Health Law and Policy Commons^™

Can Laws Be Flexible? Rethinking Legislation For Innovation, Nicholson W. Price Ii, Nick K. Schneider, Ariel Dora Stem, Jochen K. Lennerz

Articles

Agile legislation adapts principles from agile software development to lawmaking, emphasizing iteration, multi-stakeholder feedback, and embedded revision. We outline this learning-oriented governance model using three case studies: Germany’s stepwise digital health legislation, the EU AI Act, and U.S. FDA user-fee reauthorization. These examples highlight legislative designs that enable structured generation of real-world data and evidence during implementation, informing regulatory interpretation and iterative refinement in rapidly evolving technological domains.

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

Articles

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, …

What Personhood Means, Laura Portuondo

Michigan Law Review

A review of Personhood: The New Civil War over Reproduction. By Mary Ziegler.

Reflections And Revisionism: Rethinking The U.S. Response To Covid-19, Wendy E. Parmet

Michigan Law Review

A review of In Covid’s Wake: How Our Politics Failed Us. By Stephen Macedo and Frances Lee.

Factors For Patient Trust And Acceptance Of Medical Artificial Intelligence, Ana Bracic, Kayte Spector-Bagdady, Sophie Towle, Rina Zhang, Cornelius A. James, Nicholson W. Price Ii

Articles

Artificial intelligence (AI) is increasingly used in clinical care, but widespread adoption requires patient trust. Trust may be enhanced through systemic governance mechanisms or frontline clinicians providing a human in the loop for AI oversight. However, it is unclear how different approaches specifically influence patient trust in the use of medical AI. The objective is to determine the extent to which patient trust in and choice of medical scenarios involving AI are associated with governance mechanisms, clinician presence, performance, and data quality.

Religious Riders And The Sherman Act, Bailey Sanders

Michigan Law Review

Can corporations engage in anticompetitive behavior on the basis of religious belief? While the answer may seem like an obvious no, in fact this question has largely been overlooked. It has hovered at the margins of the debate over religious exemptions: Proponents of religious exemptions have essentially argued that there is no harm in providing such exemptions to businesses because a competitive market will ensure consumers who might be denied services or goods by a religious firm can still obtain those goods and services elsewhere. But what if religiously minded businesses act in ways that are specifically designed to limit …

Covid And The Great Retrenchment, Samuel R. Bagenstos

Articles

The past six years have seen two dramatic shifts in federal health and benefits policy. First, during the COVID pandemic, the government dramatically expanded public benefits. These expansions had incredibly positive effects, and recipients were largely satisfied with them. But after a relatively short time, Congress rolled back nearly all of the expansion. Worse, the immediate pullback set the stage for even more significant retrenchments in the second Trump Administration. Where in 2023 the United States came closest to universal health care in its history—with a record low uninsured rate of 7.7%—the Trump Administration’s Medicaid cuts and failure to extend …

An Incidental Standard For Medical Ai, Nicholson W. Price Ii

Articles

Medical AI is poised to make a major difference in the provision of health. It brings major challenges, though: how can developers and implementers ensure that it will work safely and effectively—especially within the context of complex and highly variable health-care systems? Standards provide one key tool, potentially providing guidelines for everything from privacy to accuracy to how AI interacts with human clinicians. This Essay considers the last of these, describing a powerful quasi-standard from a surprising source: an FDA guidance document that tells developers when certain AI systems are not considered medical devices, and are therefore not regulated by …

Algorithmic Medicine And The Duty To Disclose: Informed Consent Through The Lens Of Radiology, Lee Rodriguez

Michigan Law Review

Informed consent is the law’s mechanism for protecting patient autonomy by requiring disclosure of facts that bear on the decision to accept or refuse care. Artificial intelligence now helps decide what is medically true for patients, yet informed consent law still assumes that diagnostic judgment is rendered by a human mind whose reasoning is at least in principle communicable. Radiology has become the leading setting for this tension. AI systems triage worklists, flag suspected abnormalities, and anchor first-pass impressions in ways that guide radiologists’ attention and, in practice, can coauthor diagnostic conclusions while remaining invisible to patients. When patients are …

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

Articles

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 …

Health Care Civil Rights: Addressing The American Maternal Mortality Disparity Through Health, Law, And Policy, Victoria Pedri

