Facts and Social Values,” American Psychologist 47, no. 3 (1992): 373–88, https://doi.org/10.1037/0003-066x.47.3.373. K. W. M. Fulford, Moral Theory and Medical Practice (Cambridge: Cambridge University Press, 1989), https://search.worldcat.org/oclc/19456328.

[22] Coleman et al., “Standards of Care, Version 8” (hormone therapy targets suppression of endogenous sex steroids and induction of secondary sex characteristics; pre-treatment fertility counseling; sterilizing nature of orchiectomy and hysterectomy with oophorectomy); Hembree et al., “Endocrine Treatment” (treatment goals include suppression/induction; ongoing monitoring; counsel on potential infertility); Feil et al., “Fertility, Contraception, and Fertility Preservation” (summary of fertility impairment across regimens; preservation options).

[23] National Institute for Health and Care Excellence (hereafter NICE), Evidence Review: Gonadotrophin Releasing Hormone Analogues for Children and Adolescents with Gender Dysphoria (hereafter NICE, GnRH Review), March 2021, https://cass.independent-review.uk/wp-content/uploads/2022/09/20220726_Evidence-review_GnRH-analogues_For-upload_Final.pdf; NICE, Evidence Review: Gender-Affirming Hormones for Children and Adolescents with Gender Dysphoria (hereafter NICE, Hormones Review), March 2021, https://cass.independent-review.uk/wp-content/uploads/2022/09/20220726_Evidence-review_Gender-affirming-hormones_For-upload_Final.pdf.

[24] Hilary Cass, Independent Review of Gender Identity Services for Children and Young People: Final Report, April 2024, https://cass.independent-review.uk/wp-content/uploads/2024/04/CassReview_Final.pdf.

[25] These reviews lay out clear, publicly available methods and transparent grading of evidence quality. Their low-certainty ratings reflect limits in the underlying studies rather than reviewer bias. The point is not UK-specific: they exemplify methodological safeguards any jurisdiction should expect before authorizing high-stakes, irreversible interventions. While critics dispute aspects of the Cass Review and the NICE appraisals, even critical commentaries typically concede that the current pediatric evidence base is too limited to support confident claims of long-term benefit. My reliance here is limited to that modest point; accordingly, I do not undertake in this article to adjudicate any ongoing disputes over interpretation, scope, or policy implications. NICE, GnRH Review; NICE, Hormones Review; Cass, Final Report.

[26] See notes 23–25. For a detailed treatment of the standard criteria for evaluating arguments from expert authority, see Douglas Walton, Appeal to Expert Opinion: Arguments from Authority (University Park: Pennsylvania State University Press, 1997), https://www.psupress.org/books/titles/0-271-01694-9.html.

[27] D. C. Schindler, “Can Transitioning Be Healthcare? A Reflection on Sex as Symbol,” Humanum Review, U.S. v. Skrmetti Special Issue, May 20, 2025, https://humanumreview.com/articles/can-transitioning-be-healthcare-a-reflection-on-sex-as-symbol. Schindler argues that medicine’s integrity lies in serving the good of the whole human being, understood as a unity of body and person; when its ends are recast in terms extrinsic to that wholeness, it ceases to be medicine in the proper sense.

[28] I use “duty of care” in the clinical-ethical (fiduciary) sense: obligations of beneficence and non-maleficence, balanced by proportionality between expected benefits and foreseeable burdens. See Tom L. Beauchamp and James F. Childress, Principles of Biomedical Ethics, 8th ed. (New York: Oxford University Press, 2019), chs. 4–6, https://global.oup.com/ushe/product/principles-of-biomedical-ethics-9780190640873; and Pellegrino and Thomasma, A Philosophical Basis of Medical Practice, 58–118.

[29] Some advocates frame the central danger as suicide. The population-level evidence remains unsettled, and current studies have not established that medical transition reduces completed suicides. See NICE, GnRH Review; J. Ruuska et al., “All-Cause and Suicide Mortalities among Adolescents and Young Adults Referred to a Gender Identity Service,” BMJ Mental Health 27, no. 1 (2024): e300940, https://mentalhealth.bmj.com/content/ebmental/27/1/e300940.full.pdf; Cass, Final Report; cf. J. M. Turban et al., “Pubertal Suppression for Transgender Youth and Risk of Suicidal Ideation,” Pediatrics 145, no. 2 (2020): e20191725 (ideation only), https://pmc.ncbi.nlm.nih.gov/articles/PMC7073269/. Prudence requires robust evidence before adopting irreversible interventions as suicide-prevention policy. Nothing here, however, denies the gravity of distress; comprehensive psychosocial and psychiatric care should be offered regardless of the treatment course.

[30] H. Tristram Engelhardt, Jr., The Foundations of Bioethics, 2nd ed. (New York: Oxford University Press, 1996), 102–34, https://global.oup.com/academic/product/the-foundations-of-bioethics-9780195057362.

[31] Edmund D. Pellegrino, “The Medical Profession as a Moral Community,” Bulletin of the New York Academy of Medicine 66, no. 3 (1990): 221–32, https://pmc.ncbi.nlm.nih.gov/articles/PMC1809760.

[32] Cass, Final Report.

[33] NICE, GnRH Review; NICE, Hormones Review; Cass, Final Report; see also note 25.

An Eastern Principle of Relational Autonomy Shaped Attitudes Toward Mask Mandate During the COVID-19 Pandemic

2025-06-14T17:40:04+00:00

Photo by Pam Menegakis on Unsplash

Abstract

The Coronavirus 2019 (COVID-19) pandemic caught the whole world off guard and overwhelmed the disease control measures of many nations. During the pandemic, many countries resorted to masking mandates as one of the most effective ways to curb the spread of the virus. The execution of this mandate revealed significant regional and cultural differences between the US and East Asia. Chinese people in Hong Kong have voluntarily and favourably adopted it more than Americans. For the Hong Kong Chinese, mask mandate compliance can be seen as a representation of personal autonomy rather than a violation of it. This attitudinal difference in a global outbreak suggests that we must reconsider the principle of autonomy through the eyes of one’s own culture and the factors that are unique to it. Governments and institutions need to acknowledge the importance of this before implementing health policies, as it can adversely affect adherence and acceptance among their citizens. This paper aims to identify the cultural differences in defining autonomy among the Chinese Hong Kong people, along with other factors that may be relatively unique and upheld by them.

Introduction

The COVID-19 pandemic caught the world off-guard and overwhelmed the disease control measures of many nations. Many countries implemented mask mandates, seen as one of the most effective ways to curb virus spread. Execution of these mandates revealed major regional and cultural differences between the US and East Asia.

This paper will explore these differences and consider how the bioethical principle of autonomy can vary based on cultural and historical experience. Chinese people in Hong Kong generally viewed mask mandates more favorably than Americans. For Hong Kong Chinese, mask mandate compliance was a representation of personal autonomy, rather than a violation of it. In the US, where attitudes can be more individualistic, some people considered mask mandates to be an infringement of personal freedom. This paper will first analyze this variation by focusing on the unique historical factors that affected public perception in Hong Kong. It will also examine the cultural tenets and concepts of autonomy of Hong Kong Chinese people that made mask mandates so successful, while contrasting them with cultural concepts in the US that made the same policy much more controversial. Acknowledging these different cultural interpretations of autonomy can help governments and institutions design health policies that are more likely to be accepted by their citizens, leading to more effective public health interventions.

Background

Empirical evidence suggests that timely government responses were critical to curbing COVID-19 spread, but a lack of evidence-based consensus prevailed on many health measures, like mask requirements.[1] Enough scientific evidence is now available proving the efficacy of mask wearing during the pandemic, in conjunction with social distancing practices, in reducing casualties and deaths – when compliance was high.[2] In fact, data suggests mask-wearing became more popular as the scientific evidence about the airborne nature of COVID-19 transmission increased.[3]

Mask mandate implementation triggered varying responses, with data demonstrating attitudinal differences between the West and the East.[4] It is imperative to understand cultural considerations when it comes to mask mandates, both at a personal and community level, to understand this divergence. Unlike people in East Asian regions like Hong Kong and Japan, wearing masks in public was novel and uncommon for most North Americans before the COVID-19 outbreak, and resulted in sustained opposition in some areas. Violation of individual autonomy and paternalism were often cited as reasons people were opposed to mask mandates.[5] This global division is a result of cultural, political, and social differences between individuals and societies, with far more mask mandate opposition seen in the US than in Hong Kong.

Even in places like the US, some individual rights can be legally restricted to a certain degree for compelling societal goals, such as preventing the transmission of COVID-19. Individual or community rejection of wearing masks during the pandemic triggered ethical, health, and safety concerns. An unmasked person is more vulnerable in crowded and poorly ventilated places, as the virus is air-borne. By not taking proper precautions to protect themselves or others, people added to the heavily burdened health care system. Resistance to health guidelines exacerbated political polarization, especially in the West. Mask mandates in some North American countries ignited protests by “anti-maskers” who viewed such restrictions as an infringement on their rights to freedom and democracy,[6] and, more extreme, as a way for the government to exercise control over its people.[7] In extreme cases, masks served as a trigger for xenophobia and violence against Asian-Americans and Asian immigrants.[8] In Hong Kong, mask mandates were not viewed as a violation of personal or public autonomy.

Hong Kong appeared better prepared for the COVID-19 pandemic than other countries. It applied strategies for controlling virus spread quickly, likely due to personal and institutional memory of the 2003 severe acute respiratory syndrome (SARS) outbreak.[9] As an epicenter of the SARS outbreak, Hong Kong had 1,750 confirmed cases and 286 deaths, including eight healthcare professionals.[10] The explosive spread of the virus had caught the health and hospital authorities unprepared.[11] Implementing reforms inspired by that experience, by the third week of 2020, the Hong Kong Special Administrative Region’s (HKSAR) government activated its anti-epidemic response plans as COVID-19 was first emerging. Residents responded quickly and eagerly, with high rates of voluntary masking, handwashing, social distancing, and the use of thermometers at the entrances of many public spaces.[12] The collective memory of SARS positively impacted their understanding of and response to COVID-19. They prioritized civic responsibility and community well-being in critical public health crises.[13] The high mask compliance controlled community spread.[14] As a result, Hong Kong emerged relatively unscathed despite its dense population, especially in the early days of the pandemic.[15] However, it was not necessarily just their recent historical experience that influenced Hong Kong’s willingness to follow public precautions.

The Concept of Autonomy and How it Differs by Region and Culture

The word autonomy, derived from Greek words autos (‘self’) and nomos (‘rule’, ‘governance’ or ‘law’), originally referred to self-rule or self-governance of independent city-states.[16] Personal autonomy is defined as, at a minimum, self-rule that is free from controlling interference by others and from limitations that prevent meaningful choice, like inadequate understanding. Respect for autonomy is widely accepted as a dominant value in contemporary biomedical ethics. It is considered integral to informed consent,[17] a concept that gained prominence in the movement to end involuntary participation in medical research.[18] Conceptually, it evolved in Western contexts and disregards some non-Western regional and cultural influences.[19] The pandemic led to questions about how autonomy is defined and operationalized, prompting some bioethicists to call for an alternative to this individualistic vision.[20] Traditionally, autonomy enjoys the highest priority in American bioethics,[21] yet some suggest that this was never the intent. Instead, the original goal was to construct a concept of respect for autonomy that is not excessively individualistic, not excessively focused on reason, and not unduly legalistic.[22] By not neglecting emotions or downplaying social practices, this broader definition aligns well with the Hong Kong Chinese view on autonomy.

The Western concept of autonomy focuses on self-determination, prioritizing the subjective value of individual independence. The East Asian or Hong Kong Chinese concept may, by contrast, be perceived as relatively more objective, family-facilitated, and culturally-comprised.[23]

Mask mandates came at a huge personal cost.[24] Apart from the physical discomfort, there was an increased sense of self-social isolation and anxiety when mask mandates were imposed during the pandemic; children could not develop their language and social skills normally with their masks on; people with hearing difficulties could not understand and communicate effectively with others in the absence of facial and visual cues.[25] In many places, their removal came as a great relief and brought back a semblance of normal everyday life. While Hong Kong was one of the last places in the world to remove mask mandates (it did so on March 2, 2023),[26] many people preferred to keep their masks on.[27] This attitude may have a cultural and social basis.[28] The masking rate was high, and the public was confident of its effectiveness.[29] Most people didn’t intend to violate the mandate, were rather eager to wear masks and reluctant to take them off even after 945 days when Hong Kong lifted its mask mandate.[30] Culturally, this could be seen as an alternative way of exercising autonomy.

Relational Autonomy

In recent years, bioethicists have emphasized relational autonomy as a way to incorporate a wider variety of ethical experience.[31] For purposes of this paper, the definition of relational autonomy is the capacity to make decisions as an individual embedded in social relationships.[32] Humans are always involved in a network of social relations. Their choices are highly influenced by social categories like gender, ethnicity, and culture.[33] The broader conception of autonomy may provide a robust alternative to thinner, individually centered definitions and can encompass responses like those seen in Hong Kong more completely. This approach may also provide a more sustainable ethical grounding for intrusive social interventions in future crises.[34]

In Hong Kong, high mask mandate compliance during the pandemic may be evidence of relational autonomy. It has a network of close physical and social relations, partially due to crowding and limited living space. As of 2022, close to 30 percent of Hong Kong’s over 7 million residents live in public rental housing.[35] As of March 2023, the average living space for renters was 13.8 square meters per person. A large population of poor people live in cage homes, which are subdivided flats with bed-sized areas enclosed in wire mesh.[36] Individual autonomy is hard to exercise without the input or influence of others who share this small, confined space.

In addition to being a reflection of physical space, relational autonomy can also align with deeper historical and cultural norms. In Chinese society, the concept of family is often tightly bound by traditional and cultural values. In the Chinese language, ‘autonomy’ (zi-zhu, 自主) also means self-determination of units of people, such as a family and community, rather than individuals. Under this conception of autonomy, family members of a patient are involved in making healthcare decisions together with the patient. This version of autonomy is more family-centric than individual-based; consideration of the group may supersede individual consideration.

Conceptions of autonomy are further linked to communitarian values held by many Chinese people, including those in Hong Kong. Individual autonomy in Chinese culture is strongly influenced by a culture of filial considerations. Communitarianism is the interlinking idea that human identities are largely shaped by different kinds of constitutive communities or social relations and that this conception of human nature should inform our moral and political judgments as well as policies and institutions.[37] Pure individualism is not considered ideal for forming moral judgments and making daily decisions. Humans are not meant to live alone; they need a sense of belonging, acceptance, and identity in their community. Interdependence motivates and nurtures an individual to care for others out of moral obligation. Communitarianism and relational autonomy reflect a more nuanced understanding of how human identities are shaped by constitutive communities and impact moral and political judgments as well as policies and institutions.[38]

Relational autonomy could be a result of such undesirable social and environmental conditions. It is a relatively dynamic attribute that considers relationship complexities reflecting a more precise reality.[39] On a positive note, a family sharing a small living space can live happily if there is enough support and love. This echoes the concept that relational autonomy does not necessarily reject the notion of self but reflects how an individual with support from family and friends can make decisions and enjoy autonomy while considering others. Willingness to comply with mask mandates during the pandemic aligns with these general cultural differences between the Chinese and the Americans.[40]

Adherence to Mask Mandate is an Act of Both Personal and Relational Autonomy

It is common for sick people in Hong Kong to wear masks in public places during cold and flu seasons to protect themselves and minimize spread.[41] The original intention of Asians wearing masks was not to protect themselves but to protect others first.[42] The high mask compliance in Hong Kong is not only due to its past experiences, but also a sense of collective responsibility and civic duty to reduce disease transmission. It is an active expression of autonomy–both personal and relational–which is perceived differently in some parts of the West. Mask mandates allow individuals to do what they want to do, like protecting themselves and others in a health crisis in a densely populated city like Hong Kong.

Hong Kong Chinese people are inclined to include others in their considerations and actions due to cultural and philosophical influences. Exercising their autonomy, including relational autonomy, by choosing to adhere to mask mandates during the pandemic is closely linked to the communitarian values that are heavily influenced by Confucianism.

A Comparison with the US

The willingness to wear masks during the COVID-19 pandemic was not restricted to Chinese people or East Asians in general. Many Westerners also embraced face masks during the outbreak, but the sharp difference between the rates of compliance and the protests against mask mandates was notable between the East and the West.[43] Those with preexisting conditions who felt fragile and vulnerable to infections, or wanted to protect the people who did, donned masks regardless of location. Cancer patients in the US felt unprotected from COVID-19 when there was no mask mandate.[44] Some were harassed and insulted by “anti-maskers” when they wore masks for their protection. In certain cases, patients were anxious when their health care providers didn’t wear masks. To others, mask mandates were perceived as restrictions infringing on their freedom.[45] Traditionally, individual rights and freedom are highly esteemed in the US.[46] Anti-mask rallies across North America further divided the public on mask use.[47] This resistance, due to its individualistic nature,[48] was especially apparent during the initial spread of the virus. However, not all reasons for refusing to wear a mask were explicitly political. The top three reasons for opposing public mask wearing in the US were physical discomfort and negative effects, lack of effectiveness, and being unnecessary or inappropriate for certain people or under certain circumstances. Apart from individual freedom, there were medical and social reasons for not complying with mask mandates during the pandemic.

Varying Recommendations Among Countries and Trust in Experts

Not all debates about mandates are as clear as an analysis of autonomy. Trust in health experts, medical organizations, and health authorities is an important factor that correlates with citizens’ compliance during pandemics.[49] Doctors and scientists were often among the most trusted professions.[50]

Post-pandemic, many studies have reported a lower trust in doctors and scientists.[51] Contrasting views on face masks, especially during the beginning of the COVID-19 pandemic, contributed to this decrease in trust.[52] In the US, the CDC did not recommend mask-wearing and even said masks would not be effective, contrary to the approaches of Asian countries. It later reversed course, saying mask mandates would be effective, recommending mask use in April 2020 for individuals with respiratory symptoms who had close contact with family members.[53] By contrast, early on, some Chinese government officials and public health experts called for universal use of face masks in public spaces. Inconsistent official guidelines and expert opinions confused the public and health care professionals, and hindered risk communications during the pandemic, complicating the acceptance of mask mandates beyond underlying ethical precepts.[54]

Counterarguments

Despite its usefulness during the COVID-19 pandemic, masking is not free of side effects. The most obvious downside is its physical discomfort, causing difficulty breathing, facial irritation, headache, etc.[55] Mask mandates had many social and developmental costs, especially for young children. As noted above, mask mandates came at a huge personal cost.[56] Apart from the physical discomfort, there were increased senses of self-social isolation and anxiety; children could not develop their language and social skills; people with hearing difficulties could not understand and communicate effectively.[57] Even if relational autonomy applied, the influence of and benefit to the greater community calls for a balanced analysis and evidence-based policies. Consideration of the uncertainty during the early pandemic and the noted problems associated with long-term mask wearing may justify some degree of opposition to masking.

Arguably, relational autonomy is already implicitly part of the practice of autonomy in the US. A person’s values are shaped by their family upbringing, education, experience, and their surrounding communities. An individual is free to consult anyone when making healthcare decisions and evaluating public health recommendations. A recent survey showed that about 43 percent of Americans believed that it is extremely important to wear a mask in crowded settings when feeling sick.[58] In the same survey, 74 percent of people agreed that it is also extremely important to avoid contact with vulnerable people when feeling sick. These findings show that many Americans are also considerate about the well-being of other people as a group or community while at the same time exercising their own autonomy to protect themselves by wearing masks.

These findings show it is wrong to assume that everyone in the US was an anti-masker. Anti-masking may be rooted in the deep political divides of the US population. Democrats and Republicans are seldom aligned and their views towards the mask mandates also vary widely. Republicans had significantly more negative attitudes toward masks and lower intentions to wear them.[59] These competing factors show that it is important to treat values like autonomy with nuance and consider the range of opinions and political tensions within a population as well as between.

Conclusion

Key differences existed between American and Hong Kong Chinese people’s attitudes toward mask-wearing during the pandemic. Hong Kong Chinese people were accustomed to wearing masks in crowded spaces, when they were unwell, or while taking care of the young or the elderly at home, even after the mask mandate ended. It was considered an act of personal autonomy, yet it also explicitly reflects relational autonomy. Countries with more developed traditions of relational autonomy stemming from communitarian or family-oriented traditions had higher compliance with mask mandates. Their people gave up a certain extent of “freedom” to ensure a higher level of safety for themselves, their family, and society amid the pandemic. In some parts of the US, people prioritized individual freedom and self-comfort. The US and other Western world leaders, including medical professionals, undermined their own credibility and thus public trust in them due to unclear guidelines and policies at the beginning of the pandemic, making it hard for citizens to abide by mask mandates at a later stage. Asian people, in general, displayed a higher level of trust in their public health authorities, creating mutually reinforcing tendencies that made the public more willing to embrace mask mandates.

In conclusion, traditional values and principles upheld by the Hong Kong Chinese people influence how autonomy is perceived and exercised. The concept of autonomy evolves with historical experience and can be impacted by a sequence of events, cultural factors, social norms, and education. Using mask mandates as an example, relational autonomy accommodates a more inclusive definition of self-decision than traditional autonomy, as the former acknowledges and values the influence of relationships between people and their communities when making individual choices. Taking these relationships into account when designing policies, especially in times of crisis, can be critical to a successful response.

[1] Blavatnik School of Government, University of Oxford. (n.d.). About the project. https://www.bsg.ox.ac.uk/research/covid-19-government-response-tracker#:~:text=Current%20empirical%20evidence%20strongly%20supports.

[2] Howard, J., Huang, A., Li, Z., Tufekci, Z., Zdimal, V., Westhuizen, H.-M. van der, Delft, A. von, Price, A., Fridman, L., Tang, L.-H., Tang, V., Watson, G. L., Bax, C. E., Shaikh, R., Questier, F., Hernandez, D., Chu, L. F., Ramirez, C. M., & Rimoin, A. W. (2021). An evidence review of face masks against COVID-19. Proceedings of the National Academy of Sciences, 118(4). https://doi.org/10.1073/pnas.2014564118; Kwon, S., Joshi, A. D., Lo, C.-H., Drew, D. A., Nguyen, L. H., Guo, C.-G., Ma, W., Mehta, R. S., Shebl, F. M., Warner, E. T., Astley, C. M., Merino, J., Murray, B., Wolf, J., Ourselin, S., Steves, C. J., Spector, T. D., Hart, J. E., Song, M., & VoPham, T. (2021). Association of social distancing and face mask use with risk of COVID-19. Nature Communications, 12(1). https://doi.org/10.1038/s41467-021-24115-7; Rader, B., White, L. F., Burns, M. R., Chen, J., Brilliant, J., Cohen, J., Shaman, J., Brilliant, L., Kraemer, M. U. G., Hawkins, J. B., Scarpino, S. V., Astley, C. M., & Brownstein, J. S. (2021). Mask-wearing and control of SARS-CoV-2 transmission in the USA: A cross-sectional study. The Lancet Digital Health. 3(3), e148-e157. https://doi.org/10.1016/S2589-7500(20)30293-4 (A cross-sectional study based on 378,207 survey responses across the U.S. reported increasing evidence regarding the importance of mask-wearing to mitigate ongoing waves of transmission as vaccines began distribution).

[3] Hale, T., Petherick, A., Phillips, T., Anania, J., Andretti de Mello, B., Angrist, N., Barnes, R., Boby, T., Cameron-Blake, E., Cavalieri, A., Di Folco, M., Edwards, B., Ellen, L., Elms, J., Furst, R., Gomes Ribeiro, L., Green, K., Goldszmidt, R., Hallas, L., ... Vaccaro, A. (2023, June). Variation in government responses to COVID-19, version 15. Blavatnik School of Government Working Paper. www.bsg.ox.ac.uk/covidtracker.

[4] Zhang, Y. S. D., Noels, K. A., Young-Leslie, H., & Lou, N. M. (2022). ‘Responsible’ or ‘strange?’ Differences in face mask attitudes and use between Chinese and Non-East Asian Canadians during COVID-19’s first wave. Frontiers in Psychology, 13. https://doi.org/10.3389/fpsyg.2022.853830; Martinelli, L., Kopilaš, V., Vidmar, M., Heavin, C., Machado, H., Todorović, Z., Buzas, N., Pot, M., Prainsack, B., & Gajović, S. (2021). Face masks during the COVID-19 pandemic: A simple protection tool with many meanings. Frontiers in Public Health, 8. https://doi.org/10.3389/fpubh.2020.606635.

[5] Kemmelmeier, M., & Jami, W. A. (2021). Mask wearing as cultural behavior: An investigation across 45 U.S. states during the COVID-19 pandemic. Frontiers in Psychology, 12. https://doi.org/10.3389/fpsyg.2021.648692.

[6] Taylor, S., & Asmundson, G. J. G. (2021). Negative attitudes about facemasks during the COVID-19 pandemic: The dual importance of perceived ineffectiveness and psychological reactance. PLOS ONE, 16(2). https://doi.org/10.1371/journal.pone.0246317.

[7] Warick, J. (2020). Anti-mask sentiment ‘very similar to brainwashing,’ prof says in wake of Sask. COVID-19 protest. Toronto: CBC. https://www.cbc.ca/news/canada/saskatoon/anti-mask-sentiment-very-similar-to-brainwashing-prof-says-in-wake-of-sask-covid-19-protest-1.5831872

[8] Choi, H. A., & Lee, O. E. (2021). To mask or to unmask, that is the question: Facemasks and anti-Asian violence during COVID-19. Journal of Human Rights and Social Work, 6, 237-245. https://doi.org/10.1007/s41134-021-00172-2.

[9] Wong, S. Y. S., Kwok, K. O., & Chan, F. K. L. (2020). What can countries learn from Hong Kong’s response to the COVID-19 pandemic? Canadian Medical Association Journal, 192(19), E511-E515. https://doi.org/10.1503/cmaj.200563.

[10] Lee, S. H. (2003). The SARS epidemic in Hong Kong. Journal of Epidemiology & Community Health, 57(9), 652-654. https://doi.org/10.1136/jech.57.9.652.

[11] Hung, L. S. (2003). The SARS epidemic in Hong Kong: What lessons have we learned? Journal of the Royal Society of Medicine, 96(8), 374-378. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC539564/.

[12] Matus, K., Sharif, N., Li, A., Cai, Z., Lee, W. H., & and Song, M. (2023). From SARS to COVID-19: the role of experience and experts in Hong Kong’s initial policy response to an emerging pandemic. Humanities and Social Sciences Communications, 10, 9. https://doi.org/10.1057/s41599-022-01467-z.

[13] Cheung, T., Fong, T. K. H., & Bressington, D. (2020). COVID‐19 under the SARS cloud: Mental health nursing during the pandemic in Hong Kong. Journal of Psychiatric and Mental Health Nursing, 28(2). https://doi.org/10.1111/jpm.12639.

[14] Tam, V. C., Tam, S., Khaw, M., Law, H. K., Chan, C. P., & Lee, S. W. (2021). Behavioural insights and attitudes on community masking during the initial spread of COVID-19 in Hong Kong. Hong Kong Medical Journal, 27(2), 106-112. https://doi.org/10.12809/hkmj209015.

[15] Tam, V. C., Tam, S., Khaw, M., Law, H. K., Chan, C. P., & Lee, S. W. (2021). Behavioural insights and attitudes on community masking during the initial spread of COVID-19 in Hong Kong. Hong Kong Medical Journal, 27(2), 106-112. https://doi.org/10.12809/hkmj209015.

[16] Beauchamp, T. L., & Childress, J. F. (2001). Principles of biomedical ethics (5th ed.). Oxford University Press.

[17] Delany, C. M. (2005). Respecting patient autonomy and obtaining their informed consent: Ethical theory—Missing in action. Physiotherapy, 91(4), 197-203. https://doi.org/10.1016/j.physio.2005.05.002

[18] Faden, R. R., & Beauchamp, T. L. (1986). A history and theory of informed consent. Oxford University Press.

[19] Chattopadhyay, S., & De Vries, R. (2008). Bioethical concerns are global, bioethics is Western. Eubios Journal of Asian and International Bioethics, 18(4), 106-109. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2707840/.

[20] Gómez-Vírseda, C., & Usanos, R. A. (2021). Relational autonomy: Lessons from COVID-19 and twentieth-century philosophy. Medicine, Health Care and Philosophy, 24, 493-505. https://doi.org/10.1007/s11019-021-10035-2.

[21] Sedig, L. (2018). What’s the role of autonomy in patient- and family-centered care when patients and family members don’t agree? AMA Journal of Ethics, 18(1), 12-17. https://doi.org/10.1001/journalofethics.2017.18.1.ecas2-1601.

[22] Thompson, H. (2020). Children’s autonomy and medical decision making (Honor Scholar Theses, 164, Scholarly and Creative Work from DePauw University). https://scholarship.depauw.edu/studentresearch/164.

[23] Bergstresser, S. M., Ghias, K., Lane, S., Lau, W.-M., Hwang, I. S. S., Miu, O., Klitzman, R., & Ng, H. K. (2020). What does it mean for a case to be ‘local’?: The importance of local relevance and resonance for bioethics education in the Asia-Pacific region. Asian Bioethics Review, 12(2), 173-194. https://doi.org/10.1007/s41649-020-00120-8 (outlines several local bioethical cases specific to different geographical regions (Hong Kong, Australia, Pakistan and Malaysia).

[24] World Health Organization. (2022). The impact of COVID-19 on mental health cannot be made light of. https://www.who.int/news-room/feature-stories/detail/the-impact-of-covid-19-on-mental-health-cannot-be-made-light-of.

[25] Poon, B. T., & Jenstad, L. M. 2022. Communication with face masks during the COVID-19 pandemic for adults with hearing loss. Cognitive Research Principles and Implications 7 (1). https://doi.org/10.1186/s41235-022-00376-8; Sandlund, J., Ram, D., Shamez, N. L., Kelly, S., Jeanne, N., & Tracy, B. H. 2023. “Child Mask Mandates for COVID-19: A Systematic Review.” Archives of Disease in Childhood, 109(3), e1-e7. https://doi.org/10.1136/archdischild-2023-326215; Ramdani, C., Michael, O., & Antoine, C. (2022). Communicating and reading emotion with masked faces in the Covid era: A short review of the literature. Psychiatry Research, 316(July), 114755. https://doi.org/10.1016/j.psychres.2022.114755.

[26] Hong Kong’s Information Services Department. (n.d.). Mask-wearing requirement to be lifted. https://www.news.gov.hk/eng/2023/02/20230228/20230228_095007_996.html.

[27] Hung, E. (2024). Why are young Hongkongers still wearing masks despite end of Covid rules? https://www.scmp.com/news/hong-kong/health-environment/article/3257744/hong-kongs-covid-mask-rules-are-long-gone-so-why-are-so-many-children-and-teenagers-still-covering.

[28] Cha, S. E., Ku, X., & Choi, I. (2023). Post COVID-19, still wear a face mask? Self-perceived facial attractiveness reduces mask-wearing intention. Frontiers in Psychology, 14. https://doi.org/10.3389/fpsyg.2023.1084941

[29] Tam, V. C., Tam, S., Khaw, M., Law, H. K., Chan, C. P., & Lee, S. W. (2021). Behavioural insights and attitudes on community masking during the initial spread of COVID-19 in Hong Kong. Hong Kong Medical Journal, 27(2), 106-112. https://doi.org/10.12809/hkmj209015.

[30] 32Primrose, R. & Chan, H.H. (2023). An addiction: masks come off slowly in Hong Kong as habit outlasts Covid. Financial Times. https://www.ft.com/content/e5d7fa78-642a-4189-8e83-bdbaad5ee172

[31] Campbell, S., MacKenzie, C., & Stoljar, N. (2002). Review of relational autonomy: Feminist perspectives on autonomy, agency, and the social self. Hypatia, 17(2), 165-168. https://www.jstor.org/stable/3810758; Delgado, J. (2019). Re-thinking relational autonomy: Challenging the triumph of autonomy through vulnerability. Bioethics Update, 5(1), 50-65. https://doi.org/10.1016/j.bioet.2018.12.001; Gómez-Vírseda, C., & Usanos, R. A. (2021). Relational autonomy: Lessons from COVID-19 and twentieth-century philosophy. Medicine, Health Care and Philosophy, 24, 493-505. https://doi.org/10.1007/s11019-021-10035-2.

[32] Delgado, J. (2019). Re-thinking relational autonomy: Challenging the triumph of autonomy through vulnerability. Bioethics Update, 5(1), 50-65. https://doi.org/10.1016/j.bioet.2018.12.001.

[33] Varkey, B. (2021). Principles of clinical ethics and their application to practice. Medical Principles and Practice, 30(1), 17-28. https://doi.org/10.1159/000509119.

[34] Gómez-Vírseda, C., & Usanos, R. A. (2021). Relational autonomy: Lessons from COVID-19 and twentieth-century philosophy. Medicine, Health Care and Philosophy, 24, 493-505. https://doi.org/10.1007/s11019-021-10035-2.

[35] Statista. (n.d.). Hong Kong: Public rental housing average living space per person 2023. https://www.statista.com/statistics/630746/hong-kong-public-rental-housing-average-living-space-per-person/#:~:text=As%20of%20March%202023%2C%20the.

[36] Bergstresser, S. M., Ghias, K., Lane, S., Lau, W.-M., Hwang, I. S. S., Miu, O., Klitzman, R., & Ng, H. K. (2020). What does it mean for a case to be ‘local’?: The importance of local relevance and resonance for bioethics education in the Asia-Pacific region. Asian Bioethics Review, 12(2), 173-194. https://doi.org/10.1007/s41649-020-00120-8.

[37] Bell, D. (2024). Communitarianism. Stanford Encyclopedia of Philosophy. June 7, 2024. https://plato.stanford.edu/entries/communitarianism/.

[38] Bell, D. (2024). Communitarianism. Stanford Encyclopedia of Philosophy. June 7, 2024. https://plato.stanford.edu/entries/communitarianism/.

[39] Delgado, J. (2019). Re-thinking relational autonomy: Challenging the triumph of autonomy through vulnerability. Bioethics Update, 5(1), 50-65. https://doi.org/10.1016/j.bioet.2018.12.001.

[40] Choi, H. A., & Lee, O. E. (2021). To mask or to unmask, that is the question: Facemasks and anti-Asian violence during COVID-19. Journal of Human Rights and Social Work, 6, 237-245. https://doi.org/10.1007/s41134-021-00172-2; Burgess, A., & Horii, M. (2012). Risk, ritual and health responsibilisation: Japan’s ‘safety blanket’ of surgical face mask-wearing. Sociology of Health & Illness, 34(8), 1184-1198. https://doi.org/10.1111/j.1467-9566.2012.01466.x.

[41] Wada, K., Oka-Ezoe, K., & Smith, D. R. (2012). Wearing face masks in public during the influenza season may reflect other positive hygiene practices in Japan. BMC Public Health, 12(1). https://doi.org/10.1186/1471-2458-12-1065.

[42] Choi, H. A., & Lee, O. E. (2021). To mask or to unmask, that is the question: Facemasks and anti-Asian violence during COVID-19. Journal of Human Rights and Social Work, 6, 237-245. https://doi.org/10.1007/s41134-021-00172-2.

[43] Choi, H. A., & Lee, O. E. (2021). To mask or to unmask, that is the question: Facemasks and anti-Asian violence during COVID-19. Journal of Human Rights and Social Work, 6, 237-245. https://doi.org/10.1007/s41134-021-00172-2; Burgess, A., & Horii, M. (2012). Risk, ritual and health responsibilisation: Japan’s ‘safety blanket’ of surgical face mask-wearing. Sociology of Health & Illness, 34(8), 1184-1198. https://doi.org/10.1111/j.1467-9566.2012.01466.x; Burgess, A., & Horii, M. (2012). Risk, ritual and health responsibilisation: Japan’s ‘safety blanket’ of surgical face mask-wearing. Sociology of Health & Illness, 34(8), 1184-1198. https://doi.org/10.1111/j.1467-9566.2012.01466.x; Wong, T. (2020). Corona 19: Countries with or without mask. BBC News Singapore. https://www.bbc.com/news/world-52015486.

[44] Forster, V. (2022). Lack of mask mandates leaves cancer patients feeling unprotected. Cancer Therapy Advisor. https://www.cancertherapyadvisor.com/features/lack-of-mask-mandates-leaves-cancer-patients-feeling-unprotected/#:~:text=A%20lack%20of%20mask%20mandates.

[45] Taylor & Asmundson (2021); Warick, J. (2020). Anti-mask sentiment ‘very similar to brainwashing,’ prof says in wake of Sask. COVID-19 protest. CBC. https://www.cbc.ca/news/canada/saskatoon/anti-mask-sentiment-very-similar-to-brainwashing-prof-says-in-wake-of-sask-covid-19-protest-1.5831872#:~:text=Saskatoon-.

[46] Song, S., & Choi, Y. (2022, November 16). Differences in the COVID-19 pandemic response between South Korea and the United States: A comparative analysis of culture and policies. Journal of Asian and African Studies, 58(2), 196-213. https://doi.org/10.1177/00219096221137655; Rains, S. A., Colombo, P. M., Quick, B. L., & Kriss, L. A. (2022). State mask mandates and psychological reactance theory: The role of political partisanship and COVID-19 risk in mask adoption and resistance. Social Science & Medicine, 314, 115479. https://doi.org/10.1016/j.socscimed.2022.115479.

[47] Bogart, N. (2020). Anti-mask rallies held across Canada despite increased support for mandatory masks. https://www.ctvnews.ca/health/coronavirus/anti-mask-rallies-held-across-canada-despite-increased-support-for-mandatory-masks-1.5031078

[48] Rains, S. A., Colombo, P. M., Quick, B. L., & Kriss, L. A. (2022). State mask mandates and psychological reactance theory: The role of political partisanship and COVID-19 risk in mask adoption and resistance. Social Science & Medicine, 314, 115479. https://doi.org/10.1016/j.socscimed.2022.115479.

[49] Chen, G., Zhang H., Hu, Y., & Luo, C. (2024). Trust as a catalyst: Revealing the impact of government trust and professional trust on public health policy compliance during a pandemic. BMC Public Health, 24(1). https://doi.org/10.1186/s12889-024-18449-2

[50] Clemence, M. & Jackson, C. (2022). Doctors and scientists are seen as the world’s most trustworthy professions. Ipsos Global Trustworthiness Index 2022. https://www.ipsos.com/en/global-trustworthiness-index-2022

[51] Soliman, A. (2024, November 14). US trust in scientists plunged during the pandemic — But it’s starting to recover. Nature. www.nature.com/articles/d41586-024-03723-5, https://doi.org/10.1038/d41586-024-03723-5.

[52] He, L., He, C., Reynolds, T. L., Bai, Q., Huang, Y., Li, C., Zheng, K., & Chen, Y. (2021). Why do people oppose mask wearing? A comprehensive analysis of US tweets during the COVID-19 pandemic. Journal of the American Medical Informatics Association, 28(7). https://doi.org/10.1093/jamia/ocab047.

[53] Dwyer, C., & Aubrey, A. (2020). “CDC Now Recommends Americans Consider Wearing Cloth Face Coverings in Public.” NPR, April 3, 2020. https://www.npr.org/sections/coronavirus-live-updates/2020/04/03/826219824/president-trump-says-cdc-now-recommends-americans-wear-cloth-masks-in-public; Fisher, K. A., Barile, J. P., Guerin, R. J., Vanden Esschert, K. L. Jeffers, A., Tian, L. H., Garcia-Williams, A., Gurbaxani, B., Thompson, W. W., & Prue, C. E. (2020). Factors associated with cloth face covering use among adults during the COVID-19 pandemic — United States, April and May 2020. MMWR Morbidity and Mortality Weekly Report, 69(28), 933-937. https://doi.org/10.15585/mmwr.mm6928e3.

[54] Chan, K. H., & Yuen, K.-Y. (2020). COVID-19 epidemic: Disentangling the re-emerging controversy about medical facemasks from an epidemiological perspective. International Journal of Epidemiology, 49(4), 1063-1066.https://doi.org/10.1093/ije/dyaa044.

[55] Bakhit, M., Krzyzaniak, N., Scott, A. M., Clark, J., Glasziou, P., & Mar, C. D. (2021). Downsides of face masks and possible mitigation strategies: A systematic review and meta-analysis. BMJ Open, 11(2), e044364. https://doi.org/10.1136/bmjopen-2020-044364.

[56] World Health Organization. (2022). The impact of COVID-19 on mental health cannot be made light of. https://www.who.int/news-room/feature-stories/detail/the-impact-of-covid-19-on-mental-health-cannot-be-made-light-of.

