State Restrictions On Gender-Affirming Care: Implications For Transgender And Gender Nonconforming Children's Welfare, Yasmin Hubert

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

The Intersection Of Dementia And Criminal Behavior, J. Taylor Humphrey

Marquette Law Review

As the number of individuals affected by dementia increases, the criminal justice system continues to face questions about dementia and criminal responsibility. However, gaps in the legal process have left these individuals, incapable of forming intent, vulnerable to wrongful punishment. Courts rely on traditional culpability frameworks that fail to account for the nuance in dementia-related cognitive decline, and, as a result, prisons are forced to function as de facto nursing homes lacking adequate resources to provide proper care. This Comment proposes treating dementia as a sliding scale, arguing for a context-specific response through streamlined crisis response, use of diversion programs, …

Legal Barriers To Maternal Healthcare Equity, Ashley Keith

Akron Law Faculty Publications

In examining contemporary maternal healthcare inequity in clinical care delivery, we must study the critical role played by the legal institutions in creating and perpetuating this problem. Comprehensive systems within the United States require legal advocacy and judicial enforcement to take shape and maintain their structural integrity. Healthcare in this country is no different. Legal institutions helped form and further, both intentionally and inadvertently, the racial disparities that we currently battle. Legal history plays an integral role in understanding why racial disparities in maternal mortality persist. One way for legal professionals to contribute to the ongoing efforts to achieve maternal …

Venturing Into Health, Rachel Sachs

Scholarship@WashULaw

In recent years, the landscape of venture capital (VC) investment in healthcare technologies has been altered by the introduction of new types of VC firms: those that have emerged from hospital systems and health insurers. However, the legal literature has not yet analyzed these new VC firms, the role they may play in healthcare innovation, and how innovation law and policy ought to consider their involvement. Hospital system and health insurer VC firms operate very differently than do traditional VC firms, even those that have historically developed healthcare specializations. Instead of simply investing capital into start-up firms, hospital system and …

A New Framework For Drug Pricing Law And Policy, Rachel Sachs

Scholarship@WashULaw

Scholars and policymakers have expressed concern about the impact of high prescription drug costs on patients and healthcare budgets. This Article presents a new theoretical framework for evaluating both the problem to be addressed by drug pricing reforms as well as the efficacy of potential solutions. In seeking to solve “the drug pricing problem,” our legal system has given primacy to competition rather than regulation to drive down drug prices. This Article disaggregates the broader concept of “the drug pricing problem” into four steps, each of which must be addressed and each of which elevates different institutional actors to key …

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 …

Imperfect Access: Structural Barriers And External Threats To Preventive Care, Dorit Rubenstein Reiss, Richard H. Hughes Iv

Faculty Scholarship

Access to healthcare in the United States is often partial and inequitable. This is due in large part to a highly fragmented public-private system of providing health insurance coverage to its citizens. Yet, through incremental policy developments, the United States provides more comprehensive preventive care coverage across both public and private sources of coverage than in other areas of healthcare. Moreover, it has developed safety net programs intended to gap-fill access for those without insurance coverage. This is not surprising; like other countries, the United States realize that in addition to being just and equitable, broader access to prevention has …

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 …

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. …

Interest-Holder Priorities For Health Surveillance Of People Incarcerated In Canada: A Qualitative Study, Jessica Gaber, Njideka Sanya, Alice Cavanagh, Savage Bear, Sara Howdle, Iridian M. Grenada, Michelle Howard, Adelina Iftene, Fiona G. Kouyoumdjian

Articles, Book Chapters, & Popular Press

Objectives: As a core function of public health, health surveillance for people who are incarcerated could address gaps in knowledge regarding their health status. The views of people who could use these data and who are included in health surveillance data should inform health surveillance. In this study, we aimed to identify the priorities of interest-holders for health surveillance of people incarcerated in Canadian correctional facilities.

Study design: We conducted an overall qualitative descriptive study with an embedded reflexive thematic analysis and a qualitative content analysis.

