Health Law and Policy Commons^™

Cybersecurity Risk Shifting, Deborah R. Farringer

Vanderbilt Journal of Entertainment & Technology Law

The Change Healthcare cyberattack of 2024 paralyzed the health care system for months, creating an exceedingly far reaching and devastating impact on providers, suppliers, and patients across the country. While the scope of the attack was unprecedented, the cyberattack itself was not new, unique, or isolated. Indeed, this attack came just months after the close of a year in which the United States’ Department of Health and Human Services’ Office for Civil Rights (OCR) recorded the highest number of reported breaches of protected health information and the highest number of breached records. With a medical record fetching nearly four times …

Patients Versus Profits, David A. Simon

Vanderbilt Journal of Entertainment & Technology Law

Two motives drive much of American health care. The first is the motive to heal the sick—the patient motive. The second is the motive to generate financial gains—the profit motive. This Article asks the following question: where do these two motives intersect and diverge? Using three emerging technologies as examples, this Article provides a framework for answering this question. It then uses this framework’s insights to explain when and how legal and extra-legal institutions can be used to improve care, either by constraining the profit motive or aligning it more closely with the goals of patient care. This Article concludes …

Reconceiving Safety Regulation For Ai And Ml Medical Software, Barbara J. Evans, Eric S. Rosenthal, Azra Bihorac

Vanderbilt Journal of Entertainment & Technology Law

This article explores the challenges of regulating AI and ML clinical decision support tools intended to assist trained health care professionals in delivering clinical care. Two old, twentieth-century regulatory models have dominated discussions of medical AI policy since 2013. Thinking inside these old regulatory boxes has not produced effective regulatory solutions to address the novel risks AI poses in clinical care. The first regulatory box treats software as a medical device, which tasks medical device regulators with making software safe but neglects the crucial roles physicians, nurses, administrators, medical practice regulators, and other health oversight bodies must also play to …

Ethical Sourcing In The Context Of Health Data Supply Chain Management: A Value Sensitive Design Approach, Camille Nebeker Edd, Ms, Ellen Wright Clayton, Et Al.

Vanderbilt Law School Faculty Publications

Abstract

Objective

The Bridge2AI program is establishing rules of practice for creating ethically sourced health data repositories to support the effective use of ML/AI in biomedical and behavioral research. Given the initially undefined nature of ethically sourced data, this work concurrently developed definitions and guidelines alongside repository creation, grounded in a practical, operational framework.

Materials and Methods

A Value Sensitive Design (VSD) approach was used to explore ethical tensions across stages of health data repository development. The conceptual investigation drew from supply chain management (SCM) processes to (1) identify actors who would interact with or be affected by the data …

Doctors Playing Lawyers: Lessons For Professional Regulation In Crisis, Rebecca H. Allensworth

Vanderbilt Law School Faculty Publications

When someone gets in legal trouble in America, their case is almost invariably decided by a lawyer (a judge), lay people (a jury), or a combination of the two. Professional discipline, however, is a giant unexplained exception. In professional discipline matters, accusations of dangerous or incompetent practice are decided, usually in the first instance but always in the last, by state licensing boards composed of other members of the accused’s profession. These licensing boards wield immense power as labor regulatory institutions, covering ten times as many American workers as the minimum wage and more workers than private and public sector …

Losing Lives Despite “Lifesaving” Exceptions: Examining The Fatal Flaws Of Vague Abortion Bans And The Spectrum Of Medical Decisionmaking In Cancer Care, Kiersten Wood

Vanderbilt Law Review

On June 24, 2022, the Supreme Court upended decades of precedent pertaining to reproductive health when it held that abortion fell outside the purview of constitutionally protected rights. Since then, conservative states have raced to institute stringent abortion bans, with many lacking explicit exceptions for pregnant individuals enduring medical emergencies that necessitate care. Ambiguous statutory language has induced a chilling effect in the medical arena, where providers risk criminal and civil liabilities by performing requested and medically recommended abortions for emergent patients when fetal development would risk the life of the pregnant individual. Seized in the crossfire of hyperpolarized politics, …