Michigan Journal of Gender & Law

The United States is facing a pressing issue in maternal health, standing out as uniquely dangerous among similarly situated nations, with significant disparities in maternal mortality rates, particularly affecting Black American pregnant people. This paper, “Health Care Civil Rights: Addressing the American Maternal Mortality Disparity Through Health, Law, and Policy,” argues that by addressing the root cause of the Black Maternal Mortality Disparity (BMMD)—structural racism—and implementing rigorous, enforced standards of care, the United States can ensure safer childbirth experiences for Black pregnant people. Utilizing intersectional and anti-racist frameworks, the analysis identifies inferior medical care, particularly in diagnosing and treating preventable …

From Medical Exceptions To Reproductive Freedom, David S. Cohen, Greer Donley

Michigan Law Review

Since the Supreme Court overruled Roe v. Wade in 2022, there has been a significant focus on pregnancy complications. This focus has created some risks. Highlighting medically indicated abortion stories could stigmatize the vast majority of abortion seekers who lack medical reasons for abortion and result in narrow remedies that do nothing to undermine abortion bans. This Article presents a way to convert these risks into an opportunity: to use pregnancy complications as a wedge to challenge abortion bans more generally and make abortion more accessible for everyone. We present a long-term strategy to dismantle abortion bans, using several legal …

Science And Politics In Public Health Regulation, Samuel R. Bagenstos

University of Michigan Journal of Law Reform

Much of American public discourse takes for granted a distinction between science and politics. People describe and understand that distinction in contradictory ways, however. And those contradictions themselves underscore how closely entwined science and politics actually are.

Reforming The Medical Expense Income Tax Deduction To Better Reflect "Crip Time", Diane Kemker

University of Michigan Journal of Law Reform Caveat

Extraordinary medical expenses— whether due to a one-time occurrence or a chronic condition— happen on their own time. These expenses, their causes, and their consequences (medical, personal, financial, or all of these) can rarely be neatly cabined into a single calendar year. Treatment requiring an expensive prescription medication or complex surgery not covered by insurance may address a condition that arose over years. That condition may have interfered with a taxpayer’s ability to work in prior years, the current year, and perhaps for years to come, even for the rest of the taxpayer’s earning life. The medical condition of a …

Public Patent Powers, Laura E. Dolbow

Michigan Law Review

Congress has created multiple structures for agencies to control how patents are used, but that institutional design choice has received little academic attention. This Article provides the first comprehensive survey of existing laws that expressly authorize agencies to control patents. I locate 113 express conditions across 68 laws that expressly authorize executive actors to make some form of decision about patents. These powers, which I refer to as “public patent powers,” allow the government to use patented inventions, to obtain patents, to authorize third parties to use patented inventions, and to regulate how patents are used. Agencies have used many …

Disappearing Data At The U.S. Federal Government, Janet W. Freilich, Nicholson Price Ii, Aaron S. Kesselheim

Other Publications

Health data hosted by the U.S. federal government have been disappearing. According to our analysis, between January 21 and February 11, 2025, the Centers for Disease Control and Prevention (CDC) removed 203 datasets (13% of its online datasets, a reduction from 1519 to 1316). The situation is dynamic; various datasets have been removed, restored, manipulated, or not posted as planned.

Most-Favored-Nation Drug Pricing—How Courts Could Shape Future Health Regulation, Nicholas Bagley, Craig Garthwaite, Benedic Ippolito

Other Publications

The Trump administration recently issued an Executive Order aimed at delivering most-favored- nation (MFN) drug pricing to the US. The order instructs drug manufacturers to reduce the prices of brand-name drugs to match the lowest price among selected high-income countries. If drug makers do not make significant progress toward this goal, the administration will pursue several strategies to lower prices. Most notably, the Executive Order directs the Secretary of Health and Human Services (HHS) to propose a rule to impose MFN pricing. In all likelihood, the administration will revisit prior efforts to enact MFN pricing through the Center for Medicare …

Keynote: Promoting Disability Equality Behind Bars, Margo Schlanger

Articles

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 …

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

Articles

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 …

The Comstock Act’S Equal Protection Problem, Danny Y. Li

Michigan Law Review Online

Following its victory in Dobbs, the antiabortion movement has set its sights on a national abortion ban. Affiliates of the second Trump Admin- istration—including the vice president-elect—have endorsed the re- newed enforcement of the 1873 Comstock Act as one avenue for implementing such a ban. This Essay argues that contemporary enforce- ment of the Comstock Act as a national abortion ban would be unconsti- tutional. The Act violates the Fifth Amendment’s equal protection guarantee because it was enacted with the discriminatory purpose of in- hibiting illicit sex to promote women’s sexual purity. Only contemporary reenactment of the law without constitutionally …

