Health Law and Policy Commons^™

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 …

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 …

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.

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 …

Shareholder Expression In A Time Of Heightened Political Tension, Aaron A. Dhir

Seattle University Law Review

In this article, I provide context for my forthcoming research project on shareholder proposals and racial equity audits. Since the murder of George Floyd in May of 2020, progressive shareholder actors have increasingly used the proposal mechanism to advance diversity, equity, inclusion, and justice-related goals. These proposals have frequently gone beyond requesting the usual corporate fare of diversity trainings, intersectionality workshops, affinity groups, etc. Instead, a more ambitious type of proposal asks corporate America to conduct racial equity audits, defined as “an independent, objective and holistic analysis of a company’s policies, practices, products, services and efforts to combat systemic racism …

Corporate Governance Speech, Sarah C. Haan

Seattle University Law Review

The State has always regulated the intra-firm communications that make corporate governance possible, most commonly by mandating disclosures of information by a corporation to its shareholders. Some such laws are labeled “securities regulation,” but securities regulation is a broad category that extends to speech by actors who are outside the corporate enterprise as well. Also, the conventional securities regulation category does not capture all such laws; other examples, including informationforcing mandates, can be found in state corporate law. This Article uses the term “corporate governance speech” to describe the communications among shareholders, directors, and officers through which corporate governance is …

Dark Accounting Matter, Colleen Honigsberg

Seattle University Law Review

Physicists calculate that approximately 85% of the matter in the universe is composed of “dark matter” that “does not absorb, reflect, or emit electromagnetic radiation and is therefore difficult to detect.” The S&P 500 currently trades at a price-to-book value of 4.2, suggesting that book value accounts for less than 20% of the S&P 500’s market value. The remaining 80% appears nowhere in these firms’ balance sheets—it is invisible to contemporary accounting techniques and constitutes “dark accounting matter.”

Some “dark accounting matter” is composed of factors commonly described as components of “ESG.” Human capital, for example, is an intangible asset …

The Employees’ Dilemma: Balancing Internal Reporting, Whistleblowing, And Insider Trading Risks, Geeyoung Min

Seattle University Law Review

The Essay examines how recent developments in insider trading regulations and whistleblower reward programs can lead to unintended and counterproductive results of discouraging employees from using internal reporting channels within corporate compliance programs. While the presence of a robust and well-functioning corporate compliance program is a critical factor both in mitigating the level of public enforcement actions against companies and in protecting corporate managers from liability in private litigation, these programs often provide little incentive for employees to report potential misconduct internally.

Corporate compliance programs are designed to promote the upward information flow within the company, which is essential for …

How The Antidiscrimination Law Of Commercial Transactions Really Works, Helen Norton

Seattle University Law Review

A variety of businesses now cite 303 Creative when seeking First Amendment protection for their refusal to serve certain customers based on those customers’ protected class status. How this litigation will play out remains to be seen. But future courts need not, and should not, repeat the 303 Creative Court’s misunderstanding of how the antidiscrimination law of commercial transactions actually works.

Part I of this Essay explains the Court’s longstanding understanding of the antidiscrimination law of commercial transactions, and then describes the Court’s failure to engage with this precedent in 303 Creative. Part II then identifies the 303 Creative decision’s …

Understanding The Big Three’S Wavering Support Of Environmental And Social Shareholder Proposals, Jeff Schwartz, Jefferson Jensen

Seattle University Law Review

Because of their substantial equity portfolios, BlackRock, Vanguard, and State Street (the Big 3) are central players in corporate governance. It is, therefore, critical to understand how they vote. One puzzle is that their support for shareholder proposals on environmental and social matters appears to waiver. In 2020, for instance, BlackRock supported 11.1% of environmental proposals at S&P 500 firms. In 2021, it seemingly reversed course, supporting 55.2%. It then flipped again, supporting 32.1% in 2022. Such statistics suggest that the Big 3 are constantly changing their views on these topics. This Article seeks to better understand whether this is …

Volume 48 Masthead, Seattle University Law Review

Seattle University Law Review

Volume 48 Masthead

Patient-Practitioner Relationship In The Post-Dobbs American Landscape, Lynette B. Martins, Scott J. Schweikart