[57] Poon, B. T., & Jenstad, L. M. 2022. Communication with face masks during the COVID-19 pandemic for adults with hearing loss. Cognitive Research Principles and Implications 7 (1). https://doi.org/10.1186/s41235-022-00376-8; Sandlund, J., Ram, D., Shamez, N. L., Kelly, S., Jeanne, N., & Tracy, B. H. 2023. “Child Mask Mandates for COVID-19: A Systematic Review.” Archives of Disease in Childhood, 109(3), e1-e7. https://doi.org/10.1136/archdischild-2023-326215; Ramdani, C., Michael, O., & Antoine, C. (2022). Communicating and reading emotion with masked faces in the Covid era: A short review of the literature. Psychiatry Research, 316(July), 114755. https://doi.org/10.1016/j.psychres.2022.114755.

[58] Alec, T., Lipka, M., & Deane, C. (2025). “5 years later: America looks back at the impact of COVID-19.” Pew Research Center. February 12, 2025. https://www.pewresearch.org/politics/2025/02/12/5-years-later-america-looks-back-at-the-impact-of-covid-19/.

[59] Gelfand, M., Li, R., Stamkou, E., Pieper, D., Denison, E., Fernandez, J., Choi, V., Chatman, J., Jackson, J., & Dimant, E. (2022). “Persuading Republicans and Democrats to Comply with Mask Wearing: An Intervention Tournament.” Journal of Experimental Social Psychology 101, (July), 104299. https://doi.org/10.1016/j.jesp.2022.104299.

The Ethical Duty of Residency Programs to Support the Social Well-being of International Medical Graduates

2025-06-28T00:28:01+00:00

Photo ID 171204020 © Chormail | Dreamstime.com

Abstract

Residency programs have a responsibility for supporting the holistic well-being of the international medical graduates (IMGs) who have matched with their program. A holistic approach should include support not only in their clinical development, but also in their social and emotional growth. IMGs, especially new interns, often must navigate complex personal, professional, and cultural transitions. This paper explores how the lack of social networks outside the clinical setting impacts IMGs’ well-being, resilience, and clinical performance, with implications for patient care. Drawing on existing literature, ethical frameworks, the thematic analysis of eight IMG narrative articles, and a reflexive narrative by the author, this paper outlines key questions to guide future research. I will also offer recommendations for residency program directors to better support IMG residents through their transition into graduate medical education.

Introduction

As a patient with a complex medical history, I had a lot of time on my hands after being unable to work or walk without the need for intense and ongoing physical therapy for nearly three years. During those years of care, I interacted with several medical students and residents. I became curious about who physicians are as people, and the brief responses provided by my orthopedic surgeon were not enough due to time constraints. Even then, I knew that the scope of our appointments was to discuss progress after surgeries. He had no obligation to satisfy my curiosity, so I began turning to residents instead. I started meeting with residents outside of my healthcare system to hear their stories. At that time, I did not know the term “International Medical Graduate,” but I found that residents from other countries were the ones most willing to speak with me.

International Medical Graduates (IMGs) make up about a quarter of US residency trainees, and more than 325,000 IMGs are practicing physicians, filling critical gaps in underserved areas.^[1] The contributions that IMGs make to the US Healthcare system are laudable, but they come at a great cost. IMGs face significant personal and professional challenges throughout their career, often beginning in residency. During their first post-graduate year, they relocate to a new country while simultaneously balancing the intense demands of residency. IMGs can face challenges with cultural adjustment, language barriers, and social isolation. The loss of familiar social networks and cultural understanding increases their risk for emotional distress and burnout, which in turn can weaken their clinical performance.

Residency programs have a responsibility to support IMGs beyond their clinical development. While formal mentorship within the hospital is important, the role of social networks outside the clinical setting, including peer relationships, social integration into the community, and gaining familiarity with public places, is often overlooked. This paper argues that residency programs have an ethical obligation to actively foster these social supports to reduce isolation, improve well-being, and strengthen IMGs’ professional development.^[2]

The challenges IMGs face are not simply individual struggles; they are institutional issues. The absence of local social connections leaves many susceptible to loneliness and additional stress. These issues conflict with their need for stability. Although technology helps maintain long-distance social networks, it is not a substitute for meaningful in-person connections that build belonging.^[3]

Ultimately, supporting IMGs means moving beyond clinical mentorship to intentionally help them with cultivating relationships outside the clinical environment. Doing so is not optional; it is essential to uphold the ethical standards of medical education. Providing opportunities for IMGs to build social networks outside the healthcare system in which they work supports IMGs’ well-being and ensures high-quality patient care. This paper examines the responsibilities to support IMGs comprehensively through an ethical frame and proposes practical recommendations for residency program directors.

The Role of Social Support

Social support is a soft landing in high-stress environments. Peer and supervisor support can lower burnout and increase overall well-being.^[4] Physicians with strong social networks report fewer mental health concerns and demonstrate higher clinical performance.^[5]

For IMGs, support from residency programs is especially critical. When residency programs offer mentorship, peer networks, and IMG-focused support, residents report less emotional fatigue and greater job satisfaction.^[6] This aligns with research linking loneliness to burnout in healthcare.^[7] However, while professional support is necessary and beneficial, it does not fill the social-emotional needs in the same way that peer and other nonclinical networks can. The lack of informal, personal connections outside of work leaves IMGs vulnerable to social isolation, which professional mentorship alone cannot resolve.^[8] This persistent gap highlights the need for residency programs to foster both professional and personal social networks to truly support IMGs’ well-being.

The Social Network Theory reinforces the need for both close personal ("bonding") and broader institutional ("bridging") ties.^[9] Bonding ties refer to strong, emotionally supportive relationships, such as close friendships or familial-like connections. These types of connections provide a sense of belonging and psychological safety. Bridging ties, on the other hand, connect individuals to broader networks that offer access to resources, opportunities, and professional growth. It takes time and effort to build both kinds of networks. Residency programs need to create opportunities where IMGs feel seen, included intentionally, and supported both socially and professionally. The responsibility falls not just on the individuals to adjust and make these kinds of social networks happen, but on institutions to foster the conditions under which meaningful connections can take place.^[10]

Challenges of Geographical Relocation

Geographical relocation for residency disrupts an IMG’s established social network by physically removing them from the people, places, and culture that provide emotional support and stability. This displacement means leaving social networks that have been built over time or embedded since birth. Their sudden absence removes elements such as practical help, encouragement, and a sense of belonging that are essential during the stressful transition into residency.^[11]

After relocation, IMGs find themselves in entirely new social and cultural contexts where their usual modes of communication, social norms, and familiar community settings are no longer available. Regularly frequented local establishments such as cafés, libraries, or gyms keep people grounded, help to establish a routine, and maintain a sense of familiarity. Human beings thrive in familiar surroundings because familiarity fosters a sense of comfort and resilience. This is especially true during major life transitions.^[12]

Physical spaces that improve our well-being include informal gathering spots outside of home and work that foster social connection, belonging, and a sense of community.^[13] For IMGs, they have the potential to fill a vital gap by providing an informal way to interact with others and begin building local social networks. They offer routine and unstructured opportunities for connection that don't require cultural or professional fluency to participate. These communal spaces support emotional well-being, particularly in individuals navigating transition or isolation.^[14] Without opportunities to engage with such spaces, IMGs miss a powerful pathway to social reintegration and emotional stability during training.

The Paradox of Technology: Connected and Disconnected

Access to video calls and social media helps IMGs stay connected to family and friends. However, digital communication provides only temporary relief, and overuse of digital communication may even intensify feelings of isolation when used as a substitute for in-person social interactions. Overreliance on digital forms of communication, particularly social media, is associated with increased feelings of isolation among healthcare workers.^[15] Although digital tools provide a means to keep in touch with social networks abroad, technology keeps IMGs in a paradox of being connected but still lonely.

Everyday interactions like shared meals, warm embraces, and enjoying quality time together are experiences. They cannot be recreated virtually. IMGs are often expected to perform at the highest clinical level while quietly enduring emotional disconnection, with little to no institutional recognition of how deeply it impacts their well-being.^[16]

The Effects of Loneliness

Chronic loneliness is more than just a sad feeling; it alters the mind and body by raising stress levels, disrupting sleep, weakening the immune system, and increasing the risk of heart disease and cognitive decline.^[17] The loneliness and isolation IMGs face due to losing their trusted support system could rival the premature death rate of smoking daily.^[18]

Intersections of Social Networks, Well-being, and Patient Care

Social isolation has measurable effects on professional performance. It disrupts the ability to think, make sound choices, communicate, and collaborate effectively.^[19] Some residents who feel unsupported hesitate to ask for help or raise concerns, which can lead to clinical errors, missed learning opportunities, and poor evaluations. Social distress is not just a personal burden—it is an institutional risk.

The lack of social networks contributes to emotional exhaustion, cognitive fatigue, and a reduced sense of self-efficacy. Over time, this not only harms the physician but also compromises patient safety and quality of care. Emotional well-being is not separate from clinical competence, but rather, it sustains it. A residency culture that fails to prioritize emotional care risks both physicians and patients.^[20]

The Impact of Social Networks on Identity

The clinical setting often defines success by patient outcomes, efficiency, and productivity. It measures physicians by what they do rather than who they are. In this kind of environment, medical providers need reminders that they are human beings, not just human doings. All physicians need relationships and identities outside their clinical roles to sustain emotional health.^[21] For IMGs, rebuilding a sense of self in a new country is difficult but essential. Outside the hospital, meaningful relationships provide emotional grounding. These ties remind IMGs that they are more than their clinical productivity or board scores. They offer space for connection, humor, and vulnerability. These elements of humanity often take a back seat in the lives of those who practice medicine.^[22]

Physicians who lack personal relationships outside of work report higher levels of depersonalization, emotional exhaustion, and a diminished sense of personal accomplishment.^[23] Without spaces where they are known beyond the role of doctor, IMGs risk losing connection to their identity.

Systemic Barriers to Building Local Networks

IMGs face significant barriers when it comes to forming social networks outside the hospital. These challenges are not simply about individual adjustment or personality—they are embedded in the structure of medical training. Long work hours, fatigue, and the demands of clinical performance leave little time or energy for personal connection. While all residents experience this to some extent, IMGs face additional burdens that widen the gap between them and meaningful social integration.

The structure of residency itself is a major limiting factor. Residents regularly work extended shifts, often with inadequate sleep and limited time for recovery. This level of workload is linked to burnout, reduced empathy, and poorer health outcomes for physicians.^[24] Time outside the hospital, which could be spent resting or forming personal connections, is often consumed by responsibilities unique to IMGs.

Visa maintenance is one of the pressing issues that non-IMG residents do not have to face. IMGs on visas must manage a complex system of legal requirements that include maintaining status, renewing documents, attending consulate visits, and navigating immigration policy changes. These tasks are time-consuming, high-stakes, and mentally exhausting. Failure to comply, even unintentionally, can jeopardize their residency position or legal status.^[25] Unlike their American peers, IMGs often spend what little free time they have preparing documentation, traveling long distances for embassy appointments, or consulting with immigration lawyers.

This constant administrative burden limits IMGs’ ability to engage in social life. Even when time is technically available, emotional and mental fatigue make it difficult to invest in building new relationships. The residency system, as it currently stands, gives IMGs little opportunity to practice self-care or form new social networks.

Learning from Narratives

Eight narrative articles written by IMGs and a reflexive narrative based on my interactions with an IMG neurosurgery resident provide insight into emotional, cultural, and institutional challenges frequently overlooked in mainstream graduate medical education research. The narratives are peer-reviewed, first-person accounts published in open-access academic journals.

From the narratives, the five themes below highlight how structural and cultural forces shape IMG experiences. These themes offer a meaningful framework for connecting personal stories to the ethical obligations of residency programs, particularly in supporting IMG well-being beyond the clinical setting:

Unseen and Unsupported
Stress Related to Visa Requirements
Cultural and Language Barriers
Impact of Meaningful Connections
Empowerment Provided by Narratives/Sharing Stories

In my experience meeting IMGs, the most profound conversation I had was with a neurosurgery resident from Southeast Asia. As we enjoyed the skyline view of Manhattan from the New Jersey side of the Hudson River, he looked at me and said, “I feel stupid.” Taken aback by this statement, I replied, “How is that even possible? You are literally training to be a brain surgeon. If you feel stupid, then there’s no hope for the rest of us.”

He said, “I feel stupid, and I don’t have a lot of friends here.”

“What about your colleagues?” I asked.

“I spend a lot of time in the hospital, so I don’t have time to make friends outside of that, and my colleagues don’t understand me. We spend hours performing surgery in the OR, and they make jokes I can’t understand. The humor is different in my culture, and I don’t want to laugh at something I don’t understand, so I don’t say anything. Then they get the wrong idea about me, and I don’t want to tell them it’s because I don’t understand. So, I feel stupid and alone. I don’t have friends at work, and I don’t have time to make friends outside of work. I rarely have a day off, and when I do, I just sleep.”

I offered to be his friend, but I lived six hours away from where I traveled to receive medical care, so naturally, we lost touch. The interaction was brief, about an hour and a half at most. Unfortunately, I never saw him again.

This conversation is a concrete example that further draws attention to social and emotional challenges faced by IMGs during residency.

The conversation I had with the neurosurgery resident reflects the same concerns raised in the literature and ethical framing of this paper. His feelings of isolation and disconnection from peers are not personal shortcomings. They point to larger structural issues in residency programs. Residency programs do not provide enough social or cultural support for IMGs. The neurosurgery IMG spoke about being in an environment where he did not feel like he could admit not understanding the jokes that were being told. He did not speak up for himself. He remained quiet instead of participating in the dialogue or asking for clarity. As a result, his colleagues misjudged him. He could not be fully himself at work. At the core of this experience is a lack of psychological safety, i.e., an inability to speak up, ask questions, or make mistakes without a fear of being judged or dismissed. It is foundational to learning, growth, and trust, especially in medicine, where the stakes are high and vulnerability is part of the process. Psychological safety is defined as a shared belief that a team environment allows for interpersonal risk-taking.^[26] For IMGs, those risks are amplified by differences in culture, training background, and the constant pressure to prove that they belong and that they are capable as physicians.^[27]

Institutional Responsibility

Without providing the necessary social support, residency programs violate two bioethical principles: beneficence and justice. To do good, residency programs and medical institutions have a duty to support the social and emotional needs of IMGs. This duty goes beyond teaching medical skills. It means creating environments where trainees feel included and supported as whole people. Institutions must recognize and address barriers like cultural differences and a lack of psychological safety that isolate IMGs and keep them from fully engaging in their training.^[28] The duty of care includes attending to residents’ well-being because it directly affects their ability to learn and provide good patient care. When residents feel excluded or misunderstood, like the neurosurgery resident from Southeast Asia, they lack the support needed to succeed.^[29] This is not just a personal problem; it shows a system that is not doing enough.

Justice also calls for institutions to treat people fairly ─ relational justice means creating an environment where residents are respected, included, and able to safely express themselves without fear of judgment.^[30] Because institutions hold more power than any individual resident, they carry a responsibility to dismantle barriers that lead to exclusion and ensure equitable opportunities for belonging, growth, and success.

The ongoing absence of social support for IMGs is a serious problem. It harms IMG residents’ well-being and has adverse effects on patient care. Medical institutions must make social support a required part of residency training. This is essential not only for fairness, but because it’s an ethical obligation to both doctors and patients.^[31]

Program Recommendations

1. Facilitate Local Community Engagement

Host informal gatherings in popular community spaces (e.g., cafés, bookstores, community centers) to help IMG residents build local connections outside the clinical environment. These relaxed settings foster relationships that enhance well-being and prevent social isolation.

2. Build Strategic Partnerships with Cultural and Faith-Based Organizations

Partner with community associations, places of worship, and immigrant resource centers. These partnerships can connect IMGs with cultural familiarity, mentorship, and a deeper sense of belonging—factors that reduce burnout and promote retention.

3. Develop a Host Family Program

Offer an opt-in host family initiative for first-year IMGs (and spouses, where applicable). Programs like this provide informal “family-like” ties and cultural guidance, easing the transition into residency and mitigating the emotional toll of geographic displacement.

4. Establish an International Medical Graduate Peer Mentor System

Pair incoming IMG interns with senior IMG residents or attendings from similar backgrounds who can provide culturally informed support and guidance. These near-peer relationships promote confidence, reduce errors from miscommunication, and reinforce psychological safety.

5. Create a Tailored IMG Orientation and Resource Guide

Develop a resource guide for intern IMG residents that outlines:

Local cultural norms specific to that state or region,
Community resources and local events, and
Tips for transitioning into a new culture.

6. Educate Leadership on Psychological Safety and Cross-Cultural Communication

Train chief residents on topics such as belonging, the effects of exclusion, and principles of psychological safety. This is critical to ensure IMGs can ask questions, admit uncertainty, and engage fully in the learning process, without the possibility of feeling unfairly judged or misunderstood.

Limitations

The narrative accounts included here cannot serve as a full representation of all IMGs in every situation. IMGs are often lumped together in research, without exploring specific demographic segments. IMGs have a broad spectrum of identities, experiences, backgrounds, and areas of clinical expertise. Additionally, this paper does not include perspectives from program directors or policymakers, who also contribute to systemic change. Their inclusion would strengthen the practical application and scope, as social support, networks, and inclusive activities vary greatly across institutions.

Additionally, many IMGs have positive training experiences, and it should be noted that there are many benefits for IMGs to train in US residency programs. The intent here is not to undermine the high professional value of these programs but rather to facilitate a discussion regarding graduate medical education. Graduate medical education should consider ways that IMGs can grow both personally and professionally, and deem social connection and support outside the clinical environment an important part of an IMG’s ability to thrive.

Conclusion

This paper highlights how the lack of a support system beyond work elevates the risk of emotional distress, burnout, and weakened clinical performance. Social connection is a fundamental human need that should not be overlooked, and program directors must consider how to foster these connections both inside and outside the clinical environment. Addressing these challenges should not rest solely on IMGs, as institutions are uniquely positioned to move beyond a narrow clinical checklist toward a culture that affirms physician personhood and embraces the humanizing dimensions of medicine. Residency programs carry a moral responsibility, grounded in the principles of beneficence and justice, to support IMGs as whole people, not only as physicians-in-training. Supporting IMGs is not just about fairness; it is an ethical obligation to residents, patients, and the broader medical community. When providers are cared for, physicians, patients, and institutions all benefit.

[1] Association of American Medical Colleges, 2023

[2] Valente, 2019

[3] Scannell & Gifford, 2017

[4] Halbesleben, 2006

[5] Shanafelt et al. 2015

[6] Eze et al., 2021

[7] Smith & Koven, 2022

[8] Lee et al., 2019; Walton et al., 2018

[9] Valente, 2019

[10] Holt-Lunstad, 2018

[11] Ozcelik & Barsade, 2018; Wright et al., 2023

[12] Scannell & Gifford, 2017

[13] Oldenburg, 1999 (sometimes referred to as “third spaces”.)

[14] Jeffres et al., 2009

[15] Aydin et al. 2021; Twenge et al., 2020

[16] Eze et al., 2021; Lee et al., 2019

[17] Holt-Lunstad, 2018

[18] U.S. Department of Health and Human Services, 2023, p. 7

[19] Ozcelik & Barsade, 2018; Wright et al., 2023

[20] Meyer et al., 2017

[21] Dyrbye et al., 2017

[22] Beauchamp & Childress, 2019; Edmondson, 2019

[23] Shanafelt et al., 2015

[24] West et al., 2018; Sen et al., 2010

[25] Akbar et al., 2022

[26] Edmonds, 1999

[27] Meyer et al., 2017

[28] Beauchamp & Childress, 2019; Edmondson, 2019

[29] Dyrbye et al., 2017; Shanafelt et al., 2017

[30] Hirsch, 2012

[31] Gruppen et al., 2018; Dyrbye et al., 2020

This work is dedicated to the neurosurgery resident whose story is central to this paper. By now, you are likely an attending. I hope to find you one day and thank you in person. To my orthopedic surgeon, Dr. V., because of you, I strive to care for and support all physicians, including the next generation of “ortho heroes.”

The Ethical Significance of Brain-Computer Interfaces as Enablers of Communication

2025-08-16T18:49:21+00:00

Photo ID 132826187 © Blackboard373 | Dreamstime.com

Abstract

This article argues that the primary ethical significance of brain-computer interfaces (BCIs) lies not in the specific content they transmit, but in their capacity to restore communicative agency to individuals otherwise excluded from ethical engagement due to conditions such as complete locked-in syndrome. While current ethical frameworks focus largely on risks, privacy, and clinical outcomes, this analysis foregrounds the ontological dimension: BCIs safeguard and re-establish the practical conditions under which autonomy, recognition, and interpersonal accountability can be exercised. Drawing on documented clinical cases, the article applies the concept of communicative reinstatement to describe how BCIs reconfigure relationships between patients, caregivers, and the broader moral community. The argument culminates in a normative claim: societies have an ethical obligation to maintain and protect communicative capacity where feasible, treating BCIs not merely as therapeutic tools but as infrastructures of moral inclusion. This reorientation carries implications for regulation, informed consent, policy, and distributive justice.

Introduction

Brain-computer interface (BCI) technology has emerged as one of the most ethically consequential developments in contemporary medicine and neurotechnology. Much of the public discourse surrounding BCIs has centered on high-profile commercial ventures—such as Elon Musk’s Neuralink—and the controversies these projects generate. These controversies include the ethics of animal testing protocols, speculative claims regarding human enhancement and human-AI symbiosis, and the broader societal implications of merging minds with machines.^[1] While these debates are significant, there is a more fundamental ethical dimension inherent to BCIs. They constitute a novel class of moral technology that reconfigures the very possibility of communicative agency for individuals with severe disabilities.

The current ethical literature predominantly analyzes BCIs through two prevailing frameworks. The first treats them as medical devices warranting standard risk-benefit analysis, assessing safety, efficacy, and clinical outcomes.^[2] The second framework situates BCIs within the emerging field of neuroethics, emphasizing concerns about privacy, cognitive liberty, data security, and the potential for manipulation.^[3] Although previous work has already emphasized the ethical importance of BCIs in restoring communicative capacities, this paper develops the claim further by foregrounding what may be termed the ethical function of BCIs.^[4] Their significance lies not just in enhancing particular interactions or reducing barriers, but in re-establishing the very possibility of communication, through which individuals assert their will, can participate in community, and be recognized as interlocutors. In this sense, BCIs are ethically constitutive, since they sustain the conditions under which autonomy and accountability can be expressed. Following this reasoning, this paper argues that the primary ethical significance of BCIs lies not in the specific content they transmit or in the circumstances under which they are implanted, but in the fact that they render transmission possible at all.

To develop this argument, the paper first examines documented clinical cases of BCI-mediated communication in locked-in patients. These cases show how BCIs reconfigure ethical relationships among patients, caregivers, and society by transforming patients from passive recipients of care into more active participants. Subsequently, the paper considers the broader implications of this ethical perspective for clinical practice and policy, especially regarding long-term maintenance obligations.

The central claim is that BCIs should be understood not merely as therapeutic tools but as infrastructures of moral inclusion, generating ethical duties to establish, maintain, and protect communicative capacity where feasible.

BCIs as a Way to Restore Communication

The ethical significance of BCIs becomes most evident in the context of complete locked-in syndrome (CLIS), a condition in which patients retain cognitive awareness but lose all voluntary muscle control. Traditional assistive technologies relying on residual movements, such as eye-tracking systems, become ineffective under these circumstances. Intracortical BCIs, by contrast, can restore communicative capacity by directly decoding neural signals associated with intended speech or movement.^[5] One landmark study documented an amyotrophic lateral sclerosis (ALS) patient who, after entering CLIS, learned to use an implanted BCI speller to construct sentences at a rate of approximately one character per minute. The patient’s communications ranged from the mundane, such as requesting music, to expressions of existential significance involving care preferences.^[6] Importantly, when researchers were asked how they would respond if the patient spelled “unplug my ventilator,” they emphatically stated that BCI output would not determine decisions regarding life support withdrawal. This position reflects appropriate clinical caution but also reveals a critical ethical distinction. While the content of BCI-mediated communication requires verification and contextual interpretation, the very fact that said communication occurs transforms the patient’s moral status from a passive recipient of care to an active participant in ethical dialogue.^[7]

A comparable case involved an electrocorticography (ECoG) based BCI, which restored communication for a patient previously reliant on eye movement interpretation with limited accuracy. This patient gained the ability to produce verified short phrases and, among the first communications, corrected care team assumptions about personal preferences. Such moments fundamentally reconfigure the ethical relationship, shifting the patient from an object of interpretation to a subject capable of self-representation and autonomous expression.^[8]

These cases share the same ethical pattern: the BCI’s biggest impact is not the specific messages it transmits but its role as the enabler of transmission itself. This transition from silence to speech might be termed “communicative reinstatement,” the re-entry of a person into a moral community through restored capacity for expression.

Different Dimensions of BCI Ethics

Traditional ethical frameworks for medical devices focus predominantly on what we commonly refer to as the “concrete dimension,” addressing concrete outcomes, risks, and clinical applications. For BCIs, this focus materializes in debates over whether to honor euthanasia requests (where legal) communicated through neural implants or concerns about data privacy and cognitive liberty. While these concerns are valid and urgent, they fail to capture the more “fundamental dimension,” which is how BCIs alter the conditions of moral personhood by restoring the capacity to communicate.

From a philosophical standpoint, the concrete pertains to particular instances such as the content of a patient’s message, technical specifications, or safety reports. The fundamental, by contrast, concerns the foundational preconditions that make communication and moral agency possible. This distinction bears significant ethical weight. For example, consider a patient with locked-in syndrome who can communicate “I am in pain” through a BCI. In this scenario, caregivers and clinicians must deliberate on how to interpret and respond to the patient’s expressed experience. In contrast, if the patient lacks any means of communication, no such ethical deliberation can occur because the patient’s perspective remains inaccessible to the moral and caregiving community. In this latter case, the BCI functions ethically by creating the very possibility for ethical engagement where none previously existed.

This fundamental perspective also shows why device failure or abandonment inflicts harm that transcends mere technical malfunction. Clinical reports describe psychological trauma among patients who lost access to BCI functionality due to corporate discontinuation, comparable to the loss of a sensory organ.^[9] This harm is not simply empirical or technical but ethical and existential, since it represents the collapse of a reconstructed mode of engagement and involvement with one’s community as a speaking subject. Such cases underscore that BCIs are not simply devices but essential conditions for sustaining moral agency and personhood.

Obligations of Maintenance and Moral Inclusion

From this understanding emerges an ethical imperative. If BCIs can restore communicative agency, and if communicative agency constitutes a foundation of moral personhood, then society holds an obligation to provide and maintain technologies that enable such restoration wherever reasonably possible. This obligation extends beyond traditional medical ethics in three key respects.

First, it recognizes communicative restoration as a distinct ethical good, irreducible to conventional therapeutic aims focused on curing disease or alleviating symptoms. BCIs address a deeper deprivation, namely, the exclusion from the communal domain where moral relations and agency occur.

Second, this obligation entails durable responsibilities extending beyond initial implantation. Communicative capacity depends on sustained technical support, ongoing software updates, and user training, demands that challenge existing models of medical device regulation and healthcare infrastructure. Historical cases of early BCI users abandoned by manufacturers exemplify the grave ethical costs incurred when these responsibilities are neglected.^[10]

Third, the imperative to restore communication reshapes informed consent practices. Traditional consent protocols emphasize risk disclosure and benefit assessment, but BCI users face a unique transition from communicative isolation to reinstatement that is difficult to fully apprehend in advance, especially by healthy individuals. Ethical consent must therefore encompass this experiential dimension to genuinely respect autonomy.

This imperative does not demand that BCIs be provided at any cost but prioritizes communicative reinstatement as a fundamental ethical goal in clinical practice, research, and policy. Just as society accepts obligations to provide language education or accommodations for disabilities, it must recognize a corresponding obligation to establish and maintain technologies that restore basic communicative capacity.

Policy, Practices, and Objections

Recognizing BCIs as infrastructures of moral inclusion rather than mere medical devices also requires reconsideration across multiple policy domains. Regulatory frameworks that currently evaluate BCIs mainly for safety and efficacy must be expanded to include assessments of reliability in enabling nuanced expression, guarantees of long-term continuity, and interoperability standards that prevent vendor lock-in. Funding models must evolve beyond traditional reimbursement schemes ill-fitted to support the sustained maintenance and upgrading necessary for BCI functionality. Innovative approaches might include insurance categories recognizing “communicative benefit,” public-private consortia dedicated to maintenance, or endowment funds ensuring long-term support. Ethics oversight bodies, including institutional review boards, require new frameworks tailored to the unique challenges of communicative reinstatement research. These include enhanced consent protocols addressing phenomenological shifts, mandatory plans for post-trial access, and contingency measures against commercial abandonment. Finally, legal recognition must evolve to address the evidentiary status of neural signals as expressions of intent, protections against compelled device use, and rights to device continuity.

These policy reforms formalize an ethical recognition of communicative capacities as constituting a fundamental human good that technologies like BCIs can restore, imposing corresponding social and legal obligations to protect this capacity.

Counterarguments

Several objections to this framework merit consideration. One common argument prioritizes therapeutic intervention aimed at curing disease rather than investing in assistive communication technologies. This objection falsely dichotomizes care, since communicative reinstatement often facilitates more effective therapeutic collaboration and patient-centered outcomes. Another concern involves technological risk, as invasive BCIs entail surgical and medical dangers. Yet as non-invasive alternatives continue to advance, ethical risk-benefit assessments must weigh these risks against the profound psychological and social harms of communicative isolation.

Skeptics could point to interpretive challenges, noting that BCI output represents an imperfect proxy for thought. However, all communication involves interpretative acts; ethical standards should require basic intelligibility sufficient to respect autonomy rather than perfect fidelity. Finally, distributive justice objections might cite the high cost and limited access to BCIs. This is principally an implementation challenge, paralleling the historical trajectory of other assistive technologies, which initially faced similar barriers before becoming more widely accessible.

While these concerns highlight genuine practical difficulties, they do not undermine the core ethical argument that communicative reinstatement via BCIs constitutes a distinct and critical moral good.

Another issue concerns the temporality of access. For many patients, even temporary use of BCIs may provide immeasurable benefit, restoring participation and recognition for a limited period rather than not at all.^[11] Yet reliance on devices that may later be discontinued, abandoned, or unsupported raises serious ethical risks of dependency and loss. At the same time, requiring companies to guarantee indefinite support could deter development or delay availability. Ethical evaluation must therefore balance the immediate benefits of temporary communicative access against the structural vulnerabilities introduced by uncertain long-term provision.

Conclusion

In conclusion, Brain-Computer Interfaces demand an ethical paradigm shift that recognizes their capacity to restore persons to the moral community through communicative reinstatement. By redirecting analysis from the concrete, what is communicated, to the fundamental, that communication occurs at all, BCIs are shown not to be mere medical devices but as infrastructures of moral inclusion. This ethical status generates corresponding obligations to develop these technologies responsibly, maintain them reliably, and prioritize communicative restoration as a fundamental human good. As BCI technologies advance, ethical frameworks must evolve accordingly to protect not just the users of these devices but the communicative capacities they enable, the essential threads that connect human beings as moral persons.

[1] Perez, C. (2025, June 23). The Advancements and Ethical Concerns of Neuralink. The Princeton Medical Review. https://medreview.odus.princeton.edu/2025/06/23/the-advancements-and-ethical-concerns-of-neuralink/

[2] Lavazza, A., Balconi, M., Ienca, M., Minerva, F., Pizzetti, F. G., Reichlin, M., Samorè, F., Sironi, V. A., Navarro, M. S., & Songhorian, S. (2025). Neuralink’s brain-computer interfaces: medical innovations and ethical challenges. Frontiers in Human Dynamics, 7, Article 1553905. https://doi.org/10.3389/fhumd.2025.1553905

[3] Christiansen, T. (2025). The future of medicine or an ethical nightmare? Elon Musk’s Neuralink and the advent of brain-machine interfaces. Fall 2021, Spectrum. https://voices.uchicago.edu/triplehelix/2025/01/02/the-future-of-medicine-or-an-ethical-nightmare-elon-musks-neuralink-and-the-advent-of-brain-machine-interfaces/

[4] Burwell, S., Sample, M., & Racine, E. (2017). Ethical aspects of brain-computer interfaces: A scoping review. BMC Medical Ethics, 18, Article 60. https://doi.org/10.1186/s12910-017-0220-y

[5] Chandler, J. A., Van der Loos, K. I., Boehnke, S., Beaudry, J. S., Buchman, D. Z., & Illes, J. (2022). Brain computer interfaces and communication disabilities: Ethical, legal, and social aspects of decoding speech from the brain. Frontiers in Human Neuroscience, 16, 841035. https://doi.org/10.3389/fnhum.2022.841035

[6] Chaudhary, U., Birbaumer, N., & Ramos-Murguialday, A. (2016). Brain-computer interfaces for communication and rehabilitation. Nature Reviews Neurology, 12(9), 513–525. https://doi.org/10.1038/nrneurol.2016.113

[7] Holz, T., Kübler, A., & Birbaumer, N. (2023). Brain–Computer Interfaces, Completely Locked-In State in Neuroethics. Neuroethics, 16(1), 1–12. https://doi.org/10.1007/s11673-023-10256-5 ; Sankary, L. R., Ford, P. J., Machado, A. G., Hoeksema, L. J., Samala, R. V., & Harris, D. J. (2020). Deep brain stimulation at end of life: clinical and ethical considerations. Journal of Palliative Medicine, 23(4), 582–585. https://doi.org/10.1089/jpm.2019.0129

[8] Sellers, E. W., & Donchin, E. (2006). A P300-based brain–computer interface: initial tests by ALS patients. Clinical Neurophysiology, 117(3), 538–548. https://doi.org/10.1016/j.clinph.2005.06.027

[9] Poppe, C., & Elger, B. S. (2024). Brain-Computer Interfaces, Completely Locked-In State in Neurodegenerative Diseases, and End-of-Life Decisions. Journal of Bioethical Inquiry, 21(1), 19–27. https://doi.org/10.1007/s11673-023-10256-5

[10] Bottorff, E. (2025). The Aftermath of Abandoned Neurotech: Ethical and Regulatory Challenges in the Dawn of Brain-Computer Interfaces. Knowing Neurons. https://knowingneurons.com/abandoned_neurotech/

[11] Blain-Moraes, S., Schaff, R., Gruis, K. L., Huggins, J. E., & Wren, P. A. (2012). Barriers to and mediators of brain-computer interface user acceptance: Focus group findings. Ergonomics, 55(5), 516–525. https://doi.org/10.1080/00140139.2012.661082

THE ETHICAL STARTUP?

2025-07-28T13:39:53+00:00

Photo ID 345549 © Jonathan Mulkey | Dreamstime.com

Abstract

Emerging DNA marketplace startups aim to empower individuals with greater control and potential profit-sharing over their genetic data, but they face ethical tensions in navigating uncertain technological and commercial environments. Drawing on ethnographic research and ELSI scholarship, this piece uses the lens of bounded ethicality to show how limits in information, consent, and decision-making call for distributed “ethics supports” beyond individual users and firms. Focusing on cases such as LunaDNA, it outlines strategies, such as decision-support tools, transparent communication, and collaborative ethics infrastructures, to strengthen collective responsibility and ethical capacity in genomics and related fields.

Introduction

With universities in much of the world placing more emphasis on entrepreneurship and technology transfer,^[1] the private sector is depicted as a key to advancing both basic and applied sciences. At the same time, widely publicized data breaches and stories of fraud have fueled skepticism about whether private sector innovation serves the public good.^[2] In response, some biotech startups have begun to position themselves as ethical alternatives to traditional research and business models.

This paper examines the ethical and institutional burdens that accompany corporate promises to empower consumers in managing their own health data, using emerging DNA marketplaces as a case study. Unlike earlier biobanking models, which relied on broad consent to data use and offered little direct benefit to individual participants, the profit-sharing approach promises more consumer control. These companies let individuals decide how their data can be used and share in the financial benefits when companies sell access to that data. But even companies that think carefully about these dynamics face challenges as they create technologies for a future that is difficult to anticipate. Startups can respond to the ethics challenges that come along with such uncertainty; this paper provides guidance on some key pathways. My interviews, surveys, and focus groups with employees and leadership confirm that many companies are searching for guidance on how to embed ethics into their operations.^[3]

DNA marketplaces offer a compelling site for examining ethical challenges that arise when companies promise to empower individuals with control over their health data, in part because companies, such as LunaDNA and EncrypGen, explicitly frame their platforms as “empowering” users.^[4] Yet, these companies blur the boundaries between consumer platforms, research intermediaries, and data brokers, placing particularly complex ethical demands on users and institutions alike. This paper argues that such models reveal not only the limits of individual decision-making under conditions of complexity and uncertainty but also the ethical shortcomings of systems that shift responsibility onto consumers without sufficiently engaging the broader obligations of companies, platforms, and institutional actors.

A Framework for Ethics Supports

Among the many genomics products launched in recent years, a series of companies has emerged that offer a means for individuals to “rent” their DNA to companies and universities for research and product development. These DNA marketplaces have promised compensation in exchange for personal data, as well as privacy and transparency through novel technologies. Nebula Genomics, co-founded in 2016 by George Church, offered free genome sequencing in exchange for data-sharing on their blockchain-secured platform, or redeemable Nebula tokens for sharing genomic data sequenced elsewhere.^[5] The following year, EncrypGen launched a blockchain marketplace which uses proprietary cryptocurrency to pay individuals for de-identified data,^[6] and LunaDNA launched an offering of non-voting shares in the company in exchange for data use—e.g., 300 shares for a whole genome shared, a $21 value according to the company’s preliminary offering circular.^[7] The marketplace model also allows participants to specify which types of studies their data would support, enabling them to opt in or out of research domains based on topic, perceived risk, or institutional or corporate affiliation of the research team. LunaDNA regularly invites participants to review and approve data use for new studies, including those with different levels of data access or revised shared offers.

In addition to the challenges faced under prior models of consumer genetic data sharing (e.g., through Ancestry.com, 23andMe), these companies have struggled to meet the expectations they set around user control, data ownership, and financial benefit. LunaDNA was founded as a public benefit corporation, with the premise that by receiving shares, participants would benefit financially from any proceeds LunaDNA earned from that data. The company failed to build a steady revenue stream and eventually closed in early 2024, without issuing payouts to contributors, as the company reported no cash reserves.^[8] Ethical, legal, and social implications (ELSI) researchers have noted the challenges that these DNA marketplaces face as data brokers that must gather ongoing consent and manage data privacy.^[9] In this piece, I highlight the broader ethical challenges that such marketplaces face, considering the startup sector’s demand for continual innovation and often grandiose speculation, even in the face of frequent organizational change and evolution.

While firms may have ethics infrastructures, such as ethics committees or institutional ethics policies, ethical issues today increasingly cluster beyond the confines of an individual company. Many problems emerge in the complex landscape of angel investors, venture capital firms, private wealth management entities, crowdfunding, accelerators, incubators, co-branded partnerships, tech transfer offices, service providers, and industry networks. While ethical approaches, such as anticipatory ethics, have been developed to predict and address ethical challenges early in the development of emerging technologies,^[10] many issues today arise in spaces that lie beyond the control of a single platform, ranging from downstream data sharing by a DNA platform customer to further data use by unknown subsequent parties, to company acquisition, bankruptcy, breaches by partners, and other challenges.^[11]

To analyze these challenges, this paper applies the theory of bounded ethicality. Bounded ethicality suggests that social, psychological, and practical pressures limit people’s ability to make ethical decisions. For example, limits on available information, time constraints, decisional complexity, and bias contribute to ethical decision-making.^[12] These limits point to the importance of moral supports to promote ethics and justice. Bounded ethicality recognizes the limits of the individual moral agent, instead spreading moral labor across platforms, collectives, supportive technologies, and contingencies. As shown below, combining this lens with a focus on downstream thinking can help companies and individuals establish well-designed ethical supports.

Ethics Challenges for DNA Marketplace Platforms

DNA marketplaces risk overpromising the degree to which they can protect data. In response to criticisms of earlier genomics companies that sold user data to pharmaceutical and other companies, including data brokers, without sharing benefits, these companies have created data use policies and means to allow participants to benefit.^[13] But even so, substantial risks to data privacy remain. Data breaches, government or law enforcement demands that override privacy protections, and within the limits of both users' and technologists' capacity to anticipate abstract future scenarios.^[14] The bounded ethicality lens draws attention to the importance of caution in companies’ framings of their offerings, recognizing the limits even with our best efforts for ethical practice, thus guiding us toward hedging the zeal with which companies advertise privacy protections, untraceability, and individuals’ control over their data’s use.

Difficulties also arise because of the complexity of tasks DNA marketplaces ask of their users. The complexities of these tasks include taking control of their genetic data, assessing scientific risk, postulating future scenarios, quickly learning enough genetic science to become ably informed as part of a consent process, and engaging in ongoing monitoring of developments with the platform. Growing research shows that decision fatigue, readerly limitations, distraction, comprehension and educational factors, momentary mood or energy levels, and more impede sound decision making.^[15] Unlike other industries where consent may be a one-time hurdle, DNA marketplaces demand repeated, proactive choices about whether to share their genetic data, opt in or re-consent to new studies, allow certain types of future use, and decline participation in others based on study type, affiliated institutions or companies, or perceived risk. It is crucial that companies describe the terms and conditions to help customers grasp the yet unknown ways in which data could be used, including adverse scenarios. At the same time, lengthy consent documents cannot fill this need, as they overwhelm participants and do not invite deep engagement with the issues at hand.^[16]

Another ethical issue is that significant debate persists about the risks of re-identification of ostensibly de-identified genomic data, which is possible with limited public information.^[17] While some argue that little incentive exists for re-identification, there is insufficient evidence to support this claim.