Methods: We conducted virtual or phone-based focus groups and interviews with people across Canada, …

Tribal Health Self-Determination: The Role Of Tribal Health Systems In Actualizing The Highest Attainable Standard Of Health For American Indians And Alaska Natives, Vanessa Ann Racehorse

Publications

In this Article, I explore the concept of Tribal self-determination in the context of systems that serve American Indian and Alaska Native communities. I investigate the vast health disparities that exist in Tribal communities, as well as the history and current legal framework for the provision of health care in Indian Country. Part of this discussion also provides information on the federal laws and policies that have fractured the traditional lifeways of Native communities and contributed to the disparate health outcomes that now exist. I also provide background on the fundamental federal laws and policies, particularly the Indian Self-Determination and …

Public Patent Powers, Laura E. Dolbow

Publications

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 …

Displaying Wastewater Surveillance Data: An Ethics Framework, Govind Persad, Anne Barnhill, Douglas Mackay

Publications

No abstract provided.

Age And Saving Lives In Crisis Standards Of Care: A Multicenter Cohort Study Of Triage Score Prognostic Accuracy, Michael Hermsen, Patrick G. Lyons, Govind Persad, Alice F. Bewley, Chengsheng Mao, Kaveri Chhikara, Anoop Mayampurath, Matthew Churpek, Monica E. Peek, Yuan Luo, William F. Parker

Publications

No abstract provided.

Health Equity In Times Of Crisis: The Impact Of Economic And Public Health Shocks On Access To Care Among Women In Zimbabwe And The United States, Vimbainashe Dihwa

Theses and Dissertations

Abstract

This dissertation examines health equity during times of national public health and economic crises by examining access to care among women of reproductive age. Papers 1 and 2 estimate the effects of the 2020 Covid-19 pandemic in the United States (US). Paper 3 examines the potential effects of the 2008 hyperinflation and subsequent economic crisis in Zimbabwe.

Paper 1 assessed the role of health professional shortage areas (HPSAs) in the Covid-19 pandemic-related temporal trends in mental health access among women in the 18 to 44 years age group with self-reported anxiety and/or depression. The findings suggest decreased unmet prescription …

Who Decides: The Role Of Parental Rights In Abortion And Gender-Affirming-Care Decisions For Minors, Joanna L. Grossman

Faculty Journal Articles and Book Chapters

The American legal system presumes that children’s interests are best protected by their parents and, secondarily, by the state’s parens patriae authority. Yet this structure falters when parental authority and state power are infused with political and ideological agendas. This Essay examines how these dynamics have distorted decision-making authority in two contexts—minors’ access to abortion and gender-affirming medical care—and allowed children’s welfare and autonomy to be sacrificed to partisan aims. The law is inconsistent on the role of parental rights—typically empowering parents to grant or withhold consent to a minor’s abortion but categorically stripping them of the power to consent …

Pertanggungjawaban Etik Dokter Dalam Melakukan Aksi Mogok Kerja Di Indonesia, Farel Rifandanu

Jurnal Hukum & Pembangunan

The implementation of strikes by doctors is a complex phenomenon with significant implication that give rise to ethical dilemma. Doctors have a responsibility to provide health services, so that a strike can endanger the health care system. On the other hand, doctors also have the right to fight for fair and decent working conditions. In view of these problems, this study has two (2) problem formulations, how the legal regulations regarding the actions of doctors who go on strike and how the ethical responsibilities of doctors who go on strike. This study uses a normative legal research method that …

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 …

Artificial Intelligence And The Hipaa Privacy Rule: A Primer, Stacey A. Tovino

Faculty Articles

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, …

Pumpable Hours: Legal Protections For Lactating Individuals Through The Lens Of The Legal Profession, Elise Gonzalez

American University Journal of Gender, Social Policy & the Law

The Supreme Court denied women the right to be admitted to the legal profession in 1872. Since this ruling, women have entered the legal profession with force in growing numbers. Today, women comprise nearly 55% of law students across the country and 40% of practicing attorneys in the United States. Despite the growing number of women in the legal profession, women are often reminded of the profession’s sexist history, particularly during a period that is uniquely connected to women—motherhood.