Pace Law Review

The patient-practitioner relationship is among the most sacred and fundamental in health care, particularly in the realm of reproductive care. Laws regulating what practitioners can and cannot discuss in the exam room with patients have made a resurgence in the post-Dobbs era. In the reproductive care context, these restrictive laws impact patients’ access to critical medical services but also the fundamental underpinnings of the patient-practitioner relationship. In a post-Dobbs era, laws restricting abortion are increasingly dangerous to the health of those seeking these services. With no federal protection for access to abortion services and abortion services hinging on …

We Have Lost Our Minds, Teneille Ruth Brown

Pace Law Review

This Article examines the paradoxical treatment of autonomy in American healthcare law. While autonomy has become the dominant principle in medical ethics and neoliberal market philosophies, pregnant people have been systematically denied this same autonomy through increasingly restrictive abortion statutes. Using the rhetoric of “informed consent,” abortion-restrictive statutes ironically pervert the animating principles behind the doctrine—rendering it almost meaning- less. I argue that this contradiction stems from the dehumanization of pregnant people who seek abortions, particularly through the denial of their capacity to have individual, complex mental states and feelings. Drawing on moral psychology, the Article demonstrates how pregnant people …

Formulating Public Pharma, Shweta Kumar

IPIPC Papers & Reports

In 2022, prices for both brand-name and generic drugs in the U.S. were nearly three times as high as prices in comparably industrialized nations, with the cost of insulin products in particular being nearly ten times as high. As a result, 3 out of 10 American adults cannot afford to take their medication as prescribed. Furthermore, in 2024 the U.S. experienced its worst drug shortage in over a decade, with more than 300 drugs in short supply. Generic drugs are particularly vulnerable to shortage, as manufacturers have poor economic incentives to produce drugs with slim profit margins. While the Biden …

Establishing A Perinatal Medical-Legal Partnership To Address The Health-Harming Legal Needs Of Pregnant And Postpartum Birthing People, Loral Patchen, Roxana Richardson, Lisa Kessler, Deborah Perry, Kimberly Martinez, Vicki W. Girard

Georgetown Law Faculty Publications and Other Works

This Report from the Field chronicles the establishment of Georgetown University’s Perinatal Legal Assistance and Wellbeing Project, a medical-legal partnership in Washington, D.C. It describes foundational steps, implementation strategies, and lessons learned, and reflects on impacts of addressing the unmet legal needs of birthing individuals.

Antiracist Medicine In Colorblind Courts, Govind Persad

Michigan Law Review

This Article considers how health professionals’ efforts to combat racial health inequities interact with legal restrictions constraining their ability to consider race. In light of the Roberts Court’s recent invalidation of two university admissions programs, intensifying a “colorblind” judicial shift, the collision between antiracist medicine and colorblind law is a pressing concern. This Article anticipates the implications of this collision and explores how health professionals and systems can design programs that survive judicial examination.

In Part I, the Article examines the frameworks that will apply if antiracist medicine faces legal challenges. These include the Equal Protection Clause and federal statutes …

Clinical Use Of Placebos: Medicine, Neuroscience, Ethics And The Law, Steven B. Perlmutter

Tennessee Journal of Law and Policy

My patient, a twenty-eight year old woman, presented with a three-week history of constant twitching of her left lower eyelid. She found it distracting and annoying, albeit it did not impair her vision. She had no other ocular symptomatology. Past ocular and medical histories were unremarkable, and she took no medications. She was preoccupied with a toxic divorce, which was traumatizing her eight-year-old son. She noted difficulty falling and staying asleep. Six weeks prior, her internist pronounced her a healthy but stressed woman. My examination revealed left lower orbicularis myokymia, i.e., spontaneous, involuntary twitching of the left lower eyelid. Her …

Aspek Keperdataan Dalam Upaya Penyelesaian Sengketa Medis Antara Pasien Dengan Tenaga Medis Berdasarkan Undang-Undang Kesehatan, Lintang Zandra Camellia, Adhitya Widya Kartika

Jurnal Hukum & Pembangunan

Medical disputes in the civil field are disputes that can occur between patients and doctor as a medical-professionals and are related to the full fillment of the rights and obligations of the binding relationship as a legal result in the provision of medical services. Medical disputes can lead to losses suffered by patients which can be in the form of limb disability, even death. The emergence of law and health provides a beneficial collaboration, where the health field can be used to face public health challenges and the law can be used to maintain peace and order in society. The …

Medical Aid In Dying (Maid): A Comparative Analysis Of Domestic And International Approaches To This Controversial Subject, Shaini Gofman