Companies must remain responsible for protecting users, rather than placing responsibility on consumers for protecting themselves via consent procedures.^[18] Many ethical frameworks acknowledge that consent alone does not waive organizational obligations. But in practice, many organizations have consent procedures and documents that resemble legal contracts more than tools for participant understanding, designed more to limit liability than to foster meaningful participant engagement.^[19] Beyond these legal shields, companies owe participants real efforts to support truly informed consent, given the substantial asymmetries in expertise and control that make meaningful consent difficult without institutional support, and the broader ethical imperative to build public trust in data systems where risks are often collective, long-term, and structurally mediated. Companies can implement insights from the robust consent literature, including offering decision support tools such as interactive or pre-highlighted written information, digitally enhanced user support tools, and re-consent cues at key moments, such as when a company is acquired or when scientific developments enable new unanticipated uses of genetic data.^[20] If DNA marketplaces have models that presume ongoing user engagement, support to sustain such engagement is essential.

This discussion makes it clear that platforms cannot reasonably suggest to users that they will maintain the privacy that many companies tout. A more ethically grounded approach could include planning for and explaining to users recourses for when a site is hacked, compromised, or down, etc. Privacy is more than a platform security issue. The future contains new kinds of capabilities that can "de-privatize” previously privatized data by way of future datasets that we never predicted, IT capacities that we cannot yet envision, and other difficult-to-predict circumstances.

The Way Forward: Expanding Moral Capacity

Actionable strategies include tools to help consumers make informed decisions. Again, using the lens of bounded ethicality, I propose possible areas of intervention, but such strategies cannot completely solve moral problems or guarantee “right” moral choices; rather, they can support ethical action by redirecting attention and resources, including personal, organizational, institutional, and even technological, to spaces of moral risk, and expand capacity in those areas.

Innovate in Comprehension and Decision Support

Since DNA marketplaces ask users to perform complex mental tasks, including analytic, abstraction, anticipatory, and calculative work in decisions about sharing, privacy, future risks, and personal benefit. Bounded ethicality points to the need for more assistance so that consumers are not too limited when making important decisions. Significant research discusses the challenges of consent as well as possibilities for addressing them.^[21] And while I advocate the use of decisional, visualization, and simulation tools to support consumers at crucial moral moments, literature in the social sciences and humanities make the dangers of expecting technology to solve all challenges clear.^[22] Instead, I am advancing a vision of how today’s technologies can be designed to support the structural interventions needed to advance justice and equity.^[23]

Lead with Limitations

Substantial empirical data show that in the face of goals that we, as moral agents, really want to achieve, we enact what many refer to as “willful blindness,” sidelining moral considerations.^[24] Ethics supports would then involve leading by introducing potential limitations through marketing, communication, explanations, consent processes, etc. Leading with limitations may be the only way that users cognitively “register” the downsides of given options. Companies need to overstate the limitations of their platform’s security, the exceptional vulnerability of all digital data, the prospect that sharing their data may not lead to potential, specific cures, and the possibility that market demands may impact the company’s future practices or unravel its present policies. While this may seem counterproductive to current business goals, the very emergence of DNA marketplaces selling themselves as equitable and just alternatives to older models suggests that ethical practice can increasingly be seen as a selling point for some companies.

While bounded ethicality supports enhancing the capacity of users (say, overemphasizing that which data shows we are psychologically prone to tune out), the model also requires migration away from an ethics powered mostly by sole subjects. Ethics strategies that load most of the moral risk onto individuals via the consent process, the self-report, or “honor systems” discharge too much moral labor onto a single subject, often imagined to have indefatigable capacities. Instead, the view proposed here would ask companies to do more to prevent or decrease the risk of a breach of privacy, unexpected later use of data, and reidentification. Companies should use more systems, personnel, practices, and tools to help shoulder the risks. Regulatory frameworks such as the California Consumer Privacy Act (CCPA), the General Data Protection Regulation (GDPR), and the Genetic Information Nondiscrimination Act (GINA) provide important protections and set meaningful legal baselines. But as technologies and data practices evolve, ethics strategies can be a key site for anticipating emerging forms of risk and responsibility that may fall outside current regulatory scope.

Ethics Beyond Individual Platforms

DNA marketplaces are also subject to concerns that genetic data, accessible through genetic databases of various types, could be used for deleterious purposes – to make claims, for example, about the genetic superiority of certain groups over others. LunaDNA addressed this by creating a data access committee that would grant research rights only to parties engaged in health research. Again, solutions have focused on the individual company level. But by requiring us to address and compensate for limits on ethical decision making, the approach described involves thinking beyond the self in much the way thinking about accessibility involves thinking about assistance at both technological and structural levels.^[25]

There have been increasing efforts to build collaborations across the private sector genomics industry for addressing ethics and policy issues.^[26] Such approaches would multiply the power of efforts at the level of individual companies. For example, creating a common database of suspicious or declined data access requests, accessible by all DNA marketplace companies, could help protect against nefarious uses and users and facilitate collective moral problem-solving. Responsibility should be distributed widely and across actors, since relying on individual moral exemplars (who leave), company cultures (which change), or terms of service (which ignore out-platform problems) puts too many of one’s ethical eggs in one basket. Thinking beyond individual moral agents in ethics breeds strategies that go beyond individual executives, platforms, policies, and even users.

Applying empirical data about limitations on ethical decision making leads to solutions that empower consumers and individual companies by eliminating the limitations that impede high-quality moral decision making (unbinding the ethicality). Because DNA marketplace platforms like LunaDNA have specifically sold themselves as a more ethical alternative to older models, they are an ideal place from which to build these approaches.

[1] Robert E. Litan, Lesa Mitchell, and E.J. Reedy, “The University As Innovator: Bumps in the Road,” Issues in Science and Technology 23.4 (2007); Jordan Eidlisz, Isabelle von Simson, and Gabrielle Gold-von Simson, “Exploring the current state of technology transfer in the United States: perspectives and improvement strategies from the experts,” Frontiers 9 (2024): doi.org/10.3389/frma.2024.1376185; William R. Meek and Peter T. Gianiodis, “The Death and Rebirth of the Entrepreneurial University Model,” Academy of Management Perspectives 37.1 (2023): doi.org/10.5465/amp.2020.0180.

[2] Cathy Hwang et al., “The Lost Promise of Private Ordering.” Cornell L. Rev. 109 (2023-2025): 1-61. https://publications.lawschool.cornell.edu/lawreview/2024/01/30/the-lost-promise-of-private-ordering/

[3] Alexis Walker, “Diversity, Privacy, Profit: An Empirical Study of Industry Employees’ Views on Ethics in Private Sector Genomics,” AJOB Empirical Bioethics 13(2022):166-178. https://doi:10.1080/23294515.2022.206399; Elizabeth Adetiba and Alexis Walker, “‘Forget the Age of HIPAA and Lean Into The Age of Consumer Privacy’: Exploring Ethics and Responsibility among Private Sector Genomics Leaders Using Group Interviews.” New Genetics & Society. Forthcoming.

[4] LunaPBC, “LunaPBC Raises $4.6 Million to Accelerate Company Growth and Drive Health Breakthroughs,” PR Newswire (2019), https://www.prnewswire.com/news-releases/lunapbc-raises-4-6-million-to-accelerate-company-growth-and-drive-health-breakthroughs-300846139.html; Innovations of the World, “LunaDNA: The World’s First People-Powered Health Data Platform,” Innovations of the World (n.d.), https://innovationsoftheworld.com/lunadna/; LunaPBC and Genetic Alliance, “Genetic Alliance and LunaPBC Partner to Support Personal Health and Accelerate Medical Breakthroughs,” PR Newswire (2018), https://www.prnewswire.com/news-releases/genetic-alliance-and-lunapbc-partner-to-support-personal-health-and-accelerate-medical-breakthroughs-300781275.html.

[5] Molteni, Megan. “These DNA Startups Want to Put All of You on the Blockchain.” Wired (2018), https://www.wired.com/story/these-dna-startups-want-to-put-all-of-you-on-the-blockchain.

[6] Ben Herschler, “Cashing in on DNA: Race on to Unlock Value in Genetic Data.” Reuters (2018), https://www.reuters.com/article/us-health-genomics-blockchain/cashing-in-on-dna-race-on-to-unlock-value-in-genetic-data-idUSKBN1KO143

[7] U.S. Securities and Exchange Commission, “Offering Circular: LunaDNA, LLC,” Form 253G2 (2018), https://www.sec.gov/Archives/edgar/data/1741687/000119312518340286/d631377dpartiiandiii.htm.

[8] Jonathan D. Grinstein, “Total Eclipse of LunaDNA: Once Touted Genome Data Sharing Platform Goes Dark,” Inside Precision Medicine, January 18, 2024, https://www.insideprecisionmedicine.com/topics/precision-medicine/total-eclipse-of-lunadna-once-touted-genome-data-sharing-platform-goes-dark/.

[9] Eman Ahmed and Mahsa Shabani, “DNA data marketplace: an analysis of the ethical concerns regarding the participation of the individuals,” Frontiers in Genetics 10 (2019): 10.3389/fgene.2019.01107.

[10] Philip A.E. Brey, “Anticipatory ethics for emerging technologies,” NanoEthics 6 (2012): 1-13, https://doi.org/10.1007/s11569-012-0141-7.

[11] Donna M. Gitter, “Informed consent and privacy of non-identified bio-specimens and estimated data: lessons from Iceland and the United States in an era of computational genomics,” Cardozo Law Review 38.4 (2016); Julie Cook Lucas et al., “Donating human samples: who benefits? Cases from Iceland, Kenya and Indonesia,” in Benfit Sharing, eds. Schroder et al (Springer, 2013), https://doi:10.1007/978-94-007-6205-3_5; Stephen J. O'Brien, “Stewardship of human biospecimens, DNA, genotype, and clinical data in the GWAS era,” Annual Review Of Genomics And Human Genetics 10 (2009): 193-209, 10.1146/annurev-genom-082908-150133.

[12] Dolly Chugh and Mary C Kern, “A dynamic and cyclical model of bounded ethicality,” Research in organizational behavior 36 (2016): 85-100, https://doi:10.1016/j.riob.2016.07.002; Dolly Chugh, Max H. Bazerman, and Mahzarin Banaji, “Bounded ethicality as a psychological barrier to recognizing conflicts of interest,” in Conflicts of interest: Challenges and solutions in business, law, medicine, and public policy, eds D. Moore, D. Cain, G. Loewenstein, & M. Bazerman (New York: Cambridge University Press, 2005).

[13] Linnea I. Laestadius, Jennifer R. Rich, Paul L. Auer, “All your data (effectively) belong to us: data practices among direct-to-consumer genetic testing firms,” Genetics in Medicine 19 (2017): 513-520.

[14] Christi J. Guerrini, Jill O. Robinson, Devan Petersen, and Amy L. McGuire, “Should police have access to genetic genealogy databases? Capturing the Golden State Killer and other criminals using a controversial new forensic technique,” PLOS Biology 16 (2018): 10, doi.org/10.1371/journal.pbio.2006906.

[15] Laura M. Beskow and Kevin P Weinfurt, “Exploring understanding of “understanding”: the paradigm case of biobank consent comprehension,” The American Journal of Bioethics 19.5 (201): 6-18, 10.1080/15265161.2019.1587031.

[16] Lydia O’Sullivan et al., “An evaluation of the process of informed consent: views from research participants and staff,” Trials 22.544 (2021): https://doi.org/10.1186/s13063-021-05493-1.

[17] Muhammad Naveed et al., “Privacy in the Genomic Era,” ACM Computing Surveys 48 (2015): 1-44. doi.org/10.1145/2767007.

[18] Ella Corren, “The Consent Burden in Consumer and Digital Markets,” Harvard Journal of Law & Technology 36.2 (2023).

[19] David B. Resnik, “Do Informed Consent Documents Matter?” Contemporary Clinical Trials 30, no. 2 (2009): 114–115. (2009), doi:10.1016/j.cct.2008.10.004; Keith Porcaro, “It’s Time to Burn Medical Consent Forms,” Wired (June 16, 2022), https://www.wired.com/story/health-data-consent-forms/.

[20] Holly K. Tabor, “My46: a Web-based tool for self-guided management of genomic test results in research and clinical settings,” Genetics in Medicine 19 (2017): 467-475, https://doi:10.1038/gim.2016.133.

[21] R. Jean Cadigan, et al, “Online education and e-consent for GeneScreen, a preventive genomic screening study,” Public Health Genomics 20.4 (2017): 235-246, 10.1159/000481359; T.J. Kasperbauer, et al, “Incorporating biobank consent into a healthcare setting: challenges for patient understanding,” AJOB Empirical Bioethics (2020): 113-122, https://doi:10.1080/23294515.2020.1851313; Michelle M. Langer, et al, “Development and validation of a genomic knowledge scale to advance informed decision making research in genomic sequencing,” 2.1(2017): https://doi:10.1177/2381468317692582; Megan Prictor, Harriet J.A. Teare, Jane Kaye, “Equitable participation in biobanks: the risks and benefits of a ‘dynamic consent’ approach,” Front Public Health 6 (2018): 253, 10.3389/fpubh.2018.00253; Harriet J.A. Teare, Megan Prictor, and Jane Kaye, “Reflections on dynamic consent in biomedical research: the story so far,” European Journal of Human Genetics 29 (2021): 649-656.

[22] Hamid Ekbia et al., “Big data, bigger dilemmas: A critical review,” Advances in Information Science 66.8 (2015): doi.org/10.1002/asi.23294.

[23] Melissa S. Creary, “Bounded Justice and the Limits of Health Equity,” Jounral of Law, Medicine & Ethics 49.2 (2021): 241-256, https://doi:10.1017/jme.2021.34.

[24] Margaret Heffernan, Willful Blindness: Why We Ignore the Obvious at Our Peril. (Walker & Company, 2012).

[25] Elvan Dogan Kumtepe et al., “Design based exploration of medical system adoption: Case of wheelchair ramps,” Technology in Society 66 (2021): https://doi.org/10.1016/j.techsoc.2021.101620.

[26] BLINDED

Pet Euthanasia and Human Euthanasia

2025-07-30T13:14:41+00:00

Photo ID 213552852 © Yuryz | Dreamstime.com

Abstract

A criticism of assisted death is that it’s contrary to the Hippocratic Oath. This opposition to assisted death assumes that death is harmful to the person who dies. In this paper, I argue that the fact that we possess a rational nature is insufficient to preclude the possibility that death is in our best interest in the same way it is for our pets. I specifically respond to the objection posed by Leon Kass and Thomas Cavanaugh, who resist the comparison between pet euthanasia and human euthanasia. I show that their argument, that humans transcend suffering in a way that animals cannot, ultimately fails.

Introduction

A common criticism of assisted suicide and euthanasia, together “assisted death,” is that they violate the moral prohibition against intentionally killing innocent people. This prohibition often stems from the belief that death necessarily harms the person who dies, which is an idea found in numerous contexts, including discussions about the intrinsic goodness of life as well as the Hippocratic Oath that commands doctors to give no deadly drug and do no harm.^[1] While the prohibition is appealing to many, it makes sense only if we assume that death is necessarily harmful to the person who dies, for if death were in someone’s best interest, then that prohibition would state that it would be wrong to do something beneficial, which is implausible.^[2] Accordingly, if it is true that death can be in someone’s best interest, then invoking a prohibition against intentionally killing innocents on the basis of doing no harm would not constitute a strong objection to assisted death.^[3]

This paper uses the analogy of pet euthanasia to critique the claim that death is necessarily bad for us because our rational nature allows us to transcend our suffering,^[4] arguing that the propositions that give us reason to think that death can be good for our pets also apply to human beings. Moreover, the concern that we cannot predict future quality of life and therefore cannot say for certain that death is ever in someone’s best interest also applies in the case of our pets. Ultimately, the pet-human euthanasia analogy gives one reason to think that since pet euthanasia is justified, human euthanasia is justified too.

Pet Euthanasia

It is a commonly accepted practice to euthanize our pets because we do not want them to continue to suffer.^[5] This means that we often euthanize our pets for their sake. If this is true, which I assume it is, then this practice assumes that death can be in our pets’ best interest.

There are a number of basic propositions that, when taken together, support this belief.

Our pets’ lives can go better or worse, meaning that their well-being and ill-being can fluctuate.
Their amount of future ill-being can outweigh their amount of future well-being.^[6]
It is prudentially better for our pets not to exist if the alternative is for them to have greater future ill-being than future well-being.^[7]
Death is characterized by nonexistence.

My position is that our rational nature does not render any of the above basic propositions inapplicable to human beings. Like many philosophers, I assert that what mainly distinguishes us from the rest of the animal kingdom is our rational nature.^[8] Accordingly, if there is reason to think death cannot be in our best interest, like it can be for our pets, it is likely grounded in the fact that we are the rational animal.^[9]

With that in mind, I propose that 1 and 4 are not the ones under debate in the pet-human euthanasia analogy. Both sides generally agree that human lives can go better or worse, and that death is characterized by nonexistence. This leaves propositions 2 and 3. So now the question is whether there is good reason to think that our rational nature renders 2 or 3 inapplicable to human beings. I do not believe there is.

Regarding 2, the fact that we have theoretical and practical rationality, or whatever other trait that characterizes us, does not prevent us from having greater future ill-being than future well-being. Indeed, it seems obviously true that there are periods of our lives that can be dominated by more suffering, and there is no reason to think that our rational nature would make this imbalance impossible for the future of any particular individual. Furthermore, any plausible account of well-being must allow for the possible experience of overall suffering — that is, a greater amount of ill-being than well-being; thus, we need not be committed to any particular theory.

Our rational nature would also not preclude the applicability of 3, which states that nonexistence is prudentially better than having greater future ill-being than well-being. Yes, we can attain truth, we have excellent means-ends reasoning, we are self-conscious, and we are moral agents, but these are not the right kinds of reasons to show that 3 is inapplicable to humans. What would be needed is a disproof of the position that death is good for us when it deprives us of overall future ill-being (deprivationism^[10]), and specifically, a disproof of deprivationism for humans that simultaneously allows it to be true for nonhuman animals.

The Transcendence of Suffering

Some who push back against the pet-human euthanasia comparison emphasize our unique ability to transcend our suffering. In essence, they argue that due to our rational nature, we can find meaning, draw insights, and even grow spiritually when faced with significant obstacles, whereas animals cannot have any of these goods given their limited natures.^[11] The argument of transcendence relates to well-being in the following way: Transcending our suffering amounts to attaining higher goods that result from our suffering, and attaining these higher goods means that suffering is not a net cost to our overall well-being. The transcendence claim is best understood as a challenge to proposition 2 (which is about weighing ill-being against well-being) in the case of humans.

In response, it is true that humans can transcend suffering in a way that pets cannot; our rational nature does enable us to attain higher goods. And, indeed, humans voluntarily do many painful things because we find them to be meaningful — e.g., run marathons.^[12] However, for a few reasons, the fact that we are able to does not mean that we will.

First, while our rationality enables us to attain higher goods, it also enables us to suffer greater bads, so it is not clear that the former outweighs the latter. Our pets, on the other hand, presumably cannot suffer existentially.^[13] They are presumably unable to believe that their life was wasted or that it had no meaning. They presumably do not feel toxic shame or deep regret. Moreover, while we do have access to medical care, and perhaps better medical care than our pets have, existential suffering persists. In fact, the primary reasons people seek an assisted death (in Oregon and Canada) are loss of autonomy and inability to engage in activities that make life meaningful to them. And most who seek it already receive palliative/hospice care.^[14]

Second, not all human beings can experience those higher goods due to their age and/or cognitive decline. Infants, for instance, presumably do not possess the required cognitive capacities to find meaning, draw insights, or grow spiritually. Therefore, for these groups who suffer but will not improve, they will likely experience more overall future ill-being.

And third, even in cases where a human being is attaining higher goods from their suffering, it does not follow that they will continue to gain if they continue to suffer. Suppose there is a cancer patient with six months to live. It seems unlikely that they must benefit overall from dying in six months rather than in five. On the contrary, it seems likely or reasonably expected that, at some point, their quality of life could be overall negative.

For these reasons, our ability to transcend our suffering does not disprove proposition 2, which says future ill-being can outweigh future well-being, in the case of humans.

The transcendence claim is also no challenge to proposition 3, which states that nonexistence is prudentially better than a future with greater overall ill-being, in the case of humans. In fact, it is consistent with it. Assuming the transcendence claim is true, i.e., that humans can attain higher goods despite (or even because of) our suffering due to our rational nature, it does not follow that nonexistence is worse than continued living. Actually, the transcendence claim does not deny the truth value of any comparison between nonexistence and quality of life; it merely speaks to the fact that suffering may contribute to overall well-being.

To elaborate, proposition 3 for humans can be reformulated as a conditional. A simple version of it would say, “If a person will experience greater overall future ill-being, then nonexistence is prudentially better for them.” The transcendence claim aims to address the antecedent. It suggests that transcending suffering contributes to overall well-being, which ultimately outweighs the ill-being the person experiences. It does not address the conditional itself. Therefore, one could accept the conditional but deny that the antecedent ever obtains. So, the transcendence claim is not a challenge to proposition 3 in the case of humans. Overall, the fact that we can transcend our suffering does not render propositions 2 or 3 inapplicable to human beings.

Ignorance

An opponent may accept the possibility of death being in our best interest but still support a prohibition against assisted death because we cannot predict a person’s future quality of life. Since we cannot know if any particular person’s future ill-being will outweigh their future well-being, we should apply a precautionary principle that states that we should not intentionally end the life of an innocent human being. Such an argument grants the claim that ill-being may outweigh well-being but justifies the prohibition of assisted death on the grounds of uncertainty.

In response, while it is true that no one can predict the future, this is also true of our pets’ futures, and yet, that does not justify banning pet euthanasia. To elaborate, we can only guess as to whether death is good for our pets, because we cannot know what it is like for our pets to suffer. What is it like for a dog to have dementia? Can they experience more overall well-being simply by being held and caressed despite suffering from that condition? We do not know. We may have reasonable expectations, but we do not know. It is conceptually and practically difficult to measure well-being in another species, which brings us to an important point.

We can communicate with people who seek assisted death. We cannot communicate with dogs and cats, at least not to the degree that, or in the same manner as, we can with humans. This gives us reason to think that we can more reliably guess some people’s future well-being/ill-being state than our pets’ future well-being/ill-being state. A person diagnosed with terminal cancer can tell us what they value and how their illness is affecting their quality of life, which, to some extent, can forecast their future quality of life. They can tell us how they want to live and how they want to die. Nonhuman animals cannot do any of these things. Essentially, we can have better knowledge and data about the suffering of another human being. So, interestingly, the difference between humans and other animals that opponents highlight to justify prohibiting euthanasia actually works against them here.

Conclusion

Some opponents of the pet-human euthanasia analogy argue that death cannot be good for us because our rational nature enables us to transcend our suffering. However, despite this ability, the basic propositions that support the belief that death can be good for our pets also apply to human beings. This gives good reason to think that death can be good for us too. Moreover, some could argue that we should still prohibit assisted death because of our inability to predict future quality of life. While it is true that future ill-being is often not precisely predictable for any particular person, this is also true in the case of our pets, and yet, that ignorance has never been a sufficient justification to ban pet euthanasia. Consistency demands that this point is not a sufficient justification to ban it for humans either.

[1] Finnis believes that life is a basic human good. John Finnis, “A Philosophical Case Against Euthanasia,” in Euthanasia Examined: Ethical, Clinical, and Legal Perspectives, ed. John Keown (Cambridge: Cambridge University Press, 1995), 23-35. Cavanaugh explicitly states that giving a patient a lethal drug is a harm. Thomas A. Cavanaugh, “Why the Hippocratic Oath Prohibits Physician-Assisted Suicide,” Public Discourse, November 20, 2019, https://www.thepublicdiscourse.com/2019/11/57243/ . While not contained in the original Oath, the maxim “first, do no harm” is also raised in the same context for the same reason. See Andreas Fontalis, Efthymia Prousali, and Kunal Kulkarni, “Euthanasia and assisted dying: what is the current position and what are the key arguments informing the debate?” Journal of the Royal Society of Medicine 111, no. 11 (2018): 407–413, https://doi.org/10.1177/0141076818803452

[2] There has been significant work by deprivationists and Epicureans on the prudential effect of death on the deceased. Deprivationists argue that death can be good or bad for you, while Epicureans argue that it cannot. For a good review of the debate, see Travis Timmerman, “A Dilemma for Epicureanism,” Philosophical Studies 176, no. 1 (2019): 241-257, https://doi.org/10.1007/s11098-017-1014-2, and Steven Luper, “Death,” in The Stanford Encyclopedia of Philosophy, ed. Edward N. Zalta (Metaphysics Research Lab, Stanford University, 2021), https://plato.stanford.edu/archives/fall2021/entries/death/;

[3] I use “best interest,” “good for,” and “prudentially better” to refer to something that leads to a higher total amount of well-being. So, saying that x is in someone’s best interest, or is good for someone, or is prudentially better, means that x leads to a higher total amount of well-being for that person.

^[4] Others have made this comparison. See Jessica Pierce, “Human and Animal Euthanasia: Dare to Compare?,” Psychology Today, November 29, 2011, https://www.psychologytoday.com/us/blog/all-dogs-go-heaven/201111/human-and-animal-euthanasia-dare-compare; Julian Baggini, “Euthanasia for Animals: What Can It Teach Us about Assisted Suicide in Humans?,” Independent, July 21, 2015, https://www.independent.co.uk/life-style/health-and-families/features/euthanasia-for-animals-what-can-it-teach-us-about-assisted-suicide-in-humans-10405840.html; Mark S. Komrad and Oliver Glass, “Euthanasia in Animals and Humans: Distinctions to Consider,” Psychiatric Times, July 29, 2024, https://www.psychiatrictimes.com/view/euthanasia-in-animals-and-humans-distinctions-to-consider; John Shand, “Putting Animals & Humans To Sleep,” Philosophy Now, 2018, https://philosophynow.org/issues/129/Putting_Animals_and_Humans_To_Sleep.

[5] Any reference to pets should be understood as a reference to typical pets—that is, those animals that can have subjective experiences.

[6] The argument I present does not require a simple mathematical approach to measuring ill-being and well-being. Rough estimates are sufficient and are, in fact, what we use to determine when to euthanize our pets.

[7] “Greater” here refers to both quantity and/or quality. I do not provide a formula for how to weigh the two. Importantly, again, we do not require such a formula when we judge that it is better for our pets not to exist.

[8] There are other potentially morally relevant differences between humans and pets, but this paper focuses on rationality as a key distinguishing factor. And more specifically, the focus is our ability to transcend our suffering that comes from our rational nature.

[9] Note that I do not list these propositions to show how the justifiability of pet euthanasia automatically transfers over to the human case; rather, my argument is about well-being. I say this because some who push back against the comparison between pets and humans will undoubtedly say that human life is more valuable than animal life, and so the moral permissibility of euthanizing animals does not transfer over to euthanizing human beings. While that may be true, it is a separate argument. We can consistently hold the following two beliefs: (1) human beings are more valuable than nonhuman animals, and (2) death can be good for us too. My argument pertains specifically to the latter.

[10] See Nagel for an explanation of why death can be bad for us. Thomas Nagel, “Death,” Noûs 4, no. 1 (1970): 73–80. Deprivationists also believe that death can be good for you if it deprives you of future ill-being. L. W. Sumner, Physician-Assisted Death: What Everyone Needs to Know (Oxford University Press, 2017), 11–12.

^[11] Leon R. Kass, “‘I Will Give No Deadly Drug’: Why Doctors Must Not Kill,” in The Case Against Assisted Suicide: For the Right to End-of-Life Care, ed. Kathleen Foley and Herbert Hendin (Baltimore, Maryland: The John Hopkins University Press, 2002), 38; Thomas A. Cavanaugh, “Dignity, Pet-Euthanasia and Person Euthanasia,” in G.E.M. Anscombe and Human Dignity, ed. John Mizzoni (Aston, Pennsylvania: Neumann University Press, 2016), 117–42.

[12] Paul Bloom, The Sweet Spot: Suffering, Pleasure and the Key to a Good Life (London: The Bodley Head, 2021)

[13] To be clear, existential suffering does not have to be quantifiable in order for it to be a greater bad, just like meaning does not have to be quantifiable in order for it to be a higher good.

[14] Oregon Health Authority, Oregon Death with Dignity Act: Data Summary, 2024; Health Canada, Fifth Annual Report on Medical Assistance in Dying in Canada 2023, 2024.

Acknowledgement: I would like to thank Benjamin Parviz, Eric Mathison, and the anonymous reviewers for their helpful feedback.

Social Media Suicide Watch

2025-06-28T00:29:52+00:00

Photo ID 136328652 © Tobias Knoepfli| Dreamstime.com

Abstract

Two tragedies illustrate the need to both monitor suicidal ideation more effectively and protect individuals from harmful influences. In the UK, a 14-year-old girl named Molly Russel died by suicide after consuming self-harming content online, while her own distressing signals on social media went unnoticed. In contrast, Conrad Roy III died by suicide after encouragement from his girlfriend via texts and calls, demonstrating the devastating consequences of alerting the wrong person to a mental health crisis. These cases highlight the moral ambiguity of tracking public expressions of suicidal ideation ─ when is it appropriate to monitor this data, and with whom should it be shared? The public was compelled to weigh in on this issue in 2014 when Samaritans implemented an app that scanned Twitter users’ posts for signs of suicidal ideation and alerted fellow users. There was an immediate backlash due to concerns over privacy and the potential for stalkers and bullies to misuse this data and encourage suicide or self-harm, like Roy’s girlfriend did. However, for some individuals, like Molly Russel, social media posts may be a cry for help, which could be met with thoughtfully crafted interventions. This paper proposes a new model for monitoring suicidal ideation online ─ one that promotes autonomy, respects confidentiality, and provides evidence-based support. This model includes direct user alerts, safety planning, and opt-in data-sharing with mental health professionals.

Introduction

Molly Russel is a household name in the UK. After dying by suicide at age 14, an inquiry into her death revealed that Molly was suffering from depression and the negative effects of harmful online content. She was repeatedly exposed to posts that displayed hopelessness and misery. Her own Twitter account revealed signals of her worsening mental health crisis.^[1] While better content censoring could have helped, an algorithm capable of detecting her worsening mental state and alerting trusted individuals could have also served as a crucial safety net. Notifying mental health professionals and law enforcement of potential suicide risk is considered a protective factor.

Yet, this same technology could have unintended and devastating consequences by alerting a wrongdoer. In 2014, Conrad Roy III died by suicide after his girlfriend encouraged him to end his life via text messages. While this was not a social media case, after he filled his truck with toxic fumes, she urged him to get back inside and listened as he died, making no attempt to intervene.^[2]² This case highlights the danger of alerting the wrong person to suicidal ideation. When such sensitive information falls into the wrong hands, it can be weaponized.

These two opposing stories emphasize the double-edged nature of using technology to detect and respond to mental health crises. So, who do we save—Molly or Conrad? Which scenario is more likely? The public weighed in on this dilemma in 2014, when the charity Samaritans launched a Twitter app that allowed users to receive alerts if someone they followed posted messages suggesting suicidal thoughts.^[3] There was almost immediate backlash. Critics flagged concerns about privacy, surveillance, and the potential for harm. Yet, the question remains: While some posts are publicly visible, others are deliberately restricted to followers only. Flagging the former may raise ethical questions, but alerting others to the second more clearly violates the app’s own terms of use. Could an app truly prevent suicide and promote well-being? And if so, does that outcome justify infringing on individuals’ expectations about privacy or the nonconsensual analysis of their posts?

Ethical Analysis

The strongest argument in favor of apps like Samaritan’s Radar is their potential to predict individuals at risk for suicide and self-harm accurately. Psychiatrists and most primary care physicians are trained to assess suicide risk based on factors such as previous suicide attempts, chronic pain, legal problems, and financial difficulties.^[4] However, these traditional methods are often too broad to be consistently effective in clinical settings.^[5] Apps like Samaritan’s Radar could refine risk prediction by providing real-time data, potentially improving intervention efforts. AI can be used to retrospectively analyze posts from individuals who died by suicide to identify patterns imperceptible to the human eye. These algorithms could then be applied to current users to more accurately identify at-risks populations.

However, even if an app offers the possibility of more accurately identifying suicide risk, it may be that therapists and clinicians are better trained to assess the sincerity of flagged posts than an app. For example, a post stating, "I have so much homework, I’m gonna kill myself," may warrant attention but more likely reflects a state of frustration rather than real suicidal intent.

Furthermore, apps may struggle to recognize the nuanced stages of suicide risk, such as contemplation, suicidal intent, the development of a plan, intent to act, and suicidal behaviors. These distinctions are critical in determining the appropriate level of intervention, something that human judgment may handle more effectively than algorithmic detection.

Additionally, existing systems designed to prevent suicide already infringe on individual rights. For example, under HIPAA, therapists and psychiatrists are permitted to contact emergency services, for example by calling 911, when there is a threat to safety.^[6] Psychiatric hospitalization can help prevent suicidal behavior by providing immediate safety and stabilization. It also offers an opportunity to initiate treatment, including medication and counseling. Suicide safety planning and follow-up contact initiated during these hospitalizations has also been shown to improve suicidal ideation and psychological stress in the months following discharge.^[7] Alerting trusted individuals or emergency services is one of the most effective ways to intervene and save lives. For many families who have lost a relative to suicide, the opportunity to protect a life far outweighs the concerns about the temporary intrusion of privacy.

Regarding the issue of consent, patients who disclose suicidal ideation to a healthcare professional typically do so with the understanding that providers have a mandatory reporting policy. They are required to share this stipulation with patients at the outset. In the context of a psychiatric or mental healthcare appointment, patients share their inner thoughts knowing their exact audience. However, the Samaritan’s Radar app did not notify users that an algorithm was analyzing their content for signs of distress. Even more concerning, email alerts were sent to anyone who signed up to follow a given user, without that user’s consent. Some may argue that the posts on Twitter are public and can be viewed by anyone. However, this does not equate to consent for an app to actively warn or alert others about a user’s mental health status. Doing so risks breaching privacy and may misrepresent the user’s state.

Furthermore, alerting users whom the individual did not designate as trusted without consent risks further harm. Their relationship to the at-risk user would be unclear, and their response could inadvertently worsen the situation. They may lack the appropriate words to offer support. In worse cases, they could unintentionally shame, stigmatize, or even bully the individual. When Conrad Roy shared his suicidal ideation with his girlfriend, she weaponized that vulnerability. Similarly, individuals on Samaritan’s Radar may deliberately follow trends of emotional distress to hurt, rather than help individuals.

Additionally, such alerts might discourage people from posting altogether, robbing friends and relatives of the opportunity to naturally reach out in a way that feels organic rather than intrusive. In the best-case scenario, those who see a concerning post could offer resources or, if necessary, contact emergency services on their own initiative.

Rethinking Samaritan’s Radar: A Path Forward

To balance user privacy with the need to protect individuals struggling with mental health issues, apps should be able to analyze publicly posted messages for signs of suicidal ideation. However, rather than notifying others without the user’s consent, the app should first alert the individual directly, presenting the detected concerns. It should then offer options such as calling a suicide helpline, contacting emergency services, or reaching out to a trusted person of their choice (e.g., a parent, friend, or designated support). This approach provides support to users while reinforcing their agency by giving them choice in how to proceed.

Even more effective would be the inclusion of a suicide safety plan, a tool that has been shown to reduce suicidal behavior significantly.^[8] If users have previously and voluntarily identified themselves as high risk, the app could provide this plan proactively. Otherwise, it could be offered in moments of acute crisis, delivering evidence-based support at the time it is most needed.

It may also be beneficial to have an opt-in feature that allows apps to share information with trusted health professionals or guardians. With user permission, the app could notify psychiatrists, not just of suicidal content, but of posts suggesting worsening mental stability, enabling earlier intervention before it’s too late. If the content raises serious concern, and the user has given prior consent, the psychiatrist may contact a parent or an appropriate authority to ensure the individual’s immediate safety.

Furthermore, app developers should collaborate with trained psychiatrists when designing these technologies, given their expertise in identifying and treating suicidal behavior. They may provide insight into crisis management strategies that may not be familiar to those outside of the mental health field. Before implementation, such apps should be examined through formal studies to assess their effectiveness and psychological impact. To justify their use, it is essential to prove that they reduce suicide attempts and cases.

While the Samaritan app was created with good intentions, it overlooked important ethical principles. It alerted the wrong people and bypassed users entirely, failing to respect their autonomy or offer them resources. However, one app should not ruin all future progress. Countless people express despair, hopelessness, and signs of self-harm and suicidal ideation online. With careful design, we don’t have to choose between saving Molly or protecting Conrad. We can help them both. It is time we revisit the issue of using technology as a tool for suicide prevention.

[1] Crawford, A. (2023, November 29). Molly Russell: Tech firms still failing after teenager's death, says father. BBC News. https://www.bbc.com/news/uk-67556756

[2] Seelye, K. Q. (2017, June 16). Michelle Carter is found guilty in texting suicide case. The New York Times. https://www.nytimes.com/2017/06/16/us/suicide-texting-trial-michelle-carter-conrad-roy.html

[3] Orme, J. (2014, November 7). Samaritans pulls 'suicide watch' Radar app over privacy concerns. The Guardian. https://www.theguardian.com/society/2014/nov/07/samaritans-radar-app-suicide-watch-privacy-twitter-users

[4] Brown, G. K., & Green, K. L. (2014). A review of evidence-based follow-up care for suicide prevention: Where do we go from here? American Journal of Preventive Medicine, 47(3 Suppl 2), S209–S215. https://doi.org/10.1016/j.amepre.2014.06.006; Centers for Disease Control and Prevention. (2024, April 25). Risk and protective factors for suicide. U.S. Department of Health and Human Services. https://www.cdc.gov/suicide/risk-factors/index.html

[5] Hawton, K., Lascelles, K., Pitman, A., Gilbert, S., & Silverman, M. (2022). Assessment of suicide risk in mental health practice: Shifting from prediction to therapeutic assessment, formulation, and risk management. The Lancet Psychiatry, 9(6), 518–528. https://doi.org/10.1016/S2215-0366(22)00232-2; Lucey, J. V., & Matti, B. (2021). Suicide risk assessment: Time to think again? Irish Journal of Psychological Medicine, 40(3), 323–325. https://doi.org/10.1017/ipm.2021.76

[6] ((45 CFR §164.512(j)).

[7] Stanley, B., Brown, G. K., Brenner, L. A., Galfalvy, H. C., Currier, G. W., Knox, K. L., Chaudhury, S. R., Bush, A. L., & Green, K. L. (2018). Comparison of the Safety Planning Intervention with follow-up vs usual care of suicidal patients treated in the emergency department. JAMA Psychiatry, 75(9), 894–900. https://doi.org/10.1001/jamapsychiatry.2018.1776

[8] Orme, J. (2014, November 7). Samaritans pulls 'suicide watch' Radar app over privacy concerns. The Guardian. https://www.theguardian.com/society/2014/nov/07/samaritans-radar-app-suicide-watch-privacy-twitter-users

The Right to Die

2025-05-20T20:38:37+00:00

Photo by Kateryna Hliznitsova on Unsplash

Abstract

This paper examines whether the autonomous self can give rise to a right to die in the form of a right to physician-assisted death (PAD) with a geographic focus on Europe. The paper questions whether a patient’s request for PAD can be justified as an expression of true autonomy or whether autonomy itself must be understood as inherently relational. The paper further explores case-law concerning human rights and the incompatibility of a right to die with the right to life, which serves as the foundation for human rights protections. The paper argues that neither patient autonomy nor the right to life provides a sufficient basis for establishing a right to die. Rather, autonomy should be viewed within an interdependent ethical framework that recognizes human vulnerability and mutual responsibility. The paper concludes that legitimizing PAD risks altering the meaning of care and eroding societal and medical commitments to preserving life.

Introduction

This paper examines whether autonomy justifies a right to die in the form of physician-assisted death (PAD) and explores the possible implications of this right in the European countries where PAD is legal. The paper begins by analysing autonomy in the context of end-of-life care, through the lens of the patient-doctor relationship and the decision-making process. The issue is whether a patient’s request for PAD can be seen not only as justifiable but also as necessarily grounded in the patient’s autonomous decision-making capacity. The paper then delves into the legal implications of a putative right to die, exploring its incompatibility with the right to life, which is a cornerstone of protecting all human rights. The paper also investigates the conditions under which PAD might nevertheless be legally permissible, e.g., under European Law. Finally, the paper concludes that neither patient autonomy nor the right to life provides a solid foundation for a right to die. It argues that patient autonomy should be understood as inherently relational, emphasizing that individual decisions impact society at large, and that autonomy as a purely individualistic concept is ultimately illusory. Moreover, the theoretical foundation of the self is shown to depend on its relation to others, which implies that the act of killing is not only an act against the other but also against the self.

