Health Law and Policy Commons^™

Patent Pending: How The Current Patent Utility Requirement Hinders Biotechnological Innovation, Madison Drlik

Journal of Law and Health

The legal system is always playing catch up to adapt to new legal landscapes, doctrines, and technology; however, patent law needs help to compete with biotechnological research in the race towards innovation. Biotechnological research in the realm of human health and medicine often involves the use of therapeutic drugs. The field of healthcare biotechnology takes biological systems and processes and generates novel, creative solutions to a number of human health conditions. However, the translation process for a new drug, therapy, or process is long and expensive which requires investors to help the researchers and scientists move their creations from inception …

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 …

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 …

Cutting Out The Middleman: How States Can Save Medicaid Dollars By Firing Pharmacy Benefit Managers, Hannah Garden-Monheit, Tyler Haydell

Center for Law and the Economy

Medicaid programs are currently under significant pressure from the passage of H.R. 1 (the “One Big Beautiful Bill”), which cuts federal Medicaid spending by an estimated $911 billion over 10 years — billions of dollars per state — and is projected to increase the number of uninsured by 10 million. H.R. 1 also imposes significant administrative burdens on both American families and states, by creating new work and reporting requirements. Faced with these challenges, cash-strapped states are scrambling to reduce costs.

One way certain states can realize cost savings is by removing Pharmacy Benefit Managers — middlemen known as “PBMs” …

Brief Of Law Scholars As Amicus Curiae In Support Of Appellees And Affirmance, Charles Duan

Amicus Briefs & Court Filings

Amici are law professors and scholars who focus their scholarship and teaching on intellectual property law, property law, regulatory law, and health law. They write to address the plaintiff, Novartis Pharmaceuticals Corporation (Novartis), contention that the Medicare drug price negotiation program effectuates a taking of personal property in violation of the Fifth Amendment. Amici submit this brief to provide the Court with the historical and legal background necessary to understand two issues: first, the constitutionality of government price negotiations and price regulations; second, the federal government’s use of patents. The amici explain how Courts have historically ruled on these questions, …

Making A Case For Legal Health Advocacy: A Socio-Legal Exploration Of The Law As A Tool For Physician Health Advocacy, Jeanne L. Webber

Master of Studies in Law Research Papers Repository

This paper grapples with the question of whether physicians have a unique moral, ethical or professional responsibility to engage in health advocacy. If so, what are the sources of that obligation, and how is advocacy understood in this context? These questions are addressed through a critical examination of the bio-medical, ethical, and legal literature and medical professional practice standards.

This research explores emergent themes in the literature including how advocacy is conceptualized, the challenges inherent in defining the term, and the consequent difficulty teaching health advocacy in medical education. This paper also examines how the value of advocacy is represented …

A Dynamic Alternative: Alumnus Thrives In International Trade Compliance, Catherine Deyarmond

Black History at St. Mary's University - 2025 Collection

Alum Robert Dunlap reflects on his time at St. Mary’s University in the International Relations Joint Degree Program and how it has set him up for his success in his chosen field. Dunlap’s dedication to his education and work has paid dividends in his professional career, allowing him to work in a San Antonio manufacturing business with ties to Mexico, but also for West Pharmaceutical Services, where he has handled new regulations impacting different sites around the world. Dunlap’s success is a shining example of the possibilities of an education at St. Mary's University, but also how alternatives to a …

How Is Access To Legal Resources And Advocacy Foundational To Health Justice?, Yael Zakai Cannon

Georgetown Law Faculty Publications and Other Works

Health justice as a movement incorporates research about how to more effectively leverage law, policy, and institutions to dismantle inequitable power distributions and accompanying patterns of marginalization that are root causes of health inequity. Legal advocacy is key to health justice because it addresses patients’ health-harming legal needs in housing, public benefits, employment, education, immigration, domestic violence, and other areas of law. In medical-legal partnerships, lawyers and clinicians are uniquely positioned to jointly identify and remove legal barriers to patients’ health, advocate for structural reform, and build community power.

