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 …

Fifty Years After Estelle V. Gamble—Where Does Carceral Health Law Go From Here?, James René Jolin, Jenean Docter, Benjamin A. Barsky

Faculty Scholarship

Fifty years ago, the US Supreme Court decided Estelle v.Gamble—a landmark case commonly known for establishing a duty on the government to provide health services to incarcerated people, whether before or after conviction. In this column, we offer a brief critical reappraisal of Estelle by reviewing its demanding legal standard and identifying a set of related litigation barriers that stymie the availability of relief in federal court. Given these constraints, we argue for a carceral health law paradigm that moves beyond the current, dominant focus on litigation.We use Medicaid law and policy as a case study to explore the …

The Coming Health Insurance Transition, Brendan S. Maher

Faculty Scholarship

For decades, the dominant form of private health insurance in the United States—by far—has been employment-based group health insurance. Somewhere in the range of 175 million employees and their families receive health care coverage through a system in which employers serve as financiers, procurers, administrators, and fiduciaries of the health insurance promise. An overwhelming percentage of those health insurance arrangements are governed by ERISA, with little room for state law.

That is going to change.

This Article explains—for the first time anywhere—why and how. Because of the tremendous and as-yet unrecognized power of an obscure-sounding funding arrangement called the Individual …

Angel Gutierrez-Zacatenco V. Rosa Herrera, 142 Nev. Adv. Op. 52 (Aug. 13, 2026), Sana Azim

Nevada Supreme Court Summaries

Incomplete medical records can be authenticated for admissibility purposes through a sufficient fact-specific demonstration of authenticity.

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 …

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.

Preemption Of State Fraudulent Transfer Law By The Bankruptcy Code, David G. Carlson

Articles

The article argues that state law tort claims based on fraudulent transfers are preempted by the Bankruptcy Code. It contends that allowing such tort claims to persist interferes with a bankruptcy trustee's ability to achieve universal settlements and recover assets, as the trustee cannot guarantee immunity from third-party tort liabilities.

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, …

Hipaa Coverage Of Pre-Processed Neural Telemetry From Brain-Computer Interface Implants, Yurie Lee

Cornell Law Library Cantwell Prize for Exemplary Student Research Papers

Brain-computer interface implants allow patients with degenerative neurological conditions to control robotic limbs or electronic devices through neural commands alone and suppress Parkinson's tremors or seizures in real time. These implants record neural signals millisecond-by-millisecond from electrodes implanted in the brain.

Nevertheless, BCI manufacturers have argued that this data falls outside the scope of HIPAA's Privacy Rule. Existing legal scholarship also seems to have accepted this as true.

This paper challenges that conclusion. It rebuts and considers manufacturers’ counterarguments, concluding that patients have a right to their pre-processed neural telemetry under HIPAA's right-of-access provision.

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.

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.

"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, …

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.

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 …

Birthdate Phaseout To A Nicotine Free Generation, Katharine B. Silbaugh

Faculty Scholarship

This Article explores the Nicotine Free Generation ("NFG") policy, an emerging endgame strategy for tobacco products that employs a completely novel legal design. Tobacco remains the leading cause of preventable death, killing almost half of its users and imposing $600 billion in social costs each year. We see two basic choices for regulating sales: prohibition or a legal age-gate, such as twenty-one, for retail sales. NFG charts a third way. Recognizing the dire harm of tobacco and the serious consequences of abrupt prohibition, NFG lays the groundwork for a gradual transition to a sales sunset. In place of the twenty-one …

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

Colorado Law Student Scholars

No abstract provided.

The American Asthma Patient, Ana Santos Rutschman

Faculty Publications

On average, one in twelve people in America have asthma, and ten patients die from asthma every day. A largely manageable disease, asthma nonetheless takes a tremendous toll on patients in the United States.

For almost two decades, these patients have seen the cost of asthma medication rise exponentially, even though some of the most commonly prescribed treatments have existed since the mid-twentieth century. Today, one in six asthma patients reports skipping, delaying or foregoing treatment for financial reasons.

This article presents a case study on a specific product—asthma inhalers—as a lens through which to examine the origins of the …

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 …

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 …

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.

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 …