Background

In Europe, six countries – Switzerland, the Netherlands, Belgium, Luxembourg, Spain, and Austria – have legalized some form of assisted dying, while others, including England and Wales, are in the process of doing so. In addition, Colombia, Canada, New Zealand, ten states in the US and six states in Australia allow assisted dying. In some countries, patients can access assisted dying only in case of terminal illness, while in others the requirement can be ‘severe suffering’ from a ‘chronic disease,’ which may encompass mental health conditions. Generally speaking, the legislative safeguards which place conditions on access to PAD raise concerns over equal access.^[1] Yet the safeguards are meant to protect against uses of PAD that legislatures have not approved and to make sure that citizens requesting PAD are doing so freely and without any form of coercion and external pressure.

The Concept of the Autonomous Self in End-of-Life Care and Its Implications

Autonomy is a central concept in Beauchamp and Childress’s four principles of biomedical ethics, often seen as the cornerstone of medical ethics. To these authors, respecting autonomy means recognising a person’s right to make choices based on their values and beliefs, not just by avoiding interference but by actively supporting their ability to decide freely.^[2] Beauchamp and Childress’s conceptualization of autonomy explains the paradigm shift of the past half century from the ‘doctor knows best’ tendency towards a more balanced doctor-patient approach where patients are seen as active protagonists with their own opinions, desires, and, above all, a right to know about and consent to medical treatment. Patients’ autonomous choices may not always align with what doctors consider to be in their best interests, as seen in refusals of life-saving treatments that their medical practitioners deem essential. And, patients cannot force doctors to administer medical treatments that they do not consider optimal. These two assumptions create tension when it comes to life-and-death decisions and whether the patient’s autonomous choice can stretch to the point of choosing when and how to die. The questions, therefore, are whether a legitimate request for PAD can stem from autonomy. According to Beauchamp and Childress, public policies on PAD should prevent abuse but should not undermine its moral justification: “A favourable response by a physician to a request for assistance in facilitating death by hastening it through prescribing lethal medication is not relevantly different from a favourable response to requests for assistance in facilitating death by easing it through removal of life-prolonging technology or use of coma-inducing medication.”^[3] On this view, the principle of autonomy (the ‘patient’s perspective’) and the principle of beneficence (the ‘clinicians’ perspective’, i.e., a positive obligation to contribute to the welfare of others) do not necessarily conflict ethically, although competing principles should be balanced on a case-by-case basis. Countries where some forms of PAD are legal offer an example of how these principles need some kind of ‘support’ to avoid exploitation.

An Autonomy-Based Argument for PAD

The expressivist objection to assisted dying claims that allowing PAD for a specific group of persons expresses a negative judgment on whether their life is worth living. Some argue that an autonomy-based approach is the only way to address this objection. For example, Esther Braun claims that policies permitting assisted dying to all autonomously choosing it avoid the expressivist objection.^[4] To Braun, the autonomy-based approach is the way forward since “assisted suicide should not be understood as a medical procedure that can be ‘indicated’ but rather as an autonomous action that can be carried out for all sort of reasons that should not be judged by others.”^[5] Consequently, PAD should not be considered a medical practice because, as such, it would fall under the umbrella of indicated treatments under certain circumstances (such as irremediable suffering) where the patient would benefit.^[6] Second, intentionally terminating the life of a patient can lead to a harmful division within the clinician’s medical and social role. Instead, “the judgment of whether her [the patient]’s life is worth living is strictly the patient’s.”^[7] According to Braun, assisted suicide should be removed from the realm of beneficence relevant to all medical procedures and confined to the autonomous self who has full power over his or her fate. Braun’s autonomy-based position is that it would be legal to provide PAD to anyone who makes an autonomous request regardless of their medical condition, thus circumventing the principle of beneficence. To her, restrictions would be needed only to ensure that the patients’ decision to end their own life is taken autonomously (so the patient has decision-making capacity, the decision is informed and voluntary). This avoids depicting any group as less worthy of living. However, Braun refrains from delving into the practical implications of this kind of autonomy-based approach to PAD.

Given the fact that people are situated in social contexts, the question is whether this decisional power stemming from the autonomous self, in particular in circumstances of vulnerability, can be seen as entirely beginning and ending in the individual – as Braun maintains – or can be the subject of external influences.

“Desperation and a feeling of being superfluous”^[8] form the context in which individuals exercise self-determination.^[9] This creates a fragile foundation for both autonomy and decision making. Therefore, Ole Hartling defines autonomy when it comes to deciding about one’s own death as a “prison of freedom.”^[10] The idea of deciding autonomously – understood as acting independently not only of other people’s influence but also of any duress (physical or psychological) may seem like an illusion. End-of-life decisions are undoubtedly grounded in the concept of autonomy, but not in the individualistic sense that views human beings as isolated entities. Rather, these decisions reflect that people are deeply embedded in the fabric of society, which shapes their identities in both positive and negative ways.

Autonomy needs to be considered in the context of the wider ethical framework of medicine and society.^[11] It is not just a matter of individual will, but it is relational: when patients express their desire to die due to suffering, clinicians should look beyond autonomy and focus on relieving the suffering, not ending the life of the sufferer. Patient choices are not an isolated exercise of will and can also affect others both directly and indirectly – to such an extent, for instance, that in countries where PAD is legal, it has increased at a steady pace in the years immediately following its legalization, likely due to rising public acceptance.^[12] Unassisted suicide has also increased in jurisdictions where PAD is legal.^[13]

PAD and A Duty of Care

PAD is not a "neutral" act but has profound implications not only for the patient but for the clinicians’ duty of care embedded in their professional ethos, since this becomes the umbrella under which PAD falls. In this regard, the American Medical Association Code of Medical Ethics is clear: “Physician-assisted suicide is fundamentally incompatible with the physician’s role as healer, would be difficult or impossible to control, and would pose serious societal risks.”^[14] Some assert that doctors’ role in PAD undermines the moral integrity of their profession in a way that is similar to doctors’ refusal to help their patients during their end-of-life stage.^[15]

As mentioned above, doctors are not obligated to do everything in their power to prolong a patient’s life. Patients can refuse treatment and doctors can prescribe palliative drugs whose side effects may include some shortening of life. “But while patient autonomy gives us a right to refuse procedures, it does not give us a right to demand them; it is a shield, not a sword.”^[16] In fact, “[p]atient autonomy yields to the inviolability of life.”^[17]

Does the Right to Life Encompass the Right to Die? A Legal Overview

Human rights laws protect individuals from undue interference with the rights and liberties considered pillars of human dignity and its preservation. The right to life is the first and foremost right protected by the European Convention on Human Rights (ECHR) since its deprivation prevents the protection of any subsequent rights. The right to life is an absolute right that may be derogated only “(a) in defence of any person from unlawful violence; (b) in order to effect a lawful arrest or to prevent the escape of a person lawfully detained; (c) in action lawfully taken for the purpose of quelling a riot or insurrection.”^[18] The state has both a positive duty to ensure that “[e]veryone’s right to life shall be protected by law”^[19] and a negative duty not to deprive citizens of their life unless the exceptional cases stated above apply. This right must also be protected without discrimination on any ground.^[20] When it comes to healthcare provisions, Article 2 is often read in conjunction with Article 8 (right to respect for private and family life):^[21] “Article 2 cannot, without a distortion of language, be interpreted as conferring the diametrically opposite right, namely a right to die; nor can it create a right to self-determination in the sense of conferring on an individual the entitlement to choose death rather than life.”^[22]

Pretty v. The United Kingdom (2002) clearly established that Article 2 cannot be stretched to include the opposite right, namely, the right to die.^[23] This statement has been reiterated in cases concerning euthanasia and/or assisted suicide that underwent scrutiny by the European Court of Human Rights (ECtHR), also referred to as the Court of Strasbourg. This does not imply that contracting States cannot allow PAD because when there is no general agreement on such sensitive matters, the European Court of Human Rights (ECtHR) affords States a margin of appreciation. In fact, States must guarantee safeguards (they have positive obligations) to protect their citizens from coercion and make sure their decision is made autonomously. As the Court recently stressed in Daniel Karsai v. Hungary (2024), “Article 2 does not prevent the national authorities from allowing or providing PAD, subject to the condition that the latter is accompanied by appropriate and sufficient safeguards to prevent abuse and thus secure respect for the right to life.”^[24] This would mean that the right to life is not seen as a priori contrary to provisions of euthanasia or PAD.

In Mortier v. Belgium (2022),^[25] the Court addressed the State’s positive obligations relating to euthanasia and PAD. The issues were “whether the Euthanasia Act, as in force at the relevant time, offered an effective safeguard for protecting vulnerable individuals’ right to life and whether the euthanasia of the applicant’s mother was performed under the conditions compliant with Article 2 of the Convention.”^[26] The Court of Strasbourg found the Belgian law on euthanasia compliant with Article 2 ECHR with the requirement to provide material safeguards while in breach of the right to life in relation to procedural safeguards applicable once the patient has died.

As the Court of Strasbourg highlighted in Mortier, “the legislative framework governing pre-euthanasia procedures must ensure that an individual’s decision to end his or her life has been taken freely and with full understanding of what is involved.”^[27] As stated in Haas v. Switzerland (2011),^[28] the national authorities have the duty “to prevent an individual from taking his or her own life if the decision has not been taken freely and with full understanding of what is involved.”^[29] The Court is particularly mindful that the risk of abuse in the provision of assisted dying is directly proportional to the ease and speed of access to such provision. Since the Mortier case concerns mental and not physical suffering, the Court expects “enhanced safeguards in the euthanasia decision-making process.”^[30] The Court found that the legislative framework in place in Belgium did sufficiently protect patients seeking euthanasia for mental illness. Article 2 ECHR requires independence among medical practitioners consulted by patients to obtain the green light for euthanasia: independence both in terms of institutional connections (formal independence) and de facto independence. While the former can be considered in terms of hierarchical connections (such as a junior-senior work relationship) the latter is vaguer. It is not clear what degree of acquaintance would negate independence. In the Mortier case, the majority of judges did not view the doctors’ shared affiliation with the Life End Information Forum (LEIF), which advocates for dignified death for all, as sufficient evidence of a lack of independence.^[31] Medical practitioners’ independence also concerns the post-euthanasia procedural safeguards where an independent judicial system needs to establish that no suspicious circumstances led to the patient’s death. The Belgian Euthanasia Act established an independent board of 16 members nominated by a legislative assembly of qualified doctors, lawyers, and professionals expert in end-of-life issues to review each case. However, the law did not prevent doctors who actively participate in the case under review from voting on whether their own acts complied with the law.^[32] In Mortier, a doctor was involved in both the case and its review. This is one of the reasons (alongside the undue length of the criminal investigation) that the Court found the a posteriori safeguarding process in breach of Article 2 ECHR.

There is a significant grey area surrounding the compatibility of PAD provisions and the Article 2 ECHR. In fact, the State’s positive obligations may extend to National Health Service (NHS) medical practitioners since the NHS is government-owned and directed and publicly funded (primarily through taxation)^[33]: “[T]he negative obligation prohibits the State from conducting euthanasia and assisted suicide itself, even as part of a well-regulated scheme with appropriate safeguards. This means, under the Convention, States may allow/tolerate private parties from conducting euthanasia/assisted suicide with appropriate safeguards but the State itself cannot conduct them.”^[34] NHS medical practitioners can be considered State employees. If assisted dying were implemented in England and Wales, medical practitioners in charge of assisting patients through the process would likely be NHS-funded; therefore, a plausible case can be made that a law of this kind is incompatible with the ECHR.^[35] However, the ECtHR has not yet addressed cases specifically concerning the role of state-funded doctors in PAD.

Hence, the fact that other European countries already permit physicians employed by the state or state-run healthcare system to perform PAD does not, per se, resolve the issue. The Court of Strasbourg addresses only those cases brought by individuals who are directly affected and only after all national remedies have been exhausted. Yet, in Mortier dissenting opinion Judge Serghides argued that euthanasia has no legal basis within the Convention and that if the drafters had wanted to insert PAD provisions they would have included a separate protocol (as it happened when, first, protocol no. 6 and then protocol 13 entered into force to abolish the death penalty in both wartime and peacetime). Moreover, if the State’s positive obligations to protect human life are not read together with the State’s negative obligations not to act against human life (obligations in place “regardless of whether the threat comes from State agents using lethal force or from State organs applying euthanasia procedures and practices”^[36]) there would be no room for the negative obligations to protect the right to life effectively.

The right to life is considered an absolute right. The right to life does not inherently include a right to die, as such an interpretation contradicts the fundamental principles of the right to life. However, it remains possible in law to enact legislation permitting the active hastening of death, provided there is a robust framework in place to protect citizens from potential abuses of their right to life (positive obligations).^[37] Hence, “the devil is in the detail”^[38] in terms of whether PAD, assessed case-by-case and in terms of procedure, violates Article 2. Yet, when it comes to State negative obligations in relation to Article 2, they can become blurred in particular since they fall under the ‘margin of appreciation’ umbrella. In Karsai the ECtHR reiterated that criteria for PAD such as terminal illness should not be perceived as attaching less value to the lives of people meeting them, instead “these criteria can be viewed as reflecting the delicate balance to be struck between respect for human dignity and the right to self-determination on the part of patients with full mental capacity who wish to die, and the risks involved in allowing PAD beyond a narrowly defined scope.”^[39] However, this position – likely rooted in the principle that competent patients can refuse life-sustaining treatments even if this hastens death – risks conflating cases that are apparently similar but are instead fundamentally different. This surely further muddies the waters.

Relational Autonomy and the Impossibility of a Right to Die

In recent weeks, the Terminally Ill Adults (End of Life) Bill,^[40] proposed by Labour MP Kim Leadbeater, which seeks to legalise PAD for terminally ill, competent adults in England and Wales, has been the subject of extensive discussion.^[41] While proponents of the Bill stressed the value of the patient’s autonomy, which they argue should encompass when and how the patient would die, opponents emphasised the need to invest in the palliative care system and the risk that the law could pose to vulnerable people and society at large if medical boundaries are stretched and the doctor-patient relationship is indelibly compromised.

The path to accessing PAD begins with a preliminary discussion with a registered medical practitioner. Eligible individuals must be terminally ill, mentally competent adults with a life expectancy of no more than six months, registered with a GP in England and Wales, and ordinarily residing in England and Wales for at least the past year. Doctors have no obligation to initiate a conversation about PAD. However, a doctor is permitted to raise the subject proactively with an adult patient. If a doctor declines to discuss PAD and a patient expresses interest, the doctor must offer the patient the relevant information to allow the patient to seek PAD elsewhere. The preliminary discussion must be followed by a first declaration signed by both a ‘coordinating doctor’ and another person. Following the initial assessment, a seven-day reflection period begins. Then, a second doctor independently evaluates the patient to confirm the findings of the initial assessment. It may also be necessary to obtain a further assessment if the previous doctor is not satisfied that the patient meets the required criteria. Then, the first declaration and the two medical assessments are sent to the Voluntary Assisted Dying Commissioner, appointed by the Prime Minister, and forwarded to a multidisciplinary three-person Assisted Dying Panel.

After that, the patient needs to make a second declaration, which must be witnessed by both the coordinating doctor and another person. Then a second reflection period begins, typically lasting fourteen days. At this point, once all conditions are met, the coordinating doctor can provide the patient with the lethal substance to be self-administered. The coordinating doctor (or another authorized medical practitioner) must be available to the patient until the end of the process, though not necessarily in the same room.

During the parliamentary discussion that led to the approval of the Bill at its second reading in the House of Commons, the Bill’s proponent, Kim Leadbeater MP, stated: “I struggle to see how it is fair or just to deny anyone the autonomy, dignity and personal choice of taking control of their final weeks. And the right to choose does not take away the right not to choose. Giving the choice of an assisted death to those who want it would of course not stop anyone who is terminally ill from choosing not to make that choice.”^[42] In contrast, Barry Gardiner MP’s concern is that Leadbeater “has focused today on the individual and the individual choice, but we are here to legislate for society as a whole. […] Rather than simply focusing on the individual suffering, which we all recognise is acute, we must broaden the debate to the impact that the legislation will have on society as a whole.”^[43]

This discussion, emblematic of the current debate on PAD, appears polarized between two opposing views: one emphasizing the patient’s autonomy in an individualistic way – the right to choose and, therefore, the right to die – and the other advocating that this kind of autonomy must be tempered by recognition of a shared social bond. According to the latter perspective, an individual’s decision to end their life through PAD could disrupt the psycho-emotional equilibrium of others in society and fundamentally undermine the doctor-patient relationship. However, this polarisation fails to see something crucial that can revolutionize the concept of individual autonomy, now seen as relational and not individualistic. Human beings are, in their essence, vulnerable, and for this reason, other human beings are essential to them.^[44] Human vulnerability exposes the self as fundamentally anchored in and developed through another self. Vulnerability also creates a responsibility towards others, which means letting oneself be exposed in front of others and having the capacity to suffer with the sufferer and alleviate their suffering by all adequate means. Imagine someone standing on the edge of a bridge, ready to jump into freezing water, believing it will put an end to their suffering. Someone witnessing this would not push the person, even if they requested it, to overcome their possible hesitation. Instead, they would offer a helping hand in various ways, such as by contacting the appropriate authorities or engaging in conversation to provide support. This is not because people do not care about neighbours’ suffering, but because ultimately, they know that death cannot be the proper answer to their cry for help. The experience of death is solely that of witnessing someone else’s death; the death witnessed is never one’s own. Thus, encountering another’s death always reflects back on the self. However, if death has been artificially induced, it signifies a deliberate disengagement from one’s inner responsibility to others, like pushing someone standing on the edge of a bridge. This disengagement becomes violence, since it assumes that the other can be fully understood and hence fully ‘possessed,’ while “[t]o be in relation with the other face to face – is to be unable to kill.”^[45]

Conclusion

The autonomous self does not give rise to a right to die. Moreover, the notion of an autonomous self, fully capable of deciding to bring about one’s own death, and the clinician’s supposed duty to assist in such a decision, is based on an illusory conception of autonomy – one that disregards the deeply relational nature of human existence, which carries significant social and ethical consequences. More fundamentally, this perspective fails to acknowledge that human beings are inherently interconnected, existing in relationships with others. Recognizing this relational dimension is crucial to understanding the untenability of a right to die, as such a right would neglect two essential aspects of the human condition: intrinsic vulnerability and ethical responsibility toward others. Human existence is marked by interdependence, where each individual is not only shaped by but also responsible for those around them. Within this framework, autonomy cannot be reduced to isolated self-determination, but must be understood in relation to the broader ethical and social fabric in which decisions are made. Furthermore, the principle of responsibility, which underpins human coexistence, restrains acts that constitute an ultimate usurpation of another’s existence – killing. If the right to die were to be legitimized as an extension of personal autonomy, it would not only risk eroding the moral and legal foundations that protect human life but also shift the understanding of care from an ethic of ‘support, palliate and accompany’ to one that may, under certain circumstances, justify the active termination of life. This shift would have profound implications for the medical profession, the doctor-patient relationship, and society’s perception of suffering, dependency, and aging. Ultimately, the argument against a supposed right to die is deeply ethical and ontological. It challenges the very foundation of what it means to be human: to exist in relation to others, to be vulnerable, and to bear responsibility for one another in ways that preclude acts of harm, even when framed as autonomy or compassion. The fact that the ECtHR legitimizes assisted suicide and/or euthanasia but refrains from explicitly enshrining a right to die is symptomatic of an uneasiness regarding this possible new right. The right to life is an absolute right which cannot be restricted or limited unless in prescribed circumstances. However, as the analysis above has shown, the Court of Strasbourg has allowed PAD and/or euthanasia provisions to fall under article 2 ECHR positive obligations – meaning the practice can be lawful, as long as appropriate safeguards are in place to protect, at least, nominally citizens’ right to life, thereby leaving legal space for the active termination of life.

Patients’ autonomy, understood as a bulwark against unwanted medical treatments, should not be equated with the idea of patients’ autonomy to choose PAD. The former remains relational, involving care and the possibility of reversing the decision if the patient later chooses to resume treatment. The latter, by contrast, treats autonomy as a tool to reject care altogether and embrace killing.

[1] See R. McDougall, B. Pratt, ‘Too much safety? Safeguards and equal access in the context of voluntary assisted dying legislation,’ BMC Medical Ethics, 2020, 21 (38), at 2. https://doi.org/10.1186/s12910-020-00483-5

[2]TL. Beauchamp, JF. Childress, Principles of Medical Bioethics. Seventh Edition. New York: Oxford University Press (2009), 106-107.

[3]Beauchamp and Childress, 185.

[4]E. Braun, ‘An autonomy-based approach to assisted suicide: a way to avoid the expressivist objection against assisted dying law,’ Journal of Medical Ethics, 2023, 49, at 498 https://doi.org/10.1136/jme-2022-108375

[5] Braun, 500.

[6] Braun, 499-500.

[7] Braun, 499.

[8] O. Hartling, ‘Euthanasia and assisted dying: the illusion of autonomy,’ BMJ 2021, 374, at n2135 https://doi.org/10.1136/bmj.n2135

[9] Hartling.

[10] Hartling.

[11] D.P. Sulmasy, et al. ‘Physician-Assisted Suicide: Why Neutrality by Organized Medicine is Neither Neutral Nor Appropriate,’ Journal of General Internal Medicine. 2018, 33 (8), at 1395. https://doi.org/10.1007/s11606-018-4424-8

[12] See A.D. Colombo, G. Dalla-Zuanna, ‘Data and Trends in Assisted Suicide and Euthanasia, and Some Related Demographic Issues,’ Population and Development Review, 2024, 50 (1): 233-257. https://doi.org/10.1111/padr.12605

[13] D. Paton, S. Girma , ‘Assisted suicide laws increase suicide rates, especially among women,’ 2022https://cepr.org/voxeu/columns/assisted-suicide-laws-increase-suicide-rates-especially-among-women

[14] American Medical Association (AMA), ‘Physician Assisted Suicide AMA Policies. Council on Ethical and Judicial Affair, 2009, https://code-medical-ethics.ama-assn.org/ethics-opinions/physician-assisted-suicide

[15] CL. Sprung, et al., ‘Physician-Assisted Suicide and Euthanasia: Emerging Issues from a Global Perspective,’ Journal of Palliative Care, 2018, 33 (4): at 200. https://doi.org/10.1177/0825859718777325

[16] E. Jackson, J. Keown, Debating Euthanasia, Oxford: Hart Publishing (2012), 91.

[17] Jackson, and Keown.

[18]Art. 2 ECHR.

[19] Art. 2 ECHR.

[20] Art. 14 ECHR. “The enjoyment of the rights and freedoms set forth in this Convention shall be secured without discrimination on any ground such as sex, race, colour, language, religion, political or other opinion, national or social origin, association with a national minority, property, birth or other status.”

[21] Art. 8,2 ECHR. “There shall be no interference by a public authority with the exercise of this right except such as is in accordance with the law and is necessary in a democratic society in the interests of national security, public safety or economic well-being of the country, for the prevention of disorder or crime, for the protection of health or morals, or for the protection of thee rights and freedoms of others.”

[22] Case of Pretty v. The United Kingdom, App. No. 2346/02 (29 July 2002), §39.

[23] Ibid, §40. (“The Court accordingly finds that no right to die, whether at the hands of a third person or with the assistance of a public authority, can be derived from Article 2 of the Convention.”)

[24] Daniel Karsai v. Hungary, App. No. 32312/23 (13 June 2024), §145. The case concerns Mr Karsai, a 47-year-old human rights lawyer affected by amyotrophic lateral sclerosis. The applicant argues that the prohibition on seeking assisted dying under Hungarian law breaches his right to private life (art. 8 ECHR) alone and in conjunction with his right not to be discriminated against (art. 14 ECHR) because terminally ill patients dependent on invasive medical treatments have the option to refuse them at any point. The Court found no violation of the applicant’s rights on either ground.

[25] Mortier v Belgium, App. No. 78017/17 (4 January 2023). The case concerns the applicant’s mother – a Belgian citizen in her 60’s suffering from chronic severe depression – who has been euthanised under the Belgian Act on Euthanasia (2002) without having properly informed her adult children. The applicant, her son, claimed that the government failed to protect his mother’s right to life (art. 2 ECHR) and her right to respect for private and family life (art. 8 ECHR). The Court of Strasbourg unanimously found Belgium in breach of art. 2 ECHR in regard to the a posteriori procedure to investigate deaths caused by euthanasia.

[26] Mortier v. Belgium, §144.

[27] Mortier v. Belgium, §146.

[28] Case of Haas v. Switzerland, App. No. 31322/07 (20 June 2011). The case concerns Mr Haas, a 58-year-old who had been suffering from serious bipolar affective disorder for the past twenty years and had been denied assisted suicide by Dignitas. For these reasons, he contacted, with no success, various bodies seeking permission to obtain sodium pentobarbital (a lethal substance) without prescription from a pharmacy. The applicant contended that his right to respect for his private life (art. 8 ECHR) has been unlawfully restricted, while the Court of Strasbourg reached the opposite conclusion.

[29] Case of Haas v. Switzerland, §54.

[30] Mortier v. Belgium, §147.

[31] Mortier v. Belgium, §162.

[32] Mortier v. Belgium, §§177-178.

[33] The Government, more specifically the Department of Health and Social Care, provides the overall direction of the NHS system and also sets its objectives/framework of practice. Since the Health and Social Care Act 2012 entered into force private healthcare companies (governmental approved and compensated) can run some NHS services.

[34]R. Shah, ‘Assisted Suicide on the NHS would breach the ECHR,’ UK Human Rights Blog, 2024. https://ukhumanrightsblog.com/2024/11/01/guest-post-assisted-suicide-on-the-nhs-would-breach-the-echr/

[35] R. Shah, ‘Rejoinder to Deb and Graham: Yes, the ECHR prohibits States from euthanising people,’ UK Human Rights Blog, 2024https://ukhumanrightsblog.com/2024/11/19/rejoinder-to-deb-and-graham-yes-the-echr-prohibits-states-from-euthanising-people-by-rajiv-shah/

[36] Mortier v. Belgium – Separate Opinions – Partly Dissenting Opinion of Judge Serghides, §6.

[37] Mortier v. Belgium, §139.

[38] N. Papadopoulou, L. Wicks, ‘Taking ‘the right to life’ seriously: Addressing the role of ‘the right to life’ in the context of assisted dying,’ Medical Law International, 2025, 25 (2), at 97.

[39] Daniel Karsai v Hungary, §148.

[40] Latest version of the Bill as approved by the House of Commons on 20^th June 2025, https://bills.parliament.uk/publications/61635/documents/6734

[41] At the time of writing, the Terminally Ill Adults (End of Life) Bill has passed its third reading at the House of Commons (313 votes in favour, 291 against and 39 abstentions) and it is at its second reading at the House of Lords.

[42] House of Commons, Terminally Ill Adults (End of Life) Bill, Volume 757, Debated 29 November 2024. https://hansard.parliament.uk/commons/2024-11-29/debates/796D6D96-3FCB-4B39-BD89-67B2B61086E6/TerminallyIllAdults(EndOfLife)Bill

[43] House of Commons, Terminally Ill Adults (End of Life) Bill

[44] See E. Levinas, Humanism of the Other, Chicago: University of Illinois Press (2006).

[45] E. Levinas, Entre Nous. Thinking-of-the-Other, New York: Columbia University Press (1998), 10.

In an Age of Anti-Intellectualism, What is the Value of Expertise?

2025-06-02T23:32:38+00:00

Photo ID 25835385 © Travelling-light| Dreamstime.com

Abstract

The nature of the scientific enterprise is sometimes misunderstood by large sections of the public. Failure to understand how progress occurs within scientific disciplines can lead to nonadherence with expert recommendations, with devastating consequences. Why does the public put enough stock in scientific research and medical science to comply with certain research findings but are skeptical of others? Through careful attention to history, current socio-cultural contexts, scientific data, and knowledge development within professions, we argue in favor of greater public deference to expertise. Though we rely on a variety of examples rooted in medical science, our focus is on general conceptions of expertise and what might be learned from reflection on its proper role. We situate our analysis within the context of current discussions in philosophy, bioethics, and public policy around the idea of ‘wicked problems’.

Introduction

Expertise, broadly speaking, has come under serious attack in recent years. The current presidential administration is engaged in large-scale dismantling of the scientific and public health infrastructure at a variety of federal agencies. This is happening concurrently with ongoing attacks on academic institutions. This should concern not just members of the scientific and academic community but also the public at large. Unfortunately, the nature of the scientific enterprise is sometimes misunderstood by large sections of the public.^[1] Although trust in science remains high among Americans, the level of trust contrasts sharply depending on one’s political affiliation.^[2] There has been growing hostility toward science itself.^[3] This can have devastating consequences when a failure to understand how progress occurs within scientific disciplines leads to ignorance of and even nonadherence to expert recommendations. How ought members of the public be persuaded to put enough stock in scientific research and medical science to listen to and comply with sound research findings but remain appropriately questioning of expert advice? For instance, recent polling data suggests that a majority of US adults are concerned that agencies such as the CDC will make decisions that are influenced by politics.^[4]

Through careful attention to history, current socio-cultural contexts, the role of expertise, and knowledge development within the scientific professions, we argue in favor of greater, albeit prudent, deference to expertise. Our hope is that lessons will be learned for better responses to future public health crises and other collective action problems that require public support to properly address them. We are careful to focus our efforts on the value of expertise, which is hard-won and takes years to cultivate. We situate our analysis within the context of current discussions of pandemics as ‘wicked problems,’^[5] responding to potential critiques rooted in concerns about epistemic justice,^[6] and suggest bioethics as a working model for addressing these concerns and bioethicists as potential leaders in future public policy discussions.

The Authority of Experts

The authority of experts has increasingly attracted the attention of ethicists. For instance, some ethicists have argued that we should be wary of the authority of experts because experts are human beings that may have conflicts of interest, speak outside their area of expertise (“epistemic trespassing”), or offer advice that is not useful.^[7]

Managing deference to the authority of experts has long been a challenge in the United States. The authority of experts has waxed and waned throughout the history of the United States. For instance, the authority of experts was under assault during the era of Jacksonian democracy in the early 19^th century.^[8] Licensure of professionals was repealed. Many irregular physicians practiced medicine. The prevailing ideology held that each individual could and should decide how to manage their own health. This was the state of affairs for much of the 19^th century. But, with the rise of laboratory science and the demonstrable efficacy of the germ theory of disease, the authority of physicians grew. As chronicled in the classic book The Social Transformation of American Medicine, physicians enjoyed an unparalleled run of cultural and moral authority throughout much of the 20^th century.^[9] Today, health care professionals such as physicians and nurses typically hold the top rung in Gallup surveys of public trust (although they suffered a downturn as a result of COVID).^[10]

Public health experts have always struggled for the same level of cultural authority. Despite the successes of public health in the 20^th century, medicine garnered the lion’s share of resources. Respect for those treating individual patients surpassed respect for public health officials, who offered prevention strategies and focused on infectious disease avoidance, vaccination, and food safety. It also surpassed those engaged in the practice of medicine in clinics and publicly funded venues serving individuals who were stigmatized – the poor, minorities, individuals with disabilities, individuals with mental illness or addiction, or immigrants. Public health journalist Laurie Garrett highlights the difference in a rather stark way by comparing the public health school at Harvard with the medical school building: “The medical school is all marble, with these grand columns….The school of public health is this funky building, the ugliest possible architecture, with the ceilings falling in….That’s America.”^[11]

During the COVID-19 pandemic, for example, the authority of public health and scientific experts came under withering attacks. President Trump dismissed the authority of scientific experts when the pandemic first started. Trust in expertise was further eroded by right-wing media personalities attacking figures such as Anthony Fauci. Ideally, public health and medicine should acknowledge mistakes and be transparent to the public. Robert F. Kennedy, Jr, the current head of the Department of Health and Human Services (HHS), has continued the administration’s undermining of science and expertise by promoting falsehoods about autism, vaccines, chemtrails and fluoride. Trust as precious social capital is diminished when officials in positions of power promote mistruths.

It is this social capital of trust that is essential in preserving the authority of credible experts. Since no one is an expert in everything, we must have some level of trust in the expertise of certain individuals. But who merits our trust? With the vast amount of information available, it is increasingly difficult to determine who is trustworthy and who is not. We have witnessed a stratification of trust toward individuals and institutions based on income and education. For instance, more highly educated individuals tend to trust academic experts. And this trust goes beyond individual trust to institutional trust. The CDC has enjoyed a good deal of trust throughout its history. Yet even this agency has seen its trustworthiness diminish with its recommendations during COVID of school closings, mandatory vaccination, isolating, and masking. Institutional trustworthiness is historically more precarious than the trustworthiness of individuals, but both have been undermined in recent years.

Historically, professional experts have grossly abused their authority. We have witnessed this with unethical experiments in Nazi Germany and human rights abuses in the US, including Tuskegee, Willowbrook, the Iowa ‘monster’ stuttering studies, Havasupai Tribe gene studies, and the Stanford prison experiments, among many others. Ordinary people rightly question the authority of experts when such a legacy of abuse exists.

The COVID pandemic highlighted a great deal of disagreement among a variety of experts. Dr. Vinay Prasad, now in high office at the FDA, emerged as a staunch critic of mainstream public health measures, such as vaccine and mask mandates.^[12] So did those who authored the Great Barrington Declaration.^[13] Mark Battersby stated, “Disagreement among experts renders appeals to authority fallacious. But many of the interesting cases one deals with will involve conflict among experts.”^[14] The pandemic reflected not only disagreement but the very undermining of the notion of expertise.

Others have highlighted the role of anti-intellectualism in American life. Anti-intellectualism reflects a suspicion of experts and the expert class. The scholar and public intellectual Tom Nichols chronicled this phenomenon in his 2017 book The Death of Expertise.^[15] It also harbors a suspicion toward ‘the academy,’ or institutions of higher education. (Nichols provides a stinging critique of the academy and its dereliction of promoting logical discourse and reason.) This kind of suspicion and mistrust has persisted throughout US history and has seen a resurgence in recent years with the election and re-election of Trump. Such attitudes support populist or even conspiratorial explanations for complex phenomena, such as the COVID-19 pandemic, chemtrails, and climate change. As Merkley and Loewen state: “People who are highly distrusting of experts are not simply willing to put aside their distrust of these sources to resolve the crisis and return to normalcy. Relaying information from experts is unlikely to be of use in persuading these individuals, even in times of crisis. Other communication strategies are needed.”^[16]

For many individuals who are distrustful of public health advice, their experience with COVID-19 may have only reinforced that distrust. Asymptomatic people or those with very mild symptoms led to the spread of the virus to vulnerable members of society who were more likely to experience severe COVID-19 complications. Thus, the failure to heed public health advice placed a significant burden on the US healthcare system, even if some individual persons had mild or asymptomatic cases. Although awareness of how viruses are transmitted improved during and after the pandemic, misinformation and disinformation often undermined understanding. Viruses that change or mutate, such as COVID-19, make efforts to communicate new information from experts to the public extremely difficult. These challenges are further compounded in the current climate of assault toward experts and the value of expertise. Before turning to the value of expertise itself, it is important to respond to a set of arguments that has received wide attention of late.

Politicization in the Face of Expertise

One argument against trusting experts is that experts’ advice has been compromised by politics. This argument stems from the intertwining of politics and healthcare (broadly understood). Politicians who find themselves offering recommendations that are at odds with experts have trotted out this reasoning, particularly those in leading roles in the Trump administration. Dr. Josh Sharfstein suggests HHS Secretary Robert F. Kennedy, Jr., engages in this technique. In his analysis of the role of expertise relative to political power (referring to Kennedy’s guidance), Sharfstein noted that, “Kennedy has been sowing doubt in public health for years. He's basically saying, here's my view; here's some thoughts, and you can't trust what people who – you know, their whole career, their whole goal is to support health, and they have all this expertise – you can't trust them at all.”^[17] Understanding what this claim means is important to understanding why it is both mistaken and wrongheaded, and it might mean at least one of four things.

First, consumers of information can sometimes lack the relevant knowledge and critical skills to properly assess who might be an expert. The possibility of mistaken and fraudulent “experts” is a real and too common occurrence. Second, given the diversity of thought and the lack of critical assessment skills and opportunities, it is possible for people to find “experts” to support their own pre-existing views. Third, the view that everyone is or can be an expert is arguably common. This point is of special interest to bioethicists who generally recognize that all people are (or might be) experts with respect to their own sets of values, but not with respect to other bodies of knowledge, such as medical science. The idea that anyone can be an expert can be coupled with an effort-focused qualification (“they could be if they just put their mind to it”; consider, e.g., the meme ‘I did my own research’). Fourth, some argue that those who are dubbed experts are selected based only upon non-relevant factors, such as their political stances, as opposed to their knowledge of medicine or of epidemiology. Experts can then be seen as political tools, as the perception is that they are chosen for reasons that are not relevant. Some may feel that they have all “sold out” to someone or something—big pharma, big law, billionaire philanthropists, big food, celebrity, tenure, etc.

Concerns about conflicts of interest, personal expertise, the ability to become an expert, post hoc expert shopping, and the lack of critical reasoning and knowledge base familiarity should give pause to those who understand the importance of expertise. These considerations, however, are not without response. For instance, one line of response to the politics charge is to simply drive a wedge between politics and science (whether that be medical science, scientific research, or another body of knowledge with practical importance and application that is distinct from politics). For instance, the former director of the National Institutes of Health, Francis Collins, said, “When you mix politics and science, you just get politics.”^[18] Others argue that the only way for science to escape the political allegation is to keep politics completely out of science. However, neither view offers a viable response, as the health needs of the public are – in different ways – the purview of both sets of expertise (politics and science). Further, it is unclear how driving such a wedge rebuts the lack of trust in experts, nor is it clear whether such a wedge could be successfully driven into spaces which are intertwined.

Politics is a part of what research gets done, who gets to do it, what messaging is utilized, and whether that messaging is amplified or squashed. The way to manage the dismissal of expertise as “just politics” is neither to deny the reality of politics nor pretend that it can be safely isolated, but rather to insist on methods to tamp down the direst consequences of one on the other. There are, at least, two methods that can be employed for this purpose.

First, it is important to remember that though people are referred to as experts, expertise belongs to groups as well as individuals. Peer consensus among individual experts (even false or would be “experts”) drives the legitimization of expertise—not who is the loudest, most educated, flashiest, best funded, most quoted, or the closest friend of those in power. Checks of claims and assessments offered by experts from other, relevantly situated experts are essential. This notion is the basis for peer review, among other common substantiations of the claims of experts.

Second, expertise must be vindicated by application. Consider, for example, the importance of replicability in scientific experimentation. Consider also the importance of consensus that follows on an understanding of expertise that that which belongs to a group, not merely to a set of individuals. If, for example, the majority of climate experts successfully predict continuing rising temperatures, more humidity, more algae outbreaks, species extinctions, excessive heatwaves, more wildfires, and nastier storms, then climate change deniers lose credible standing. When the predicted instances occur, the usefulness of proper expertise is highlighted. If a scientist or a political official dismisses the values of vaccines but then witnesses outbreaks of measles, mumps, hepatitis or flu, then that scientist or official ought to lose credibility. This is not to say that experts cannot make mistakes; however, in such cases, explanations of the mistake and revisions of expertise-dependent reviews are needed. An official or scientist who rejects the germ theory of disease, for example, shoulders the burden of explaining the reduced morbidity and mortality that occurred in the early 1900s after that theory gained prominence and physicians (and others) began washing their hands more diligently. In other words, the ability to apply expertise successfully falsifies the ‘it’s just or all politics’ argument.^[19]

Expertise

(i) Expertise

In popular discussions, the idea that one must do something for “10,000 hours”^[20] has permeated considerations of who counts as an expert. It takes time and resources to develop expertise in a specific area, as well as particular skill sets to be able to master a practice or gain command of the tools of a discipline. That said, our aim in this section is not to articulate a full description of what counts as having expertise, but rather to highlight two features of expertise relative to its boundaries, which should inform the role of expertise within public discussions of public health.

In their classic work on the nature of expertise, Chi, Glaser, and Farr describe seven key characteristics of experts, two of which apply to the limits of expertise. The first is that “Experts excel mainly in their own domains” (Chi, Glaser, and Farr, xvii). When reflecting on and evaluating “authority,” it is important that notions of expertise are taken seriously. It is not mere authority which marks out proper expertise. Experts are such only in their particular domain and we make a significant mistake if we defer to the authority of an expert of the wrong domain. For example, we might look to the famed Red Sox baseball player and author of the Science of Hitting Ted Williams for advice on how to hit a baseball. Williams was, by all accounts, an expert at it. However, it does not follow that society should have relied on him for recommendations of legal interpretation of baseball stadium and game regulations, cooking (even of ballpark franks), or public health measures (even about crowding at baseball games). Williams likely had views about these latter matters; he may even have had informed opinions having spent time in many stadiums around the country, but he did not hold any expertise in these latter areas.

