Health Law and Policy Commons^™

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 …

Reproductive Innovation And Reproductive Exceptionalism: How Private Health Insurance Coverage Of Fertility Treatment Complements Hostile Governmental Action And Expands Access To Assisted Reproduction In The United States, Myrisha S. Lewis

Faculty Publications

The use of fertility treatment and assisted reproductive technology (ART) in the United States and globally is increasing over time. As of April 2023, the World Health Organization estimates that approximately one in six individuals have faced infertility globally. Fertility treatment includes the use of drugs to stimulate egg production, in vitro fertilization (IVF), and, for some, the use of gestational surrogacy to aid in childbirth. Debates have abounded and continue to abound in federal legislatures, state legislatures, and society more broadly about the morality of abortion, contraception, and assisted reproduction, as well as whether governments, public insurers, and private …

High Hopes, Clouded Realities: Minnesota's Cannabis Legalization And The Hidden Health Risks, Allison Crescimanno

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

Green Dividends: A Case Study In Green Dividends And The Conditions For Private Ordering Solutions, Anne M. Tucker

Seattle University Law Review

This Essay introduces a novel private ordering solution to facilitate corporate investments in pro-social and environmental initiatives: Green dividends. Green dividends are an optional increase in shareholder dividends that are returned to the company to be reinvested in environmental initiatives or kept by a shareholder.

Green dividends pose an alternative to the current gridlocked debate that corporations can’t, won’t, shouldn’t, and shouldn’t even try to act in pro-social or environmental ways. Turning the common refrains on their head converts each narrative into an element for a successful private ordering solution: authority, accountability, shareholder buy-in, and government- backed enforcement. With Green …

Does Climate Disclosure Work To Reduce Greenhouse Gas Emissions? Emerging Evidence Suggests Cautious Optimism, Cynthia A. Williams

Seattle University Law Review

Significant regulatory resources have been spent developing global, voluntary climate and sustainability disclosure standards, such as the TCFD, TNRD, and ISSB’s Sustainability and Climate Disclosure standards, or domestically required disclosures, such as in the EU and in the U.S. Thus, it is important to evaluate whether this disclosure, particularly voluntary, qualitative disclosure, will have the power to shift the allocation of capital, will have a significant effect on the management of climate risk within firms, and ultimately will reduce climate change risk and biodiversity loss.

In this Article, several interrelated questions will be discussed. First, what does the empirical evidence …

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 …

Medication Abortion And The Mails: The Ghost Of Anthony Comstock Rides Again?, Lars Noah

UF Law Faculty Publications

Mail-order dispensing of the prescription drug mifepristone has become the latest flashpoint in this country’s long-running debate over abortion access. It also has brought back from the dead one of the oldest federal statutes to address that contentious subject. In their fight to limit access to a drug approved by the FDA one quarter of a century ago, abortion opponents have rediscovered the Comstock Act. Although amended on several occasions since 1873, Congress never managed to repeal or clarify its ambiguous language relating to abortion. On its narrowest reading, this provision would have no impact whatsoever on access to mifepristone; …

Flaws In The Preemption Defense To Liability Claims Against Generic Drug Manufacturers, Lars Noah

UF Law Faculty Publications

More than a dozen years have passed since the U.S. Supreme Court decided that federal preemption protects manufacturers of generic (but not brand-name) drugs from most types of products liability claims. This seemingly arbitrary distinction sprang from a peculiarity in the regulations of the U.S. Food and Drug Administration (FDA). That agency soon thereafter proposed to modify its rules in order to eliminate this asymmetry in how the implied preemption defense worked to bar inadequate warning claims, but its effort ultimately failed, while lower courts have confronted some creative efforts to circumvent the special protection enjoyed by generic drug manufacturers. …

Cognitive Decline And The U.S. Presidency: The Case Of Joe Biden, Mark Fisher, Sandy Sanbar

Health Matrix: The Journal of Law-Medicine

This article examines the intersection of cognitive health, medical ethics, and constitutional governance through the lens of President Joe Biden’s medical history and recent cognitive performance. Highlighting the absence of formal neurocognitive testing protocols for presidential candidates and sitting Presidents, it raises critical questions about transparency, accountability, and the statutory and ethical obligations of medical professionals serving in political contexts. The paper discusses Biden’s stroke history, neurosurgical interventions, and subsequent lack of documented cognitive assessments, emphasizing the implications for public trust and the constitutional duty to ensure an executive fit for office. It advocates for the implementation of standardized, objective …

The Chemical Straightjacket: Institutional Over-Use Of Psychotropic Drugs On Children In Lieu Of Therapeutic Community Mental Health Services, Marisa Leib-Neri

Indiana Journal of Law and Social Equality

This Article argues that the abysmal state of children’s mental health in America is in part due to an overreliance on and over prescription of psychotropic drugs inside psychiatric residential institutions in lieu of community based mental health services. This overreliance on residential institutions and psychotropic drugs has allowed a new form of chemical restraint to flourish—the chemical straitjacket. This Article uses the medication lists of twelve children in seven different North Carolina psychiatric residential treatment facilities to demonstrate how the chemical straitjacket operates: the prescription of drugs not approved for pediatric populations, counter to evidence-based practices for particular diagnoses, …

A Bloody Mess: Why Blood Plasma Donation Centers Are Not Public Accommodations Subject To Title Iii Of The Americans With Disabilities Act, Kevin D. Marshall

Indiana Journal of Law and Social Equality

No abstract provided.

