Health Law and Policy Commons^™

Addressing The Challenges Of Cognitive Decline In The Physician Workforce, Sharona Hoffman

Faculty Publications

This book chapter examines the growing challenge of cognitive decline among aging physicians and analyzes various approaches to addressing it. In 2024, twenty percent of working physicians were sixty-five or older, and evidence suggests that 12-14% of older clinicians have cognitive deficits that may affect job performance. The chapter evaluates two primary approaches to cognitive assessment: employer-initiated programs and programs operated by state medical boards. Employer "late career practitioner policies" (LCPP) that require older physicians to undergo testing are becoming increasingly popular among health care organizations. But they are vulnerable to challenge under disability and age discrimination laws, as evidenced …

Lessons Learned For The Independent Panel For Evidence For Action Against Amr From Previous International Science Panels: Stakeholder Views From The 2025 Lagos Workshop, Iruka N. Okeke, Anthony Mcdonnell, Ayodele A. Akinyele, Javier Guzman, Kevin Outterson

Faculty Scholarship

In September, 2024, the UN General Assembly assigned the Quadripartite Joint Secretariat on Antimicrobial Resistance (AMR) the task of establishing an Independent Panel for Evidence for Action against AMR (IPEA). To promote stakeholder views and input around the constitution and functioning of this Panel, which could feed into the Quadripartite Joint Secretariat’s consultation process, we independently commissioned seven papers to examine the lessons that could be learned from other high-level scientific panels. We then convened 85 stakeholders, primed with the background papers. The Workshop, held in Lagos, Nigeria in April, 2025, drew representation from around the world, particularly low-income or …

Brief Of Public Health And Health Law Scholars As Amici Curiae Urging Affirmance In Support Of Plaintiffs-Appellees, Rachel L. Zacharias, Zeinab Bakhet, Kevin Costello, Maya Manian

Amicus Briefs & Court Filings

INTRODUCTION: Physicians’ use of their judgment and expertise to prescribe drugs and devices for purposes other than those approved by the Food and Drug Administration (“FDA”)—colloquially known as off-label use—is an indispensable feature of modern medicine. The FDA approves drugs as “safe and effective for specific indications.” Christopher M. Wittich, Christopher M. Burkle & William L. Lanier, Ten Common Questions (and Their Answers) About OffLabel Drug Use, 87 Mayo Clinic Procs. 982, 982 (2012). Federal law then generally leaves prescribing decisions, including off-label use of FDA-approved drugs and devices for a patient’s particular indication, to physicians acting under state law …

Bodies In The Beds: How Reits, Private Equity Firms, And County Hospitals Monetize Nursing Home Residents As Real Estate Acquisitions, Daniel L. Hatcher

All Faculty Scholarship

Nursing home residents have become monetized targets of real estate acquisitions. Established in 1960, Real Estate Investment Trusts (REITs) were envisioned as allowing individuals to invest in commercial real estate without owning properties. That seemingly innocuous investment idea has led to the growth of a behind-the-scenes empire of little-understood conglomerates of REITs buying up nursing homes and other healthcare facilities across the country. Capitalizing on tax-exempt income incentives, exploiting “triple-net” leasebacks, funneling profits through subsidiaries, and shielding ownership and assets from the liability of operations, the corporatized owners extract cash from facilities and leave harm in their wake. And to …

Rbr Management, Llc V. Eighth Judicial District Court [State Of Nevada], 142 Nev., Adv. Op. 44 (June 18, 2026), Erika Loveland

Nevada Supreme Court Summaries

Emergency medical service providers and ambulances are not "provider[s] of health care" under NRS 41A.017, so claims against them are not professional negligence claims and require no expert affidavit.

Off-Label Neuroimaging, Jane C. Moriarty

Law Faculty Publications

The growth of neuroimaging evidence in the courtroom is consistent with the increased reliance on technical and machine-based specialties at trial. Litigants routinely seek to introduce neuroimaging evidence in both civil and criminal trials to supplement traditional medical, psychiatric, and psychological opinion testimony. A substantial portion of neuroimaging evidence is still in the developmental stage—what I term “off-label neuroimaging.” Unsurprisingly, evaluating the reliability of developing neuroimaging poses challenging questions for gatekeeping courts. Among the complex evidentiary issues neuroimaging presents for courts and litigants, this Article considers one foundational question: How should courts determine whether neuroimaging evidence is sufficiently reliable for …

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, …

Planned Parenthood Mar Monte, Inc. V. State Ex Rel. Office Of The Nevada Attorney General (Civil), 142 Nev. Adv. Op. 40 (May 28, 2026), Charnel Gibson

Nevada Supreme Court Summaries

Nevada’s parental notification abortion statute is likely unconstitutionally vague because it fails to provide physicians with adequate notice of the conduct required and permits arbitrary enforcement.

