Health Law and Policy Commons^™

Ai, Medicine, And Social Determinants Of Health Data, Ryan Doyloo, Nicholson Price

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This article examines how medical AI systems are incorporating SDoH data and the governance challenges that follow. The authors show that while SDoH integration can enhance clinical workflows and predictive accuracy — potentially improving outcomes for underserved populations — it also introduces acute risks of proxy discrimination, where facially neutral variables replicate protected characteristics. Surveying U.S., EU, and international frameworks, the authors argue that existing regimes lack clear ex ante guidance to distinguish beneficial from harmful uses of SDoH data. In response, they advance post-market monitoring as a pragmatic and scalable pathway: generating real-world, SDoH-stratified evidence that can support enforcement, …

Vaccines, Religious Liberty, And The Gvr As Doctrinal Signal, Zalman Rothschild

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This Essay proceeds in four Parts. Part I traces the doctrinal baseline, showing that vaccines have long functioned as the limit case for religious liberty. Part II briefly describes the doctrinal changes of the COVID-19 era — the Supreme Court’s expansion of religious equality doctrine, and its emergency-docket denials that left vaccine mandates formally unresolved — before explaining why the GVR in Miller signals a different move: the extension of the religious liberty framework to vaccine mandates, bypassing the comparability analysis that had allowed most courts to sustain them under the equality model. Part III turns to Miller itself and …

Advancing Neurotech Justice In Youth Digital Mental Health: Insights From An Interdisciplinary And Cross-Generational Workshop, Francis X. Shen, Craig W. Mcfarland, Donnella S. Comeau, Leo Anthony Celi, Benjamin C. Silverman, Sepideh Abdi, Mahsa Alborzi Avanaki

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Researchers and clinicians are increasingly looking to leverage artificial intelligence (AI) and digital tools to improve psychiatric care. Of particular promise is addressing the youth mental health crisis. Yet, the introduction of AI-enabled digital technologies for psychiatric treatment of young adults raises a host of ethical, legal, and societal issues (ELSI). To provide guidance in addressing these issues, we convened a two-day meeting at the Radcliffe Institute for Advanced Study at Harvard University: Advancing Neurotech Justice in Mental Health: Insights from an Interdisciplinary and Cross-Generational Workshop. The meeting brought together a diverse cohort of 17 experts and 5 students …

Monitoring, Oversight, And Learning In Medical Ai, W. Nicholson Price Ii

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When medical AI errs, it often goes unnoticed. If there’s a specific patient injury, and the link to AI is obvious, that problem might be reported to the Food and Drug Administration (FDA), but not always. And many other types of problems, like worse performance on specific groups or ineffective integration into health system workflows, simply don’t fall within the contours of regularized reporting. Even if they are noticed by the health system—far from a given—there’s no obvious way to share that information more broadly. Against this backdrop, there are justified calls for better oversight and reporting. But there’s the …

Expanding Equity And Innovation In Pharmaceutical Law And Drug Development: Paying Clinical Trial Participants For Their Data, Steve Calandrillo, Bernadette Tosti, Jefferson Smith, Jamison Koeman

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Bringing a drug to market is exceedingly expensive and exposes pharmaceutical manufacturers to significant legal risk. But when companies are successful, their profits make the PowerBall jackpot look like petty cash. Staggering rewards measure in the billions or millions for the firms, CEOs, pharmacies, drug benefit managers, data brokers, and many more actors in the pharmaceutical-to-patient pipeline. The only individuals who don’t get paid handsomely are the clinical trial participants, whose voluntary participation and data helped make those successes possible. It is long past time that we reform the legal and regulatory roadblocks to paying clinical trial participants in the …

Decision-Making Supports And Cognitive Decline, Rebekah Diller

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For persons with a range of cognitive disabilities, supported decision-making, rooted in a human rights approach to disability, has emerged as a tool that permits them to make legally binding decisions and avoid guardianship. As supported decision-making policy has evolved in the United States, state statutes have primarily focused on formal agreements through which individuals can designate trusted supporters to assist in obtaining information, processing that information, and communicating a decision. This Article argues that supported decision-making has promise for preserving the autonomy of persons living with dementia, but that the model of a supported decisionmaking agreement embodied in the …

Keynote: Promoting Disability Equality Behind Bars, Margo Schlanger

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A few years back, I finished a five-year appointment as a “settlement monitor” in a state prison system for a civil rights case about deaf and hard-of hearing people incarcerated there. With the consent of the parties, I had been appointed by a federal court to spend time in the state’s prisons, talking to prisoners and staff, and reviewing records and facilities. I saw some obvious problems. I recall one deaf prisoner; he used American Sign Language to communicate and could not speak at all. He was found to have committed a disciplinary infraction at a proceeding where he could …