Prescribing A Balance: Sustaining Environmental Health With Pharmaceutical Interest In Puerto Rico, Derek Warzel

Indiana Law Journal

Puerto Rico, often referred to as the “Medical Cabinet of the U.S.A.,” is a hub for pharmaceutical manufacturing, contributing significantly to the American medical supply chain and Puerto Rico’s economy. However, decades of industrial activity, compounded by climate events like Hurricane Maria, have led to severe environmental damage, particularly through groundwater contamination and damaged Superfund sites. This Note examines the historical intersection of economic incentives and environmental neglect in Puerto Rico, focusing on the pharmaceutical industry’s impact. By critically analyzing the Superfund program and proposing reforms, this Note advocates for a balanced approach: introducing proactive environmental protections and financial incentives …

Birth On Mother Earth: Mitigating The Maternal Health Crisis, Jill C. Engle

Faculty Scholarship

Maternal health outcomes in the U.S. are remarkably poor, especially when compared to those in other industrialized countries. For example, our maternal death rate is more than twice that of Canada’s. Women of color in the U.S. suffer maternal morbidity and mortality at rates considerably higher than white women. Indigenous women experience the worst maternal health outcomes of all. Yet, most maternal deaths and injuries are preventable. Furthermore, rates of maternal harm, including death, are lower when midwives and similar birthing attendants are involved. This Article is the first to fully explore the unique skillset of traditional birth attendants (TBAs). …

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 …

Federalism, State Action, And Workers’ Medical Privacy, Ani B. Satz

Faculty Articles

Injured workers entering state workers’ compensation systems effectively forego their medical privacy. This is due to widespread judicial misinterpretation of the HIPAA Privacy Rule (HPR) as excluding injured workers from federal medical privacy protections. As a result, medical privacy for workers’ compensation claims is effectively governed by state law. This Article argues that states have failed to protect the medical privacy of injured workers adequately and that there is a pressing need for legislative reform. The Article presents the first comprehensive survey in the legal literature of state action protecting the medical privacy of injured workers. Part I describes the …

Moral Panic Or Public Health Crisis? Lessons From Drugs And Gambling For “Addictive” Design, Matthew B. Lawrence, Haomin (Kevin) Yan

Faculty Articles

In her important book, Unwired: Gaining Control Over Addictive Technologies, Gaia Bernstein illustrates the value of a comparative approach, drawing lessons from fights around the regulation of tobacco and ultra-processed food for the regulation of social media. Building on Bernstein’s work, this symposium contribution aims to draw additional insight from experience with drug and gambling regulation for the regulation of social media, video games, AI, and other potentially-addictive technologies.

Specifically, after introducing Bernstein’s book and the foundation it lays, we draw six lessons from the study of psychoactive drugs and gambling. As we elaborate below: Lesson one is that …

Defederalizing Opioid Addiction Care, Matthew B. Lawrence

Faculty Articles

Lack of access to evidence-based care for drug addiction is an urgent problem amid a decades-long overdose crisis that kills tens of thousands of Americans a year. Opioid addiction is the primary driver of overdoses today, and medicines exist to treat such addiction that can dramatically improve quality of life while reducing the risk of deadly overdose by more than half. Yet fewer than one in four of the nine million Americans who need such evidence-based medical care for their addiction receive it. Chief among barriers to access are restrictive and burdensome federal requirements limiting the use of narcotic medications …

Recent Changes In Discretionary Denials Of Drug Patent Challenges, S. Sean Tu, Arti K. Rai, Aaron S. Kesselheim

Faculty Scholarship

Recent policy shifts at the U.S. Patent and Trademark Office (USPTO) have sharply limited the use of two administrative pathways for patent reviews, inter partes review (IPR) and post-grant review (PGR). Congress created these administrative pathways to provide a faster and less costly way to challenge weak patents. Recently, the USPTO has expanded the use of “discretionary denials,” invoking a new “settled expectations” rationale that blocks IPR petitions for patents more than about six years old. From May to September 2025, 60% of 506 requests for discretionary denial were granted, triple historical levels, including one-third involving drug patents. These changes …

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. …

Healthcare Ai's Unlearned Intermediaries, Charlotte A. Tschider

Faculty Publications & Other Works

The U.S. Food & Drug Administration (“FDA”), as the largest and one of the most influential federal agencies, plays a significant role informing downstream tort actions, such as product liability claims against medical product manufacturers.  The contours of the relationship between regulatory behavior and tort law are allocated according to congressional act and through judicial interpretation of agency action.  While artificially intelligent medical devices are technically regulated by the FDA, FDA regulatory approaches may not meaningfully reduce the probability of patient injury.  When, despite inadequate ex ante processes, injured plaintiffs cannot recover in tort due to court perceptions of regulatory …

Fighting Fgm In Minnesota: Minnesota Legislation Vs. Model Legislation, Molly Rosenfield

Mitchell Hamline Law Review

No abstract provided.