On The Human Right To Healthy Menstruation, Bridget J. Crawford

Elisabeth Haub School of Law Faculty Publications

This short essay introduces the Bellagio Declaration on the Human Right to Healthy Menstruation, a statement signed by an interdisciplinary group of academics, artists, policymakers, clinicians, and practitioners in 2024. The Declaration frames the human right to healthy menstruation as including (1) non-discrimination on the basis of menstruation; (2) dignity in all matters related to menstruation; (3) access to facilities, resources, and supplies that facilitate the management of menstruation in a manner that is affordable and safe and that fosters a clean, healthy, and sustainable environment; (4) lifelong access to timely and medically accurate information about all aspects of menstruation; …

Drug Dealing And The Internal Morality Of Medicine, Matt Lamkin

Articles, Chapters in Books and Other Contributions to Scholarly Works

Which practices qualify as “medical” in nature? This question has important legal implications. Every state has laws prohibiting the “unauthorized practice of medicine.” Health insurance policies generally limit coverage to procedures that are “medically necessary.” And physicians can be prosecuted as drug traffickers if they prescribe controlled substances without a “legitimate medical purpose.” Each of these questions—and many others—hinge on how medicine is defined.

As with many common terms, we all have a general understanding of what medicine is and this heuristic suffices to carry us through our daily lives without complication. Yet when called on to produce a precise …

Exploring The African Regional Human Rights Standards As The Basis For An Enabling Environment For Self-Managed Abortion, Lucia Berro Pizzarossa, Michelle Maziwisa, Ebenezer Durojaye

Washington and Lee Journal of Civil Rights and Social Justice

Self-managed abortion holds great promise to save lives and promote reproductive autonomy, particularly in Africa. Indeed, the African region records very high numbers of unsafe abortions, and the burden of abortion-related mortality is the highest globally. Abortion remains generally criminalized in violation of numerous internationally and regionally recognized human rights standards. The advent of abortion medicines and the increased grassroots energy geared towards curbing the harms of unsafe abortion evince medical abortion holds great promise for revolutionizing people’s access to high-quality reproductive care. This study discusses regional human rights frameworks, policy, case law, and a few representative domestic legislative frameworks …

A Geographically Targeted Approach For A Preceptor Tax Incentive Using Primary Care Health Professional Shortage Areas (Hpsas), Julia Mattingly, Sarah Belcher, Samuel C. Kessler

Commonwealth Policy Papers

Years before the COVID-19 pandemic brought on a health care shortage in Kentucky, its rural areas were already struggling to obtain and attract primary care medical practitioners. Even though the number of medical school graduates in the U.S. has steadily increased throughout the years, there is a general disinterest in rural or small-town practice, and legislators throughout the country have pondered ways to address this issue plaguing communities. Versions of Preceptor Tax Incentive legislation in Kentucky have been proposed in the General Assembly to address care shortages in the state, however, all have been unsuccessful at truly targeting rural areas …

The Reckoning: The Return Of Genomic Results To 1444 Participants Across The Emerge3 Network, Ellen W. Clayton, Kathleen A. Leppig, Et Al.

Vanderbilt Law School Faculty Publications

The goal of Electronic Medical Records and Genomics (eMERGE) Phase III Network was to return actionable sequence variants to 25,084 consenting participants from 10 different health care institutions across the United States. The purpose of this study was to evaluate system-based issues relating to the return of results (RoR) disclosure process for clinical grade research genomic tests to eMERGE3 participants.

Medicine, Structural Racism, And Systems, Daniel G. Aaron, Fatima Cody Stanford

Utah Law Faculty Scholarship

Medicine is having a reckoning with systemic racism. While some continue to believe medicine is apolitical and grounded purely in science, history and research reveal that medicine is inseparable from underlying systems, laws, and policies. Obesity is a useful case study. Weight loss trials have shown the immense difficulty in achieving and sustaining weight loss without addressing overlying systems. Barriers are double for Black, Indigenous, and People of Color (BIPOC) with obesity, who must contend with multiple layers of oppressive systems. Increasingly, illness is not a matter of bad luck, but is a function of oppressive structures. COVID-19 likely originates …

Opioid Accountability, Daniel G. Aaron

Utah Law Faculty Scholarship

The opioid crisis has steadily killed Americans for twenty years. In total, we have lost 450,000 American lives since the 1990s, and countless more suffer from chronic addiction.

