Health Law and Policy Commons^™

Avoiding Four Fallacies In The Fair Allocation Of Influenza Countermeasures, Govind Persad, Johan L. Dellgren, Ezekiel J. Emanuel

Publications

No abstract provided.

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, …

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 …

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 …

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.

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 …

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). …

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 …

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 …

Dirty Water, Breanna Booker, Michael S. Sinha

All Faculty Scholarship

Plastics are taking over. Every day, humans are exposed to plastic pollutants in a variety of ways. From the water we use to water crops in the field, to the water in our taps, to the liquids we drink from plastic containers, it can be found virtually anywhere you look. Not only is it everywhere in the environment, but it is also within us. It builds up in our bodies. Plastics have become a major public health concern; researchers estimate that the total healthcare cost related to plastic chemicals may be as much as $250 billion.[1]

Water has always …

Consequences Of Artificial Intelligence In Health Insurance: Lawsuits, Policy, And Ethics, Alyssa N. Roberts

Honors Undergraduate Theses

In recent years, the healthcare system has been burdened by a multitude of obstacles that hinder the ability to provide effective, affordable, and timely care. Among these, one of the most significant challenges is the role that health insurance plays in shaping the quality of care. Health insurance companies are designed to decrease financial strain on patients, but they have introduced inefficiencies through delayed coverage approvals, increased denials, and administrative costs. Artificial intelligence (AI) has started to play an integral role in resolving these issues for the health insurance industry. Through its quick automated claim processing, fraud screening, and reduced …

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. …

Navigating The Legal Risk Universities’ Healthcare Providers Potentially Face From Medical Decisions Impacting Collegiate Athletes’ Future Nil Income While Following The Ncaa’S Mental Health Best Practices, Kenneth D. Ferguson

Fordham Law Review

No abstract provided.

Moral Politics Theory Applied To Abortion: Utopias, Dystopias, And Dobbs, Susan Ayres

Faculty Scholarship

This article examines Moral Politics Theory (MPT) as a way to understand current tensions in the US concerning reproductive justice. MPT, as developed and researched for over thirty years by cognitive scientist, George Lakoff, provides a way to explain differences in political worldviews. According to Lakoff’s research in Moral Politics and Don’t Think of an Elephant!, conservatives tend to hold a strict-father model, and progressives hold a nurturant-parent model. People in the political middle tend to endorse both models; Lakoff labels those in the middle as “biconceptuals,” and discusses how this group is most susceptible to persuasion because metaphors frame …

The United States Healthcare System: From Medicare To Post-Pandemic Health Policy, William M. Sage

Faculty Scholarship

My purpose in this essay is to comment on national health policy in the United States over the past sixty years.  My conclusions are less optimistic than what I had hoped when I began my teaching and research career in the 1990s to be able to say in 2025.  In particular, the successful expansion of publicly supported health coverage via the passage of the Affordable Care Act (“ACA” or “Obamacare”) in 2010 seems to have triggered -- though I hesitate to say that it caused – a backsliding from broader commitments to clinical performance, population health, and social solidarity that …

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 …

Most-Favored-Nation Drug Pricing—How Courts Could Shape Future Health Regulation, Nicholas Bagley, Craig Garthwaite, Benedic Ippolito

Other Publications

The Trump administration recently issued an Executive Order aimed at delivering most-favored- nation (MFN) drug pricing to the US. The order instructs drug manufacturers to reduce the prices of brand-name drugs to match the lowest price among selected high-income countries. If drug makers do not make significant progress toward this goal, the administration will pursue several strategies to lower prices. Most notably, the Executive Order directs the Secretary of Health and Human Services (HHS) to propose a rule to impose MFN pricing. In all likelihood, the administration will revisit prior efforts to enact MFN pricing through the Center for Medicare …

From Myriad To Moderna: The Modern (Bio)Pharmaceutical Company, Ana Santos Rutschman

Faculty Publications

This Article examines the emergence of two modern pharmaceutical companies: Myriad and Moderna. After providing a brief background on each company, this Article contrasts them across the following areas: the technologies they have brought to market; their location; their start-up stages and the role that venture capital played in catalyzing their evolution from start-ups to large corporate structures; their relationships with other entities in the private sector, in academia and in the public sector; and their intellectual property and licensing strategies.

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.

Promoting Public Health And Public Safety By Ending The Exclusion Of Incarcerated Children From Access To Medicaid, Eduardo R. Ferrer

Georgetown Law Faculty Publications and Other Works

This essay is a response to Professor Den Houter's article entitled Children are Not Inmates in which she effectively calls eliminating the exclusion of indigent incarcerated children from Medicaid coverage pursuant to the Medicaid Inmate Exclusion Policy (MIEP). This essay affirms and builds upon Professor Den Houter's recommendation. Part I of this response provides additional support for why ensuring system-involved youth receive timely, uninterrupted, high-quality behavioral health services is critical to improving both public health and public safety. Part II analyzes the benefits and risks attendant to excluding indigent incarcerated children from the MIEP. Part III proposes the implementation of …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Table Of Contents, Seattle University Law Review

Seattle University Law Review

Table of Contents

Corporate Scenarios: Drawing Lessons From History, Madison Condon

Seattle University Law Review

As corporations are increasingly pressed to reveal information about their exposure to climate-related risks, they are often asked to undertake and disclose the outcome of “scenario analysis.” In this exercise, corporations, including financial institutions, examine how their business would fare under different pathways the future may take. One oft-used scenario, for example, is the International Energy Agency’s “Net-Zero by 2050: A Roadmap for the Energy Sector.” This Essay presents a history of the use of scenarios as a corporate planning tool, particularly in the oil industry, arguing that it is key for understanding our present moment and the role of …