The second boundary-relevant criterion that Chi, Glaser, and Farr note is that “Experts have strong self-monitoring skills” (Chi, Glaser, and Farr, xx) (Chi, 2009). The ability to restrict oneself in one’s capacity as an expert is important for at least two reasons. First, as we often appeal to experts in situations that are complex (in ways relevant to their expertise), it is likely that laypersons making the appeal lack the ability or struggle to draw clear lines as to when the expert has overstepped. The domains of expertise, especially where multidisciplinary and interprofessional teams are needed to properly respond to an issue, are a good example of the sometimes vague or murky lines of expertise and need for experts to carefully self-monitor. Second, self-monitoring is important not only when the bounds of expertise are murky, but in situations where the dissemination, use, and influence of the results of that expertise occur through channels that may not involve the expert. If an ordinary manager of a baseball team aims to share the results of Ted Williams’ hitting expertise, he needs to take care in both ensuring (to the best of his ability) that Williams has not overstepped, but also that he is not conflating his standing as a star with the results of the expertise he is sharing.

Public health is an especially important example of this potential confusion and conflation for several reasons. First public health responses are complex – requiring multi-disciplinary and interprofessional teams of experts. Second, those disseminating and then acting upon the information shared by particular experts within the team often have standing to share this information due to other kinds of expertise or a different kind of authority. Thus, a political leader – a president or governor, for example – may be charged with the care of the public and so it is within their purview to disseminate relevant scientific information that they receive. However, it would be an abuse of authority or – in the very least, a conflation – to fail to self-monitor and, say, to share one’s own opinions under the auspices of expertise.

It is especially important in our current socio-cultural and political moment to pay attention to the bounds of expertise. During the COVID-19 pandemic, many individuals frequently stepped outside of the proper bounds of their expertise. Merely because someone is an expert on a particular subject matter does not mean, as noted above, that they are competent to discuss complicated matters which, even if relevant to the subject area, require different training, experiences, or knowledge bases to master, or those especially challenging problems which require an interdisciplinary team to fully address.

Consider another pandemic-relevant example: an expert in supply chain management might possess sufficient expertise to comment on and evaluate the way in which COVID-19 vaccine materials made their way from production and transportation mechanisms to distributions centers. However, they should show restraint and not comment on the merits of particular vaccines, as that would properly fall to biochemists, virologists, vaccinologists or other experts.

During a public health crisis, notions of expertise can become blurred. Individuals properly understood to be experts in an area relevant to understanding and responding to the pandemic might have widened their scope to address other facets created by the pandemic, such as the use of ventilators in ICUs. As noted, expertise in one area of a complex subject matter does not necessarily translate to expertise in another area, and this expertise creep or seep can occur more easily in responses to public health crises as they require interdisciplinary responses to be effective. Experts must be cognizant of this fact, and receivers of information ought to be critically engaged and informationally literate in evaluating information shared with them dependent upon expertise. This has been documented in both the academic and popular literature addressing the pandemic. Understanding who the proper experts are is important in public health contexts where the results of sharing mistaken information can have devastating consequences. Mistakes are not always easy to walk back. As David Shribman writes, “Even though expertise is the means by which we separate fact and truth from emotion and myth, emotion and myth are sometimes far more powerful and enduring than these rivals.”^[21] What is needed in response is not an emotionless approach, as one cannot expect evaluations devoid of emotion in challenging times. Rather, what is needed is deference only to properly bounded expertise, as noted above, and affording experts the space to make progress as their own domains entail.

(ii) Space for Progress

The proper self-monitoring of the expert who remains focused on her own domain is a great asset to society. However, for this expertise to be beneficial, and then usefully employed in practical solutions to public health challenges, it must be put into practice. Though there exist several challenges in enacting the recommendations of experts, a lack of trust in scientific expertise is of primary concern when facing current and future pandemics. It is especially perplexing to those interested in and working in virology, public health, and immunology, as well as those who put stock in scientific research. This point is illustrated by the practice of masking.

Masking practices became politicized and wearing or not wearing masks came to be bound up with people’s identities and politics in complex and nuanced ways. The opening that allowed this to occur is, as we suggested above, a lack of appreciation by the large swaths of the public about how scientists (and how many scientific disciplines) make progress. It is here that deference to bounded expertise requires a basic understanding about how progress is made within different disciplines.

The reason cited by some members of the public for rejecting the masking recommendations of experts (virologists, epidemiologists, environmental engineers, and public health researchers) was that originally masks were deemed less effective as a response to COVID-19 and given the supply shortage, they were asked to be held for healthcare workers. The second point is less relevant as it does not speak to a lack of scientific literacy but to considerations of prioritization in a resource-scarce situation. The first point, however, highlights the fact that discovery takes time along with the ability to adapt to new evidence. The more research that is done, the greater the number of samples, cases, tests, et cetera, the more likely we are to get an accurate picture of the phenomenon under scrutiny. Though early research was mixed, with US public health experts suggesting that masking would not be effective, research later showed conclusively that it was. To accept the scientific claim that masking would be ineffective but not the later evidence-based claim that it was effective suggests a misunderstanding about how scientific progress occurs. Progress in any discipline takes flexibility and time to evaluate new evidence. Experts should have an opportunity to revise their claims as they do more research. The virologist or toxicologist who needs more samples should not be ignored because they engaged in the processes proper to progress (and simply getting things right) within their domains. To argue for time and space for scientific discovery is not to downplay the time pressure which exists in responding to pandemics; in fact, time pressures are one of the four features of what are termed ‘super wicked problems.’^[22]

Thus, if we are to take expertise seriously (including citing early results from recognized experts or communities of experts) then we must give the experts space to do the necessary work. This is not to suggest that it is not challenging to be patient when results take longer or change, such as those who died or were sickened by COVID-19 pre-vaccine. Affording experts space to make progress does not mean that pressure cannot be placed on them, that they cannot be urged or sped along. Rather, it means that while trying to hasten the speed of progress, individuals are bound to follow the best current advice and to take on – even if inconvenient –an epistemic stance that affords time for progress. Masking, if it limited the spread of COVID and gave more time to create a safe and effective vaccine, was a practice that ought to have been taken up by all. In return, vaccination experts owe the public speedy work but not work that ignores the need to shift recommendations as evidence accumulates.

Important Objections

There are a variety of objections to our framing of the relevant issues and our position on expertise.^[23] The most powerful cluster of objections is the assessment of pandemics as a super wicked problem and a proper rejection of more traditional notions of expertise.^[24] As described by J. Ravetz, “The insight leading to Post-Normal Science is that in the sorts of issue-driven science relating to environmental debates, typically facts are uncertain, values in dispute, stakes high, and decisions urgent.”^[25] This is a fair description of the COVID-19 pandemic and highlights why it is understood by some as a wicked problem which is,“…not a single problem but a web of problems intersecting in complex ways as a largely unmanageable system. Such problems are not amenable to the conventional logical problem-solving approaches typically applied to linear or tame problems. Applying such approaches to wicked problems not only fails to tackle them but may create undesirable consequences.”^[26]

Super wicked problems are problems which have the following four characteristics: “those who must solve the problem are also causing it (we benefit from the very collective patterns of behavior that contribute to the spread of the virus), there is no central authority (for example, to ensure coordinated international action), there is time pressure (a critical window of opportunity to tackle the problem), and long-term solutions are discounted due to their short-term costs.”^[27] The crucial insight from analyzing pandemics as a wicked or super wicked problems is that the analysis rightly highlights the depth and breadth of the problem and the contributing factors. These cannot be limited to biomedical responses, as they are in part due to social, political, cultural, and, more generally, value-laden features. As such, appeals to merely traditional scientific expertise miss the mark. An especially helpful question is whether we should prioritize research on vaccinations or devote efforts to increase and ensure food security when planning for future pandemics.^[28] Biomedical sciences are not sufficient to address questions like this, though addressing them is necessary both in responding to and preparing for the next pandemic.

The potential for epistemic injustice is significant in such cases, especially if expertise is understood relationally – as something that some have because others do not – and some members of a community of discourse are systemically excluded from it. However, we do not believe this needs to be the case, even if it has been in the past. The potential critique rooted in concerns about epistemic injustice is an excellent objection to some accounts of preferences for expertise, but not ours. In fact, we both appreciate the critique and agree with it. It does not follow from our claims about expertise that there is one relevant expertise. Yet, we do find biomedical science to be immensely helpful in responding to public health challenges.

In fact, we believe that the field of bioethics offers excellent examples of how to give deference to expertise and how to avoid committing epistemic injustice. Bioethics brings the expertise of nurses, philosophers, theologians, lawyers, physicians, sociologists, technologists, humanists, and many others to bear on bioethical issues and challenges. It should also acknowledge and respect the perspectives of non-experts. We see this routinely play out in the clinical setting where the expertise of clinicians may be challenged by patients and or their families. Similarly, in public health, the views of the public should be acknowledged. A kind of cultural humility should acknowledge the values of communities that must live with the recommendations of experts. It embraces interdisciplinary and team responses to challenging problems, recognizing the importance of a diversity of voices. However, this does not mean that the rigor of, say, philosophical analysis is lost. It is simply that each discipline, when properly bounded and in conversation with other disciplines relevant to bioethical issues, contributes to the best answer to the problem. Expertise in each discipline is recognized, and space and time for the assessment of and responses to the relevant problem need to be afforded and understood.

Conclusion

We have argued for greater yet careful deference to expertise with the hope that lessons will be learned that enable better responses to future public health crises. Public health relies on experts who may change recommendations as evidence emerges. Furthermore, complex problems call for an array of experts, each of whom should provide evidence-based recommendations consistent with their subject matter expertise, education, and experience. Understanding distinct disciplinary processes, the context in which disagreements occur, and what is proper expertise, as well as appropriate disagreement should enable more productive future work in collective responses to threats to humanity.

[1] According to Pew: "Roughly seven-in-ten (71%) Americans with a postgraduate degree are classified as high in science knowledge, answering at least nine of 11 items correctly. By contrast, about two-in-ten (19%) of those with a high school degree or less perform as well on the scale." (https://www.pewresearch.org/science/2019/03/28/what-americans-know-about-science/

[2] Tyson A, Kennedy B. Public Trust in Scientists and Views on Their Role in Policymaking. Pew Research Center.

https://www.pewresearch.org/science/2024/11/14/public-trust-in-scientists-and-views-on-their-role-in-policymaking/, Nov. 14, 2024

[3] Hotez, Peter J. The Deadly Rise of Anti-Science: A Scientist’s Warning. Baltimore: Johns Hopkins University Press, 2023.

[4] Brownstein, Maya. Poll: Many Americans say they will lose trust in public health recommendations under federal leadership changes. April 29, 2025. Poll: Many Americans say they will lose trust in public health recommendations under federal leadership changes | Harvard T.H. Chan School of Public Health

[5] Rittel, Horst W. J., and Melvin M. Webber. “Dilemmas in a General Theory of Planning.” Policy Sciences 4, no. 2 (June 1973): 155–69. https://doi.org/10.1007/BF01405730.

[6] Fricker, Miranda. Epistemic Injustice: Power and the Ethics of Knowing. Repr. Oxford: Oxford University Press, 2011.

[7] Watson, Jamie. The Trouble with Expertise: Why You Should Usually Trust Experts (But It’s Complicated). The Philosophers’ Magazine https://philosophersmag.com/the-trouble-with-expertise-why-you-should-usually-trust-experts-but-it-s-complicated/

[8] Haber, Samuel. The Quest for Authority and Honor in the American Professions: 1750 - 1900. Chicago, Ill.: Univ. of Chicago Press, 1991.

[9] Starr, Paul. The Social Transformation of American Medicine: The Rise of a Sovereign Profession & the Making of a Vast Industry: With a New Epilogue by the Author. Updated edition. New York: Basic Books, 2017.

[10] Inc, Gallup. “Ethics Ratings of Nearly All Professions Down in U.S.” Gallup.com, January 22, 2024. https://news.gallup.com/poll/608903/ethics-ratings-nearly-professions-down.aspx.

[11] Bruni, Frank. “Opinion | She Predicted the Coronavirus. What Does She Foresee Next?” The New York Times, May 2, 2020, sec. Opinion. https://www.nytimes.com/2020/05/02/opinion/sunday/coronavirus-prediction-laurie-garrett.html.

[12] “Dr. Vinay Prasad: You’re Right Not To Trust Public Health.” Accessed April 10, 2024. https://reason.com/podcast/2023/03/08/dr-vinay-prasad-youre-right-not-to-trust-public-health/.

[13] https://gbdeclaration.org

[14] Battersby, Mark E. (1993). Assessing Expert Claims: Critical Thinking and the Appeal to Authority. Paideusis: Journal of the Canadian Philosophy of Education Society 6 (2):5-16.

[15] Nichols, Thomas M. The Death of Expertise: The Campaign against Established Knowledge and Why It Matters. Second edition, Updated and Expanded edition. New York: Oxford University Press, 2024.

[16] Merkley, Eric, and Peter John Loewen. “Anti-Intellectualism and the Mass Public’s Response to the COVID-19 Pandemic.” Nature Human Behaviour 5, no. 6 (June 2021): 706–15. https://doi.org/10.1038/s41562-021-01112-w.

[17] Huang P. Analyzing what RFK Jr. said on 'Morning Edition' about his health policy vision

[18] Freiden, J. Mixing Science and Politics Leads to Trouble, Former NIH Director Says. MedPage Today. May 1, 2025 https://www.medpagetoday.com/publichealthpolicy/healthpolicy/115393

[19] Arthur L. Caplan, “Regaining Trust in Public Health and Biomedical Science following Covid: The Role of Scientists,” HastingsCenter Report 53, no. 5 (2023): S105-S109. DOI: 10.1002/hast.1531

[20] Gladwell, Malcolm. Outliers: The Story of Success. 1st, Back Bay. New York, NY Boston MA London: Back Bay Books Little, Brown and Company, 2011.

[21] Shribman, D. M. 2019. What’s wrong with experts? Notre Dame Magazine. https://magazine.nd.edu/stories/whats-wrong-with-experts/. Accessed 12/2/20.

[22] Mormina, Maru. “Knowledge, Expertise and Science Advice During COVID-19: In Search of Epistemic Justice for the ‘Wicked’ Problems of Post-Normal Times.” Social Epistemology 36, no. 6 (November 2, 2022): 671–85. https://doi.org/10.1080/02691728.2022.2103750.

[23] It should be noted that even though our position puts great stock in experts, experts must provide evidence and reasoning and should not lack transparency.

[24] For example, consider: Levin, K., B. Cashore, S. Bernstein, and G. Auld. 2012. “Overcoming the Tragedy of Super Wicked Problems: Constraining Our Future Selves to Ameliorate Global Climate Change.” Policy Sciences 45 (2): 123–152, Rittel, Horst W. J., and Melvin M. Webber. “Dilemmas in a General Theory of Planning.” Policy Sciences 4, no. 2 (June 1973): 155–69. https://doi.org/10.1007/BF01405730, Mormina, Maru. “Knowledge, Expertise and Science Advice During COVID-19: In Search of Epistemic Justice for the ‘Wicked’ Problems of Post-Normal Times.” Social Epistemology 36, no. 6 (November 2, 2022): 671–85. https://doi.org/10.1080/02691728.2022.2103750.

[25] Ravetz, J. R. 1999. “What is Post-Normal Science.” Futures-The Journal of Forecasting Planning and Policy 31 (7): 647–654

[26] Mormina, Maru. “Knowledge, Expertise and Science Advice During COVID-19: In Search of Epistemic Justice for the ‘Wicked’ Problems of Post-Normal Times.” Social Epistemology 36, no. 6 (November 2, 2022): 671–85. https://doi.org/10.1080/02691728.2022.2103750.

[27] Mormina, Maru. “Knowledge, Expertise and Science Advice During COVID-19: In Search of Epistemic Justice for the ‘Wicked’ Problems of Post-Normal Times.” Social Epistemology 36, no. 6 (November 2, 2022): 671–85. https://doi.org/10.1080/02691728.2022.2103750.

[28] Mormina, 2022.

Confronting the Gap between Classroom Ideals and the Reality of Clinical Culture: A Student’s Perspective

2025-05-22T20:33:35+00:00

Photo by Hush Naidoo Jade Photography on Unsplash

Abstract

This pair of narratives engages with the moral and emotional tensions experienced by a medical student and a faculty physician in the context of a clinical encounter involving an incarcerated patient. The student narrative recounts the discomfort and internal conflict provoked by witnessing behavior she perceived as racially biased and dehumanizing, alongside her uncertainty about how—or whether—to speak up. The companion piece, written by her faculty mentor, reflects on this moment through the lens of the hidden curriculum, arguing that medical education too often neglects to cultivate the moral courage necessary for such moments. Together, these essays illuminate the silent lessons of professional socialization, the limits of formal ethics instruction, and the urgent need to teach advocacy and moral agency as core components of clinical training.

Essay 1 of 2: Confronting the Gap Between Classroom Ideals and the Reality of Clinical Culture: A Medical Student’s Perspective by Isabelle Band

Case

A surgical resident ushers me, a medical student on her first day of third-year clinical clerkships, into the trauma operating room (OR) and whispers, “Inmate from Rikers. Stabbed four times. They need a student to help them retract.” The patient is JA, a 31-year-old man with no past medical history presenting to the emergency department at a public hospital in New York City, after sustaining a penetrating stab wound to the abdomen with omental evisceration. After stabilization, he is rapidly transferred to the OR for exploratory laparotomy.

Three surgeons surround the operating table where the patient is intubated and his abdomen dissected and splayed open from sternum to pelvis. Despite my earnest attempts at suctioning, blood decorates the team’s blue gowns and seeps into their socks and shoes. As the surgeons systematically “run the bowel,” sliding their fingers along every centimeter of JA’s small intestine, the scrub technician leans towards the intern and asks, “What happened here?”

The intern chuckles, “inmate from Rikers. Another stabbing, by another inmate! It’s all in his chart.”

After the bowel injuries are repaired, the attending surgeon removes his gown and gestures to the senior resident, “you got the rest, right?”

She nods. The resident offers me the opportunity to staple closed the incision. It is my first day on the surgery clerkship. The resident models the first few staples, then I take her place and close the remaining length of the wound. The scar is long and crooked, with poorly aligned skin edges in several places. “Good enough,” the resident says. “He won’t care if this looks good.” I leave the OR feeling uncomfortable, but do not mention the experience to anyone.

I had many sessions on professionalism and humanism in medical school, but none prepared me for this moment. What made it so hard for me to speak up?

Commentary

My medical school curriculum dedicated one day per week, during the first and second year, to humanism in medicine. The sessions often focused on the provision of compassionate and equitable care for vulnerable patients, including but not limited to those who are temporarily unhoused, incarcerated, or undocumented. These sessions inspired us. Professors discussed the harms of using stigmatizing language in the electronic medical record and how to write about patients with sensitivity. A panel of lesbian, gay, bisexual, transgender, queer, intersex, and asexual (LGBTQIA+) patients shared experiences of discrimination in healthcare and advised students on providing sensitive and patient-centered care. Small groups of students regularly reflected on systemic racism in the American healthcare system and discussed principles of antiracist medical practice.

As I started my third year and entered the clinical arena for the first time, I anticipated that the real patients I met would be afforded the same painstaking care and thoughtfulness as the hypothetical patients we had discussed in the classroom. Unfortunately, I quickly learned that exalted classroom principles, like confidentiality, devolved precipitously in busy hospitals. I most often witnessed this as seemingly innocuous gossip about patients, which casually floated through hallways and work rooms. Trainees on the trauma service traded shocking patient stories like pieces of bubblegum. During rounds, a resident whispered, “She woke up to her husband standing over her bed ready to stab her with a kitchen knife.” While genuine empathy for patients was usually expressed, I wonder what purpose recounting these narratives served and what harms these casual disclosures produced. Did it allow for the collective reflection on tragic cases? Or did it nourish egos as if to say, this tragedy befell this patient, but I was there to sweep in and save them?

In the classroom, I had learned to avoid talking about patients in hallways and elevators, and to exclude stigmatizing, medically irrelevant descriptors (such as “inmate”) from the electronic medical record and even from discussions with team members. Why were these teachings so readily ignored on the trauma surgery service? Perhaps the team assumed the patient had forfeited confidentiality when JA was admitted to the hospital in an orange jumpsuit, accompanied by a prison guard. Or maybe the team felt a general sense of helplessness against deeply entrenched societal inequities, such as mass incarceration and systemic racism, that had already set JA at such a disadvantage. What additional harm could be borne by gossiping about the only black body in the room, that also happened to be the only one naked and anesthetized? Or by allowing an inexperienced student to fumble with a stapler on a gaping abdominal wound?

Another justification for shirking ethical principles on the floors was that residents, attendings, and other care team members often felt exhausted and overburdened by a broken system. Studies show that high levels of stress and burnout are associated with decreased empathy.[1] Residents worked 24-hour shifts every three days. Given the low volume of nursing staff, surgical residents were expected to wheel patients to the operating room, place IV’s and draw labs. Their exhaustion was compounded by the fact that most of their patients were among the city’s most vulnerable, including incarcerated persons like JA. Pathologies were more often more severe, and patients needed considerable support to ensure they could be safely discharged.

My understanding of this context contributed to my silence in this unsettling situation. If I had spoken up, would the team assume I was questioning their moral judgment or accusing them of providing substandard care and respond defensively? Would I appear idealistic and naive, implying that the team had the time to debrief every case or the capacity to provide culturally sensitive care to every patient on their busy service?

I am not proud to admit it, but I also worried about my rotation grade. I had learned that a key ingredient to a good grade on a clerkship is getting residents to like you, which requires being perceived as helpful but also having situational awareness (i.e., knowing when to be quiet and get out of the way). My experience of feeling silenced was not unique; a 2005 study found that third-year medical students frequently avoided speaking up about ethical conflicts for fear of reprisal.[2] A more recent paper noted that trainees and clinicians most commonly perform professional misdeeds when they are forced to make quick decisions in heightened emotional states, or when they face toxic work environments or hierarchical pressures.[3] This is the clinical reality I had to navigate, yet I was not prepared.

Moral courage is defined as doing the right thing, or not doing the wrong thing, despite the risk of consequences to oneself or other barriers including hierarchy.[4] Speaking up, when discussions about social justice and ethics are discouraged or even dangerous, requires tremendous moral courage. A study about moral courage among residents at Northeastern academic medical centers found that women are less likely than men to act on their moral beliefs, likely due to gender-based differences of empowerment among trainees. Other findings were that interns were less likely to exhibit moral courage versus residents.[5] Subconsciously, I think that being both a woman in a male dominated surgical service and a student at the bottom of the hierarchy, contributed to my silence. Ethicists have suggested that the development of moral courage should be a formal objective in medical education.[6] Teachings should not only focus on the development of moral reasoning and moral courage but should also attempt to explain why many “good” people sometimes don’t do the right thing.[7]

I wished that my pre-clinical years had better prepared me for what was a jarring transition from the controlled preclinical environment to the unpredictable clinical setting. Rather than questioning the team in real time or asking to debrief JA’s case, I chose to discuss the case months later with a thoughtful and trusted mentor, who highly values humanism in medicine, antiracism, and ethical practice. Those conversations inspired this reflection, which I hope will resonate with other trainees who have similarly been disappointed with their transition to clerkships and have struggled to find their voice in situations that felt wrong.

Essay 2 of 2: Teaching What Isn't Formally Taught: Moral Courage in the Face of Medicine's Hidden Curriculum by Krishna Chokshi

Ethics is a fundamental component of clinical practice, shaping physicians’ identities and guiding interactions with patients and colleagues. As educators, we aim to instill in learners the virtues of compassion, empathy, respect, and humility. Though we explicitly teach the attitudes, perspectives, and values of trustworthy and ethically minded physicians, we often fail to prepare them for the reality of clinical practice, where these ideals are eroded by competing demands and a medical culture that sometimes contradicts them. To navigate this dissonance, students must cultivate moral courage—the capacity to uphold ethical standards despite potential personal risk or discomfort—and learn from negative role models.

As preclinical students transition to clerkships, we must prepare them to confront scenarios where their values are challenged. Learners are usually indoctrinated into the realities of clinical practice through immersive experiences, often without formal guidance and support about how to navigate uncomfortable, unprofessional, or unethical behavior. Accepting this gap in education as a “reality” is morally injurious, especially as learners develop their professional identities during this critical phase. Both learners and seasoned clinicians need support as they grapple with the disconnect between aspirations and daily practice.

Studies highlight that many students witness or even participate in ethically troubling situations, such as violations of patient dignity or procedures performed without adequate consent. A 2015 study found that up to 60 percent of students were involved in situations where they felt they violated a patient’s dignity or participated in a procedure without the patient’s consent, at their instructor’s request.[8] Another study found that fewer than half of students feel empowered to speak up about unsafe or unethical behaviors, likely due to the hierarchical nature of clinical teams, fear of retribution, and self-doubt.[9] Over time, this environment may desensitize learners as they progress into residency.[10]

One student’s account of her first day in clerkships is a powerful testimony to how witnessing indignity burdens the conscience.[11] Negative attitudes towards patients, whether communicated through gossip or stigmatizing language, violate our basic duty of respect. The student experienced moral injury, which “results from traumatic ruptures between what people do and who they are.”[12] Burnout, emotional exhaustion, and loss of meaning in work often stem from feeling complicit in doing the wrong thing or constrained from doing what’s right. Our silence speaks volumes to the shameful aspects of medical culture we fail to challenge. Unfortunately, learning to be a doctor is intertwined with learning to ignore, accept, or feel defeated by the unethical behavior we normalize.

While what was said in the operating room was harmful, the student’s internal struggle about how to respond was likely more distressing. Fear of repercussions or not knowing what to say often silences students and clinicians alike. Our healthcare culture does not support such courage for learners, trainees, or even seasoned practitioners. In a large multicenter survey, nearly 30 percent of physicians were reluctant to question authority.[13] This silence not only fuels moral injury and burnout, but also compromises patient safety and care quality.

Amid a morally fraught clinical environment, ethics education has increasing importance. It should teach not only ethical principles but also the virtues of compassionate, trustworthy physicians.[14] In the student’s case here, ethical “rules” clearly indicate a violation of the patient’s privacy, but a virtue ethics approach highlights the clinical team’s failure to show care or respect. Their racist and callous words had a profound impact on the student, suggesting that her ethics education successfully imparted ethical sensitivity and self-awareness. The issue wasn’t insufficient humanistic education, but a lack of tools to cope with the disappointment of observing unethical behavior from her seniors.

Outside the formal curriculum, the informal curriculum (“how we do things here”) and the hidden curriculum (the tacit culture of values and norms they observe) may more strongly influence learners’ development in the clinical environment.[15] This “null curriculum,” that which is not formally taught, is influential. A 2016 medical school graduation questionnaire found that more than half of all students observed behaviors that contradicted what they had been taught about professionalism.[16] In this way, medical training may undermine empathy and ethical commitment, giving rise to moral distress.[17]

While negative role models contribute to the disconnect, contradictions between stated institutional values and actual practices deepen this tension. Learners often observe that though their academic institutions exalt health equity, they support several practices that contribute to health disparities, such as a two-tiered system, affording better services to patients with more socioeconomic privilege. The hidden curriculum is evident not only in clinical interactions but also in how academic healthcare institutions treat patient communities and uphold – or fail to uphold – their mission statements.

While negative role models are problematic, they offer critical learning opportunities. Witnessing unethical behavior helps students define their moral boundaries and deepen their commitment to ethical practice. These uncomfortable experiences clarify personal values and sharpen ethical convictions.

Still, ethics education often fails to equip students to act ethically under pressure. We teach students to identify ethical issues but not to navigate the emotional and professional complexities of acting on them. Embedding moral courage as an explicit competency is essential. We must expose the hidden curriculum to counteract its effects. Educators should encourage students to feel comfortable speaking up - that is, to develop moral courage, the ability to do the right thing or not do the wrong thing, even in the face of competing self-interests. In this example, the student’s role was to be a learner, not a “watchdog” of good behavior. Speaking up in the moment, as she reflected, may have been perceived as arrogance or self-righteous behavior. The student did nothing wrong by remaining silent, but she needed a space to reflect with trusted role models. The learning environment did not support her enough. Was she given the chance to explore what this experience meant for her professional identity?

Despite widespread ethics instruction, defining goals and measuring the impact of such education remains a challenge, resulting in heterogeneous approaches across academic institutions.[18] Most curricula emphasize ethical knowledge and frameworks. Instructors may present clinical cases for analysis, but it is harder to foster reflective practice and real-world application. Small group, case-based learning supports this reflection, and these spaces can also promote leadership skills and confidence, skills that are necessary for moral courage.

Investing in the moral courage of our students will improve the culture and moral habitability of our organizations for physicians, learners and staff, and the quality of healthcare for our patients. Moral courage involves calling out harmful behaviors in others and in ourselves and is essential for cultivating future physicians who advocate for their patients and a more just system. Not surprisingly, few students feel comfortable critiquing someone else’s behavior compared to rectifying their own.[19] Learning to provide respectful and constructive feedback, however, is a lifelong professional skill and critical to reforming our troubled healthcare system.

How can medical educators foster environments that build moral courage?

Acknowledge the Hidden Curriculum: Be transparent about ethical challenges students will face - pressures to conform, the normalization of unethical behavior – so students are prepared and can develop strategies to resist.
Structured Reflection: Reflection helps students process difficult clinical experiences and understand their ethical values. Use narratives, discussions, or writing prompts to deepen ethical insight.
Safe Spaces for Ethics Discussion: As students encounter more clinical situations, they need ongoing forums to explore ethical dilemmas. Role-playing, real-world case discussions, and debates in safe spaces without fear of judgment can foster readiness and courage.
Active Role Modeling and Mentorship: Educators should demonstrate moral courage and reflect openly on their own experiences with ethical challenges. When students see their mentors take a stand for what is right, they are more likely to emulate this behavior. Longitudinal mentorship helps guide students through identity formation and moral growth and allows students to seek guidance when faced with moral dilemmas.
Skill Development: Teach students how to speak up through structured training (i.e., role-playing or with standardized patients), just as communication skills are taught.
Anonymous Reporting Mechanisms: Minor transgressions often go unreported, yet they shape toxic culture. Involve students in designing transparent and effective reporting systems.

Our learners will inevitably encounter moments where they struggle to do the right thing – whether that requires calling out a colleague, advocating passionately for a patient, or confronting their own moral commitments. Just as we train our learners to communicate clinical information effectively and compassionately, we need to prepare them to not only identify ethical action, but to also consider what acting ethically requires of themselves. Empowering learners to take ethical action – not just recognize it – is transformative. The development of moral courage should be a core competency in ethics education. To achieve this, we must shift from asking “What is the right thing to do?” to “How will you do the right thing?”

[1] Galit Neufeld-Kroszynski, Keren Michael, and Orit Karnieli-Miller, “Associations between Medical Students’ Stress, Academic Burnout and Moral Courage Efficacy,” BMC Psychology 12 (May 27, 2024): 296, https://doi.org/10.1186/s40359-024-01787-6.

[2] Catherine V. Caldicott and Kathy Faber-Langendoen, “Deception, Discrimination, and Fear of Reprisal: Lessons in Ethics from Third-Year Medical Students,” Academic Medicine: Journal of the Association of American Medical Colleges 80, no. 9 (September 2005): 866–73, https://doi.org/10.1097/00001888-200509000-00018.

[3] Catherine V. Caldicott, “Revisiting Moral Courage as an Educational Objective,” Academic Medicine: Journal of the Association of American Medical Colleges 98, no. 8 (August 1, 2023): 873–75, https://doi.org/10.1097/ACM.0000000000005239.

[4] Caldicott and Faber-Langendoen, “Deception, Discrimination, and Fear of Reprisal”; “Measuring Moral Choices by Physicians: Standing up for Patients,” American Medical Association, August 3, 2016, https://www.ama-assn.org/delivering-care/ethics/measuring-moral-choices-physicians-standing-patients.

[5] “Measuring Moral Choices by Physicians.”

[6] Caldicott and Faber-Langendoen, “Deception, Discrimination, and Fear of Reprisal.”

[7] Caldicott, “Revisiting Moral Courage as an Educational Objective.”

[8] Lynn V. Monrouxe et al., “Professionalism Dilemmas, Moral Distress and the Healthcare Student: Insights from Two Online UK-Wide Questionnaire Studies,” May 1, 2015, https://doi.org/10.1136/bmjopen-2014-007518.

[9] Neufeld-Kroszynski, Michael, and Karnieli-Miller, “Associations between Medical Students’ Stress, Academic Burnout and Moral Courage Efficacy.”

[10] Alastair V. Campbell, Jacqueline Chin, and Teck-Chuan Voo, “How Can We Know That Ethics Education Produces Ethical Doctors?,” Medical Teacher 29, no. 5 (January 1, 2007): 431–36, https://doi.org/10.1080/01421590701504077.

[11] Katharine R. Meacham, “Preventing Moral Injury in Medicine: Student Physician Stories of Moral Distress, Alienation, and Moral Imagination,” Public Philosophy Journal 2, no. 2 (2019), https://doi.org/10.59522/WHEQ3650.

[12] Katharine R. Meacham, “Preventing Moral Injury in Medicine: Student Physician Stories of Moral Distress, Alienation, and Moral Imagination,” Public Philosophy Journal 2, no. 2 (2019), https://doi.org/10.59522/WHEQ3650.

[13] Linda H. Aiken et al., “Physician and Nurse Well-Being and Preferred Interventions to Address Burnout in Hospital Practice: Factors Associated With Turnover, Outcomes, and Patient Safety,” JAMA Health Forum 4, no. 7 (July 7, 2023): e231809, https://doi.org/10.1001/jamahealthforum.2023.1809.

[14] David J. Doukas et al., “Virtue and Care Ethics & Humanism in Medical Education: A Scoping Review,” BMC Medical Education 22, no. 1 (February 26, 2022): 131, https://doi.org/10.1186/s12909-021-03051-6.

[15] Lisa Soleymani Lehmann et al., “Hidden Curricula, Ethics, and Professionalism: Optimizing Clinical Learning Environments in Becoming and Being a Physician: A Position Paper of the American College of Physicians,” Annals of Internal Medicine 168, no. 7 (April 3, 2018): 506–8, https://doi.org/10.7326/M17-2058.

[16] “Medical School Graduation Questionnaire: 2016 All Schools Summary Report” (Association of American Medical Colleges, July 2016), https://www.aamc.org/media/8321/download.

[17] Doukas et al., “Virtue and Care Ethics & Humanism in Medical Education.”

[18] Rachael E. Eckles et al., “Medical Ethics Education: Where Are We? Where Should We Be Going? A Review,” Academic Medicine: Journal of the Association of American Medical Colleges 80, no. 12 (December 2005): 1143–52, https://doi.org/10.1097/00001888-200512000-00020.

[19] Neufeld-Kroszynski, Michael, and Karnieli-Miller, “Associations between Medical Students’ Stress, Academic Burnout and Moral Courage Efficacy.”

From Catalyst to Clarity

2025-04-10T18:55:36+00:00

Introduction

Orphan drugs are therapeutics that treat rare diseases, defined as affecting 200,000 or fewer people in the United States, that normally would not receive investment given the small patient population. Passed in 1983, the Orphan Drug Act (ODA) promoted orphan drug development through incentives, including seven years of exclusivity.^[1] However, a 2021 court decision undermined the original spirit of the ODA, resulting in fewer incentives for researching and developing critical therapeutics necessary for treating patients suffering from rare diseases, particularly children. The Retaining Access and Restoring Exclusivity Act (RARE Act),^[2] would rectify the impacts of this decision and restore the ODA to its original intent. This would also fulfill the state’s obligations to justice under the application of the difference principle to drug development priority-setting.

Background

Under the ODA, drug companies obtain an orphan designation prior to clinical trials.^[3] If the drug is proven to be safe and effective, then the FDA approves the drug for a specific use or indication. For example, the FDA could approve a cystic fibrosis drug for adults with a given genetic mutation. The exclusivity would then apply only to the use of the drug in that population.^[4] The orphan drug designation gives the pharmaceutical company seven years of market exclusivity.

Catalyst v. Becerra

In 2009, Catalyst received an orphan drug designation for its drug Firdapse (amifampridine) for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS), an autoimmune disease that affects less than 0.001 percent of the population. The FDA approved Firdapse for adults with LEMS in 2018 and granted Catalyst exclusivity through 2025. Jacobus had developed Ruzurgi (amifampridine, the same drug) to treat LEMS and received an orphan drug designation in 1990. In 2019, the FDA approved Ruzurgi for patients less than 17 years old.^[5] Catalyst sued the FDA, challenging the FDA’s long-standing interpretation of market exclusivity.

The case, Catalyst Pharmaceuticals v. Becerra, centered on how broad exclusivity is and sought to answer the question of whether or not the statutory phrase “same disease or condition” contained in the ODA was ambiguous.^[6] The 11th Circuit determined that the phrase was not ambiguous, broadening the traditional FDA interpretation of “same disease or condition.” The court found that FDA approval of Ruzurgi for pediatric patients violated Catalyst’s exclusivity. The court held that Congress would have included specific language for “use or indication” if it had intended the statutory phrase to be interpreted to limit exclusivity to the specific use and indication and to allow other brands to market to subgroups after demonstrating safety and efficacy in those groups.^[7]

Prior to Catalyst, the FDA interpreted the ODA to limit exclusivity to particular uses and indications. The FDA encouraged other companies to engage in clinical trials to serve subpopulations and approve existing drugs for additional subgroups within a disease. That way, FDA approval of a drug for adults would not discourage others from researching the same drug for pediatrics.^[8] The RARE Act would clarify and codify the FDA’s long-standing interpretation of the ODA limiting exclusivity to use or indication.

The Ramifications of Catalyst

The court’s interpretation of orphan drug development has created a policy landscape that deters orphan drug research, straying from the ODA’s intent. For example, a company that studies an existing drug with an orphan designation but for a different population subgroup, such as children, and demonstrates its safety and effectiveness, would be unable to receive a period of exclusivity.^[9] Without that key incentive, many companies would likely focus on other areas of research. Exclusivity is meant to promote rare disease research and eventually lead to new treatments for patients, not constrain them. The court’s ruling has jeopardized the underlying purpose of the ODA in serving the needs of rare disease communities. The downstream effects of Catalyst on drug development are already being observed in FDA approval rates for new drugs. In the 16 months preceding the Catalyst decision, the FDA approved 217 orphan drugs.^[10] After Catalyst, that dropped to only 95 drugs being approved.^[11]

The interpretation proposed by Catalyst and held by the 11th Circuit also ignores important scientific truths recognized by both medical experts and Congress. Children are not simply “small adults.”^[12] Children can have different manifestations of the same diseases as adults, as well as respond differently to treatment.^[13] In the context of rare diseases, advancing drug treatments is especially important for pediatric populations, as many rare diseases develop during childhood.^[14] Congress has sought to address the need to promote drug treatment research in children by passing both the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act.^[15] The interpretation in Catalyst ignores this fact and errs in ignoring the critical need to distinguish indications for granting exclusivity.

Without clarification of the RARE Act, drug companies might also be deterred from future orphan drug development, given the existing confusion on the approval process and ambiguity in regulatory guidance. In Catalyst, the court ordered the FDA to set aside the drug in question. While the FDA complied with the court, it also posted a notification in the Federal Register in 2023 regarding its continued intent to grant approvals beyond the scope of Catalyst, using the standard of use or indication.^[16] The FDA justified this decision by saying continued adherence to the ambiguous language of the statute would “best serve the public health by facilitating patient access to orphan drugs, especially for difficult-to-study patients such as young children.” The RARE Act would remove any confusion in the approval process by granting the FDA the explicit statutory authority to approve the same drug from different manufacturers if they are able to treat different patient populations. It would also remove the possibility of future drug sponsors challenging competing orphan drug approvals on the basis of the reasoning in Catalyst.

The Difference Principle in Context

Only about 5 percent of rare diseases have an FDA-approved therapy, and this is after four decades of targeted research and development incentives through the ODA.^[17] Subgroups like pediatric populations fail to attract investment and research attention from industry because barriers like confusion over exclusivity exist. Some might argue that incentivizing research into subgroups for rare diseases is a misguided approach, as it encourages investment into drugs which would benefit only a very small population. Why should we promote the use of significant resources for these small populations when those resources could go to drug research that could benefit more people? The difference principle, as proposed by John Rawls, enriches and supports our understanding of the state’s obligations in the context of drug development and priority-setting in research incentives. The principle holds that social and economic inequalities are justified only if they benefit the least advantaged members of society.^[18] Applied here, it supports prioritizing research for pediatric rare diseases—even if only a small group benefits—because doing so helps those who are most disadvantaged in the healthcare system, providing them with opportunities to live a good life, as they conceive it, that they would not otherwise have. Congresswoman Doris Matsui (CA-07), co-chair of the Rare Disease Congressional Caucus, answered the question more concisely by stating that “access to medicine shouldn’t be sacrificed for drug companies’ bottom line.”^[19] If you believe that children with rare diseases deserve a fighting chance and should not be neglected for the sake of profit, the RARE Act is a necessary and urgent step to fulfilling that moral commitment.