Environment Scan Of Generative Ai Infrastructure For Clinical And Translational Science, Hua Xu, Jiang Bian, Chunhua Weng, Yifan Peng, Betina Idnay, Zihan Xu, William G. Adams, Mohammad Adibuzzaman, Nicholas R. Anderson, Neil Bahroos, Douglas S. Bell, Cody Bumgardner, Thomas Campion, Mario Castro, James J. Cimino, I. Glenn Cohen, David Dorr, Peter L. Elkin, Jungwei W. Fan, Todd Ferris, David J. Foran, David Hanauer, Mike Hogarth, Kun Huang, Jayashree Kalpathy-Cramer, Manoj Kandpal, Niranjan S. Karnik, Avnish Katoch, Albert M. Lai, Christophe G. Lambert, Lang Li, Christopher Lindsell, Jinze Liu, Zhiyong Lu, Yuan Luo, Peter Mcgarvey, Eneida A. Mendonca, Parsa Mirhaji, Shawn Murphy, John D. Osborne, Ioannis C. Paschalidis, Paul A. Harris, Fred Prior, Nicholas J. Shaheen, Nawar Shara, Ida Sim, Umberto Tachinardi, Lemuel R. Waitman, Rosalind J. Wright, Adrian H. Zai, Kai Zheng, Sandra Soo-Jin Lee, Bradley A. Malin, Karthik Natarajan, Nicholson Price, Rui Zhang, Yiye Zhang

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This study reports a comprehensive environmental scan of the generative AI (GenAI) infrastructure in the national network for clinical and translational science across 36 institutions supported by the CTSA Program led by the National Center for Advancing Translational Sciences (NCATS) of the National Institutes of Health (NIH) at the United States. Key findings indicate a diverse range of institutional strategies, with most organizations in the experimental phase of GenAI deployment. The results underscore the need for a more coordinated approach to GenAI governance, emphasizing collaboration among senior leaders, clinicians, information technology staff, and researchers. Our analysis reveals that 53% of …

Clinicians In The Loop Of Medical Ai, W. Nicholson Price Ii

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As medical AI begins to mature as a health-care tool, the task of governance grows increasingly important. Ensuring that medical AI works, works where it’s used, and works for the patient in the moment is a challenging, multifaceted task. Some of this governance can be centralized—in review by FDA or by national accreditation labs, for instance. Some must be local, performed by the hospital or health system about to use the product in their own, unique environment. But a large amount of governance is left to the individual provider in the room, the human in the loop who presumably knows …

Do Specialized Medical Llms Demand A Radically New Approach Under The Eu's Medical Device Regulation, Hannah Louise Smith, W. Nicholson Price Ii

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We examine the arguments made by Onitiu and colleagues concerning the need to adopt a “backward-walking logic” to manage the risks arising from the use of Large Language Models (LLMs) adapted for a medical purpose. We examine what lessons can be learned from existing multi-use technologies and applied to specialized LLMs, notwithstanding their novelty, and explore the appropriate respective roles of device providers and regulators within the ecosystem of technological oversight.

The European Health Data Space As A Compass For Academic/Industry Collaborations, Gabriela Lenarczyk, Hannah Louise Smith, W. Nicholson Price Ii

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Against the backdrop of a deepening funding crisis for academic research in the US, how and when can closer relationships between academia and industry better support the research enterprise? Spector-Bagdady (2025) explores this potential response, bringing insight from genetic data sharing between academia and industry—and the benefits and challenges that arise from that sharing. She calls for a response that aligns academic institutional policy to support the realization of any public good, recognizing the pitfalls and problematic incentives that shape individual responses. It’s a timely call, and an attractive one in a time of urgent uncertainty about funding and support. …

Disability Discrimination By Clinical Algorithm, Elizabeth Pendo, Jennifer D. Oliva

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In response to America’s escalating drug poisoning crisis, the federal government has funded, incentivized, and mandated that states adopt and implement prescription drug monitoring programs (“PDMPs”) to electronically surveil controlled substances and other “drugs of concern.” State PDMPs utilize proprietary, predictive software platforms that deploy algorithms to determine whether a patient is at risk for drug misuse, drug diversion, doctor shopping, or substance use disorder. PDMPs have never been validated by a federal agency or peer review, yet states have mandated their use throughout the health care delivery system.

