Health Law and Policy Commons^™

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.

Byte By Byte: Breaking Down The Third-Party Doctrine And Reproductive Health Apps After Dobbs, Travis Handler

Oklahoma Law Review

No abstract provided.

Pro And Con Choice? Moral Equality, Neutrality, And Abortion Pill "Reversal", Melissa Ballengee Alexander

Oklahoma Law Review

No abstract provided.

Putting The “Social” Into Social Determinants Of Health: Why Policymaking For Improving Health Must Tackle Social Isolation And Loneliness, Laura C. Hoffman

Oklahoma Law Review

No abstract provided.

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, …

Equipped To Manage Risk, Case Western Reserve University School Of Law, Law-Medicine Center

Case Law-Med

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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 …

Beyond The Hype: The Use Of “Artificial Intelligence” In Healthcare And The Legal And Business Risks Associated With This New Technology, Greg Gulick

Marquette Intellectual Property & Innovation Law Review

None.

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, …