Dobbs V. Brown, Benjamin H. Barton

Dickinson Law Review (2017-Present)

Dobbs v. Jackson Women’s Health Organization1is the most important and impactful Supreme Court decision since at least Roe v. Wade, and potentially since Brown v. Board of Education. Past survey data show that most Americans can only name two Supreme Court opinions: Roe and Brown. Dobbs will surely join that list. This Article compares the history, drafting, and opinions of Dobbs and Brown to show what a missed opportunity Dobbs represents. Regardless of whether you agree or disagree with the opinion, it should be clear that Dobbs was one of those unique times (like that of Brown) where the Court …

Advancing Virtual Care Practices Across The Cognitive Impairment Continuum, Tara Sklar, Kathryn Huber

Health Matrix: The Journal of Law-Medicine

As the population of older adults grows, providing high-quality, costeffective healthcare for those with cognitive impairments is an increasing priority. The COVID-19 pandemic accelerated the shift towards receiving virtual care at home through temporary Medicare flexibilities. However, the uncertainty surrounding the continuing extension of these flexibilities at the federal level and variations in reimbursement policies across the states present challenges for virtual care practices to meet the rising demand for care amid unprecedented workforce shortages. Sustainable, long-term reimbursement at the federal and state levels, a trained and integrated healthcare workforce, and adherence to recognized accreditation standards and guidelines are essential …

A Small Price To Pay For Better Mental Health Crisis Care: Why States Should Be Funding The New 988 Hotline Through Phone Fees, Katherine Menello

Law Student Publications

Mental health care in the United States is uncoordinated, underresourced, and overall insufficient. Mental health crisis care is much the same, but with much higher stakes. The lack of a comprehensive mental health crisis care system across the country has led to law enforcement involvement becoming the default system in most communities. Yet, an overwhelming majority of Americans want a better way; in a survey conducted in summer 2023, “85% of people sa[id] they want a mental health response to someone experiencing a mental health, drug or suicide crisis, not a police response.”...

Integration Over Institutionalization: Addressing Rhode Island’S Institutionalization Of Developmentally Disabled Children Through An Olmstead Compliance Framework, Anna Macgillivray

Roger Williams University Law Review

No abstract provided.

The Value Of A Statistical Life: From Skin In The Game To Vision Zero, Michael C. Duff

All Faculty Scholarship

This essay discusses justice issues surrounding occupational safety and health and assesses the ethical legitimacy—the justice—of regulatory cost benefit analysis when the costs in question involve the risks and realization of workplace injury and fatalities. The current “value of a statistical life” for legal-regulatory purposes is 13.1 million dollars. While economists are careful to say that this figure does not “really” represent an attempt to value any particular life, the purpose of even calculating the number is to provide an “aggregated” statistical justification for saying “no” to rules requiring safer work. This seems acceptable until you, or someone you love, …

Pharmaceutical-Telehealth Confederacies, Michael S. Sinha

All Faculty Scholarship

Access to prescription pharmaceuticals has historically been controlled by a physician’s pen. As a result, pharmaceutical companies spend billions of dollars on advertising and promotion to mitigate this barrier: first and primarily, to physicians and other prescribers, and more recently, to the general public through direct-to-consumer advertising. The success of these promotional efforts can be seen in greater prescribing of costly brand-name medicines, even in settings where lower-priced generic alternatives exist. Brand-name prescriptions now make up only 10% of all prescriptions written yet account for 87% of drug spending. Despite these substantial returns on investment, companies continue to seek opportunities …

Ethical Issues In Pandemic Prevention, Preparedness, And Response, Govind Persad

Publications

Pandemic policies raise complex ethical challenges, as well as scientific and technical ones. This chapter examines four critical areas where ethical analysis is essential for effective pandemic prevention, preparedness, and response: spending decisions, clinical research, restrictions on rights and freedoms, and fair allocation of scarce medical resources.

Spending on pandemic prevention, preparedness, and response often involves trade-offs with other societal priorities, such as education, infrastructure, and environment. Navigating these trade-offs requires careful consideration of opportunity costs and distributional impacts.

Rights and freedoms can likewise present difficult trade-offs when pandemic policies restrict individual liberties, requiring clear goals and proportionate responses that …

Defining The Field Of Wellness Law, Barbara Zabawa

Faculty Works

Some lawyers practice “wellness law” without knowing what it is and how it differs from more recognized fields of practice such as health law, public health law, and medical malpractice. This article defines the field of wellness law using in a prescriptive manner the organizational framework that identifies the common and distinctive patterns in wellness and the law that surrounds it. This examination entails reviewing statutes and cases that differentiate between conventional health care and products or services outside of it to identify the core problems that are common and unique to wellness law. Those core problems are twofold. First, …