Dobbs And The Destabilization Of Clinical Trials, Allison M. Whelan

Vanderbilt Law Review

This Article explores an important yet overlooked collateral consequence of the U.S. Supreme Court’s elimination of the constitutional right to abortion in Dobbs v. Jackson Women’s Health Organization: the destabilization of clinical research. Specifically, this Article focuses on the harms to pregnant persons, persons capable of pregnancy, and persons of color that may transpire as a result of new barriers to clinical research in the aftermath of Dobbs. By hindering clinical research, these new obstacles will exacerbate existing health disparities experienced by these populations, which have historically been excluded from or exploited by the American healthcare and research systems.

This …

Societal Implications Of The Dobbs V Jackson Women's Health Organization Decision, Ellen Wright Clayton, Claire D. Brindis Dr., Ph.D., Melissa H. Laitner, Ph.D., Susan C. Scrimshaw, Ph.D., Barbara J. Grosz, Ph.D., Lisa A. Simpson, Md.

Vanderbilt Law School Faculty Publications

On June 24, 2022, the US Supreme Court's decision in Dobbs v Jackson Women's Health Organization marked the removal of the constitutional right to abortion in the USA, introducing a complex ethical and legal landscape for patients and providers. This shift has had immediate health and equity repercussions, but it is also crucial to examine the broader impacts on states, health-care systems, and society as a whole. Restrictions on abortion access extend beyond immediate reproductive care concerns, necessitating a comprehensive understanding of the ruling's consequences across micro and macro levels. To mitigate potential harm, it is imperative to establish a …

Patent Law's Role In Protecting Public Health, Sean B. Seymore

Vanderbilt Law School Faculty Publications

Innumerable inventions implicate public health-including drugs, vac- cines, dietary supplements, and sewage treatment plants. Over the past cen- tury, the Patent Office and the courts have modulated the ability to obtain or enforce patents for these inventions-whether in response to a public health crisis or to protect the credulous public from unscrupulous inventors. While normative and policy-based arguments can justify these interventions, they've disrupted the delicate balance of two competing policy objectives in patent law- enhancing public welfare and promoting innovation. This Article offers a new approach for courts to protect public health in patent cases-by making public health an …

On The Defensive: Analyzing Insurers' Duty To Defend Pharmaceutical Companies For Contributing To The Opioid Epidemic, Madison Perry

Vanderbilt Law Review

Opioids have had a devastating impact on the United States. They have drained governmental agencies’ resources, decreased property values, and destroyed families and entire communities. A growing number of individuals, local governments, and states have filed lawsuits, aiming to hold pharmaceutical companies accountable for their negligent contributions to the epidemic. Such manufacturers, distributors, and retailers have called upon their insurers, asserting that their commercial general liability policies demand an insurer- backed and bankrolled defense. Courts are divided in their interpretation of the language contained within the at-issue policies. Some consider the claims made by certain states and local governments to …

Exasperated But Not Exhausted: Unlocking The Trap Set By The Exhaustion Doctrine On The Fda’S Rems Petitioners, Michael Krupka

Vanderbilt Law Review

When health is at stake, bureaucratic delays can be disastrous. This is especially true in the field of pharmaceutical regulation. Fortunately, concerned parties—ranging from research institutions and universities to doctors and pharmaceutical companies—can file citizen petitions to urge the Food and Drug Administration (“FDA”) to regulate potentially risky drugs through Risk Evaluation and Mitigation Strategies (“REMS”) programs. But despite submitting comprehensive citizen petitions calling for changes to REMS determinations, petitioners regularly await the FDA’s response for years. When these petitioners, still awaiting an FDA determination, have sought recourse in the courts, the agency has argued that these petitioners have not …

Too Stubborn To Care For: The Impacts Of Discrimination On Patient Noncompliance, Alice Abrokwa