Some argue that without broad exclusivity for an entire disease, companies might not invest in orphan drug development at all. But this concern is overstated. The FDA’s earlier approach still gave companies meaningful protection for specific indications, like adults, while allowing others to step in and develop treatments for different groups, such as children. Broad exclusivity shuts that down, blocking follow-on research that could reach patients with no other options. The RARE Act would fix this by restoring a more practical balance between rewarding innovation and expanding access.

Conclusion

The House passed the RARE Act in September 2024, although it fell short of being signed into law. Although there has been consistently strong bipartisan support for the legislation, confounding political tensions concerning government inefficiency have caused these provisions to be left in a state of legislative suspension. The language of the RARE Act has been introduced once again as a part of the Give Kids a Chance Act and introduced to the House by Representative Michael McCaul (R-TX) this March. Catalyst has jeopardized the original spirit of the ODA as a means of helping those who need it most. Congress must pass the RARE Act to realign the function of the ODA with its intended purpose and fulfill the state’s obligations under an ethical framework that is committed to prioritizing the most vulnerable and worst-off.

[1] Katie Cohen, “A Catalyst For Reform: Charting A Future For Orphan Drug Exclusivity,” University of Pennsylvania Law Review vol. 173, iss. 3 (2025): 909. https://scholarship.law.upenn.edu/cgi/viewcontent.cgi?article=9883&context=penn_law_review

[2] Now included as Section 6 of the Give Kids a Chance Act (H.R. 1262),

[3] Karin Hoelzer, “Congress should protect the intent of the Orphan Drug Act and pass the RARE Act,” NORD, https://rarediseases.org/pass-the-rare-act/

[4] Ibid.

[5] Catalyst Pharmaceuticals, Inc. v. Becerra, No. 20-13922 (11th Cir. 2021), 7-9.

[6] Catalyst Pharmaceuticals, Inc. v. Becerra, No. 20-13922 (11th Cir. 2021), 2.

[7] Catalyst Pharmaceuticals, Inc. v. Becerra, No. 20-13922 (11th Cir. 2021), 13.

[8] “FDA’s Overview of Catalyst Pharms., Inc. v. Becerra,” https://www.fda.gov/industry/medical-products-rare-diseases-and-conditions/fdas-overview-catalyst-pharms-inc-v-becerra

[9] Ibid.

[10] Katie Cohen, “A Catalyst For Reform: Charting A Future For Orphan Drug Exclusivity,” University of Pennsylvania Law Review vol. 173, iss. 3 (2025): 920. https://scholarship.law.upenn.edu/cgi/viewcontent.cgi?article=9883&context=penn_law_review

[11] Ibid.

[12] Thomas R. Welch, “Children are not Small Adults,” Journal of Pediatrics vol. 271(2024).

[13] Ibid.

[14]Apoorva Kakkilaya, Mahnum Shahzad, and Florence T. Bourgeois, “FDA Approval of Orphan Drug Indications for Pediatric Patients, 2011-2023,” JAMA Pediatr. 179, 2 (2025): 203-205. https://doi.org/10.1001/jamapediatrics.2024.5280

[15] Michael Christensen, “Best Pharmaceuticals for Children Act and Pediatric Research Equity Act: Time for Permanent Status,” J Pediatr Pharmacol Ther. 17 (2) (2012):140.

[16] “Clarification of Orphan-Drug Exclusivity Following Catalyst Pharms., Inc. v. Becerra; Notification,” Federal Register, https://www.federalregister.gov/documents/2023/01/24/2023-01179/clarification-of-orphan-drug-exclusivity-following-catalyst-pharms-inc-v-becerra-notification

[17] Hannah-Alise Rogers, “The Orphan Drug Act and Catalyst Pharmaceuticals, Inc., v. Becerra,” Congressional Research Service (2023). https://sgp.fas.org/crs/misc/R47653.pdf

[18] John Rawls, “A Theory of Justice,” Harvard University Press (1971): 65.

[19] “Legislation Included as Part of Rare Disease Package,” https://matsui.house.gov/media/press-releases/house-passes-matsuis-rare-act

Gene Editing Anxiety

2025-03-31T22:01:10+00:00

Introduction

Many parents diagnosed with debilitating anxiety disorders fear their children will suffer from the same psychiatric illness that has plagued their entire lives. While Preimplantation Genetic Diagnosis has long allowed parents to screen out embryos with a predisposition to certain disorders, the practice collides with many religious or personal beliefs. With the advancement of genetic-engineering technologies, such as CRISPR-Cas9, scientists have speculated about using such techniques to alter genetic material to reduce the risk of acquiring – or passing along – complex psychiatric disorders. Although somatic cell engineering could theoretically correct genetic variants associated with anxiety in any one individual, the prospect of editing the germline to permanently induce genetic changes for multiple generations proves enticing. However, the unforeseen consequences of applying germline engineering for complex anxiety disorders raise important moral considerations. The unpredictable health risks to future generations incurred by germline genetic engineering for anxiety disorders outweigh the potential probabilistic benefits through a consequentialist lens.

Health and Genetic Risks of Germline Editing

Editing the human germline to prevent psychiatric disorders poses serious health risks to individuals. Currently, scientists warn that genetically altering the human genome can result in off-target mutations that increase the risk of disease. For instance, gene-editing technologies like CRISPR-Cas9 can make unintended cuts in the genome, possibly preventing important genes from functioning properly. Additionally, cells may divide before gene-editing has completed, or the editing technology may inadvertently modify only one copy of the target alleles. Such mistakes produce a mixture of distinct genotypes within a single individual—a phenomenon known as genetic mosaicism.^[1]

However, even assuming germline editing has advanced enough for these off-target effects to prove negligible, serious consequences still may arise from the intended genetic alterations due to pleiotropy. Many individual genes impact various aspects of physiology or behavior. For example, the CCR5 gene encodes a macrophage receptor targeted by certain HIV strains. Interestingly, a naturally-occurring 32 base-pair deletion within the CCR5 gene confers greater resistance to these strains of HIV.^[2] While inducing this deletion in the germline via genetic editing would seemingly reduce HIV transmission – a clear benefit to humanity – such a mutation may increase a person’s susceptibility to infection due to CCR5’s role in staging an immune response.^[3] These pleiotropic effects extend to psychiatric disorders influenced by multiple genes, in which alleles associated with OCD risk, for example, positively contribute to educational attainment and performance.^[4] Therefore, even if off-target effects are mitigated, editing anxiety risk genes can lead to unforeseen consequences due to their non-specific nature.

There is a risk that genetic germline engineering would affect all of society due to its generational implications. While somatic engineering ensures any effects are contained to a single individual, altering the genetic material of germline cells may create pleiotropic consequences or genetic mosaicism that will persist for generations. Importantly, without sufficient quality control measures, researchers cannot know the precise effects of germline editing until after birth—and some problems may only emerge years later.^[5] As a result, large portions of society may endure the unintended ramifications or elevated risks of editing anxiety-related genes for generations.

In contrast, the British bioethicist John Harris equates the potential harms inflicted by germline editing as no more risky than natural sex: “Human reproduction involves genes being recklessly combined in the dark, with unforeseeable consequences for the resulting children, parents, and the generations to come.”^[6] However, the risks associated with conception through “natural sex” do not justify conducting an expensive procedure with unknown effects given the mere probabilistic nature of anxiety-related genes. Proposing such a comparison assumes a cavalier attitude towards the real risk of pleiotropic effects and increasing the prevalence of ill-suited alleles. In essence, if germline editing is no different from conventional reproduction, why bother using the technique at all for anxiety disorders? At least with natural reproduction, parents avoid unnecessary costs and the potential guilt of unintentionally harming their child’s cognitive development or increasing their risk for other disorders.

The Complex Heritability of Anxiety Disorders

Because genetic germline engineering does not guarantee desired outcomes for anxiety-related disorders, its potential harms outweigh the anticipated benefits. The germline is not a sacrosanct entity considering its fluidity in everyday life: the genetic material of sperm modulates with age while sexual selection determines the combination of genes for potential offspring.^[7] Researchers and clinicians should approach germline editing like any other medical procedure, weighing the benefits against potential harms. Of course, anxiety-related disorders lead to serious manifestations in patients, often requiring decades of psychopharmacology and psychotherapy.^[8] However, genetic germline engineering does not provide a definitive and permanent solution to the underlying causes given the very nature of anxiety-related disorders. While anxiety disorders exhibit a heritability of 30-60 percent depending on the specific disorder, genes associated with such disorders behave probabilistically – not deterministically.^[9] Whether a person develops a disorder and the severity of a disorder depend significantly on environmental factors.^[10] As such, the variants associated with anxiety do not invariably lead to disorders.

As a result, parents may be opting in to preemptively treat a disorder their child may not develop in the first place. Despite this, even if their offspring do develop an anxiety disorder, the magnitude of the condition may not warrant a treatment as drastic as germline engineering—one that risks unforeseen pleiotropic effects that last generations. Even if genes for anxiety could be edited with great predictive success, the line separating non-genetic anxiety from pathological versions is unclear. Emotions like fear and anxiety have evolved as important survival mechanisms for dangerous situations.^[11] Gene editing could inadvertently weaken their protective functions.

Safer and Less Intrusive Alternatives

Genetic germline engineering offers a drastic option for individuals concerned about their high genetic risk for anxiety disorders, especially when safer and less extreme alternatives are available. Currently, multiple treatment options exist to improve the quality of life of patients living with mild anxiety disorders. For instance, medication and cognitive-behavioral therapy commonly manage many disorders, such as mild to moderate forms of social anxiety disorder (SAD) and obsessive-compulsive disorder (OCD).^[12] Unfortunately, many individuals living with severe anxiety disorders do not respond to mainstream interventions. In these patients, overwhelming thoughts and compulsive tendencies that prevent basic facets of daily life may warrant treatments more aggressive than standard medication or therapy. Nonetheless, these patients could still explore the possibilities of genetic engineering technology without altering their germline and potentially endangering future generations. Somatic cell engineering more closely resembles standard medical treatments in that an individual weighs the benefits and harms to his or her own person. In the case of somatic cell editing, any unforeseen complications will die with the patient, preventing multiple generations from inheriting elevated health risks. Therefore, editing somatic cells to alter anxiety-correlated genes can yield similar results as genetic germline engineering without the added unknown ramifications. Although germline engineering may appear more cost-effective due to its long-lasting, multi-generational impact, the potential savings do not justify the risks of a therapy that could have severe consequences for many individuals. In addition, while the current costs of somatic engineering could be prohibitive, ongoing innovation may reduce its price over time. Considering individuals can benefit from less severe treatment plans if and only if they develop an anxiety disorder in the first place, germline engineering should not be offered for anxiety-correlated genes.

Autonomy Concerns

Genetic germline engineering violates the autonomy of potential offspring by imposing a procedure without their informed consent. Medical professionals and researchers must disclose enough information for individuals to weigh the benefits and risks of participation, enabling fully informed consent. However, germline editing causes repercussions that extend many generations into the future. It is clearly impossible to obtain consent of future individuals.^[13] Proponents of genetic germline engineering refute this, citing the immense influence society generally allows parents to hold over their children’s education, medical issues, and more.^[14] Although true, this argument assumes an absolute totalitarian view of parenthood in which parents never discuss medical risks with their child before making a final decision. Moreover, there is a huge ethical difference between genetically correcting a fatal disease caused by a single gene and altering anxiety-related genes in terms of autonomy. For instance, suppose a couple decides to genetically correct the gene that causes cystic fibrosis in their germline, obviously without clear consent from their potential offspring. This decision arguably promotes the overall autonomy of their children by removing the physical limitations imposed by the disease, thus outweighing any previous infringements on autonomy. In contrast, variants influencing anxiety-related disorders are not as concrete, given their complex genetic nature and susceptibility to environmental factors. Therefore, children would be subject to the risks and unknowns of germline editing all to preemptively treat a disorder they may or may not have developed. Rather, parents should allow future generations to dictate their own treatment – if any treatment is indicated at all – whether that entails medication, therapy, or (one day) somatic cell engineering.

Conclusion

While genetically engineering the germline to permanently reduce transmission of anxiety-related genes may seem like an ideal solution to prevent anxiety disorders, the practice presents substantial risks and unclear benefits. There is a risk of pleiotropic effects that could trigger health problems as serious or more severe than the targeted anxiety disorder itself.

The potential complications not only endanger the recipient but jeopardize the health of future generations by altering the germline. These ramifications trump the prospective benefits of germline engineering for anxiety disorders considering anxiety-correlated genes act probabilistically – not deterministically — and are subject to a host of environmental influences. Based on a typical risk-benefit analysis, genetic germline engineering of anxiety-related genes crumbles in comparison to therapy, medication, and somatic cell engineering – all safer treatments that can be applied after birth, if necessary.

[1] Edward Lanphier and Fyodor Urnov, “Don’t Edit the Human Germ Line,” Nature; London 519, no. 7544 (March 26, 2015): 410–11, http://dx.doi.org.ezp-prod1.hul.harvard.edu/10.1038/519410a.

[2] Alison P. Galvani and John Novembre, “The Evolutionary History of the CCR5-Δ32 HIV-Resistance Mutation,” Microbes and Infection 7, no. 2 (February 1, 2005): 302–9, https://doi.org/10.1016/j.micinf.2004.12.006.

[3] Jean K. Lim et al., “Genetic Deficiency of Chemokine Receptor CCR5 Is a Strong Risk Factor for Symptomatic West Nile Virus Infection: A Meta-Analysis of 4 Cohorts in the US Epidemic,” The Journal of Infectious Diseases 197, no. 2 (January 15, 2008): 262–65, https://doi.org/10.1086/524691; Maximiliano Ruben Ferrero, Luciana Pádua Tavares, and Cristiana Couto Garcia, “The Dual Role of CCR5 in the Course of Influenza Infection: Exploring Treatment Opportunities,” Frontiers in Immunology 12 (January 20, 2022), https://doi.org/10.3389/fimmu.2021.826621.

[4] The Brainstorm Consortium et al., “Analysis of Shared Heritability in Common Disorders of the Brain,” Science 360, no. 6395 (June 22, 2018): eaap8757, https://doi.org/10.1126/science.aap8757.

[5] Lanphier and Urnov, “Don’t Edit the Human Germ Line.”

[6] John Harris, “Germline Modification and the Burden of Human Existence” 25, no. 1 (2016): 6–18, https://doi.org/10.1017/S0963180115000237.

[7] Harris.

[8] Borwin Bandelow, Sophie Michaelis, and Dirk Wedekind, “Treatment of Anxiety Disorders,” Dialogues in Clinical Neuroscience 19, no. 2 (June 2017): 93–107.

[9] In addition, many DNA variants linked to anxiety disorders are not exclusive to a single syndrome, further complicating the ability to predict risk scores for polygenic anxiety conditions.

[10] The Brainstorm Consortium et al., “Analysis of Shared Heritability in Common Disorders of the Brain.”

[11] Joseph E. LeDoux, “Chapter 21 - Evolution of Human Emotion: A View through Fear,” in Progress in Brain Research, ed. Michel A. Hofman and Dean Falk, vol. 195, Evolution of the Primate Brain (Elsevier, 2012), 431–42, https://doi.org/10.1016/B978-0-444-53860-4.00021-0.

[12] Bandelow, Michaelis, and Wedekind, “Treatment of Anxiety Disorders.”

[13] Lanphier and Urnov, “Don’t Edit the Human Germ Line.”

[14] Harris, “Germline Modification and the Burden of Human Existence.”

EMTALA and State Abortion Bans

2025-02-24T23:53:08+00:00

Photo by Manny Becerra on Unsplash

Abstract

This paper argues that EMTALA and state laws governing abortion access do conflict and that federal law should preempt state law to the extent of the conflict. This paper’s purpose is to give a brief overview of the legal issues, identify practical issues and dangers associated with restrictive abortion laws, and contextualize preemption in the current political moment. The topic here is medical emergency – this paper does not address abortion for either nonmedical or nonemergency reasons. Lastly, this paper is designed to appeal to those in many disciplines, including bioethics, and provide a primer on the relevant legal concepts for those not practicing law. Much of it reads as an explainer addressing many intertwined laws and arguments.

Introduction

The Emergency Medical Treatment and Labor Act (EMTALA)^[1] appears to conflict with restrictive state abortion laws. Generally, federal law preempts state law in matters where they conflict.^[2] State abortion laws should be unenforceable when they conflict with EMTALA, i.e., specifically when abortions are needed to stabilize patients. We argue that EMTALA preempts restrictive state abortion laws when the medical intervention required to stabilize the patient is an abortion. In Moyle v. Idaho,^[3] addressing the issue of whether EMTALA preempted the restrictive Idaho abortion law, the Supreme Court sent the case back to the lower courts, but the justices addressed many of the relevant issues: whether the laws conflict, preemption and the Supremacy Clause, the Spending Clause, and various interpretations of EMTALA and Idaho’s abortion law.^[4] This paper’s purpose is to give a brief overview of the legal issues, identify practical issues and dangers associated with restrictive abortion laws, and contextualize preemption in the current political moment. The topic here is medical emergency – this paper does not address abortion for either nonmedical or nonemergency reasons. Lastly, this paper is designed to appeal to those in many disciplines, including bioethics, and provide a primer on the relevant legal concepts for those not practicing law. Much of it reads as an explainer addressing many intertwined laws and arguments.

What Does EMTALA Require?

EMTALA requires emergency departments to screen patients to determine whether they are experiencing a medical emergency. EMTALA defines medical emergency as follows, “a person is having a medical emergency if they are in labor or suffering from a condition that, without immediate attention, could be reasonably expected to place their health in serious jeopardy, seriously impair their bodily function, or cause serious dysfunction to an organ.”^[5] Once screened, if an emergency medical condition is present, the hospital must stabilize, or if stabilization is not possible in the facility, transfer the patient. EMTALA caselaw covers what level and type of screening and stabilization meets the rigor of the law. When a hospital cannot stabilize the person, a timely transfer is imperative.

EMTALA requires hospitals to stabilize patients when “the absence of immediate medical attention could be reasonably expected to either result in a serious health risk, or seriously threaten bodily functions or organs.”^[6] Stabilize is defined as providing treatment necessary “to assure, within reasonable medical probability, that no material deterioration of the condition is likely to result from or occur during the transfer of the individual from a facility, or . . .to deliver (including the placenta).”^[7] Medical literature demonstrates that abortion may be necessary for life-threatening complications of pregnancy, including sepsis. Therefore, EMTALA requires hospitals to provide abortions if the physician determines that terminating the pregnancy is required to stabilize the patient.^[8] Many scholars, lawyers, and healthcare providers take the position that abortion can be medically necessary and that EMTALA should ensure abortions to stabilize, providing a robust body of ethics, legal, and medical literature.^[9]

Has Violating EMTALA Harmed Women?

Since restrictive state abortion laws became enforceable after Dobbs v. Jackson Women’s Health,^[10] twelve states enacted (or began to enforce) severely restrictive abortion laws.^[11] State policies vary concerning exceptions for saving the life of the mother and for pregnancies resulting from rape and incest.^[12] Beyond the twelve states that nearly ban abortion, 15 states have restrictive laws prohibiting abortion after various gestational stages.^[13] In Georgia, at least two women have died due to the restrictive law. One attempted a medical abortion at home and did not go to the hospital out of fear they would not treat her. The other “languished” in the hospital while doctors refused to perform dilation and curettage despite sepsis.^[14] In Florida, women were denied abortion care and received risky substandard care. One was sent home with antibiotics after preterm premature rupture of membranes, i.e., after her “water broke” before she was full term.^[15] She almost died, losing significant blood when the miscarriage occurred in her own bathroom.^[16] Restrictive abortion laws have led to sub-standard care including inappropriate discharges resulting in severe outcomes including sepsis.^[17] Infections grow quickly and the need for an abortion can become dire as sepsis is described as “a race against time.”^[18]

There are many personal stories – yet it has been difficult to aggregate the numbers. ProPublica has tried to track how many women have died or suffered serious medical harm due to a lack of timely abortions during medical emergencies.^[19] Yet states have not been properly tracking deaths and other physical harms due to delays in emergency abortion care.

Additionally, many women have driven themselves or been transferred and airlifted to neighboring states without restrictive laws.^[20] In Moyle v. United States, Justice Kagan noted that, “To ensure appropriate medical care, the State’s largest provider of emergency services had to airlift pregnant women out of Idaho roughly every other week, compared to once in all of the prior year (when the injunction was in effect).”^[21] However, when time is of the essence, stabilization must be local.^[22] Delays in providing care can cause hemorrhage, loss of the uterus, infertility, or death.^[23]

A 2022 study on the impact of Texas’s six-week abortion ban in two hospitals found significantly worse outcomes arose when all patients in preterm labor with at least one clinical indication for induction of labor were treated with state-required “expectant management” rather than induction. Expectant care or expectant management means waiting for the miscarriage to finish on its own and may involve bed rest, examination by ultrasound, and antibiotics.^[24] Fifty-seven percent of those with ruptured membranes experienced “a serious maternal morbidity,” such as infection or hemorrhage.^[25]

EMTALA requires abortion when its delay could damage the uterus and fallopian tubes.^[26] Additional emergencies that may require emergency treatment include premature rupture of membranes, ectopic pregnancy, incomplete miscarriage,^[27] sepsis, molar pregnancy, and pre-eclampsia.

States have ethical obligations to protect citizens experiencing emergencies and should avoid imposing barriers that prevent others from assisting. A floor based on constitutional or federal law had offered protection prior to Dobbs v. Jackson Women’s Health Organization.^[28] Ethical obligations of doctors in emergencies may conflict with restrictive state laws arising after Dobbs.^[29] Obligations of government to the people are thwarted by restrictive laws at the state level and by a failure of EMTALA enforcement or hard law^[30] to clarify or codify a specific right to emergency abortions.

What is Preemption?

Preemption is the idea that a law of a higher authority will govern rather than a law of the lesser authority. It generally applies when laws conflict. The Constitution includes the Supremacy Clause, which states that the Constitution, federal laws, and treaties are the “supreme Law of the Land.”^[31] The breadth of preemption law covers the ways in which the federal government, including administrative agencies, can set floors and ceilings for state laws, can take over certain subject matters (like the FDA governs approval of prescription drugs), and must prevail over conflicting state and local laws, including state constitutions. However, preemption is not absolute; it requires that the federal law is within Congress’ authority,^[32] and cannot unconstitutionally infringe on states’ rights. The “presumption against preemption” holds that courts should not assume federal laws governing areas normally left to states, i.e., state police powers, do preempt.^[33] Preemption cases look at the validity of the federal law rather than focusing on the state law exclusively.

What is the Basis for EMTALA's Preemption of State Law?

EMTALA contains a preemption clause which states, “The provisions of this section do not preempt any State or local law requirement, except to the extent that the requirement directly conflicts with a requirement of this section.”^[34] Therefore, the law is not ambiguous; preemption is explicit rather than implied. EMTALA preempts state law when it conflicts with it.

EMTALA should govern as per the Supremacy Clause and the breadth and depth of Supreme Court cases on preemption. It seems to be a clear express preemption and yet somehow the Fifth Circuit concluded the opposite, prioritizing state law over federal, and issued an injunction against enforcement of EMTALA when such enforcement requires an abortion to stabilize the patient in violation of Texas’ abortion ban.^[35]

Does the Preemption Clause Apply to Restrictive State Abortion Laws?

Impossibility Preemption. State and federal law are most obviously in conflict when “compliance with both federal and state regulations is a physical impossibility.” Fla. Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963). The paradigmatic case of “impossibility preemption” occurs when, as in the FLSA overtime example, a federal statute says “private entities must do X” and a state law says “private entities may not do X.” When that occurs, the Supremacy Clause plainly voids the state law.^[36]

The state laws prohibit actions that EMTALA compels. Any other reading of the state laws and EMTALA would limit either EMTALA or the state law. If EMTALA were read to never require abortion, then there would be no conflict, but the ability of EMTALA to effectively require screening and stabilization would be undermined. State laws would endanger women seeking abortion care for things like sepsis.

Moyle v. United States Procedural History

Moyle v. United States is currently the best indication of where the Supreme Court stands on EMTALA and abortion. Idaho’s law bans abortion except to prevent death.^[37] There is an exception for cases of rape and incest, and the law imposes a paper trail to validate those legal abortions. The US District Court issued an injunction against enforcement of the Idaho law when it conflicts with EMTALA. The Ninth Circuit Court of Appeals declined to stay the injunction. Then, the Supreme Court granted certiorari (before the Ninth Circuit heard the appeal), staying the injunction for months earlier in 2024. (This means from January to June Idaho was permitted to enforce its strict abortion law. To comply with EMTALA without violating Idaho’s criminal law, Idaho hospitals arranged airlifts for patients in need of abortions to stabilize them. In many cases, they did not provide abortions to those patients presenting with medical emergencies for which an abortion would be the standard of care and a stabilizing procedure.) The Supreme Court heard arguments but, at the end of June, decided that certiorari was improvidently granted. Therefore, the injunction against Idaho’s law was reinstated. Justice Jackson suggests that the Supreme Court will need to face the preemption issue at some point.^[38] The disparity between the Fifth and Ninth Circuit courts indicates the need for resolution. In the meantime, the Department of Justice has dropped the Biden-era case against Idaho.^[39]

Do EMTALA and Idaho Law Conflict? Does EMTALA Ever Require Abortion?

The Supreme Court decision that certiorari was improvidently granted in the Idaho case touched on the relevant preemption issues.

Justice Kagan wrote a statutory analysis, joined by Justice Jackson and Justice Sotomayor. Idaho argues that EMTALA never calls on doctors to violate state laws. Kagan notes that Idaho’s argument is unlikely to succeed on the merits given that EMTALA and the Idaho law conflict:

EMTALA requires a Medicare-funded hospital to offer an abortion when needed to stabilize a medical condition that seriously threatens a pregnant woman’s life or health. See 42 U. S. C. §1395dd. Idaho allows abortions only when “necessary to prevent” a pregnant woman’s “death.” Idaho Code Ann. §18–622(2)(a)(i) (Supp. 2023).^[40]

Kagan responds to Justice Alito’s position that EMTALA never requires abortion. Justice Kagan’s analysis notes the importance of stabilizing patients and preventing loss of fertility and other serious harms. (Justice Jackson wrote on her own as well, suggesting the Court keep the case rather than withdraw its grant of certiorari.)

Do Other Federal Laws or Recent Amendments Alter or Limit EMTALA's Requirements?

Justice Alito’s dissent, joined by Justices Thomas and Gorsuch, suggests a reading of EMTALA that does not require abortion to stabilize women even if the woman would face grave harm or death. He suggests the Hyde Amendment indicates EMTALA was not meant to require abortion. The Hyde Amendment is a 1977 law that prohibits federal funding for abortion except when the pregnant person is endangered by the pregnancy or when the pregnancy is the result of rape or incest.^[41] He also notes the word abortion is not in the law – this implies he would expect all emergency procedures from appendectomy to IV antibiotics to be listed. His interpretation is a deviation from common sense and legal interpretations.

Alito refers to EMTALA’s provisions for the unborn. EMTALA was revised to ensure that women could seek emergency care for fetal distress even if there is not a risk to the pregnant women themselves. As Kagan noted, this is not a “tacit withdrawal” of the otherwise well accepted requirement to treat women in need of abortions to avoid serious harm or bodily/organ injury. The references to the unborn child extend the rights of the pregnant woman to seek care, allowing women to protect the fetus and seek medical care on its behalf. Other references to the unborn similarly extend consideration to the fetus in decisions to facilitate transfers of women in labor. While considering the fetus is often the priority of the woman seeking care, “dual stabilization” is not always possible and arguably not always an appropriate goal.^[42]

Might EMTALA Violate the Spending Clause?

Justice Alito further entertains claims that the Spending Clause should prevent EMTALA from placing binding conditions on Idaho as Idaho was not a party to it. He uses the language of contracts about the federal law. He suggests that EMTALA has ambiguity in violation of the Spending Clause. He complicates his assertions by discussing the right to refuse and distinguishing it from the right to demand care that violates the law. EMTALA itself creates an obligation to provide stabilizing care – that patients may refuse or demand care is not relevant to the statute.

Justice Barrett’s concurrence, joined by Justices Kavanaugh and Roberts, also suggests an open issue about whether EMTALA can preempt state law as it imposes on private businesses. She is open to Alito’s view of the Spending Clause. Questioning the very validity of the federal law rather than focusing solely on the state law in question is a way of approaching the preemption issue. Unconstitutional federal laws should not preempt state laws.^[43] If EMTALA’s obligations imposed on states are invalid under the Spending Clause because states were “not party” to the agreement between hospitals that accept Medicare and the federal government, then all other provisions afforded by EMTALA could be invalidated as well. This would greatly impact the ability of the public to obtain emergency medical care. It is noteworthy that six justices seem to entertain the idea that EMTALA potentially violates the Spending Clause.

Is the State Law Ambiguous?

Justice Barrett’s concurrence suggests that a broad reading of Idaho’s law does not require death to be imminent. Rather the law allows a liberal interpretation of performing an abortion to prevent death. Her reading of “abortion to prevent the death of the mother” seems to interpret Idaho’s law to mean that if a doctor were to think death would eventually result there is wide discretion to go ahead with an abortion. The number of airlifts out of Idaho suggests doctors do not feel so free to interpret the criminal law loosely.

Idaho could clarify its law if it does intend a loose interpretation. Amending the law, enacting additional laws, or through the state court system, Idaho could clarify that emergency abortions are acceptable and that the “saving a life” exception does not require waiting until the patient is on the brink of death or until a fetal heartbeat or cardiac rhythm stops.

Executive Actions

After Dobbs v. Jackson Women’s Health shifted abortion lawmaking to the states,^[44] President Biden signed an executive order that noted the intention to take “action to protect healthcare service delivery and promote access to critical reproductive healthcare services, including abortion.”^[45] In July 2022, the Department of Health and Human Services (HHS) issued a guidance reiterating the obligation to continue to treat pregnant patients or patients experiencing pregnancy loss.^[46] In 2023, HHS issued a reminder letter after research found violations in Missouri and Kansas.^[47] In 2024, following the Supreme Court’s opinions removing its grant of certiorari in Moyle v. Idaho, the White House reiterated its plans to continue EMTALA enforcement, noting that EMTALA may require abortion in certain circumstances.^[48] CMS, HHS, and the White House have expressed intention to promote enforcement of EMTALA. So far, the Trump administration has left EMTALA intact. Yet, as noted, the Department of Justice is not pursuing ongoing EMTALA cases concerning emergency abortion and restrictive state laws.

Preemption and Politics

The political moment is giving rise to questions about federalism and preemption when state and federal laws clash. The current administration is characterized by a mission to reduce executive agencies’ size and scope. The “DOGE” organization threatens to eliminate the bureaucracy, a sign that letting state law stand when it conflicts with federal law may be the favored position.

However, the Trump administration may be inconsistent about preemption for various reasons. A president wanting to invoke presidential power may use federal law to control states. And a president prioritizing any particular legislative agenda item may ignore preemption when an existing federal law blocks a state law that is consistent with his agenda.

While it is doubtful that a Trump executive action would have the tone and substance of Bidens’, it is possible that having already extracted the votes he needed to be elected, Trump has no reason to weigh in on abortion at all. It is unclear, but not necessarily unlikely, that a Trump HHS would continue to issue letters enforcing EMTALA. Robert F. Kennedy, Jr. was pro-choice and may be unlikely to change his stance as he acclimates to his role as secretary of HHS.

Should the Definition of Abortion be Universal and Exclusive?

Several states have changed the definition of abortion to exclude the removal of embryo/fetus for ectopic pregnancy, miscarriage, or molar pregnancy or have codified exceptions to their restrictive laws.^[49] For example, a 2023 Texas bill provides an affirmative defense for ectopic pregnancy and premature rupture of membranes.^[50] Tennessee passed a similar law allowing abortion for ectopic pregnancies and miscarriage management. There is no evidence that states wish to treat ectopic pregnancies as viable ones and prevent standard-of-care medical treatment. The lack of clarity around miscarriage care^[51] leads to confusion. States have placed blame on doctors for misinterpreting the law and failing to provide emergency abortions.^[52]

A definition of abortion that excludes nonviable or low survival chance pregnancies is seen as a creative way to avoid complying with strict laws. While a common sense definition of abortion could exclude evacuating a fetus without a heartbeat, it would be difficult to narrow it enough to exclude removing a fetus that has a heartbeat but is not expected to survive post-birth or until full term or will not survive due to ruptured membranes or genetic anomalies.

Without clarity and a universal definition of abortion across law and medicine and among states, doctors have seemingly “played it safe” by risking women’s lives rather than risking prosecution.

Why Do Doctors Go Along?

A fear of prosecution, having to defend oneself in court, a guilty verdict, incarceration, and loss of license are at the root of denying or delaying abortion in emergencies. In some instances, physicians who were willing to provide necessary abortions were prevented from doing so by hospital lawyers.^[53] The uncertainty about definitions and exceptions leads to a fear of legal action.

Hospital emergency departments fear that a legal system may interpret “to prevent death” very narrowly. When restrictive state laws went into effect, the laws provided little guidance to hospitals and providers. Hospitals and doctors note a lack of clarity about how close to death the patient must be for an abortion to be permissible under the state’s law. It is possible that doctors and hospitals are being overly cautious – interpreting the laws narrowly themselves. Clarification as to whether doctors can treat women earlier and do not need to wait for death to be imminent or for a fetal heartbeat or cardiac rhythm to stop would be helpful.

There are no known cases of doctors being prosecuted for violating state restrictive abortion laws when the doctor performed the abortion based on the patient’s emergency medical condition.^[54] It appears the fear of criminal prosecution is a deterrent.^[55]

The Hippocratic Oath appears inconsistent with denying care to women in need and at risk of serious complications and death. Rather than approaching EMTALA violations as a failure by doctors, much of the literature blames the restrictive laws, the uncertainty, and the fear of liability as if they justify the failure to provide care.^[56] Possibly, if a prosecutor brought charges, some doctors would win cases, receive light to no sentences, perhaps community service, or even get clemency. Doctors have many legal and ethics theories on their side: avoiding violating federal law; a crime of necessity; benevolence/beneficence; acting as Good Samaritans and deserving immunity; conscientiously objecting to the law; rules of statutory construction for ambiguous laws; striking down the law as ambiguous or arbitrary and capricious.^[57] The prison sentences built into the laws have not yet been tested in the courts.

Will Travel Bans for Abortion Care Contribute to EMTALA Noncompliance?

Several Texas counties adopted laws to prohibit travel for abortions. These laws create a cause of action that anyone can bring against someone traveling for an abortion. They are considered “abortion trafficking” laws. Idaho and Tennessee have laws prohibiting accompanying a minor out of state for an abortion. There is an assumption that these laws prevent healthcare practitioners from recommending out-of-state abortions or facilitating travel or appointments.^[58] Dicta from Justice Kavanaugh in Dobbs suggested that the right (found in caselaw) to interstate travel makes travel bans unconstitutional.^[59] Nonetheless, the fear caused by a travel ban could have a chilling effect on seeking emergency care out of state. Travel bans also would conflict with EMTALA as providing a transfer to a facility for emergency care is a foundational part of the law.

Shield laws in states providing abortions may bar states from prosecuting people traveling for abortions.^[60] Privacy of health information continues to be important if states were to attempt to prosecute those leaving for abortion.^[61]

Is the Reason for an Abortion a Consideration?

A law that targets the reason for an abortion may better reflect the religious nature and political priority of those supporting state restrictive abortion laws. Some anti-abortion-legality literature condemns all abortion, as do some religious organizations. However, 92 percent of Democrats, 89 percent of independents, and 79 percent of Republicans support access to abortion during pregnancy-related emergencies and miscarriage.^[62] Some members of anti-abortion-legality groups approve of abortions to save women and to prevent serious medical harm – they approve of the abortions compelled by EMTALA – but they do not approve of abortion for other reasons.

A state could say abortion to prevent any medical harm of which the person bears a substantially elevated risk (e.g., ruptured membrane, preeclampsia, unexplained significant bleeding) is permissible. This can be comparable to rape and incest provisions – those exceptions concern extenuating circumstances beyond the patient’s control. Generally, the laws with exceptions for medical emergencies that threaten the life or health of the patient are examples of laws based on the reason for abortion care.

Who is the Most Impacted by Restrictive Abortion Laws During Emergencies?

These laws target biological women exclusively. The sex gap itself is a form of discrimination. Women in positions of vulnerability, whether by location, income, race, or ethnicity are worse off. People from rural areas, people with low incomes, and people from marginalized communities who traditionally struggle to access health care seek care in emergency departments more often than those with high incomes and reliable health insurance.^[63] The poor will be affected by restrictive abortion laws more than the wealthy, who have a higher likelihood of traveling to access safe abortion care. Nonetheless, the danger cuts across all income groups in that dire emergencies develop quickly and regardless of income, people with impending sepsis may run out of time. Some people/groups do have an elevated risk:

Those with the least money and resources;^[64]
Those with less access to transportation;^[65]
Those without health insurance;^[66]
Those living in rural communities;^[67]
Undocumented immigrants;^[68] and,
Those with disproportionately more maternal mortality (e.g., Black women) than other groups.^[69]

The Black population is high in many of the states with the most restrictive laws. Other than the District of Columbia, Mississippi and Louisiana have the highest proportions of Black Americans at 38 percent and 33 percent, respectively.^[70] Black and Hispanic women are more likely to experience pregnancy complications. Texas has a large Hispanic population^[71] deeply impacted by the strict laws.

When groups have faced significant past discrimination, including racism, they arguably should be protected. While they do not necessarily require special treatment to make up for the past, there are strong ethics-based arguments to ensure that populations that have experienced racism and other discrimination be ensured of equal treatment, ethically speaking, and equal protection under the law. In bioethics, the principle of justice is used to prevent preying upon the vulnerable and to establish practical ways to ensure and promote fairness.^[72] State abortion laws are an injustice in that the denial of emergency care would not be the same across the board – instead, these denials of care directly impact women only and disproportionately impact historically and currently vulnerable groups.

Big Takeaways

Doctors and hospitals will likely continue to face uncertainty in the short term. States and the Supreme Court may weigh in on EMTALA, preemption, and state law. In the long run, Congress can make a law protecting abortion rights; states can provide guidance defining abortion; and additional bills like Texas 3058 can clarify which emergency services are excluded from prohibitions on abortion. There are continuing risks to those potentially requiring emergency abortions:

The Spending Clause arguments could invalidate EMTALA despite the tenuous reasoning.
The Supreme Court will continue to be imbalanced and politicized.
States could begin enforcing the laws/prosecuting practitioners.

However, some checks on state power remain:

The right to interstate travel is likely to remain intact.
Nonprofit organizations provide safe and reliable interstate travel and accommodations.
Referendums, grassroots campaigns, and bad publicity may lead to the repeal of restrictive state laws.
HHS may continue to provide guidance suggesting EMTALA will be enforced.

And other strategies have not been satisfactorily tried:

Lawsuits challenging state laws based on racial disparity/discrimination rather than preemption will likely continue, and states may resolve them differently, based on state constitutions.
Arguments based on equal protection for gender were unaddressed in Dobbs.^[73]
Providers of abortion could perform all emergency care required by EMTALA, forcing states to choose to prosecute or not and forcing state judicial systems to become even more involved.

Conclusion

Arguments abound on both sides of the issue contributing to some legal uncertainty. This explainer set forth some of the disputes concerning the law. However, EMTALA should preempt state law when the two conflict. The conflict is narrow. In cases where an abortion is needed as life-saving care or to prevent significant injury or organ damage, hospitals should provide stabilizing abortion. Regardless of EMTALA and state laws, saving lives and preventing harm is an ethical duty in the field of medicine. Despite Spending Clause challenges and Justice Alito’s tenuous reasoning, EMTALA should be enforced. It should survive constitutional challenges and protect those providing all sorts of emergency care to people in need.

[1] 42 U. S. C. §§1395dd. (Medicare-participating hospitals with an emergency department are required to screen patients for medical emergencies and provide stabilizing treatment before transferring or discharging the patient, irrespective of an individual's ability to pay.)

[2] For more about the preemption doctrine, which stems from the Supremacy Clause, see Congressional Research Service (2019) Federal Preemption: A Legal Primer. https://crsreports.congress.gov/product/pdf/R/R45825/1; Clark, B. (2003) The Supremacy Clause as a Constraint on Federal Power. 71 Geo. Wash. L. Rev. 91. https://scholarship.law.gwu.edu/cgi/viewcontent.cgi?article=1474&context=faculty_publications (suggests federal law that “exceeds the scope” of congressional authority should be subject to judicial review – the Supremacy Clause refers to federal laws properly enacted with congressional authority; argues that judicial review should not be limited to review of the state law in preemption cases; it should include review of whether the federal law was properly enacted.)