"Market Shift Liability" For Generic Drugs: Market Share Theory's Eccentric New Cousin, Lars Noah

UF Law Faculty Publications

Market share liability, which permits allocating proportional responsibility to each tortious member of an industry when victims cannot identify the exact source of their injurious exposure, enjoyed its judicial heyday in the 1980s. It originated in the peculiar setting of litigation over a distinctive cancer that developed decades after in utero exposure to the drug diethylstilbestrol (“DES”), which a few hundred companies had produced and sold for the prevention of miscarriages before federal regulators withdrew it from the marketplace. Although judges have occasionally attempted novel extensions of this theory to other products, and academic commentators remain fascinated by its use, …

Preserving Life In An Age Of Autonomy: A Critique Of Physician-Assisted Suicide, Adeline Holcombe

Senior Honors Theses

This thesis critiques physician-assisted suicide (PAS) as a reflection of Western thought’s shift from a biblical sanctity-of-life ethic toward autonomy and relativism. Through analysis of biblical and historical foundations, major cases, and state PAS laws, it argues that legalization weakens the state’s interest in preserving life, normalizes suicide, and exposes vulnerable populations to coercion, inadequate safeguards, and legal expansion. The thesis concludes that PAS laws should be repealed and that palliative care, hospice, and mental health treatment provide more compassionate and ethically sound alternatives.

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

Articles

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 …

Argument For Statewide Vaccine Mandates—An Ethical And Legal Analysis, Liv Hymowitz

Colorado Law Student Scholars

No abstract provided.

Trust, Transparency, And The Fragile Promise Of Data Governance In The Era Of Modernization, Fallon Julia Cochlin, Regen Weber-Fares, Jami Crespo, William M. Sage, Cason Daniel Schmit

Faculty Scholarship

Public health data modernization in the United States has accelerated since COVID-19 exposed systemic weaknesses in fragmented data infrastructure and governance. Technical solutions have advanced, but legal and relational barriers still complicate data sharing across jurisdictions. Traditionally, interjurisdictional data sharing has relied on individually negotiated Data Use Agreements (DUAs), a process that is both resource-heavy and often opaque. To address this, the Centers for Disease Control and Prevention have proposed a Core DUA to standardize terms and reduce administrative burden. However, its success depends on trust — a fragile foundation increasingly strained by politicization, perceived lack of transparency, and controversial …

Medical-Legal Partnership As Value-Based Primary Care: Interprofessional Teamwork For Health-Related Social Needs, Jin K. Park, Andrew F. Beck, Keegan D. Warren, William M. Sage

Faculty Scholarship

Today’s primary care physicians are being asked to address patients’ health-related social needs (HRSN) as part of their routine care practices. An aging population, with a growing complement of intersecting medical and social needs, increases this burden on primary care. Medical-legal partnerships (MLP) are interprofessional collaborations that combine clinical and legal expertise to address HRSN involving housing, public benefits, employment, and other domains remediable by civil legal assistance. A value-based approach to integrating MLP into the health system may help primary care practices more effectively address HRSN and, in turn, better balance revenue and expenses. At the practice and healthcare …

Probing The Prevalence Of Pharmaceutical Corruption, Marc A. Rodwin

Suffolk University Law School Faculty Works

This article reviews the history and current evidence of systematic pharmaceutical industry corruption.  It draws on studies by the OECD on international corruption; reports of the Securities and Exchange Commission; studies of the Public Citizen health Research Group of settlement agreements between federal and state authorities and pharmaceutical firm; the history of the Medicare and Medicaid Anti-Kickback Act; professional and industry codes of ethics; the literature on institutional corruption; and studies of conflicts of interest.  These sources support findings of systemic corruption since the mid-20th century. The paper also explores the relationship between classic corruption, institutional corruption and conflicts of …

A New Standard: Default Inclusion Of Children In Clinical Trials, Megyn Gordon

Colorado Law Student Scholars

No abstract provided.