Vanderbilt Law Review

The role of implicit racial biases in police interactions with people of color has garnered increased public attention and scholarly examination over time, but implicit racial bias in the healthcare context can be as deadly, particularly when it intersects with ableism and sexism. Researchers have found that medical providers are more likely to consider Black patients “noncompliant,” meaning the patient has not adhered to recommended treatment, even without evidence Black patients are less compliant than other patients. Being labeled noncompliant can have grave health consequences; providers are less likely to treat pain aggressively when they consider a patient noncompliant and, …

A Bayesian Analysis Of E-Cigarette Risk Perceptions In The United Kingdom, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

Public Health England has communicated that e-cigarettes provide at least a 95% risk reduction compared to conventional cigarettes. This article's survey evidence indicates that adults in the United Kingdom believe that e-cigarettes are only 30%–40% safer overall and that they reduce lung cancer risks and total mortality risks by a similar percentage. A Bayesian analysis of risk beliefs finds that e-cigarette risk perceptions are anchored on prior cigarette risk beliefs. The public, especially smokers, underestimates the magnitude of the risk reduction being communicated by public health officials. Those who are aware of e-cigarette messages from Public Health England assess lower …

A New Green Wave: Lessons From Argentina's Marea Verde For Legalizing Abortion Over Religious Opposition In The United States, Morgan Peck

Vanderbilt Journal of Transnational Law

This Note examines the role Christianity, particularly Roman Catholicism, played in influencing abortion laws in the United States and Argentina and offers a solution for new federal protections of abortion rights in the United States. Part II discusses the evolution of abortion rights in both countries, from their foundations to their recent reversals. Part III scrutinizes the ways in which religious ideology factored into the different logical frameworks utilized by the different parties involved in the fight for abortion access, the relevant tactics employed, and the subsequent outcomes. Considering the impact in Argentina of US jurisprudence regarding abortion rights, the …

Mixed-Up Origins: The Case For A Gestational Presumption In Embryo Mix-Ups, Betsy A. Sugar

Vanderbilt Law Review

Embryo mix-ups-instances in which fertility clinics mistakenly implant one couple with another couple's embryo confound courts' determinations of who, between the two couples, are the legal parents. Lax regulation of the fertility industry permitted this relatively new injury to develop, and it has led to morally and legally fraught questions of parenthood and personal autonomy. This Note reviews parentage doctrines, beginning with a discussion of the martial presumption; it also tracks how courts have traditionally responded to parentage questions that fertility medicine has generated, including embryo division in divorce and parentage in surrogacy contracts. It then analyzes potential approaches to …

How Are You Holding Up? The State Of Judges' Well-Being: A Report On The 2019 National Judicial, Terry A. Maroney, David X. Swenson, Joan Bibelhausen, David Marc

Vanderbilt Law School Faculty Publications

Judges have always faced significant stressors, including the burden of consequential decision-making, exposure to disturbing evidence, and isolation. While every judicial assignment has its own mix of concerns, challenge is a constant. Recurrent experiences of serious stressors place judges at risk of burn-out, secondary trauma, poor mental and physical health, and substance use disorders.

Historically, such issues have been addressed primarily in the context of judicial fitness - that is, only when individual judges were suffering to the degree that they could no longer competently perform their duties would the system respond, and then usually for the purpose of discipline …

Is A Child's Life Twice As Valuable As An Adult's?, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

The rise of interest in evidence-based policymaking has created incentives for regulatory agencies to demonstrate the overall benefit-cost merits of their policies. An agency can use evidence to choose more cost-beneficial policies, or it can create the appearance of desirable policies by changing the ground rules by which it assesses a policy's merits.

The Consumer Product Safety Commission (CPSC) recently chose the latter course when monetizing the benefit of mortality risk reductions for children from a proposed safety standard for operating cords on custom window coverings. The cords are currently estimated to be responsible for nine fatal injuries annually. Each …

Developing Ethics And Equity Principles, Terms And Engagement Tools, Ellen W. Clayton, Rachele Hendricks-Sturrup, Shilo Anders, Et Al.

Vanderbilt Law School Faculty Publications

Background:

Artificial intelligence (AI) and machine learning (ML) technology design and development continues to be rapid, despite major limitations in its current form as a practice and discipline to address all sociohumanitarian issues and complexities. From these limitations emerges an imperative to strengthen AI and ML literacy in underserved communities and build a more diverse AI and ML design and development workforce engaged in health research.