Research demonstrates that clinical overreliance on the risk scores generated by …

Blurring Boundaries: A Proposed Research Agenda For Ethical, Legal, Social, And Historical Studies At The Intersection Of Infectious And Genetic Disease, Seethal Jose, Juli Bollinger, Gail Geller, Jeremy Greene, Leslie Meltzer Henry, Brian Hutler, Eric Thomas Juengst, Jeffrey Kahn, Anna Mastroianni, Graham Mooney

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Contemporary understanding of the mechanisms of disease increasingly points to examples of “genetic diseases” with an infectious component and of “infectious diseases” with a genetic component. Such blurred boundaries generate ethical, legal, and social issues and highlight historical contexts that must be examined when incorporating host genomic information into the prevention, outbreak control, and treatment of infectious diseases.

Medical-Legal Partnerships Reinvigorate Systems Lawyering Using An Upstream Approach, Kate L. Mitchell, Debra Chopp

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The upstream framework presented in public health and medicine considers health problems from a preventive perspective, seeking to understand and address the root causes of poor health. Medical-legal partnerships (MLPs) have demonstrated the value of this upstream framework in the practice of law and engage in upstream lawyering by utilizing systemic advocacy to address root causes of injustices and health inequities. This article explores upstreaming and its use by MLPs in reframing legal practice.

What Can State Medical Boards Do To Effectively Address Serious Ethical Violations?, Tristan Mcintosh, Elizabeth Pendo, Heidi A. Walsh, Kari A. Baldwin, Patricia King, Emily E. Anderson, Catherine V. Caldicott, Jeffrey D. Carter, Sandra H. Johnson, Katherine Matthews, William A. Norcross, Dana C. Shaffer, James M. Dubois

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State Medical Boards (SMBs) can take severe disciplinary actions (e.g., license revocation or suspension) against physicians who commit egregious wrongdoing in order to protect the public. However, there is noteworthy variability in the extent to which SMBs impose severe disciplinary action. In this manuscript, we present and synthesize a subset of 11 recommendations based on findings from our team’s larger consensus-building project that identified a list of 56 policies and legal provisions SMBs can use to better protect patients from egregious wrongdoing by physicians.

What Is The Goal Of Health Insurance Reform?, Gabriel Scheffler

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No abstract provided.

Religious Clause Challenges To Early Abortion Bans, Caroline Mala Corbin

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The substantive due process right to abortion is gone. But other parts of the Constitution may also protect women’s right to control their bodies and live as equals in the United States. This Essay addresses what role the two religion clauses may play in advancing reproductive autonomy. Because religion and reproduction are intertwined, the religion clauses may provide some measure of constitutional protection.

The Establishment Clause bars the government from imposing religion onto those who do not share it. It also forbids the government from taking sides in theological disputes. Early abortion bans not only favor one religious belief on …

Locating Liability For Medical Ai, W. Nicholson Price Ii, I. Glenn Cohen

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When medical AI systems fail, who should be responsible, and how? We argue that various features of medical AI complicate the application of existing tort doctrines and render them ineffective at creating incentives for the safe and effective use of medical AI. In addition to complexity and opacity, the problem of contextual bias, where medical AI systems vary substantially in performance from place to place, hampers traditional doctrines. We suggest instead the application of enterprise liability to hospitals—making them broadly liable for negligent injuries occurring within the hospital system—with an important caveat: hospitals must have access to the information needed …

Rethinking Innovation At Fda, Rachel E. Sachs, Nicholson Price, Patricia J. Zeitler

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In several controversial drug approval decisions in recent years, the Food & Drug Administration (“FDA”) has publicly justified its decision partly on the ground that approving the drugs in question would support innovation in those fields going forward. To some observers, these arguments were surprising, as the Agency’s determination whether a drug is “safe” and “effective” does not seem to depend on whether its approval also supports innovation. But FDA’s use of these innovation arguments in drug approval decisions is just one example of the ways in which the Agency has come to make many innovation-related judgments as part of …

Covid-19 Pandemic’S Impact On Online Sex Advertising And Sex Trafficking, Coxen O. Julia, Vanessa Castro, Bridgette Carr, Glen Redin

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Disruptive social events such as the COVID-19 pandemic can have a significant impact on sex trafficking and the working conditions of victims, yet these effects have been little understood. This paper examines the effect of the COVID-19 pandemic on sex trafficking in the United States, based on analysis of over one million sexual service advertisements from the online platform Rubratings.com, using indicators of third-party management as potential proxies for trafficking. Our results show that there have been measurable changes in online commercial sexual service advertising, both with and without third-party management indicators, in the United States, with a significant decrease …

The Commerciality Of Non-Profit Hospitals Requires Them To Be Taxed: Bringing The Debate To A Conclusion, Edward A. Zelinsky

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It is now time to conclude our prolonged debate about the tax-exempt status of nonprofit hospitals. The contemporary nonprofit hospital is a commercial enterprise, materially indistinguishable for tax purposes from its profit-making, taxed competitor. The federal income tax and the states’ income, sales and property taxes should treat all hospitals alike, regardless of whether such hospitals are nonprofit or for-profit enterprises. In the interests of equity and efficiency, these similar institutions should be taxed similarly.