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

Articles

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 …

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

Articles

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

Articles

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. …

Reformed But Not Repaired, Nia Johnson

Michigan Journal of Race and Law

Traditionally, scholars and policymakers concerned with making improvements to health care systems and structures have focused on insurance reform. The ACA— the United States’ most recent and substantial healthcare reform—was hoped to be an intervention that would help provide equity to all Americans. Indeed, scholars and policymakers viewed increasing access to health care through insurance coverage as a victory. And yet, despite these interventions, the COVID-19 pandemic revealed a number of policy gaps that disproportionately impacted racial minorities. Specifically, racially marginalized Americans still experienced the starkest disparities in COVID-19 complications and mortality. This has left scholars and policymakers to answer …

Comity & Federalism In Extraterritorial Abortion Regulation, Jensen Lillquist

Michigan Journal of Gender & Law

On June 24, 2022, the Supreme Court decided Dobbs v. Jackson Women’s Health Organization and held that states may regulate abortion in whatever manner they wish. In the wake of Dobbs, commentators and laypersons have focused primarily on its implications for reproductive rights and other fundamental rights—such as gay marriage. Less often discussed are the questions that arise regarding state extraterritorial jurisdiction. Since Dobbs, a patchwork of laws has developed: pro-life states have placed greater restrictions on abortion, while pro-choice states have sought to expand abortion access. Questions have arisen regarding whether and to what extent states may regulate the …

Abortion Access For Incarcerated People Post-Dobbs, Kate Bock

Michigan Journal of Gender & Law

Dobbs v. Jackson Women’s Health Organization has fundamentally altered the legal landscape regarding abortion access. Though abortion rights for all people across the United States have now been eliminated or are in jeopardy, incarcerated people are a particularly vulnerable group, given the way carceral institutions restrict autonomy and the drastic health implications of an unwanted pregnancy while confined. Before Dobbs, detained people retained the constitutional right to an elective abortion while incarcerated. To remedy violations of this right, women brought claims under the Fourteenth Amendment and the Eighth Amendment. In a post-Roe world, however, incarcerated folks denied abortion …

From Biased Data Inputs To Your Discriminatory Diagnosis Outputs: A Review Of Legal Liability For Artificial Intelligence In Healthcare, Amber Bolden

Michigan Technology Law Review

While health disparities in America occur due to non-medical circumstances, certain protected classes experience healthcare disparities due to the biases of medical professionals. Biased diagnoses, both intentional or unintentional, have existed throughout the history of the medical profession. That those biases are becoming data for training algorithms raises concerns as the medical field increasingly incorporates and standardizes artificial and augmented intelligence in patient diagnosis and treatment. Currently unregulated but with lifedetermining potential, artificial intelligence (AI) when used in patient treatment leads to important questions: should the doctor, the provider, or the AI developers be liable, and for what? Section II …

Antiracist Medicine In Colorblind Courts, Govind Persad

Michigan Law Review

This Article considers how health professionals’ efforts to combat racial health inequities interact with legal restrictions constraining their ability to consider race. In light of the Roberts Court’s recent invalidation of two university admissions programs, intensifying a “colorblind” judicial shift, the collision between antiracist medicine and colorblind law is a pressing concern. This Article anticipates the implications of this collision and explores how health professionals and systems can design programs that survive judicial examination.

In Part I, the Article examines the frameworks that will apply if antiracist medicine faces legal challenges. These include the Equal Protection Clause and federal statutes …

Consumer Privacy And The Dobbs Disruption, Mason R. Clark

University of Michigan Journal of Law Reform

The right to reproductive privacy is under attack in the United States, and it is losing ground. Dobbs v. Jackson Women’s Health Organization, the Supreme Court’s 2022 decision that overruled Roe v. Wade’s constitutional protection of abortion and jeopardized privacy rights by proxy, reflects this losing posture. Scholarship in reproductive privacy varyingly critiques federal privacy initiatives, evaluates regulatory interventions, and proposes civil rights frameworks in response to Dobbs. This Article, however, pinpoints how Dobbs created a gaping hole in state consumer privacy laws even as they propagated across the United States. Currently, there are no state consumer privacy …

Liability For Use Of Artificial Intelligence In Medicine, Nicholson W. Price Ii, Sara Gerke, I. Glenn Cohen

Book Chapters

While artificial intelligence (AI) has substantial potential to improve medical practice, errors will certainly occur, sometimes resulting in injury. Who will be liable? Questions of liability for AI-related injury raise not only immediate concerns for potentially liable parties but also broader systemic questions about how AI will be developed and adopted. The landscape of liability is complex, involving healthcare providers and institutions and the developers of AI systems. In this chapter, we consider these three principal loci of liability. At the outset, we note a few issues that shape our analysis.