Objective:

AI and ML has the potential to account for and assess a variety of factors that contribute to health and disease and to improve prevention, diagnosis, and therapy. Here, we describe recent activities …

When Patients Are Assailants: Valuing Occupational Risks, W. Kip Viscusi, Elissa P. Gentry

Vanderbilt Law School Faculty Publications

Intentional violence against healthcare workers inflicts a physical and mental toll, motivating legislative proposals to better regulate these occupational risks. This article uses this context to address two novel issues for benefit assessment raised by injuries from assailants: potential heterogeneity in valuation based on the context of the injury risk and possible reductions in self-reported valuations when the exposed population has been trained to feel responsible for the risk. This article presents experimental evidence on workers’ preferences over the form of intervention: protection (risk reduction) or insurance (cost-sharing). The experiment also elicits worker valuations of occupational health care risks, calculating …

Why Punish Pharma For Making Medicine? Preserving Patent Protections And Cutting Consumer Costs, Alex Wharton

Vanderbilt Journal of Entertainment & Technology Law

The push to lower pharmaceutical drug prices has taken a stronger foothold in legislative and executive actions in recent years. With average prices rising continuously over the past decade, many consumers struggle to pay for the medications they need-—insulin being the most often cited example. Accordingly, a variety of solutions have been suggested. Some solutions support reducing barriers for generic drugs to provide competition to the big brands, others push for greater regulation of manufacturers’ ability to price their drugs, and some proposals seek greater transparency to promote price negotiations, especially when compared to prices abroad. Most concerningly, however, one …

A Game Theoretic Approach To Balance Privacy Risks And Familial Benefits, Ellen W. Clayton, Jia Guo, Murat Kantarcioglu, Et Al.

Vanderbilt Law School Faculty Publications

As recreational genomics continues to grow in its popularity, many people are afforded the opportunity to share their genomes in exchange for various services, including third-party interpretation (TPI) tools, to understand their predisposition to health problems and, based on genome similarity, to find extended family members. At the same time, these services have increasingly been reused by law enforcement to track down potential criminals through family members who disclose their genomic information. While it has been observed that many potential users shy away from such data sharing when they learn that their privacy cannot be assured, it remains unclear how …

Human-Centered Design To Address Biases In Artificial Intelligence, Ellen W. Clayton, You Chen, Laurie L. Novak, Shilo Anders, Bradley Malin

Vanderbilt Law School Faculty Publications

The potential of artificial intelligence (AI) to reduce health care disparities and inequities is recognized, but it can also exacerbate these issues if not implemented in an equitable manner. This perspective identifies potential biases in each stage of the AI life cycle, including data collection, annotation, machine learning model development, evaluation, deployment, operationalization, monitoring, and feedback integration. To mitigate these biases, we suggest involving a diverse group of stakeholders, using human-centered AI principles. Human-centered AI can help ensure that AI systems are designed and used in a way that benefits patients and society, which can reduce health disparities and inequities. …

Returning Integrated Genomic Risk And Clinical Recommendations: The Emerge Study, Ellen W. Clayton, Jodell E. Linder, Aimee Allworth, Sara T. Bland, 100 Others...

Vanderbilt Law School Faculty Publications

The potential of artificial intelligence (AI) to reduce health care disparities and inequities is recognized, but it can also exacerbate these issues if not implemented in an equitable manner. This perspective identifies potential biases in each stage of the AI life cycle, including data collection, annotation, machine learning model development, evaluation, deployment, operationalization, monitoring, and feedback integration. To mitigate these biases, we suggest involving a diverse group of stakeholders, using human-centered AI principles. Human-centered AI can help ensure that AI systems are designed and used in a way that benefits patients and society, which can reduce health disparities and inequities. …

Call Me, Beep Me, If You Want To Reach Me: Utilizing Telemedicine To Expand Abortion Access, Samantha A. Hunt