Access To Justice After Medina V Planned Parenthood South Atlantic, Daniel G. Aaron, Nicole Huberfeld

Faculty Scholarship

Access to justice is “the ability of all people to seek and obtain effective remedies through accessible, affordable, … and culturally competent institutions of justice.”¹ Historically, patients and physicians have worked together to protect the integrity of medical care as well as patients’ rights by challenging unlawful government actions in court. Yet the US Supreme Court recently issued decisions that may impede access to justice, potentially empowering federal, state, and local governments to interfere with evidence-based care. We explore constraints on access to justice that may arise after Medina v Planned Parenthood South Atlantic (PPSA) (606 US 357, 2025), …

Federal Appeals Court Rules West Virginia Medicaid Coverage Exclusion Of ‘Sex-Change’ Surgery Is Legal, Arthur S. Leonard

Other Publications

No abstract provided.

Perspectives On Choice Of Law Challenges In Multistate Precision Medicine Research, Laura M. Beskow, Catherine Hammack-Aviran, James W. Hazel, Leslie E. Wolf

Law Faculty Scholarship

This empirical legal study investigates challenges related to determining applicable law in multistate precision medicine research. Through interviews with experts in law, research ethics, and human subjects protections, the authors examine how differences in state laws governing research, genetic privacy, and data protection may affect participant rights and research practices. Interviewees reported varying levels of awareness regarding state law variation and expressed differing views on its significance. The findings suggest that uncertainty surrounding applicable legal frameworks can complicate research design, informed consent processes, and institutional oversight. The study calls for further legal and policy analysis to address these challenges and …

Can Legal Knowledge Save Lives? A Randomized Experiment In Preventive Health Screenings, Christopher Robertson, Wendy Netter Epstein

Faculty Scholarship

While the U.S. healthcare system typically imposes significant out-of-pocket costs, the Affordable Care Act (ACA) requires full insurance coverage for certain preventive health services (PHS), including cancer screenings, without cost-sharing. Despite this policy, one in four eligible Americans remains unscreened for breast, colorectal, and cervical cancer, which increases their risk of premature death. We hypothesize that a lack of awareness about the ACA’s free care requirement contributes to this gap and that explicitly informing patients could increase screening uptake. Additionally, we investigate whether prior experiences with medical debt deter individuals from seeking even cost-free care, reflecting a spillover effect of …

Beyond Subsidies And Mandates: Testing A Simple Behavioral Mechanism To Drive Health Insurance Coverage, Wendy Netter Epstein, Hansoo Ko, Christopher Robertson, Kevin Wilson, David Yokum

Faculty Scholarship

Uninsured individuals face reduced access to care, financial risk, and higher mortality. Although public programs and private subsidies have lowered uninsurance, these mechanisms remain incomplete and politically unstable. We evaluate whether a low-cost outreach intervention can increase health insurance enrollment without altering plan prices. Using a randomized field experiment involving 16,477 uninsured Maryland households, we assigned households to a no-contact control or to receive email and postcard outreach featuring affordability messaging alone or combined with responsibility or community framings. Outreach increased qualified health plan enrollment by 0.699 percentage points and total coverage by 0.967 percentage points relative to control. The …

Transforming Blood Management Systems In Developing Countries Through Technological And Artificial Intelligence-Driven Innovations, Sandeep Bhargava, Shaun Aaron Abram, Srividhya Ragavan

Faculty Scholarship

It is critical to ensure the safe and quality supply of blood among various stakeholders; however, this remains a significant challenge in today’s world, especially in developing countries. These countries face severe problems, including blood shortages, fragmented regulatory frameworks, and inconsistent quality control measures. To tackle these challenges, countries like India are trying to implement the use of artificial intelligence (AI) and its derivative platforms to transform blood collection, testing, storage, and distribution by enabling interoperability, real-time compliance monitoring, automated donor screening, optimized inventory management, and advanced component separation. The article argues that developing countries must adopt both regulatory reform …

Priority Without Progress: The Fda's Neglected Tropical Disease Voucher Program After 18 Years, Maple Goh, Kevin Outterson, Aaron Kesselheim

Faculty Scholarship

Introduction: To incentivize drug and vaccine development for neglected tropical diseases (NTDs), US Congress created the Priority Review Voucher (PRV) program in 2007. Sponsors that obtain Food and Drug Administration (FDA) approval for an eligible product receive a voucher redeemable to accelerate review of another product.

Methods: We reviewed the program’s public health impact by examining all 14 vouchers awarded for NTD products between 2007 and 2024, including the timing of FDA approval relative to World Health Organization (WHO) Prequalification, Essential Medicines List inclusion, first use in endemic countries, and voucher disposition.