After years of piecemeal efforts to address this massive loss of life and health, the opioid litigation, largely centralized in Ohio federal district court, has brought significant hope for change. But there is a notable divide between the popular sense of the litigation and its reality. A full 57% of Americans believe that opioid companies should be held accountable for precipitating a public health crisis. However, the litigation has been dedicated to …

Estimating The Appropriate Size Of Global Pull Incentives For Antibacterial Medicines, Kevin Outterson

Faculty Scholarship

Antibacterial medicines should be foundational for modern medicine—a key part of the infrastructure of contemporary practice. Recently, however, antibacterials have struggled commercially. Even with “push” incentives (grants paid before regulatory approval), antibacterials have failed on the market because revenues are tied to volume sold. There are policy initiatives under way in the United States and United Kingdom that explore paying for exceptional antibacterials with “pull” incentives (paid after regulatory approval) by delinking the payments from volume via other payment formats such as market entry rewards and subscriptions. This article discusses these initiatives but also proposes an expected net present value …

Kidney, Money, And The Shī‘Ah Implementation Of The Rule Of Necessity, Zahra Takhshid

Sturm College of Law: Faculty Scholarship

In the U.S., over 43,000 people die every year waiting for a kidney. In Iran, however, monetary incentives have eliminated such a waitlist. Iran is the only country in the world with an unrelated living kidney donor program that has allowed for monetary incentives in the form of an altruistic gift, which has become known as “the Iranian Model.” Nevertheless, the legal details of the system remain vague and scholars both in and outside of Iran continue to debate the nature of the system. Does the Iranian system consider kidneys a commodity? Can you legally buy a kidney in Iran? …

Public Health In The Opioid Litigation, Daniel G. Aaron

Utah Law Faculty Scholarship

Today, the opioid crisis is playing out in the nation’s courts. Litigants have taken a microscope to defendant opioid companies whose misconduct ignited and exacerbated the opioid crisis. As the litigation continues, one could imagine numerous ways its resolution could contribute to the end of a multi-decade overdose crisis and prevent future ones. Options include holding defendant companies accountable, releasing previously secret information for research on root causes of the epidemic, and prohibiting future misconduct through injunctive relief. Unfortunately, to date, the litigation has not been so capacious. Rather, the participants—judge included—have been preoccupied with rapid monetary settlement. Though understandable, …

Achieving Better Care In Pennsylvania By Allowing Pharmacists To Practice Pharmacy, Travis Murray

Dickinson Law Review (2017-Present)

Traditionally, state legislatures implemented Prescription Drug Monitoring Programs (“PDMPs”) to assist prescribers, pharmacists, and law enforcement in identifying patients likely to misuse, abuse, or divert controlled substances. PDMP databases contain a catalog of a patient’s recent controlled substances that pharmacies have filled, including the date, location, the quantity of medication filled, and the prescribing health care provider. Prescribers in Pennsylvania have a duty to query the PDMP before prescribing controlled substances in most clinical settings. Pharmacists have a similar duty in Pennsylvania to dispense safe and effective medication therapy to patients and to screen patients for potential signs of misuse, …

The Double-Edged Sword Of Medical Patents: How Monopolies On Healthcare Products Disparately Impact Certain American Populations, Sarah Mcgraw

The University of Cincinnati Intellectual Property and Computer Law Journal

No abstract provided.

Damage Control Interdisciplinarity: An Antidote To Death Despair In Military Medicine, Erika "Ann" Jeschke

Saint Louis University Journal of Health Law & Policy

“Diseases of despair” is a conceptually broad category used to describe the phenomenon of premature mortality caused by suicide, drug poisoning, and alcoholic liver disease. Central to this conceptualization of mortality is that death occurs too early in an entire population of individuals infected with social despair. Implicit in the diseases of despair construct is a powerful normative claim about the manner and time of death—that death is bad if it is contextualized in unwanted conditions and happens before reaching midlife. As such, diseases of despair ought to be reduced, if not eliminated. Interestingly, military medical research on combat casualties …

Amending The Ryan Haight Act: Elevating Telemedicine Law To New Heights, Dillon Vaughn