[3] Moyle v. United States, 603 U.S.___ (2024). https://www.oyez.org/cases/2023/23-726

[4] Idaho Statutes Title 18 Crimes and Punishments Chapter 6 Abortion and Contraceptives. https://legislature.idaho.gov/statutesrules/idstat/title18/t18ch6/sect18-622/

[5] 42 U.S.C. § 1395dd(e) (2018).

[6] Moyle v. United States, 603 U.S. ___ (2024)/United States v. Idaho, quoting and citing EMTALA, 42 U. S. C. §§1395dd(b)(1), (e)(1)(A). https://supreme.justia.com/cases/federal/us/603/23-726/

[7] 42 U.S.C. § 1395dd(e)(3)(A)

[8] Biden-Harris Administration Reaffirms Commitment to EMTALA Enforcement (2024). HSS Press Release. https://www.hhs.gov/about/news/2024/07/02/biden-harris-administration-reaffirms-commitment-emtala-enforcement.html

[9] For example, Rapazzo, N. (2023). Emergency Room to the Courtroom: Providing Abortion Care Under EMTALA and

State Abortion Bans, 128 DICK. L. REV. 325. https://ideas.dickinsonlaw.psu.edu/dlr/vol128/iss1/9; Macklin, A., Michael, J., and Sakimoto, K. (2023). Between EMTALA and State Abortion Restrictions: The Post-Dobbs Dilemma. American Health Law. https://www.americanhealthlaw.org/content-library/connections-magazine/article/b7a49aa7-ec78-48dd-b254-be04e2db46f7/between-emtala-and-state-abortion-restrictions-the

[10] Dobbs v. Jackson Women's Health Organization, 597 U.S. 215 (2022). https://supreme.justia.com/cases/federal/us/597/19-1392/

[11] See Abortion in the United States Dashboard, KFF. https://www.kff.org/womens-health-policy/dashboard/abortion-in-the-u-s-dashboard/(Alabama, Arkansas, Idaho, Indiana, Kentucky, Louisiana, Mississippi, Oklahoma, South Dakota, Tennessee, Texas, and West Virginia.)

[12] Policy Tracker: Exceptions to State Abortion Bans and Early Gestational Limits (2025). KFF. https://www.kff.org/womens-health-policy/dashboard/exceptions-in-state-abortion-bans-and-early-gestational-limits/ (8 states have no rape or incest exception; 6 states have no health exception.)

[13] For maps categorizing states various ways, see https://states.guttmacher.org/policies/ (uses five categories of state law); https://reproductiverights.org/maps/abortion-laws-by-state/ (12 “illegal”; additional 11 “hostile”); https://www.cnn.com/us/abortion-access-restrictions-bans-us-dg/index.html (13 states ban; 7 have a 6 to 18 week limit.); https://www.kff.org/womens-health-policy/dashboard/abortion-in-the-u-s-dashboard/ (12 ban; 6 limit between 6 and 12 weeks; four states have a limit between 18 and 22 weeks gestation.)

[14] Surana, K. (2024). Afraid to Seek Care Amid Georgia’s Abortion Ban, She Stayed at Home and Died. ProPublicahttps://www.propublica.org/article/candi-miller-abortion-ban-death-georgia; https://www.propublica.org/series/life-of-the-mother

[15] Pre-labor rupture of membranes occurs when the fetal membranes rupture before the onset of labor contractions, if this occurs before 37 weeks gestation. The pre-labor rupture increases the risk of complications such as intra-amniotic infection and placental abruption. Dayal, S., Jenkins, S., Hong, P. (2024). Preterm and Term Pre-labor Rupture of Membranes (PPROM and PROM). StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK532888/

[16] Kitchener, C., et al. (2023). Two Friends Were Denied Care after Florida Banned Abortion. One Almost Died., Washington Post. https://www.washingtonpost.com/politics/2023/04/10/pprom-florida-abortion-ban

[17] Chernoby, K. and Acunto, B. (2024). Pregnancy Complications After Dobbs: The Role of EMTALA, Western Journal of Emergency Medicine. Vol. 25, https://escholarship.org/uc/item/5j81n18f

[18] Santhanam, L. (2022). How abortion bans will likely lead to more deadly infections. PBS.

https://www.pbs.org/newshour/health/how-abortion-bans-will-likely-lead-to-more-deadly-infections

[19] Surana, K., Elba, M., et al. (2024). Are Abortion Bans Across America Causing Deaths? The States That Passed Them Are Doing Little to Find Out. ProPublica. https://www.propublica.org/article/abortion-bans-deaths-state-maternal-mortality-committees#

[20] Cohen, D., Donley, G. & Rebouché, R. (2023). The New Abortion Battleground, Columbia Law Review, Vol 123, 1 (2023) https://columbialawreview.org/content/the-new-abortion-battleground/; Goodwin, M., Whelan, A., and Gostin, L. (2024) The Supreme Court and the Emergency Medical Treatment and Labor Act—A Dangerous Time for Us All. JAMA. https://jamanetwork.com/journals/jama/article-abstract/2823760

[21] Moyle v. United States, 603 U.S. ___ (2024)/United States v. Idaho, (Kagan, conc.)

[22] Goodwin, Whelan, and Gostin, 2024.

[23] Cohen, Donley, and Rebouché, 2023.

[24] Nanda, K., Lopez, L., Grimes, D., Peloggia, A., Nanda, G. (2012). Expectant care versus surgical treatment for miscarriage. Cochrane Database Syst Rev. https://pmc.ncbi.nlm.nih.gov/articles/PMC6464924/

[25] Nambiar, A., Patel S., et al. (2022). Maternal morbidity and fetal outcomes among pregnant women at 22 weeks’ gestation or less with complications in 2 Texas hospitals after legislation on abortion. Research Letters. American Journal of Obstetrics and Gynecology. https://doi.org/10.1016/j.ajog.2022.06.060; see also Simmons-Duffin, S. (2023) In Oklahoma, a Woman Was Told to Wait until She’s “crashing” for Abortion Care. NPR. https://www.npr.org/sections/health-shots/2023/04/25/1171851775/oklahoma-woman-abortion-ban-study-shows-confusion-at-hospitals

[26] Cohen, Donley, and Rebouché, 2023.

[27] Cohen, Donley, and Rebouché, 2023.

[28] 597 U.S. ___ (2022) https://supreme.justia.com/cases/federal/us/597/19-1392/

[29] Giubilini, A., Schuklenk, U., Minerva, F., & Savulescu, J. (2024). Conscientious commitment, professional obligations and abortion provision after the reversal of Roe v Wade. Journal of Medical Ethics. 50(5), 351-358. https://jme.bmj.com/content/50/5/351.abstract; additionally, some physicians wish to never perform abortions and may find that Roe v. Wade violated their own values – in such cases conscientious objection was generally available to them as long as proper care for pregnant women could be obtained.

[30] The term hard law is generally used in international human rights and means legally binding instruments rather than guidances.

[31] Constitution of the United States (Article VI, Clause 2).

[32] Schweitzer, D. (2011). The Law of Preemption. National Association of Attorneys General. https://www.naag.org/wp-content/uploads/2020/10/The-Law-of-Preemption-2d-ed.-FINAL.pdf

[33] Wyeth v. Levine. 555 U.S. at 555 (2009). https://casetext.com/case/wyeth-v-levine-2/

[34] 42 U.S.C. § 1395dd(f).

[35] Texas v. Becerra, No. 23-10246 (5th Cir. 2024). https://law.justia.com/cases/federal/appellate-courts/ca5/23-10246/23-10246-2024-01-02.html#

[36] Schweitzer, D. (2011). The Law of Preemption. National Association of Attorneys General. https://www.naag.org/wp-content/uploads/2020/10/The-Law-of-Preemption-2d-ed.-FINAL.pdf

[37] Idaho Statutes Title 18 Crimes and Punishments, Chapter 6, Abortion and Contraceptives. https://legislature.idaho.gov/statutesrules/idstat/title18/t18ch6/sect18-622/ (abortion is permissible when it is necessary to prevent the death of the woman.)

[38] Moyle v. United States. 603 U.S. ___ (2024) https://supreme.justia.com/cases/federal/us/603/23-726/

[39]Ollstein, A. (2025). Trump admin moves to drop fight over emergency abortions, reversing Biden admin stance. Politico. https://www.politico.com/news/2025/03/04/trump-emergency-abortions-00211399

[40] Moyle v. United States.

[41] Salganicoff, A., Sobel, L., Gomez, I. (2024). The Hyde Amendment and Coverage for Abortion Services Under Medicaid in the Post-Roe Era. KFF. https://www.kff.org/womens-health-policy/issue-brief/the-hyde-amendment-and-coverage-for-abortion-services-under-medicaid-in-the-post-roe-era/

[42] Tobin-Tyler, E., Brown, B. (2024). The Medical, Ethical and Legal Case Against Dual Stabilization. JAMA Intern Med. doi:10.1001/jamainternmed.2024.7078 (clinicians face difficulty if they need to equally protect fetus and patient, i.e., provide “dual stabilization”.)

[43] Clark, B. (2003). The Supremacy Clause as a Constraint on Federal Power. Geo. Wash. L. Rev. Vol. 71, 91. https://scholarship.law.gwu.edu/cgi/viewcontent.cgi?article=1474&context=faculty_publications (suggests federal law that “exceeds the scope” of congressional authority should be subject to judicial review – the Supremacy Clause refers to federal laws properly enacted with congressional authority; argues that judicial review should not be limited to review of the state law in preemption cases; it should include review of whether the federal law was properly enacted.)

[44] Dobbs v. Jackson Women's Health Organization, 597 U.S. 215 (2022). https://supreme.justia.com/cases/federal/us/597/19-1392/

[45] Executive Order 14076. Protecting Access to Reproductive Healthcare Services, Federal Register (2022). https://www.federalregister.gov/documents/2022/07/13/2022-15138/protecting-access-to-reproductive-healthcare-services

[46] Chernoby, K. and Acunto, B., 2024; Reeder, R. (2023). EMTALA Preemption of State Laws Restricting Emergency Abortions. St. Louis U. J. Health Law & Policy, Vol 17, 337. https://scholarship.law.slu.edu/jhlp/vol17/iss2/7/

[47]HHS Secretary Xavier Becerra Statement on EMTALA Enforcement. HHS archives. https://public3.pagefreezer.com/browse/HHS.gov/02-01-2024T03:56/https://www.hhs.gov/about/news/2023/05/01/hhs-secretary-xavier-becerra-statement-on-emtala-enforcement.html (Kansas has a ban after 22 weeks)

[48] Biden-Harris Administration Reaffirms Commitment to EMTALA Enforcement. HHS. https://public3.pagefreezer.com/browse/HHS.gov/02-01-2025T05:49/https://www.hhs.gov/about/news/2024/07/02/biden-harris-administration-reaffirms-commitment-emtala-enforcement.html (“In 2022, CMS issued guidance to reaffirm that EMTALA requires providers offer necessary stabilizing care for patients suffering emergency medical conditions, which might include abortion care in certain situations. Today’s letter reinforces previous letters from Secretary Becerra and Administrator Brooks-LaSure to hospital and provider associations reminding them of their obligations under EMTALA.” Press release includes letter to hospitals and other medical providers.)

[49] Donley, G. and Kelly, C. (2024). Abortion Disorientation. Duke Law Journal, Vol. 74, 1. https://scholarship.law.pitt.edu/fac_articles/587 (“Thirteen abortion-hostile states have changed the definition of abortion since Dobbs, eleven of which have added at least one definitional exclusion, most commonly for ectopic pregnancy, miscarriage, or molar pregnancy.”); Felix, M., Sobel, L., and Salganicoff, A. (2024). A Review of Exceptions in State Abortion Bans: Implications for the Provision of Abortion Services. Women’s Health Policy. KFF https://www.kff.org/womens-health-policy/issue-brief/a-review-of-exceptions-in-state-abortions-bans-implications-for-the-provision-of-abortion-services/

[50] Texas Bill 3058 https://legiscan.com/TX/bill/HB3058/2023 (enacted in 2023).

[51] Ranji, U., Salganicoff, A., Sobel, L. (2024). Dobbs-era Abortion Bans and Restrictions: Early Insights about Implications for Pregnancy Loss. Women’s Health Policy. KKF. https://www.kff.org/womens-health-policy/issue-brief/dobbs-era-abortion-bans-and-restrictions-early-insights-about-implications-for-pregnancy-loss/

[52] Donley and Kelly, 2024.

[53] Rappazzo, N. (2023). Emergency Room to the Courtroom: Providing Abortion Care under EMTALA and State Abortion Bans Comments, Dickinson Law Review, 128, 325, p. 333; Kitchener, C. (2023). Two Friends Were Denied Care after Florida Banned Abortion. One Almost Died. Washington Post. https://www.washingtonpost.com/politics/2023/04/10/pprom-florida-abortion-ban

[54] Margaret Carpenter, a New York physician was indicted and charged with prescribing abortion pills to a person in Louisiana which has a near total abortion ban and was fined $100,000.00 by a Texas judge for sending abortion pills to a person in Texas. However, the charges and sanctions are not related to the provision of emergency medical care and thus do not raise possibility of conflict with EMTALA. Elassar, A. (2025) .New York doctor indicted in Louisiana abortion case recognized as a leader in women’s reproductive health. CNN. https://www.cnn.com/2025/02/23/us/abortion-margaret-carpenter-new-york/index.html

[55] Goodman, D. (2023). Abortion Ruling Keeps Texas Doctors Afraid of Prosecution. New York Times https://www.nytimes.com/2023/12/13/us/texas-abortion-doctor-prosecution.html

[56] E.g., Rappazzo, 2023.

[57] While generally conscientious objection often concerns failing to provide (e.g., contraception or abortion), here it refers to objecting to the restrictive law and providing abortion; the history of conscientious objection shows courts would not allow it to apply to failing to pay taxes, but it can apply to failing to provide abortion care or contraception in some cases. Whether it could apply to an objection to an abortion ban is unclear.

[58] Cahn, N. and Suter, S. (2024). Crossing state lines to get an abortion is a new legal minefield, with courts to decide if there’s a right to travel. The Conversation. https://theconversation.com/crossing-state-lines-to-get-an-abortion-is-a-new-legal-minefield-with-courts-to-decide-if-theres-a-right-to-travel-238167

[59] 597 U.S. 215 (2022).

[60] Cahn and Suter, 2024.

[61] Cahn and Suter, 2024.

[62] Ranji, U., Salganicoff, A., Sobel, L. (2024). Dobbs-era Abortion Bans and Restrictions: Early Insights about Implications for Pregnancy Loss. Women’s Health Policy. KKF. https://www.kff.org/womens-health-policy/issue-brief/dobbs-era-abortion-bans-and-restrictions-early-insights-about-implications-for-pregnancy-loss/

[63] Rappazzo, 2023.

[64] Dobbs v. Jackson Women’s Health Organization, 597 U.S. 215 (2022). https://supreme.justia.com/cases/federal/us/597/19-1392/

Breyer, Sotomayor, and Kagan, dissent. (“Some women, especially women of means, will find ways around the State’s assertion of power.”)

[65] See Forouzan, K., Friedrich-Karnik, A., and Maddow-Zimit, I. (2023). The High Toll of US Abortion Bans: Nearly One in Five Patients Now Traveling Out of State for Abortion Care. Guttmacher Institute. https://www.guttmacher.org/2023/12/high-toll-us-abortion-bans-nearly-one-five-patients-now-traveling-out-state-abortion-care (There has been a stark increase in interstate travel for abortion.)

[66] Hoffman, L., Ahmed, O., Salas-Betsch, I. (2022). State Abortion Bans Will Harm Women and Families’ Economic Security Across the U.S. Center for American Progress. https://www.americanprogress.org/article/state-abortion-bans-will-harm-women-and-families-economic-security-across-the-us/ (Of 27 states with restrictive laws (the 12 most plus 15 with significant restrictions but not total bans), “[n]one guarantee paid family and medical leave. Eighteen have gender wage gaps above the national average. Twenty-two have poverty rates for women above the national average. Seventeen have poverty rates for children above the national average. Nineteen have not extended Medicaid coverage to 12 months postpartum. Only four legally require insurers to cover an extended supply of contraceptives.” Many of the states with bans have uninsured rates above the national average.)

[67] Santhanam, L. (2022). How abortion bans will likely lead to more deadly infections. PBS.

https://www.pbs.org/newshour/health/how-abortion-bans-will-likely-lead-to-more-deadly-infections (being further from care increases the risk.)

[68] Arvallo, L., Liu, H., Setty, S., et al. (2024). Deepening the Divide: Abortion Bans Further Harm Immigrant Communities Center for Law and Social Policy. https://www.clasp.org/publications/fact-sheet/deepening-divide-abortion-bans-harm-immigrants-2024/

[69] How Abortion Bans Contribute to the Cycle of Poverty. Comic Relief. https://www.comicrelief.org/posts/how-abortion-bans-contribute-to-the-cycle-of-poverty# (Black women are three times as likely to die during childbirth; Comic Relief is a 501(c)(3) aimed at alleviating poverty.)

[70] United States Census Bureau https://www.census.gov/quickfacts/fact/table/LA/PST045224; United States Census Bureau https://www.census.gov/quickfacts/fact/table/MS/RHI225223.

[71] United States Census Bureau. https://www.census.gov/quickfacts/fact/table/TX/POP010210

[72] Beauchamp, T. L., & Childress, J. F. (2013). Principles of biomedical ethics (7th ed.). Oxford University Press.

[73] Siegel, R., Mayeri, M., and Murray, M. (2023). Equal Protection In Dobbs And Beyond: How States Protect Life Inside And Outside Of The Abortion Context. Columbia Journal of Gender and Law. https://openyls.law.yale.edu/bitstream/handle/20.500.13051/18292/g.pdf?sequence=1&isAllowed=y (Court noted parties had not asserted equal protection claims.)

Balancing Innovation and Ethics

2025-02-06T23:06:20+00:00

Photo by CDC on Unsplash

Abstract

The growth of direct-to-consumer genetic testing promises insight into health risks and ancestral roots. This essay examines how at-home DNA kits empower users to detect potential genetic conditions early, create personalized health strategies, and gain a deeper understanding of their lineage. However, the essay cautions against overreliance on these tests to define identity, noting that genetic data alone may be incomplete or imprecise. Ethical questions also arise around data privacy, psychological impact, and the need for rigorous scientific validation. By exploring cost concerns and regulatory gaps, this essay underscores the importance of balancing innovation with responsible usage. Ultimately, genetic testing can offer valuable information for proactive healthcare and self-discovery with professional medical consultation and ethical safeguards.

Introduction

Interest in genetic testing surged as social media and online marketing spread awareness about kits that can help people discover their DNA makeup. Genetic testing is the sequencing of human DNA to find genetic anomalies or mutations and can be used for many purposes, including discovering ancestral lineage. Recent innovations have made DNA testing more accessible, easy, and affordable. Currently, some of the main genetic testing companies include 23andMe and AncestryDNA, where people can effortlessly find out information about their health and family history. While genetic testing kits can improve quality of life by providing insight into health problems and helping people understand their lineage, they should not dictate identity or replace consulting medical experts.

How Genetic Testing Works

Genetic testing kits create an easy process for people to test their DNA in the comfort of their homes. Usually costing from $59 to $99, most DNA test kits include a small container for customers to spit in or a swab to collect cells from the inside of their cheeks. Then, the consumer sends the kit to a lab, where scientists isolate their cells and analyze their genes, comparing the gene alleles to those in the company database.[1] According to MIT Technology Review, “By the start of 2019, more than 26 million consumers had added their DNA to four leading commercial ancestry and health databases.”[2] The contribution of data from over 26 million people enhances the accuracy of genetic testing, as a larger dataset allows for more precise analysis and insight. After the lab receives the sample, scientists use DNA sequencing, the process of determining the sequence of nucleotides, to map out the genetics of a person. DNA nucleotides, the organic molecules that form DNA, contain four bases: adenine (A), cytosine (C), thymine (T), and guanine (G). These four bases make up the instructions that tell the body which molecules to create, allowing scientists to identify specific health and lineage traits.

Health Benefits of Genetic Testing

A key benefit of genetic testing is that it helps people understand and gain early awareness of possible health problems. From DNA testing kits, individuals can learn whether a genetic condition runs in their family before symptoms appear. Mayo Clinic points out, “If you have symptoms of a disease that may be caused by genetic changes, sometimes called mutated genes, genetic testing can reveal if you have the suspected disorder. For example, genetic testing may be used to confirm a diagnosis of cystic fibrosis or Huntington's disease.”[3] Genetic testing can also reveal illnesses that may only be caught on the genetic level. For instance, Huntington's disease, an inherited condition in which nerve cells in the brain break down over time, can only be detected through DNA testing. By using a genetic testing kit, people can learn if they carry inherited illnesses such as Huntington's disease and cystic fibrosis sooner and make adjustments to their lifestyle to improve their health.

A person receiving genetic testing can potentially prevent or treat health issues earlier and save their lives. Genetic testing can help individuals identify whether they carry an increased risk of cancer, Alzheimer's, or other diseases, and find the safest and most effective treatment for them based on their DNA.[4] Advancements in technology, such as genetic testing, have made healthcare more personalized, resulting in greater accuracy and more efficient treatments. More than a third of home testers consult a medical professional and half share their results with others, an important step in understanding and decoding the results from genetic tests.[5]

In enabling individuals to gain insight into their health predispositions, genetic testing encourages behavioral adjustments and the adoption of healthier lifestyle habits. For example, with dieting, many people lose motivation to continue nutritious eating habits and exercise when they do not notice instant results. However, genetic testing can help people stay committed by providing confidence that their efforts align with their genetic profile and will yield results over time. Observing tangible results and adding other incentives will push users to continue improving themselves.

Genetic Testing and Personal Identity

Although genetic tests can help individuals trace their lineage, the results should not be used to form their identity. Each genetic testing company maintains a genetic database used to decipher ancestral history but sometimes lacks all the data needed to create a fully accurate reading. The American Journal of Human Genetics conducted a field study on how people view their identity after taking DNA testing kits. The study revealed that companies provided underdeveloped results, stating, “pie charts showing percentages of ancestry are grossly oversimplified, revealing a probability rather than a definitive answer. They are based on science that is meant to address questions at the population level, not about specific individuals.”[6] Genetic testing companies predominantly rely on the data that their consumers send, with databases differing for each business. Companies base their results on probability and population-level statistics, grouping people based on similar genetic makeup. For instance, companies possess more data on Caucasians than on Native Americans due to the larger population size of Caucasians and their substantial representation within the consumer base. Even DNA testing company 23andMe states, “Currently 23andMe has several features that can reveal genetic evidence of Indigenous American ancestry, although they are not considered a confirmatory test or proof of such ancestry in a legal context.”[7] These companies cannot fully confirm the accuracy of their tests in finding ancestral information and therefore should not be completely relied upon for discovering self-identity.

Nevertheless, people use DNA kits to reaffirm their beliefs about their identity. Eduardo, a Mexican-American man who initially identified as White Hispanic with Native American ancestry, discovered he was also part Jewish and Celtic, but later rejected his Celtic identity, explaining, “I can pass for a Jew, there’s no question about it. There’s no way I could pass for a Celtic, because I’m dark, and sort of fat, short.”[8] His reaction shows how genetic tests can reinforce what consumers want to believe. Many times, people pick the truths they want from their tests while rejecting others, just as Eduardo dismissed his Celtic ancestry based on his physical appearance.

Additionally, a multitude of factors beyond genetics, including family and culture, influence identity. Basing heritage purely on genetics ignores all other aspects of an individual’s identity. In the Native American community, many feel threatened by scientists telling them where they “really” originate from. Kim Tallbear, a member of the Sisseton-Wahpeton Oyate tribe, a researcher at the University of Texas at Austin, and the author of Native American DNA: Tribal Belonging and the False Promise of Genetic Science, asks, “We know who we are as a people, as an indigenous people, why would we be so interested in where scientists think our genetic ancestors came from?”[9] This sentiment shows how identity is more than genetics. Identity is also formed by childhood, environment, close relationships, and culture of a person. Ultimately, a genetic test should not confirm what makes up a person, especially since companies require more research to increase the accuracy of their results. Genetics constitutes a very small part of self-identity, therefore remaining unreliable for capturing the full existence of an individual.

Accuracy Limitations and the Need for Medical Consultation

Genetic testing kits may contain inaccuracies and should not replace the consultation of medical experts. For instance, people should not fully rely on this technology for health information due to their inherent inaccuracy. The Food and Drug Administration (FDA) did not completely approve the use of genetic kits for health purposes; “in general, direct-to-consumer tests for non-medical, general wellness, or low risk medical purposes are not reviewed by the FDA before they are offered.”[10] Although the FDA does not approve some genetic testing kits for health information, they endorse companies such as 23andMe based on reliability, accuracy, and consumer comprehension.[11] The FDA states that “Results from this test should be confirmed with independent pharmacogenetic testing before making any medical decisions.”[12] These tests should help inform, not dictate, discussions with a healthcare provider.

Cost and Privacy Issues

Opponents of DNA testing companies worry about the price of kits and privacy issues. Many adversaries of genetic kits claim that the cost of the technology is too expensive. However, most insurance companies will cover the cost of genetic testing, and different types of reliable kits vary in price, starting as low as $59. Opponents also point out privacy concerns and insufficient consumer data protection. While HIPAA (Health Insurance Portability and Accountability Act) and GINA (the Genetic Information Nondiscrimination Act of 2008) protect patient privacy, they are limited. The HIPAA Privacy Rule aims to protect the privacy of individually identifiable health information. HIPAA was designed to improve the portability of health data for administrative ease – companies outside of insurance and the delivery of health care are largely excluded from its requirements. It does not apply to companies unrelated to health care.[13] GINA is designed to prevent discrimination. Insurers and employers must adhere to its requirements. Despite their limitations, these federal acts, in addition to state-level legislation and industry initiatives like the Coalition for Genetic Data Protection, mark significant progress in addressing genetic privacy concerns.

Psychological Effects

Some may feel that genetic testing kits can carry detrimental psychological effects. Tests that reveal an increased risk of various genetic diseases may induce panic or anxiety in people. In medical venues, clinicians are more likely to address the emotional responses to reports, which is an essential part of delivering responsible genetic services. However, as ancestry and heritage companies do not deliver medical care, they are unlikely to properly emotionally support their customers. People need all the information necessary to make informed decisions about their health. Individuals should also consult a medical professional regarding their test results to help them better understand these outcomes. Although test results can elicit surprise and anxiety in consumers, they can also provide relief. Understanding genetic conditions earlier reduces uncertainty and helps a person take steps to avoid possible health issues.

Conclusion

In conclusion, genetic testing kits can enhance the quality of life by providing insight into health problems and ancestral lineage but should not dictate identity or substitute consulting medical experts. Opponents of genetic testing kits emphasize the high cost, privacy issues, and psychological effects of commercial DNA tests. The March 2025 bankruptcy filing by 23andMe highlights vulnerabilities in the genetic testing industry, raising concerns about the security of genetic data held by commercial entities. However, genetic testing provides people with a deeper understanding and awareness of potential health issues, enabling them to prevent and prepare for illnesses. These kits also offer reassurance by reducing the sense of uncertainty. Furthermore, publicly available genetic testing represents a remarkable innovation that continues to advance in both convenience and accuracy. In the future, genetic testing will play a pivotal role in health care by enabling tailored prevention strategies, early interventions, and personalized treatments, while addressing ethical and privacy concerns.

[1] Hugo, Kristin. “How Do DNA Test Kits Work?” Newsweek, Newsweek, 6 July 2018, www.newsweek.com/how-do-dna-test-kits-work-difference-between-birthplace-and-heritage-1011066.

[2] Regalado, Antonio. “More than 26 Million People Have Taken an At-Home Ancestry Test.” MIT Technology Review, MIT Technology Review, 22 Aug. 2024, www.technologyreview.com/2019/02/11/103446/more-than-26-million-people-have-taken-an-at-home-ancestry-test/.

[3] “Genetic Testing.” Mayo Clinic, Mayo Foundation for Medical Education and Research, 14 Apr. 2020, www.mayoclinic.org/tests-procedures/genetic-testing/about/pac-20384827.

[4] Stein, Rob. “Results of At-Home Genetic Tests for Health Can Be Hard to Interpret.” NPR, NPR, 18 June 2018, www.npr.org/sections/health-shots/2018/06/18/609750963/results-of-at-home-genetic-tests-for-health-can-be-hard-to-interpret.

[5] Stewart, Kelly F., et al. “Behavioural changes, sharing behaviour and psychological responses after receiving direct-to-consumer genetic test results: a systematic review and meta-analysis.” Journal of Community Genetics, vol. 10, no. 2, 2 Jan. 2018, pp. 321–321, https://doi.org/10.1007/s12687-017-0353-1.

[6] Wendy D. Roth. “Genetic Ancestry Tests Don’t Change Your Identity, but You Might.” The Conversation, 19 Dec. 2024, theconversation.com/genetic-ancestry-tests-dont-change-your-identity-but-you-might-98663.

[7] “Can 23andMe Identify Indigenous American Ancestry? – 23andme Customer Care.” 23andme, customercare.23andme.com/hc/en-us/articles/202906870-Can-23andMe-Identify-Indigenous-American-Ancestry.

[8] Roth.

[9] Eveleth, Rose. “Genetic Testing and Tribal Identity.” The Atlantic, Atlantic Media Company, 27 Jan. 2015, www.theatlantic.com/technology/archive/2015/01/the-cultural-limitations-of-genetic-testing/384740/.

[10] Rotshenker-Olshinka, Keren, and Michael H. Dahan. “Fertility Care in the era of commercial direct-to-consumer home DNA kits: Issues to ponder.” Journal of Assisted Reproduction and Genetics, vol. 37, no. 3, 26 Feb. 2020, pp. 689–692, https://doi.org/10.1007/s10815-020-01711-y.

[11] Center for Drug Evaluation and Research. “Direct-to-Consumer Tests.” U.S. Food and Drug Administration, FDA, www.fda.gov/medical-devices/vitro-diagnostics/direct-consumer-tests#list.

[12] Office of the Commissioner. “FDA Authorizes First Direct-to-Consumer Test for Detecting Genetic Variants That May Be Associated with Medication Metabolism.” U.S. Food and Drug Administration, FDA, www.fda.gov/news-events/press-announcements/fda-authorizes-first-direct-consumer-test-detecting-genetic-variants-may-be-associated-medication.

[13] Clayton, Ellen Wright, et al. “The Law of Genetic Privacy: Applications, Implications, and Limitations.” Journal of Law and the Biosciences, vol. 6, no. 1, 14 May 2019, pp. 1–36, https://doi.org/10.1093/jlb/lsz007.

Medical Assistance in Dying for Persons Suffering Solely from Mental Illness in Canada

2024-11-12T13:39:23+00:00

Abstract

While Medical Assistance in Dying (MAiD) has been legalized in Canada since 2016, it still excludes eligibility for persons who have mental illness as a sole underlying medical condition. This temporary exclusion was set to expire on March 17th, 2024, but was set 3 years further back by the Government of Canada to March 17th, 2027. This paper presents a critical appraisal of the case of MAiD for individuals with mental illness as the sole underlying medical condition through the analysis of three ethical theories: principlism, deontology, and utilitarianism. Through evidence and discussion, it will be demonstrated that MAiD, in this context, may be ethically justifiable on the grounds of upholding human rights, protecting dignity, and minimizing suffering.

Introduction

In June of 2016, Medical Assistance in Dying (MAiD) was legalized in Canada.^[1] Throughout the first six years, a temporary exclusion of eligibility for persons suffering solely from mental illness was extended.^[2] The exclusion of mental illness as a sole underlying medical condition was set to expire on March 17, 2024.^[3] However, on February 1, 2024, just over a month before the set expiration, the Government of Canada once again extended the exclusion, this time setting it back three years to March 17, 2027. There are currently several countries that allow MAiD for mental illness, including Belgium, the Netherlands, and Luxembourg.^[4] Some countries, like Spain,^[5] do not give specific guidance, leaving the matter under discussion by ethicists and courts. In these countries, there are specific (although different) requirements for the process; overall, for mental illness, the illness must be verifiable and not simply related to a perception of satisfaction with the length of life.

This extension ignited discussion on whether MAiD for persons who have mental illness as a sole underlying medical condition in Canada is ethically acceptable. As a complex, multi-faceted, and interdisciplinary issue, ethicists assessing MAiD must take into account various moral obligations and considerations. This paper analyses MAiD in this context through the application of three ethical theories: principlism, deontology, and utilitarianism. This paper concludes that, based on the current evidence and knowledge of this developing situation, MAiD for persons with mental illness in Canada may be ethically justified on the grounds of upholding human rights, labour obligations, and dignity. Through the exploration of research and discussions, it will be demonstrated that society at large ought to protect liberty and act towards relieving suffering, thereby supporting the potential eligibility of MAiD for persons who have mental illness.

Principlism: The Capacity and Ability to Assess and Decide for One’s Own Life

Principlism is the application of four principles: autonomy, beneficence, non-maleficence, and justice. Principlism supports permitting MAiD for mental illness due to the importance of autonomy in decision-making, equitable and just practices for MAiD assessors, and reducing suffering for patients and their family member(s) and/or friend(s).

Carter v. Canada, the Canadian Supreme Court ruling of 2015—which changed Canadian law to allow for MAiD—held that the prohibition of MAiD infringed on Canadians’ right to “life, liberty, and the security of the person.” In a unanimous decision, the Supreme Court of Canada decided that the criminal prohibition of MAiD violates the Canadian Charter of Rights and Freedoms.^[6] The Court concluded that the criminal law prohibiting MAiD interfered with people’s autonomy and dignity, which are protected by the rights of liberty and security of the person.^[7] The ruling emphasized that Canada’s constitution reflects the fundamental importance of individual autonomy in personal decision-making.

Research provides evidence that MAiD improves autonomy: A study among psychiatric patients found that 8 of 48 psychiatric patients said the mere option of accessing MAiD was enough to assess their future options for living wholly.^[8] These findings complement a study entailing interviews with 30 adults who have mental illness, which emphasized that the ability to access MAiD allows individuals to analyze their quality of life, envision their desired future, and make decisions accordingly.^[9] Although not all participants agreed that mental illness as the only underlying medical condition was appropriate for MAiD eligibility, many participants agreed that patient autonomy in decision-making was paramount and should be respected.

However, autonomy as an ethical principle does not immediately grant all persons with mental illness the option to access MAiD. There are multiple eligibility criteria for those who wish to receive MAiD, which still must be approved and assessed. Currently, eligibility criteria for MAiD states that individuals must “give informed consent to receive MAiD, meaning that the person has consented to receiving MAiD after they have received all information needed to make this decision.”^[10] Consent requires capability or capacity, which is the ability to understand relevant information, appreciate its potential consequences, and make an informed decision for oneself.^[11] Like for many other diseases, disabilities, and conditions, patient capability is determined on a case-by-case basis.^[12] Given the stigma surrounding those struggling with mental health, this thorough case-by-case examination of an individual patient’s capability and capacity without prejudice or partiality should lead to equitable and fair treatment. Without appropriate testing, those with mental illness could be wrongly stripped of their decision-making power.

Arguments against MAiD for those with mental illness have raised concerns about the potential for individuals to harm themselves and others. A survey of MAiD providers demonstrated that physicians believed that the bereavement experience following MAiD is challenging and profoundly distinct and that bereavement support for all members involved should be required.^[13]

However, while watching one die (of MAiD) may cause harm to their families, friends, and support system at large, it is also important to recognize that watching someone suffer and struggle through their mental health journey also poses significant harm. Qualitative studies in Ontario, Canada, have interviewed family members of persons with mental illness as a sole medical condition, and interviewees shared that witnessing the illness and its impacts on their close one's lives was a very difficult experience.^[14] As it relates to MAiD, participants emphasized that those living with mental illness are in the best position to understand their own pain and suffering and, in turn, make their own decisions about relief.^[15] In an interview, a MAiD provider stated that MAiD may provide less suffering and more peace, and that, although it “depends on the family, ... usually the family is more prepared and at peace.”^[16]

On the contrary, a person who has mental illness may perceive choosing MAiD as beneficial to their family member(s) and/or friend(s). Among those who died by MAiD in 2021, 35.7 percent reported that they perceived themselves as a burden on their family and friends.^[17] While some authors report their concerns regarding such social burden as a potential driving factor for MAiD requests, others report that there are other additional burdens associated with requesting MAiD that may be financial, societal, and personal.^[18] As such, the extension of MAiD eligibility to those with mental illness will likely only allow a small number of people to be granted MAiD.^[19] Many others will be diverted to appropriate services and treatments.

Patients’ decision to choose MAID noted their ability to make choices about their own care, reflecting the value of autonomy.^[20] Although it is difficult to determine what is good for families in individual cases, MAiD presents an option that is both beneficent and non-maleficent. Therefore, these arguments satisfy the principles which do not necessarily conflict with MAiD.

Deontology: The Duty to Recognize Vulnerability and Relieve Suffering

The argument here begins with the fundamental focus of deontology—that moral duty lies in an action rather than in its consequences.

Further discussion is required to analyze the impact of MAiD on healthcare workers. The Canadian Medical Association (CMA) Code of Ethics and Professionalism requires physicians to abide by virtues, commitments, and responsibilities in delivering health care and service.^[21] The code states that “a compassionate physician recognizes suffering and vulnerability, … and alleviate[s] the patient’s suffering.”^[22]

In the context of MAiD for persons with mental illness as a sole underlying medical condition, vulnerabilities could be wide in range. Many Canadians are concerned with the interaction between mental health and other social determinants of health, such as the lack of medical, disability, financial, housing, and social support and resources.^[23] As a result, another layer to the ethical issue arises: Does permitting MAiD for mental illness treat the symptoms of the issue rather than the root problem itself (social, economic, and systemic inequities)? Some argue against MAiD, stating that the nation should first focus on developing better quality care and service.^[24] Others support MAiD as a potential harm reduction approach, given that most of these unjust conditions require a higher level of long-term structural and public policy overhaul.^[25]

The CMA Code also calls upon physicians to recognize and alleviate patients’ suffering. Some argue that while physicians and medical professionals do work to relieve suffering, they are trained to do so through a primary care-based diagnose-and-treat approach.^[26] Studies that have captured Canadian physicians’ experiences providing MAiD report that, although physicians stated that the work was rewarding, it came with many challenges, including strained relationships with coworkers, increased workload, and inadequate compensation.^[27] Physicians report that a part of the problem is that MAiD rules are written by lawyers and experts who are removed from its reality in medical practice. As a result, there is a lack of clarity surrounding practice norms and a lack of support for physicians.^[28] Thus, while healthcare practitioners have a duty to relieve patients’ suffering, they should feel adequately trained and supported in doing so.

If physicians and healthcare professionals recognize vulnerability and relieve suffering, then they should act accordingly, regardless of potential associations or outcomes. Making persons with mental illness eligible for MAiD ensures that treatment to relieve their suffering is available. However, it is imperative that there are sufficient resources and support available to healthcare professionals to ensure that they feel prepared and supported to provide MAiD, should they wish to do so.

Utilitarianism: Minimizing Intolerable Suffering and Dying with Dignity

Overall, utilitarianism is largely concerned with the greatest happiness principle—to increase the amount of happiness for the greatest number of people. So far, this paper has analyzed individual, family, and practitioner-based ethical considerations. But if MAiD were to be extended to those with mental illness as a singular underlying medical condition, what implications would this have for the world and society at large?

There is a global drive toward authorizing organized ending of life, with an increasing number of countries legalizing MAiD.^[29] The medical system is generally seen as a safe and appropriate system to carry out MAiD, especially when suicide and self-harm are regarded as “alternatives.” Yet despite these worldwide efforts, many argue through the theory of utilitarianism that the inability to see long-term consequences renders MAiD a premature solution, particularly for those who are unable or unwilling to seek other forms of potentially healing treatment or for those who may undergo MAiD only for a technological innovation or biomedical advancement to later come along as a potential cure.^[30] While it is true that MAiD does not prevent these “premature deaths,” it is also true that it does not claim to.^[31] MAiD provides an option to alleviate intolerable suffering. Some individuals with severe mental illness do describe their condition as intolerable suffering.

MAiD is seen as an option to minimize suffering. It can also be seen as a way to die with dignity and relief.^[32] While predicting outcomes is difficult, extending MAiD eligibility for persons experiencing mental illness does not undermine its ability to end suffering. It allows eligible individuals to take charge of their health, their life, and their future.

Conclusion

Based on the current evidence, allowing MAiD for persons with mental illness as their sole underlying medical condition presents as an ethically justifiable action. The right to self-determination and fair accessibility demonstrates that there is more harm done by prohibiting MAiD for mental illness than allowing it. Such liberty is a right, and in the context of relieving suffering, it is a duty that healthcare workers must uphold, although the ability to opt out of providing MAiD is well established. Thus, to recognize vulnerability and relieve suffering means to provide methods, such as MAiD, for those deeply impacted by mental illness. These justifications stand at both the individual level and for society at large.