Maternal Mortality According To State Abortion Legislative Climate Following The Us Supreme Court's Dobbs V. Jackson Women's Health Organization Ruling, Emily Nuss, Mari Iwasaki, Lindsay Robbins, Peggy Ye, Misa Hayasaka, George Saade, Tetsuya Kawakita

Department of Obstetrics & Gynecology Faculty Publications

Objective

We aimed to evaluate how maternal mortality rates have evolved across US states following the Dobbs ruling, while accounting for the confounding influence of the coronavirus disease 2019 (COVID-19) pandemic.

Study Design

We conducted a retrospective analysis of publicly available data from the Centers for Disease Control and Prevention Wide-ranging ONline Data for Epidemiologic Research (CDC WONDER) database from January 2018 to December 2024. This study period was divided into three intervals: (1) pre-COVID (January 2018 to February 2020), (2) pandemic (March 2020 to September 2022), and (3) post-Dobbs (October 2022 to December 2024). Using the Kaiser Family Foundation …

Medicare Drug Price Negotiations: A Blueprint For Ethical Pricing Across The Healthcare System, Jacqueline Fox

FIU Law Review

In a healthcare system with scarce resources, profit that exceeds the value of what is being paid for cries out for justifications. The Medicare Drug Price Negotiation Program, created by the Inflation Reduction Act of 2022, is a new program that allows Medicare to begin negotiating with drug companies to determine the maximum fair price for a small set of drugs. This Article argues that the methods for conducting these negotiations represent a significant step forward in a dramatic and important reordering of how we view the healthcare financing system, allowing us to consider rational, coherent concepts of value without …

The Interchangeable-Part Structure Of Food And Drug Law, Adam I. Muchmore

FIU Law Review

This Article demonstrates that nested tiers of interchangeable parts serve as the foundation for the regulatory programs administered by the U.S. Food and Drug Administration. Core interchangeable parts used in FDA-administered programs include product categories, prohibitions on adulteration and misbranding, agency-registration requirements, current good manufacturing practices, product standards, marketing authorization requirements, postmarket requirements, and user fees. In each of these areas, Congress or the FDA has engaged in interchangeable-part lawmaking (IPL). IPL occurs when a government takes a portion of its law in one subject area and uses it as a model for its own law in another subject area. …

Unvaccinated By Doubt: How Covid-19 Governance Sparked A Measles Revival, Ellen Black

FIU Law Review

A measles outbreak occurred in the United States this year, with measle cases reaching the highest levels in over two decades, even though the disease had been declared eliminated in 2000. In large part, this measles resurgence can be traced to unvaccinated individuals who have chosen to disregard public health officials' vaccination guidance. Clearly, the public has lost trust in their governmental public health officials. As the next disease outbreak looms, the need for restoration of trust becomes imperative.

This article demonstrates how the government's actions during COVID-19 further led to this lack of trust, by providing conflicting guidance as …

The Hunger Games: Food As A Right, Not A Privilege, Camesha F. Little

FIU Law Review

Despite the United Nations' explicit declaration that all humans have a right to food, food insecurity and hunger remain persistent problems in the United States and around the globe. The dystopian landscapes depicted in novels such as The Hunger Games and Parable of the Sower—societies crippled by poverty, oppression, and pervasive starvation—resonate with sobering contemporary realities. This Article examines existing food laws, food rights, and the current protections safeguarding the United States food supply from a humanitarian perspective. Ultimately, this Article argues that the human right to food must expand to encompass a right to healthy or natural food, and …

Decision-Making Supports And Cognitive Decline, Rebekah Diller

Articles

For persons with a range of cognitive disabilities, supported decision-making, rooted in a human rights approach to disability, has emerged as a tool that permits them to make legally binding decisions and avoid guardianship. As supported decision-making policy has evolved in the United States, state statutes have primarily focused on formal agreements through which individuals can designate trusted supporters to assist in obtaining information, processing that information, and communicating a decision. This Article argues that supported decision-making has promise for preserving the autonomy of persons living with dementia, but that the model of a supported decisionmaking agreement embodied in the …

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 …