Results: Eight (57%) achieved WHO …

Unwanted Medical Treatment Harms Patients: Taxonomy Of Healthcare Consent Infractions, Thaddeus Pope

Faculty Scholarship

Patients in the United States are subject to an ever-growing “avalanche” of unwanted medical treatment (UMT).  This is ethically, economically, and legally wrong. First, UMT constitutes a serious violation of patient autonomy and self-determination.  Second, it is waste (and often fraud or abuse) of scarce healthcare resources.  Third, but for rare exceptions, administering UMT contravenes settled legal rules and principles around consent and battery.

This article describe four types of unwanted medical treatment and how the law addresses (or fails to address) them.  The four types of UMT are (1) treatment over patient objections, (2) treatment with zero consent, (3) …

Chat M.D., Nathan Cortez

Faculty Journal Articles and Book Chapters

Large language models (LLMs) such as Claude and ChatGPT are the most powerful artificial intelligence (AI) systems ever created, and they are being used to diagnose and treat patients. But LLMs have been shown to be unreliable, unpredictable, and unsafe on occasion. New AI guidelines recommend hundreds of standards, such as ‘transparency’, ‘trustworthiness’, and ‘safety’. But there is deep uncertainty whether these are sufficient. The literature focuses mostly on which standards best suit AI models, not on how to transmute standards into law. This article does that by considering AI guidelines as a starting point, then evaluating whether existing frameworks …

Situating Stillbirth Within A Reproductive Justice Methodology Amidst Perilous Politics, Jamie Abrams

Book Reviews

Stillbirth and the Law, published in 2025 by the University of California Press, offers both a deeply personal and rigorously insightful examination of how law, medicine, and policy intersect around stillbirth. Jill Lens brings her full self to this work in ways that reflect deep feminist roots cultivated over years of Lens’s impressive scholarly production. Lens channels her lived experience of stillbirth into a comprehensive analysis that combines data, theory, law, narrative, policy, and pragmatic solutions.

The reader leaves the book equally feeling Lens’s deep love and longing for her son, Caleb, and equipped with a lengthy list of tools, …

The Deregulation Of Cancer, Daniel G. Aaron

Utah Law Faculty Scholarship

Fifty years ago, the U.S. embarked on a radical new path. Under pressure from the environmental movement, Congress passed an array of statutes aimed at regulating carcinogens out of our world. This regulatory experiment sprawled from air and water to food and consumer products.

Legal scholars have paid scant attention to this wave of cancer regulation despite its size and importance and the public’s apparent interest in avoiding carcinogens. But there is a growing literature finding flaws with individual regimes within the framework, such as the Clean Air Act, the Toxic Substances Control Act, and the Tobacco Control Act. In …

The Crisis In U.S. Cancer Care: Law, Markets, And Privatization, Daniel G. Aaron

Utah Law Faculty Scholarship

Cancer is surging among youth and young adults in the U.S., yet instead of public regulation addressing its root causes, we have outsourced the management of cancer to the private sector.  A suite of laws, embodying faith that corporations will cure cancer, has subsidized the cancer biomedical enterprise and transformed quasi-public institutions into marketized, profit-seeking entities.  These changes, across patent law, healthcare law, innovation law, and Food and Drug Administration (FDA) law, have privatized cancer. 

The market failures I describe in U.S. cancer care raise larger questions about who we entrust with managing critical social problems.  This Article provides theoretical …

First Amendment Protection For Unlicensed Wellness Coaches, Barbara Zabawa

Faculty Works

This article examines the constitutional implications of state efforts to license unregulated wellness practitioners, particularly wellness coaches. As occupational licensing expands, wellness services—ranging from nutrition counseling and life coaching to mindfulness and holistic practices—face increasing scrutiny. The paper argues that most wellness coaching involves speech rather than conduct and therefore qualifies for First Amendment protection. Drawing on Supreme Court and lower court precedent, it distinguishes between professional judgment that may justify state regulation and speech-based coaching practices that pose minimal risk of harm. The analysis situates wellness coaching within broader debates over professional regulation, consumer empowerment, and the marketplace of …

Access To Primary Care And Health Care Fragmentation, Sharona Hoffman, Ishani Ganguli

Faculty Publications

This Article examines the growing crisis of long primary care wait times and the health care fragmentation that is associated with them. Patients who feel ill or are worried about new symptoms must often wait weeks or longer for appointments. In the wake of excessive wait times for primary care physician (PCP) appointments, patients increasingly turn to convenience care models such as urgent care centers, retail clinics, direct-to-consumer telemedicine, and at-home testing. While these alternatives offer prompt attention, they sacrifice other core functions of primary care and may exacerbate poor health outcomes and inequities. The Article argues that long wait …