Vanderbilt Law Review

In June 2022, the Supreme Court handed down its decision in Dobbs v. Jackson Women’s Health Organization. The decision confirmed what the public already knew. An anonymously leaked draft version of what ultimately became Justice Samuel Alito’s majority opinion had braced the country for Dobbs’s keyholding. Overturning decades of precedent, the Court found that there is no right to abortion in the United States Constitution. Shortly thereafter, states began implementing restrictions and near-total bans on abortion. These laws had an immediate effect on the safety of pregnant people. In Tennessee, a state where abortion is now outlawed, one woman had …

Concordance Of International Regulation Of Pediatric Health Research, Ellen W. Clayton, Mark A. Rothstein Jd, Et Al.

Vanderbilt Law School Faculty Publications

International, multi-site, pediatric health research has shown great promise by vastly increasing the amount and heterogeneity of biospecimens and clinical records. However, considerable impediments are created by the significant costs and delays associated with obtaining regulatory approval in numerous countries, which is often complicated by varying and sometimes opaque research ethics standards and procedures. Although it is unlikely that the global community could reach consensus on a single set of research ethics policies and procedures, voluntary policy pronouncements by countries agreeing to defer to the approval of research ethics bodies in other countries might be a way forward.

Deference is …

Differences By Race And Ethnicity In Title Ix's Effect On Women's Health, W. Kip Viscusi, Joni Hersch, Delaney Beck

Vanderbilt Law School Faculty Publications

Title IX greatly expanded adolescent females’ participation in athletic activities, which may have led to health benefits that extend into later life. Previous research has not explored whether health benefits arising from Title IX differ by race or ethnicity and has not examined women at older ages when health problems become more evident. This article examines the effect of Title IX on racial and ethnicity disparities in health outcomes by considering women aged 42–52 years. White women in these age groups exhibit declines in their self-assessed health status and increases in many health-related ailments, consistent with other evidence on temporal …

Compensating Differentials For Occupational Health And Safety Risks: Implications Of Recend Evidence, W. Kip Viscusi, Thomas J. Kniesner

Vanderbilt Law School Faculty Publications

The most enduring measure of how individuals make personal decisions affecting their health and safety is the compensating wage differential for job safety risk revealed in the labor market via hedonic equilibrium outcomes. The decisions in turn reveal the value of a statistical life (VSL), the value of a statistical injury (VSI), and the value of a statistical life year (VSLY), which have both mortality and morbidity aspects that we describe and apply here. All such tradeoff rates play important roles in policy decisions concerning improving individual welfare. Specifically, we explicate the recent empirical research on VSL and its related …

An Epidemic In Enforceability: A Growing Need For Individual Autonomy In Health Care Data-Privacy Protection In An Era Of Digital Tracking, Madeline Knight

Vanderbilt Journal of Entertainment & Technology Law

The health care system in the United States is under conflicting pressures. From one angle, there is a demand for the highest standard of care, which includes efficient, confidential communications between doctors and patients. From another, however, the technology that has facilitated such efficiency has outpaced the security mechanisms currently in place to protect a long-recognized right to privacy. In an era of data tracking, the important privacy interest that Congress has recognized since 1996 confronts a growing threat of data commodification. Despite significant potential consequences, however, there is neither guaranteed statutory recovery nor cohesion among states for the process …

Abortion, Pregnancy Loss, & Subjective Fetal Personhood, Greer Donley, Jill Wieber Lens

Vanderbilt Law Review

Long-standing dogma dictates that recognizing pregnancy loss threatens abortion rights-—acknowledging that miscarriage and stillbirthinvolve the loss of something valuable, the theory goes, creates a slippery slope to fetal personhood. For decades, antiabortion advocates have capitalized on this tension and weaponized the grief that can accompany pregnancy loss in their efforts to legislate fetal personhood and end abortion rights. In response, abortion rights advocates have at times fought legislative efforts to support those experiencing pregnancy loss and, more recently, remained silent, alienating those who suffer a miscarriage or stillbirth.

This Article argues that this perceived tension can be reconciled through the …

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.