As a political matter, nonprofit hospitals will continue to defend their tax-exempt status. Like any other lucrative, vested interest, nonprofit hospitals will continue to fight …

Approaches To Sea Level Rise And International Law: A Comparative View Of Emerging Policy Responses By The African And The Americas Regions, Charles Chernor Jalloh

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No abstract provided.

Cryptic Patent Reform Through The Inflation Reduction Act., Arti K. Rai, Rachel E. Sachs, Price W. Nicholson

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If a statute substantially changes the way patents work in an industry where patents are central, but says almost nothing about patents, is it patent reform? We argue the answer is yes — and it’s not a hypothetical question. The Inflation Reduction Act (“IRA”) does not address patents, but its drug pricing provisions are likely to prompt major changes in how patents work in the pharmaceutical industry. For many years scholars have decried industry’s ever-evolving strategies that use combinations of patents to block competition for as long as possible, widely known as “evergreening,” but legislators have not been receptive to …

Conditions Of Participation: Incorporating The History Of Hospital Desegregation, Sallie Sanford

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Our students ought to know about the history of formal hospital segregation and desegregation. To that end, this article urges those who teach foundational health law and policy courses to do three things. First, to teach the Simkins case. Second, to swap out the usual Medicare signing ceremony picture for one that includes W. Montague Cobb, M.D., Ph.D. Third, to highlight how the implementation of that program for the elderly led, in a matter of months, to the desegregation of hospitals throughout the country.

Open-Source Clinical Machine Learning Models: Critical Appraisal Of Feasibility, Advantages, And Challenges, Keerthi B. Harish, W. Nicholson Price Ii, Yindalon Aphinyanaphongs

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Machine learning applications promise to augment clinical capabilities and at least 64 models have already been approved by the US Food and Drug Administration. These tools are developed, shared, and used in an environment in which regulations and market forces remain immature. An important consideration when evaluating this environment is the introduction of open-source solutions in which innovations are freely shared; such solutions have long been a facet of digital culture. We discuss the feasibility and implications of open-source machine learning in a health care infrastructure built upon proprietary information. The decreased cost of development as compared to drugs and …

The Deep Architecture Of American Covid-19 Tort Reform 2020-21, Anthony J. Sebok

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The rapid emergence of the COVID-19 pandemic produced massive state actions to protect in public health through the exercise of the police powers by local, state and national governments. In the United States there were calls early in the crisis to exercise the state’s power over tort law: As early as April 2020, the American Tort Reform Association published a White Paper, Responding to the Coming Lawsuit Surge that called for “reasonable constraints on . . . lawsuits that pose an obstacle to the coronavirus response effort, place businesses in jeopardy, and further damage the economy.”

This article, prepared for …

Ai Insurance: How Liability Insurance Can Drive The Responsible Adoption Of Artificial Intelligence In Health Care, Ariel Dora Stern, Avi Goldfarb, Timo Minssen, W. Nicholson Price Ii

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Despite enthusiasm about the potential to apply artificial intelligence (AI) to medicine and health care delivery, adoption remains tepid, even for the most compelling technologies. In this article, the authors focus on one set of challenges to AI adoption: those related to liability. Well-designed AI liability insurance can mitigate predictable liability risks and uncertainties in a way that is aligned with the interests of health care’s main stakeholders, including patients, physicians, and health care organization leadership. A market for AI insurance will encourage the use of high-quality AI, because insurers will be most keen to underwrite those products that are …

Inoculating The Next Generation Of Lawyers: Mandating Substances Use And Mental Health Education For Law Students, Janet Stearns

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No abstract provided.

New Innovation Models In Medical Ai, W Nicholson Price Ii, Rachel E. Sachs, Rebecca S. Eisenberg

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In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those that resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those related to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of as …

A Cure Of What Ails You: How Universal Healthcare Can Help Fix Our Tort System, David Pimentel

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No abstract provided.