Global Business Law Review

This Note analyzes the Medical Aid in Dying (MAID) structures in various countries involving their eligibility criteria, application, and potential consequences. Section II analyzes MAID in the United States. Part A discusses the background and evolution of MAID laws in the United States on both a federal and state level. Part B is a multi-part analysis of the suggested expanded definition of terminal illness. Argument 1 evaluates the concept of the value of and respect for life; this is a threshold matter which will be the basis for the central arguments in this Note. Argument 2 explores the relationship between …

Liability For Use Of Artificial Intelligence In Medicine, Nicholson W. Price Ii, Sara Gerke, I. Glenn Cohen

Book Chapters

While artificial intelligence (AI) has substantial potential to improve medical practice, errors will certainly occur, sometimes resulting in injury. Who will be liable? Questions of liability for AI-related injury raise not only immediate concerns for potentially liable parties but also broader systemic questions about how AI will be developed and adopted. The landscape of liability is complex, involving healthcare providers and institutions and the developers of AI systems. In this chapter, we consider these three principal loci of liability. At the outset, we note a few issues that shape our analysis.

Caught In The Middle: Providing Obstetric Care When Pregnant Women Have Complications, Ellen Clayton, Luke Gatta

Utah Law Review

Physicians in abortion-restrictive states who care for pregnant women who become ill are facing new challenges as they try to meet their patients’ needs while avoiding criminal prosecution on the one hand or civil litigation if there is a bad outcome, especially when care is affected by the threat of vague statutes, on the other. All these legal actions will occur in the public eye. Unfortunately, the proposed changes to HIPAA do not protect against criminal prosecution when the medical exception for the woman’s health is at issue.

Two changes are needed. The first is amending the state statutes to …

Leading The Way: The Ninth Circuit Orders Reconsideration Of Lead-Based Paint Hazard Regulations In A Community Voice V. Environmental Protection Agency, Bae-Corine Schulz

Villanova Environmental Law Journal (1991 - )

No abstract provided.

Compounding Inequities Through Drug Ip And Unfair Competition, Shweta Kumar

IPIPC Papers & Reports

In 2024, the United States experienced its worst drug shortage in over a decade—more than 300 drugs are in shortage, leaving patients without access to lifesaving medicines. Luckily, drug manufacturers are not the only source of drugs. Through drug compounding, licensed pharmacists can create medications that are not commercially available due to discontinuations, shortages, or other supply chain issues. The recent slew of severe drug shortages has forced patients and physicians to rely on compounding pharmacies to make critical drugs for patients—particularly vulnerable patient populations, including pediatric, disabled, and transgender patients—such as mixed amphetamine salts (sold as Adderall), semaglutide (sold …

Designing And Developing A Medical-Legal Partnership To Address Cancer Patients' Health-Harming Legal Needs, Allison B. Dowling, Vicki W. Girard, Megan E. Gordon, Abigail Sweeney, Christopher M. Gallagher, Amy D. Ly, Lisa Kessler, Deborah F. Perry

Georgetown Law Faculty Publications and Other Works

The Georgetown University's Cancer Legal Assistance and Well-being Project launched in 2020 as a medical-legal partnership that works with health care providers at a Washington, D.C. safety-net hospital to treat the health-harming legal needs of historically and intentionally marginalized patients with cancer.

My Patient Or Law Enforcement, Who Gets First Say?, Hollis T. Redden

Arkansas Law Notes

Law enforcement is often left struggling with determining how to appropriately respond to nurses who refuse their request to collect a suspect’s blood when that patient is suspected of intoxicated driving and the officer has a valid search warrant. These scenarios trigger compliance issues including a patient’s right to privacy and consent, “particularly when a medical entity’s compliance with the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) provisions directly conflicts with law enforcement needs and goals.” Once a suspect becomes a patient, whose interest prevails? Is it healthcare providers’ interest in abiding by the rights, health, and safety …

Nonfinancial Conflict Of Interest In Medical Research: Is Regulation The Right Answer, Nehad Mikhael

Journal of Law and Health

Medical research plays a vital role in advancing human knowledge, developing new therapies and procedures, and reducing human suffering. Following the atrocities committed in the name of medical research by German physicians during the Nazi era, the Nuremberg trials were held, and an ethical code was created to establish the limits within which medical research can operate. Consequently, legal regimes built upon this ethical foundation to develop laws that ensure the integrity of medical research and the safety of human subjects. These laws sought to protect human subjects by minimizing conflicts of interest that may arise during the process. Furthermore, …

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; …