Nevertheless, it remains imperative to take an upstream approach that addresses the social determinants of health and aims to prevent mental illness and promote long-term, beneficial social change for those suffering, struggling, and vulnerable in our communities.

[1] Jaro Kotalik and David W. Shannon, Medical Assistance in Dying (MAID) in Canada Key Multidisciplinary Perspectives, 1st ed. 2023., The International Library of Bioethics, 104 (Cham: Springer International Publishing, 2023), https://doi.org/10.1007/978-3-031-30002-8.

[2] Department of Justice Government of Canada, “Canada’s Medical Assistance in Dying (MAID) Law,” February 21, 2024, https://www.justice.gc.ca/eng/cj-jp/ad-am/bk-di.html.

[3] Health Canada, “Final Report of the Expert Panel on MAiD and Mental Illness,” transparency - other, May 13, 2022, https://www.canada.ca/en/health-canada/corporate/about-health-canada/public-engagement/external-advisory-bodies/expert-panel-maid-mental-illness/final-report-expert-panel-maid-mental-illness.html.

[4] Federal Public Service (FPS) Health Belgium, “Federal Commission for the Control and Evaluation of Euthanasia,” n.d., https://consultativebodies.health.belgium.be/en/advisory-and-consultative-bodies/federal-commission-control-and-evaluation-euthanasia.; Government of Netherlands, “Is Euthanasia Allowed in the Netherlands?,” n.d., https://www.government.nl/topics/euthanasia/is-euthanasia-allowed.; “Information on Requesting Euthanasia or Assisted Suicide,” n.d., https://guichet.public.lu/en/citoyens/sante/fin-vie/euthanasie/euthanasie-assistance-suicide.html.

[5] Luis Espericueta, First official report on euthanasia in Spain: A comparison with the Canadian and New Zealand experiences, Medicina Clínica (English Edition), Volume 161, Issue 10, 2023, Pages 445-447,

ISSN 2387-0206, https://doi.org/10.1016/j.medcle.2023.06.021.

[6] Government of Canada, “The Canadian Charter of Rights and Freedoms,” March 15, 2021, https://www.justice.gc.ca/eng/csj-sjc/rfc-dlc/ccrf-ccdl/.

[7] Supreme Court of Canada, “Carter v. Canada,” Constitutional Law, 2015, https://scc-csc.lexum.com/scc-csc/scc-csc/en/item/14637/index.do.; Kotalik and Shannon, Medical Assistance in Dying (MAID) in Canada Key Multidisciplinary Perspectives.

[8] Karandeep Sonu Gaind, “What Does ‘Irremediability’ in Mental Illness Mean?,” Canadian Journal of Psychiatry. Revue Canadienne de Psychiatrie 65, no. 9 (September 2020): 604–6, https://doi.org/10.1177/0706743720928656; Lieve Thienpont et al., “Euthanasia Requests, Procedures and Outcomes for 100 Belgian Patients Suffering from Psychiatric Disorders: A Retrospective, Descriptive Study,” BMJ Open 5, no. 7 (July 27, 2015): e007454, https://doi.org/10.1136/bmjopen-2014-007454.

[9] Hamer Bastidas-Bilbao et al., “Walking Alongside: Views of Family Members on Medical Assistance in Dying for Mental Illness as the Sole Underlying Medical Condition,” Qualitative Health Research 33 (September 29, 2023), https://doi.org/10.1177/10497323231197365.

[10] Government of Canada, “Canada’s Medical Assistance in Dying (MAID) Law.”

[11] Commission sur les soins de fin de vie, “Les conditions de l’admissibilité à l’aide médicale à mourir au Québec: la constance dans l’évolution de la loi concernant les soins de fin de vie,” June 9, 2023, https://csfv.gouv.qc.ca/ fileadmin/docs/autres_rapports/csfv_lcsfv_conditions_ amm_2023-06-29.pdf.; Trudo Lemmens, “When Death Becomes Therapy: Canada’s Troubling Normalization of Health Care Provider Ending of Life,” The American Journal of Bioethics 23, no. 11 (November 2, 2023): 79–84, https://doi.org/10.1080/15265161.2023.2265265.

[12] Justine Dembo, Udo Schuklenk, and Jonathan Reggler, “‘For Their Own Good’: A Response to Popular Arguments Against Permitting Medical Assistance in Dying (MAID) Where Mental Illness Is the Sole Underlying Condition,” Canadian Journal of Psychiatry. Revue Canadienne De Psychiatrie 63, no. 7 (July 2018): 451–56, https://doi.org/10.1177/0706743718766055.

[13] Konia Trouton et al., “Attitudes and Expectations Regarding Bereavement Support for Patients, Family Members, and Friends: Findings from a Survey of MAID Providers,” British Columbia Medical Journal 62, no. 1 (2020).

[14] Bastidas-Bilbao et al., “Walking Alongside.”

[15] Bastidas-Bilbao et al.

[16] Trouton et al., “Attitudes and Expectations Regarding Bereavement Support for Patients, Family Members, and Friends: Findings from a Survey of MAID Providers,” 2020.

[17] Ramona Coelho et al., “The Realities of Medical Assistance in Dying in Canada,” Palliative & Supportive Care 21, no. 5 (October 2023): 871–78, https://doi.org/10.1017/S1478951523001025; Health Canada, “Third Annual Report on Medical Assistance in Dying in Canada 2021,” report on plans and priorities;transparency - other, July 26, 2022, https://www.canada.ca/en/health-canada/services/publications/health-system-services/annual-report-medical-assistance-dying-2021.html; Lemmens, “When Death Becomes Therapy.”

[18] Coelho et al., “The Realities of Medical Assistance in Dying in Canada,” October 2023.; Bastidas-Bilbao et al., “Walking Alongside.”

[19] Olivia Stefanovich, “Opposition Parties Call for Indefinite Pause to MAID Expansion for Mental Illness | CBC News,” Canadian Broadcasting Corporation, January 28, 2024, https://www.cbc.ca/news/politics/special-joint-committee-maid-mental-illness-report-1.7095679; Benjamin Lopez Steven, “Number of Assisted Deaths Jumped More than 30 per Cent in 2022, Report Says | CBC News,” Canadian Broadcasting Corporation, October 27, 2023, https://www.cbc.ca/news/politics/maid-canada-report-2022-1.7009704.

[20] Hamer Bastidas-Bilbao et al., “Searching for Relief from Suffering: A Patient-Oriented Qualitative Study on Medical Assistance in Dying for Mental Illness as the Sole Underlying Medical Condition,” Social Science & Medicine 331 (August 1, 2023): 116075, https://doi.org/10.1016/j.socscimed.2023.116075.

[21] Canadian Medical Association, “Canadian Medical Association Code of Ethics and Professionalism” (Canada: Canadian Medical Association, December 8, 2018), https://policybase.cma.ca/link/policy13937.

[22] Canadian Medical Association.

[23] Coelho et al., “The Realities of Medical Assistance in Dying in Canada,” October 2023; Stefanovich, “Opposition Parties Call for Indefinite Pause to MAID Expansion for Mental Illness | CBC News.”

[24] John Paul Tasker, “Liberal Government Promoting a ‘culture of Death’ with Medical Assistance in Dying Law, Conservative MP Says | CBC News,” Canadian Broadcasting Corporation, March 6, 2023, https://www.cbc.ca/news/politics/culture-of-death-medical-assistance-in-dying-mental-illness-1.6769504.

[25] Coelho et al., “The Realities of Medical Assistance in Dying in Canada,” October 2023; Kayla Wiebe and Amy Mullin, “Choosing Death in Unjust Conditions: Hope, Autonomy and Harm Reduction,” Journal of Medical Ethics, April 26, 2023, https://doi.org/10.1136/jme-2022-108871.

[26] Ramona Coelho et al., “The Realities of Medical Assistance in Dying in Canada,” Palliative & Supportive Care 21, no. 5 (October 2023): 871–78, https://doi.org/10.1017/S1478951523001025.

[27] Konia Trouton et al., “Attitudes and Expectations Regarding Bereavement Support for Patients, Family Members, and Friends: Findings from a Survey of MAID Providers,” British Columbia Medical Journal 62, no. 1 (2020), https://bcmj.org/articles/attitudes-and-expectations-regarding-bereavement-support-patients-family-members-and.; William Robert Nielsen, “MAiD in Canada: Ethical Considerations in Medical Assistance in Dying,” Canadian Journal of Bioethics 4, no. 2 (December 9, 2021): 93–98, https://doi.org/10.7202/1084456ar.

[28] Coelho et al., “The Realities of Medical Assistance in Dying in Canada,” October 2023.

[29] Lemmens, “When Death Becomes Therapy.”

[30] William Robert Nielsen, “MAiD in Canada: Ethical Considerations in Medical Assistance in Dying,” Canadian Journal of Bioethics 4, no. 2 (December 1, 2021): 93–98, https://doi.org/10.7202/1084456ar.

[31] Steven, “Number of Assisted Deaths Jumped More than 30 per Cent in 2022, Report Says | CBC News.”

[32] A. Plaisance et al., “Quebec Population Highly Supportive of Extending Medical Aid in Dying to Incapacitated Persons and People Suffering Only from a Mental Illness: Content Analysis of Attitudes and Representations,” Ethics, Medicine and Public Health 21 (April 1, 2022): 100759, https://doi.org/10.1016/j.jemep.2022.100759.

Trans Experiences In Healthcare

2024-11-12T13:37:27+00:00

Abstract

Healthcare providers should advocate for human and civil rights. They ought to recognize injustices that unfairly disadvantage certain groups of people and work to improve broader conditions that affect health. Healthcare systems have historically undervalued and even excluded certain voices from the creation of an evidence base for care, furthering health disparities for members of these groups. This is a form of testimonial injustice. Trans people experience a particular form of testimonial injustice in healthcare settings when evidence and expertise related to their lived experience are excluded from consideration, as was the case with the 2024 Cass Review. Such exclusion can lead to mistreatment and harm. Providers must be vigilant in recognizing and addressing testimonial injustice against trans patients and the health disparities it can cause.

Introduction

Trans individuals (people who identify as transgender, transsexual, or whose gender identity is different from the sex they were assigned at birth) face many barriers to health care. The lack of competent, knowledgeable providers poses a significant barrier to gender-affirming care, as well as other forms of everyday health care for trans people.^[1] Addressing this challenge requires health professionals to actively oppose structures that perpetuate epistemic injustice, which Miranda Fricker defines as “wrong done to someone specifically in their capacity as a knower.” Testimonial injustice (a kind of epistemic injustice) undermines collective understanding of marginalized perspectives through systemic misrepresentation or dismissal of marginalized individuals’ experiences or contributions.^[2] Testimonial injustice contributes to unjust conditions for accessing care and results in poorer health outcomes for transgender individuals. As professionals committed to ethical and equitable patient treatment, we believe it is imperative that healthcare providers recognize and carefully consider the experiences and expertise of trans people in order to address injustices experienced by trans people in healthcare settings. Through an analysis of the Cass Review, we demonstrate how a flawed interpretation of available evidence and the dismissal of trans testimonies generates an injustice that results in significant and unwarranted restrictions on gender-affirming care.

Testimonial Injustice

Trans people regularly experience testimonial injustice in health care. It occurs when providers inappropriately discount their patients’ accounts — for example, by refusing to believe patients when they say that they are trans or gender non-conforming. This results in prejudiced assumptions about health behaviors or needs, bias and stereotyping that influence clinical judgment, and harm in the form of worse physical and mental health outcomes.^[3]

Testimonial injustice takes several pernicious forms. For example, a Black woman whose reports of high postpartum pain are disregarded by her providers because of her Blackness has suffered testimonial injustice when she receives lower doses of pain medication compared to other postpartum patients at the same hospital.^[4] Her attestation of pain, an experience at once personal and universal, has been inappropriately regarded as insufficiently credible, resulting in harmful and unequal postpartum pain management.

Testimonial injustice harms the physical, mental, and social well-being of trans people, worsening health outcomes caused by systemic barriers and discriminatory practices. Negative healthcare experiences, along with mistreatment from providers, lead to disproportionately high rates of depression, psychological distress, and suicidal ideation among trans patients.^[5] These harmful interactions lead to lower healthcare utilization and delayed treatment. Trans people are also less likely to receive preventative cancer screenings, including for cervical, breast, and colorectal cancers.^[6] These disparities, compounded by the accumulation of daily stress from discrimination, contribute to not only an increased risk of cancer but also to worse cancer outcomes.^[7] Trans people are diagnosed at later stages, they are less likely to receive treatment for cancer and also have higher mortality rates for certain cancers.^[8] Similar disparities are seen in cardiovascular health;^[9] trans people are at greater risk for heart attacks.^[10] They are also more likely to have multiple concurrent chronic conditions, including coronary heart disease, asthma, arthritis, diabetes, cancer, stroke, kidney disease, etc.^[11]

Clearly, there are significant and life-threatening gaps in care for trans people. These disparities result in worsened health outcomes, increased mistrust, and preventable deaths. A key factor in addressing these disparities is awareness of testimonial injustice: providers must recognize how their personal interactions with trans individuals, in the context of broader systemic barriers to adequate healthcare, can contribute to harmful practices and negligent care. In what follows, we argue that testimonial injustice contributes to trans peoples’ well-documented experiences of healthcare discrimination.

The Cass Review

The 2024 Cass Review (“the Review”), an independent review of gender treatment for trans youth commissioned by the National Health Service (NHS) in England, has caused significant harm to young trans people in the UK. The NHS ordered the Review, comprising of six systematic reviews, after concerns arose regarding an increase in referrals for trans care associated with doubts about its scientific rationale. The Review’s recommendations stem from a narrow reading of the evidence base for gender-affirming care and have resulted in significant restrictions on puberty-suppressing medication, hormone therapy, and care availability for trans youth in the UK.^[12]

Professional organizations and transgender health providers have widely criticized the Review’s findings. They assert that it contains many errors that “conflict with well-established norms of clinical research and evidence-based health care” and “raise serious concern about the scientific integrity of critical elements of the report’s process and recommendations.”^[13] For example, the Review claims that referrals for trans care have grown exponentially (even while most transgender adolescents in the UK are not referred for care, and an expert critique of the Review led by the Integrity Project at Yale University found that the exponential growth is likely the result of double-counting referrals). This critique observes that the Review makes the provision of gender-affirming care appear “rushed, careless, and common,”^[14] despite a waiting time of over two years for the assessment. Further, of the patients seen during the Review’s period of study, only 27 percent were referred to endocrinology for consideration of medical intervention.

The Review includes an unsubstantiated concern that early supportive interventions such as puberty blockers necessarily result in irreversible effects. Puberty blockers, or gonadotropin releasing analogue (GnRHa), cause a temporary downregulation of the production of estrogen or testosterone when used during early puberty.^[15] When prescribed for cis (people whose gender identity corresponds to the sex they were assigned at birth) and trans youth alike, they pause puberty (i.e., delaying development of secondary sex characteristics) reversibly. Reproductive function is restored if endogenous puberty resumes.^[16] This therapy alone does not typically cause permanent physical changes, and when treatment is stopped, puberty resumes.^[17] GnRHa medications are commonly used in treatment for precocious puberty in cisgender youth without impairing reproductive development or function, and research has demonstrated that puberty was continued within one year after GnRHa discontinuation.^[18]^,[19] Long-acting GnRHa usage is also routinely seen in fertility preservation as the only medical option to preserve ovarian function in patients with cancer.^[20] Indeed, after starting GnRHa medications, the collection of sperm or ova for reproductive purposes is a well-established option.^[21] Studies have consistently shown that puberty blockers lead to positive outcomes for trans youth, including significant improvements in overall functioning, reductions in depressive symptoms, and lower lifetime rates of suicidal ideation.^[22]

The Review’s approach to the evaluation of evidence led to the exclusion of substantial peer-reviewed evidence in support of puberty blockers and hormones, including evidence regarding the lived experiences of trans youth. For instance, the authors deemed only one of the 50 studies in the systematic review of puberty blockers to be “high quality.” This is not a value-neutral or inevitable way to frame these studies. Rather, the research studies excluded from the Review because of “low evidence” were often qualitative or observational investigations that had no control group, while the ones considered “high quality” tended to be randomized controlled trials (RCTs).^[23] However, discounting observational studies inappropriately treats transness as exceptional because observational studies constitute much of the evidence that guides clinical care for all fields of medicine.^[24] Indeed, the World Health Organization published a series of papers in 2019 on the value of including qualitative studies in the development of clinical guidelines, arguing that “Qualitative evidence is crucial to improve the understanding on how, and whether, people perceive health interventions to be effective and acceptable. It is also essential to understand the factors influencing the implementation of health policies and interventions.” In other words, this kind of evidence provides context and reasoning that frame, rather than flattens, the complexity of human experiences that shape and are shaped by gender-affirming care.^[25]

Randomized controlled trials are often considered unethical in studying gender-affirming care. One reason for this is the lack of clinical equipoise: the medical community has already accepted gender-affirming care as the clinical standard, so there is dubious value in using limited resources to study resolved research questions.^[26] In a randomized clinical trial, the control group would typically receive psychotherapy for gender-incongruent puberty instead of medications, which would necessitate withholding beneficial gender-affirming care from participants when there is evidence that treatment prevents serious harm.^[27] On the other hand, observational studies can include more diverse patient populations and offer greater specificity about experiences than randomized controlled studies. Larger observational studies with extended follow-ups can also identify long-term benefits or harms that are useful for clinical guidelines.^[28] Treating this kind of evidence as insufficient to support trans care represents a biased approach that undermines the legitimacy of patient testimony in the development of an evidence base for trans individuals. The selective use of evidence constitutes a form of testimonial injustice, as an entire body of medical knowledge important to, and often generated by, those affected is systematically dismissed.

The Review limited meaningful involvement from trans patients and providers who had experience in the provision of gender-affirming care.^[29] The Review’s Assurance Group — which was intended to provide “expert advice” on the conduct of the review — explicitly left out trans voices, stating that its “Members are independent of … providers of gender dysphoria services, and of any organisation or association that could reasonably be regarded as having a significant interest in the outcome of the Review.”^[30] The logic of this exclusion was to ensure that nobody with a “significant interest in the outcome of the review” would bias its results through their personal or professional commitments. This approach is analogous to attempting to eliminate bias from a panel shaping clinical guidelines for heart disease by excluding both cardiologists and heart disease patients. The problem is not merely that trans people and those with expertise in their care were excluded as experts. This approach also flies in the face of contemporary best research practices that treat both lived and professional experience as important forms of expertise. Trans people and the people who provide them with health care should have been actively involved in research that affects their lives and care. The deliberate exclusion of their voices from the review process is a clear example of testimonial injustice.

The Review excludes providers with experience in gender services due to the assumption of bias. In doing so, it implies that those who are empowered to lend their expertise are without bias. By treating only support for transgender adolescents as a disqualifying bias, the Review reviews its own normativity. The framework of testimonial injustice helps us to understand the links between the discounting of individual testimony about identity and the constitution of medical authority that translates such refusal to believe into refusal to provide care.

In addition to minimizing the input of patients and providers with lived experience in the Assurance Group, the Cass Review also included healthcare workers who explicitly deny trans identity in its “online multi-professional panel to explore issues around gender identity services.” When prompted with the statement

There is no such thing as a trans child. Gender dysphoria is always an indicator of another underlying problem, and assessment should focus on understanding the causes of their distress.

21 percent of the panel responded that they strongly agree or agree. The authors of the Review may feel that excluding transgender people and the physicians who care for them preserves objectivity. We argue, however, that it is inappropriate to include as expert advisors individuals who do not acknowledge the existence of the group the Cass Review examines and whose access to care the Review will, in turn, shape.^[31] These experts call the existence of transgender youth (not just the kind of care that they need) into question: another decisive case of testimonial injustice. The Review does not make it clear that such a significant proportion of the experts it relies on do not believe in transgender children or that the root cause of distress in this population is gender. It may be unclear to policymakers and the public that people holding such views are shaping practice norms. This insight emerges only when evaluating the Likert response answers provided by the Review’s expert consultants via auxiliary reports, not via the main document or any included disclosures, discussions, or reports of the Review's limitations.

The Review has had immediate and significant ramifications for trans NHS patients’ access to gender-affirming care.^[32] It was also extensively cited as evidence against adolescent gender-affirming care provision in the oral arguments of US v. Skrmetti, a case about the constitutionality of Tennessee’s ban on gender-affirming care for minors.^[33] Citing its early findings, the British government ordered closures of children’s gender services and stopped accepting referrals for gender-affirming care.^[34] The Review was also used to justify halting the use of puberty blockers for the treatment of youth gender dysphoria, though the same medications remained available for other pediatric health needs (e.g., precocious puberty).^[35]

Systemic Testimonial Injustice

Trans people experience testimonial injustice far beyond what the Cass Review manifests. One such everyday form is how trans individuals must not only articulate the legitimacy of their identities but defend them against accusations of insufficient self-knowledge or the intent to deceive others about their gender.^[36] Many have experienced this injustice when required to convince their healthcare providers that they are “trans enough” to receive needed care. In a focus group conducted with trans youth in 2022, participants described having their gender identity questioned by providers:

I think the big question, the question I’ve come back to over and over again [the doctor] asked me is, what does being a girl mean to you? And I didn’t have an answer. He was very skeptical of my lack of an answer for that. He was like, well I just – I feel like you should be able to talk about this. I think you might be moving too fast if you can’t talk about this. And I was like, well, no I think it’s just a stupid question. But I didn’t say that because I was 14 and small and nervous… And then when my parents came back in … he said he wanted to caution us against moving too quickly because he’s against permanent changes in children at a young age. He says he doesn’t think it’s a good idea... He just doesn’t think there’s enough science behind it to back it up.^[37]

Trans youth suffer testimonial injustice when their identities and existence are met with unreasonable skepticism or discounted entirely. This perceived lack of credibility often results in challenges from medical providers who may frame their own skepticism as concerns regarding reversibility and potential for regret. While irreversible interventions may demand special scrutiny and regret is generally to be avoided, the fact of such risks should not automatically preclude the provision of gender-affirming care. The frame of testimonial injustice helps us to see how provider interactions like these exemplify the systemic prejudice that trans people and others who diverge from cisnormative expectations face when their credibility is discounted, and accounts of their own selves are deemed untrustworthy.^[38]

Clinicians’ skepticism about their adolescent patients’ need for gender-affirming care may be rooted in an assessment that there is insufficient evidence to support gender affirmation as a standard of care. While the Cass Review’s findings of such evidentiary weakness have been strongly disputed by a number of analyses discussed elsewhere in this piece, we also posit that quibbling over what the evidence reveals is only part of the task of evaluating evidence. In the case of gender transition, where the denial of care will be experienced as a significant harm to the trans person, inaction – care refusal – must not be treated as a morally neutral option. Instead, care refusal must itself be regarded as having the potential to harm. Whether someone considering the ethics of gender-affirming care begins with an assumption that care provision or care denial ought to be, the status quo is, particularly in light of the vehemence of contemporary fights over access to gender-affirming care, more a question of values than it is of evidence.

Physicians often treat patients whose symptoms cannot be proven or diagnosed with “objective” data. Myriad forms of routine medical care rely solely or primarily on patient testimony; not only is gender dysphoria unexceptional in this regard as a diagnosis, hormonal and surgical intervention to alleviate distress and bring about patient well-being is similarly standard medical procedure. Psychological and psychiatric care can often only be provided on the basis of patients’ self-reported experiences of mental illness, as those illnesses may not generate measurable physical effects. For instance, conditions such as the excess breast tissue that indicates gynecomastia in cisgender men are similarly predicated on patient articulations of their own experiences and needs. In all these cases, self-related phenomena are clinically relevant, and although some may dismiss them as empirically intractable, doing so would clearly be a mistake.^[39]

Healthcare systems also pose various significant hurdles to accessing forms of gender-affirming care, including their criteria for insurance coverage approval. Insurers’ criteria are unstandardized and often arbitrary. Yet, they profoundly shape the kind of care available, particularly given the economic precarity that prevents many trans people from paying for treatment out-of-pocket.^[40] To secure coverage, trans individuals must frame their experience in accordance with insurers’ standards rather than medical standards alone.^[41] The need to provide persuasive accounts to unlock care forces trans people to conform to specific, deficit-based descriptions of their identities as pathological and the ambiguous definition of medical necessity used by insurance companies.^[42] This system reflects a form of testimonial injustice, effectively requiring trans people to present strategic narratives to obtain care and mold their needs to fit the stringent requirements of insurance. The disparate insurance criteria for gender-affirming care undermines existing forms of evidence — which are primarily based on testimonies. It treats the knowledge that trans people possess about their bodies as insufficiently credible to warrant medical autonomy.^[43] This is an unjust standard of evidence. In this way, even well-meaning providers sometimes subject trans patients to arbitrary barriers to care purely on the basis of their gender identity.

Conclusion

All providers should understand the risk of testimonial injustice to trans people in healthcare contexts. This is particularly urgent for providers who treat trans patients. Since all providers will treat trans patients regardless of specialty, all healthcare practitioners should address testimonial injustice. Accordingly, they must work to counter the devaluation of trans testimonies, not just in individual patient and provider experiences but across the medical community and system at large. Invalidating trans-patient experiences not only erodes trust in the healthcare system but may lead to inadequate or harmful therapeutic approaches. As a result, testimonial injustice perpetuates a cycle of negative health outcomes, which can include worsened mental health,^[44] significantly greater risk of cardiovascular disease,^[45] higher rates of chronic illness,^[46] higher rates of disability,^[47] and more preventable deaths^[48] compared to cisgender individuals. The stakes here are high: testimonial justice is essential to providing good health care for all. Justice demands that we not only take the testimonies of trans people seriously but understand them as fundamental to the provision of needed health care.

^[1] Safer JD, Coleman E, Feldman J, Garofalo R, Hembree W, Radix A, Sevelius J. Barriers to healthcare for transgender individuals. Curr Opin Endocrinol Diabetes Obes. 2016 Apr;23(2):168-71. doi: 10.1097/MED.0000000000000227. PMID: 26910276; PMCID: PMC4802845.

^[2] Fricker M. Epistemic Injustice: Power and the Ethics of Knowing. New York, NY: Oxford University Press; 2007.

^[3] Fact Sheet: Protecting and Advancing Health Care for Transgender Adult Communities. Center for American Progress. https://www.americanprogress.org/article/fact-sheet-protecting-advancing-health-care-transgender-adult-communities/#:~:text=Compared%20with%20the%20general%20population

^[4]Greene NH, Kilpatrick SJ. Racial/ethnic disparities in peripartum pain assessment and management. Joint Commission Journal on Quality and Patient Safety. 2024. doi:10.1016/j.jcjq.2024.03.009; Badreldin N, Grobman WA, Yee LM. Racial disparities in postpartum pain management. Obstetrics & Gynecology. 2019;134(6):1147-1153. doi:10.1097/AOG.0000000000003561

^[5] Levine, S., Heiden-Rootes, K., & Salas, J. (2022). Associations Between Healthcare Experiences, Mental Health Outcomes, and Substance Use Among Transgender Adults. The Journal of the American Board of Family Medicine, 35(6), 1092–1102. https://doi.org/10.3122/jabfm.2022.220186r1; Inman, E. M., Juno Obedin-Maliver, Ragosta, S., Hastings, J., Berry, J., Lunn, M. R., Flentje, A., Capriotti, M. R., Lubensky, M. E., Stoeffler, A., Zubin Dastur, & Moseson, H. (2023). Reports of Negative Interactions with Healthcare Providers among Transgender, Nonbinary, and Gender-Expansive People assigned Female at Birth in the United States: Results from an Online, Cross-Sectional Survey. 20(11), 6007–6007. https://doi.org/10.3390/ijerph20116007

^[6] Kiran, T., Davie, S., Singh, D., Hranilovic, S., Pinto, A. D., Abramovich, A., & Lofters, A. (2019). Cancer screening rates among transgender adults: Cross-sectional analysis of primary care data. 65(1), e30–e37.

^[7] Jackson, S. S., & Hammer, A. (2023). Cancer risk among transgender adults: A growing population with unmet needs. Acta Obstetricia et Gynecologica Scandinavica, 102(11), 1428–1430. https://doi.org/10.1111/aogs.14686

^[8] Jackson, S. S., & Hammer, A. (2023). Cancer risk among transgender adults: A growing population with unmet needs. Acta Obstetricia et Gynecologica Scandinavica, 102(11), 1428–1430. https://doi.org/10.1111/aogs.14686 ; Jackson, S. S., Han, X., Mao, Z., Nogueira, L., Suneja, G., Jemal, A., & Shiels, M. S. (2021). Cancer Stage, Treatment, and Survival Among Transgender Patients in the United States. JNCI: Journal of the National Cancer Institute, 113(9), 1221–1227. https://doi.org/10.1093/jnci/djab028

^[9] Health disparities and equitable access to health care persist with transgender adults. (n.d.). American Heart Association. https://newsroom.heart.org/news/health-disparities-and-equitable-access-to-health-care-persist-with-transgender-adults

^[10] Alzahrani, T., Nguyen, T., Ryan, A., Dwairy, A., McCaffrey, J., Yunus, R., Forgione, J., Krepp, J., Nagy, C., Mazhari, R., & Reiner, J. (2019). Cardiovascular Disease Risk Factors and Myocardial Infarction in the Transgender Population. Circulation: Cardiovascular Quality and Outcomes, 12(4). https://doi.org/10.1161/circoutcomes.119.005597

^[11] Downing, J. M., & Przedworski, J. M. (2018). Health of Transgender Adults in the U.S., 2014–2016. American Journal of Preventive Medicine, 55(3), 336–344. https://doi.org/10.1016/j.amepre.2018.04.045

^[12] WPATH and USPATH COMMENT on the CASS REVIEW.; 2024. https://www.wpath.org/media/cms/Documents/Public%20Policies/2024/17.05.24%20Response%20Cass%20Review%20FINAL%20with%20ed%20note.pdf?_t=1716075965

^[13] McNamara M, Baker K, Connelly K, et al. An evidence-based critique of “The Cass Review” on gender-affirming care for adolescent gender dysphoria. 2024; Rew L, Young CC, Monge M, Bogucka R. [White paper]. 2020.

^[14] McNamara M, Baker K, Connelly K, et al. An evidence-based critique of “The Cass Review” on gender-affirming care for adolescent gender dysphoria. 2024; Rew L, Young CC, Monge M, Bogucka R. [White paper]. 2020.

^[15] Guss, C., & Gordon, C. M. (2022). Pubertal Blockade and Subsequent Gender-Affirming Therapy. JAMA Network Open, 5(11), e2239763. https://doi.org/10.1001/jamanetworkopen.2022.39763

^[16] Riggs, D. W., Tollit, M., & Lin, A. (2021). Refusing puberty blockers to trans young people is not justified by the evidence. The Lancet Child & Adolescent Health, 5(9), e35–e36. https://doi.org/10.1016/s2352-4642(21)00233-9

^[17] Mayo Clinic Staff. (2023, June 14). Pubertal blockers for transgender and gender diverse youth. Mayo Clinic. https://www.mayoclinic.org/diseases-conditions/gender-dysphoria/in-depth/pubertal-blockers/art-20459075

^[18] Heger, S., Müller, M., Ranke, M., Schwarz, H.-P., Waldhauser, F., Partsch, C.-J., & Sippell, W. G. (2006). Long-term GnRH agonist treatment for female central precocious puberty does not impair reproductive function. Molecular and Cellular Endocrinology, 254-255, 217–220. https://doi.org/10.1016/j.mce.2006.04.012

^[19] Kim, E. Y. (2015). Long-term effects of gonadotropin-releasing hormone analogs in girls with central precocious puberty. Korean Journal of Pediatrics, 58(1), 1. https://doi.org/10.3345/kjp.2015.58.1.1

^[20] Massarotti, C., Stigliani, S., Gazzo, I., Lambertini, M., & Anserini, P. (2023). Long-acting gonadotropin-releasing hormone agonist trigger in fertility preservation cycles before chemotherapy. ESMO Open, 8(4), 101597. https://doi.org/10.1016/j.esmoop.2023.101597

^[21] Giordano, S., & Holm, S. (2020). Is puberty delaying treatment “experimental treatment”?. International Journal of Transgender Health, 21(2), 113–121. https://doi.org/10.1080/26895269.2020.1747768

^[22] McNamara M, Baker K, Connelly K, et al. An evidence-based critique of “The Cass Review” on gender-affirming care for adolescent gender dysphoria. 2024; Rew L, Young CC, Monge M, Bogucka R. [White paper]. 2020. ; Rew L, Young CC, Monge M, Bogucka R. Review: Puberty blockers for transgender and gender diverse youth-a critical review of the literature. Child Adolesc Ment Health. 2021;26(1):3-14. doi:10.1111/camh.12437; Mayo Clinic Staff. Pubertal blockers for transgender and gender diverse youth. Mayo Clinic. Published June 14, 2023, https://www.mayoclinic.org/diseases-conditions/gender-dysphoria/in-depth/pubertal-blockers/art-20459075, Lee, J. Y., & Rosenthal, S. M. (2022). Gender-Affirming Care of Transgender and Gender-Diverse Youth: Current Concepts. Annual Review of Medicine, 74(1). https://doi.org/10.1146/annurev-med-043021-032007

^[23] Cass H. Final Report – Cass Review. cass.independent-review.uk. Published April 2024. https://cass.independent-review.uk/home/publications/final-report/

^[24] McNamara M, Baker K, Connelly K, et al. An evidence-based critique of “The Cass Review” on gender-affirming care for adolescent gender dysphoria. 2024; Rew L, Young CC, Monge M, Bogucka R. [White paper]. 2020.

^[25] Using qualitative research to strengthen guideline development. (n.d.). Www.who.int. https://www.who.int/news/item/08-08-2019-using-qualitative-research-to-strengthen-guideline-development ; Downe, S., Finlayson, K. W., Lawrie, T. A., Lewin, S. A., Glenton, C., Rosenbaum, S., Barreix, M., & Tunçalp, Ö. (2019). Qualitative Evidence Synthesis (QES) for Guidelines: Paper 1 – Using qualitative evidence synthesis to inform guideline scope and develop qualitative findings statements. Health Research Policy and Systems, 17(1). https://doi.org/10.1186/s12961-019-0467-5 ; Lewin, S., Glenton, C., Lawrie, T. A., Downe, S., Finlayson, K. W., Rosenbaum, S., Barreix, M., & Tunçalp, Ö. (2019). Qualitative Evidence Synthesis (QES) for Guidelines: Paper 2 – Using qualitative evidence synthesis findings to inform evidence-to-decision frameworks and recommendations. Health Research Policy and Systems, 17(1). https://doi.org/10.1186/s12961-019-0468-4 ; Glenton, C., Lewin, S., Lawrie, T. A., Barreix, M., Downe, S., Finlayson, K. W., Tamrat, T., Rosenbaum, S., & Tunçalp, Ö. (2019). Qualitative Evidence Synthesis (QES) for Guidelines: Paper 3 – Using qualitative evidence syntheses to develop implementation considerations and inform implementation processes. Health Research Policy and Systems, 17(1). https://doi.org/10.1186/s12961-019-0450-1

^[26] Schall TE, Jaffe K, Moses JD. Roles of Randomized Controlled Trials in Establishing Evidence-Based Gender-Affirming Care and Advancing Health Equity. The AMA Journal of Ethic. 2024;26(9):E684-689. doi:https://doi.org/10.1001/amajethics.2024.684

^[27] Ashley F, Tordoff DM, Olson-Kennedy J, Arjee Restar. Randomized-controlled trials are methodologically inappropriate in adolescent transgender healthcare. International Journal of Transgender Health. Published online June 24, 2023:1-12. doi:https://doi.org/10.1080/26895269.2023.2218357

^[28] Gershon AS, Lindenauer PK, Wilson KC, et al. Informing Healthcare Decisions with Observational Research Assessing Causal Effect. An Official American Thoracic Society Research Statement. American Journal of Respiratory and Critical Care Medicine. 2021;203(1):14-23. doi:https://doi.org/10.1164/rccm.202010-3943st

^[29] Maung, D. H. (2024, April 12). Response to the Cass Review. GenderGP Transgender Services. https://www.gendergp.com/response-to-the-cass-review/

^[30] Assurance Group – Cass Review. (2017). Independent-Review.uk. https://cass.independent-review.uk/about-the-review/assurance-group/

^[31] Online Panel with Primary and Secondary Care Professionals Cass Review Engagement Report.; 2021. https://cass.independent-review.uk/wp-content/uploads/2022/03/REPORT-Cass-Review-professional-panel-FINAL.pdf

^[32] Horton C. The Cass Review: Cis-supremacy in the UK’s approach to healthcare for trans children. International Journal of Transgender Health. 2024;1–25. doi:10.1080/26895269.2024.2328249; United Nations Independent Expert on Protection against Violence and Discrimination Based on Sexual Orientation and Gender Identity Country Visit to the United Kingdom of Great Britain and Northern Ireland (24 April -5 End of Mission Statement.; 2023. https://www.ohchr.org/sites/default/files/documents/issues/sexualorientation/statements/eom-statement-UK-IE-SOGI-2023-05-10.pdf

^[33]Search - Supreme Court of the United States. (2023). Supremecourt.gov. https://www.supremecourt.gov/search.aspx?filename=/docket/docketfiles/html/public/23-477.html

^[34] Ali J. Doctors warn “NHS is failing trans people” amid row over Tavistock gender clinic. PinkNews | Latest lesbian, gay, bi and trans news | LGBTQ+ news. Published February 9, 2023. https://www.thepinknews.com/2023/02/09/tavistock-gender-clinic-closure-staff-open-letter-trans-healthcare/; NHS England» NHS England’s Response to the Final Report of the Independent Review of Gender Identity Services for Children and Young People. www.england.nhs.uk. https://www.england.nhs.uk/long-read/nhs-englands-response-to-the-final-report-of-the-independent-review-of-gender-identity-services-for-children-and-young-people/

^[35] McNamara M, Baker K, Connelly K, et al. An evidence-based critique of “The Cass Review” on gender-affirming care for adolescent gender dysphoria. [White paper]. 2024.

^[36] Zimman L. “The other kind of coming out”: Transgender people and the coming out narrative genre. Gender and Language. 2009;3(1). doi:https://doi.org/10.1558/genl.v3i1.53

^[37] Lucas R. Factors associated with facilitators and barriers to gender-affirming care among transgender and nonbinary youth and young adults in Washington: A mixed-methods approach. University of Washington. Published July 14, 2022. http://hdl.handle.net/1773/49002

[38] While some may argue that other medical diagnoses privilege particular kinds of quantitative evidence for care efficacy, and therefore so should gender affirming care, further addressing such counterarguments is beyond the scope of this paper.

^[39] Tekin, Ş. (2017). The missing self in scientific psychiatry. Synthese, 196(6), 2197–2215. https://doi.org/10.1007/s11229-017-1324-0

^[40] Dozier R. How Navigators Influence Insurance Coverage for Gender-Affirming Surgeries: A Qualitative Study. The Permanente Journal. 2023;27(1):72-76. doi:https://doi.org/10.7812/tpp/22.115

^[41] Dietz E. More Necessary than Medical: Reframing the Insurance Argument for Transition-Related Care. IJFAB: International Journal of Feminist Approaches to Bioethics. 2020;13(1):63-88. doi:https://doi.org/10.3138/ijfab.13.1.04

^[42] Kirkland A, Talesh S, Perone AK. Health insurance rights and access to health care for trans people: The social construction of medical necessity. Law & Society Review. 2021;55(4):539-562. doi:https://doi.org/10.1111/lasr.12575

^[43] Keyes O, Dietz EA. Values and Evidence in Gender-Affirming Care. Hastings Cent Rep. 2024;54(3):51-53. doi:10.1002/hast.1592

^[44] Buyea E. The Impact of Banning Gender-Affirming Care in America: A Step Backward for Equality – Tufts CHSP. Tufts University. Published June 26, 2023. https://sites.tufts.edu/chsp/2023/06/26/the-impact-of-banning-gender-affirming-care-in-america-a-step-backward-for-equality/

^[45] Health disparities and equitable access to health care persist with transgender adults. American Heart Association. https://newsroom.heart.org/news/health-disparities-and-equitable-access-to-health-care-persist-with-transgender-adults

^[46] Barbee H, Deal C, Gonzales G. Anti-transgender legislation—a public health concern for transgender youth. JAMA Pediatrics. 2021;176(2). doi:10.1001/jamapediatrics.2021.4483

^[47] Smith-Johnson M. Transgender Adults Have Higher Rates Of Disability Than Their Cisgender Counterparts. Health Affairs. 2022;41(10):1470-1476. doi:https://doi.org/10.1377/hlthaff.2022.00500

^[48] Barbee H, Deal C, Gonzales G. Anti-transgender legislation—a public health concern for transgender youth. JAMA Pediatrics. 2021;176(2). doi:10.1001/jamapediatrics.2021.4483