Texas A&M Law Review

The Ryan Haight Act has established excessive restrictions on controlled substance prescribing through telemedicine by first requiring an in-person exam. If the Act is not amended, many individuals in need of medication will go without proper medical care. While other agencies and states have made moves to expand telehealth, the DEA has dragged its feet on making any significant changes. This Comment argues that the federal government should amend the Ryan Haight Act, allowing telemedicine providers to prescribe controlled substances without an in-person exam. This amendment would focus on the standard of care while requiring stringent documentation by physicians who …

Fetal Equality, Shaakirrah R. Sanders

Washington and Lee Law Review Online

I join Carliss Chatman’s call to fully consider the equal protection implications of the conception theory and raise an additional right to which a fetus may be entitled as a matter of equal protection: health care, which implicates state laws that provide civil and criminal exemptions to parents who choose religious healing instead of medical care for their children and minor dependents. The evidence of harm to children from religious healing is well documented. Yet, currently, approximately forty-three U.S. states and the District of Columbia have some type of exemption to protect religious healing parents in civil and criminal cases. …

No Treatment, No Hope, No Future: Decriminalization Of Heroin And Creation Of A Medical Dependent Standard, Alexander Mangano

Journal of Civil Rights and Economic Development

(Excerpt)

This Note will analyze the current ways heroin users are treated, stigmatized, and left with very little options upon recovery to support themselves and live a normal, productive life. Specifically, this Note will focus on how New York handles heroin users and their experiences with the criminal justice system. This Note proposes the decriminalization, not legalization, of only heroin use. To help addicts with recovery, diversionary courts and programs should be removed from the criminal justice system and instead act as a civil court. Additionally, the creation of a “medical dependent” classification will allow families to effectively force the …

Drowsy Driving Considerations In Non-Commercial Drivers For The Sleep Physician, Ann Marie Marciarille, Anand Bhat, David Ingram, Damien Stevens

Faculty Works

The sleep physician faces many challenges in the assessment of drowsy driving. The following article reviews current clinical evaluation methods and legal considerations at the state level in the United States.

Bearing Hospital Tax Breaks: How Non-Profits Benefit From Your Surprise Medical Bills, Taylor N. Armstrong

Georgia State University Law Review

This Note addresses the growing issue of surprise medical bills and how the United States Tax Code can be used to prevent many patients from receiving these bills. Part I provides a background on surprise billing and market factors that have led to an increase in the bills as well as current legislative solutions to the problem. Part II analyzes the role that hospitals play in the insurance market, the current standards for nonprofit hospitals to receive tax exemption under Internal Revenue Code (IRC) § 501, and how these legal standards fall short of accomplishing the goals of the tax …

Artificial Intelligence In The Medical System: Four Roles For Potential Transformation, W. Nicholson Price Ii

Articles

Artificial intelligence (AI) looks to transform the practice of medicine. As academics and policymakers alike turn to legal questions, including how to ensure high-quality performance by medical AI, a threshold issue involves what role AI will play in the larger medical system. This Article argues that AI can play at least four distinct roles in the medical system, each potentially transformative: pushing the frontiers of medical knowledge to increase the limits of medical performance, democratizing medical expertise by making specialist skills more available to non-specialists, automating drudgery within the medical system, and allocating scarce medical resources. Each role raises its …

Keynote: The Protection Of Lgbt Youth, Craig Konnoth

Publications

This keynote contains three parts. Part I addresses the intersection of two metaphors: medicine and childhood in LGBT Rights. Part II addresses the state regulation of LGBT youth. Part III offers Professor Konnoth's concluding remarks on the protection of LGBT youth.

Ethical Cannabis Lawyering In California, Francis J. Mootz Iii

St. Mary's Journal on Legal Malpractice & Ethics

Cannabis has a long history in the United States. Originally, doctors and pharmacists used cannabis for a variety of purposes. After the Mexican Revolution led to widespread migration from Mexico to the United States, many Americans responded by associating this influx of foreigners with the use of cannabis, and thereby racializing and stigmatizing the drug. After the collapse of prohibition, the federal government repurposed its enormous enforcement bureaucracy to address the perceived problem of cannabis, despite the opposition of the American Medical Association to this new prohibition. Ultimately, both the states and the federal government classified cannabis as a dangerous …

Health Care Referrals Out Of The Shadows: Recognizing The Looming Threat Of The Texas Patient Solicitation Act And Other Illegal Remuneration Statutes, Trenton Brown

St. Mary's Law Journal

Abstract forthcoming