Health Law and Policy Commons^™

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 …

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 …

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 …

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 …

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. …

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 …

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.

Sociotechnical Safeguards For Genomic Data Privacy, Ellen W. Clayton, Zhiyu Wan, Et Al.

Vanderbilt Law School Faculty Publications

Recent developments in a variety of sectors, including health care, research and the direct-to-consumer industry, have led to a dramatic increase in the amount of genomic data that are collected, used and shared. This state of affairs raises new and challenging concerns for personal privacy, both legally and technically. This Review appraises existing and emerging threats to genomic data privacy and discusses how well current legal frameworks and technical safeguards mitigate these concerns. It concludes with a discussion of remaining and emerging challenges and illustrates possible solutions that can balance protecting privacy and realizing the benefits that result from the …

Honoring The Public Trust: Curbing The Bane Of Physician Sexual Misconduct, Rebecca H. Allensworth, K. S. Sindhu, Et Al.

Vanderbilt Law School Faculty Publications

The Federation of State Medical Boards defines physician sexual misconduct as any "behavior that exploits the physician-patient relationship in a sexual way." Although several attempts have been made in recent years to clarify its incidence in the United States, physician sexual misconduct is almost certainly underreported. Physician sexual misconduct represents a severe and irreversible violation of the compact underlying the patient–physician relationship and can have far-reaching consequences on the lives of patients and their families. In addition, the credibility of and trust in physicians, both essential to the provision of medical care, could well erode in the eyes of the …

Direct-To-Consumer Genetic Testing, Ellen W. Clayton, Et Al.

Vanderbilt Law School Faculty Publications

Direct-to-consumer genetic testing is marketed as a tool to uncover ancestry and kin. Recent studies of actual and potential users have demonstrated that individuals’ responses to the use of these tests for these purposes are complex, with privacy, disruptive consequences, potential for misuse, and secondary use by law enforcement cited as potential concerns. We conducted six focus groups with a diverse sample of participants (n = 62) who were aware of but had not used direct-to-consumer genetic tests, in an effort to understand more about what people considering these tests think about the potential value, risks, and benefits of such …

A Regulatory Policy Strategy For Protecting Immigrant Workers, W. Kip Viscusi, N. Marquiss

Vanderbilt Law School Faculty Publications

Immigration has become a focal point of many political campaigns, most notably that of President Trump in 2016 and again in 2020. Populist rhetoric also decries immigrant workers for taking Americans' jobs and depressing wages for U.S.-born workers. Yet immigrants serve a constructive role by working in some of the most dangerous occupations in the country. It is well-known that immigrant workers, particularly those from Mexico with limited English language skills, face a higher workplace fatality rate than native workers. Efforts to reverse this trend have long been the focus of the Occupational Safety and Health Administration (OSHA), which undertook …

Becoming Visible, Jennifer B. Shinall

Vanderbilt Law School Faculty Publications

This Article will consider the consequences of a large number of workers making their health conditions known to their employers during the pandemic. Becoming visible will likely have short-term costs for both employers and employees-—in terms of health-status discrimination, privacy, and administrative burdens. Nonetheless, this Article will ultimately argue that becoming visible also has a major benefit: improved information flow between employers and employees. Although the long-run cost-benefit analysis of increased health-status visibility during the pandemic remains to be seen, increased visibility ultimately has the potential to improve the employer-employee relationship.

The Perceived Risks Of E-Cigarettes To Others And During Pregnancy, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

Background

Public Health England has concluded that e-cigarettes are much safer than cigarettes for the user and for secondhand exposures, but it has not reached a definitive conclusion regarding pregnancy risks. How people perceive the risks to others is less well understood.

Methods

This study uses an online UK sample of 1041 adults to examine perceived e-cigarette risks to others and during pregnancy. The survey examines relative risk beliefs of e-cigarettes compared to cigarettes and the percentage reduction in harm provided by e-cigarettes.

Results

A majority of the sample believes that secondhand exposure to e-cigarette vapors poses less risk than …

Leave In The Time Of Covid: Examining Paid Sick Leave Laws, Jennifer B. Shinall

Vanderbilt Law School Faculty Publications

In the wake of the COVID-19 pandemic, Congress (as well as several states') passed emergency paid sick leave legislation? The federal legislation, known as the Families First Coronavirus Response Act (FFCRA), guaranteed most workers the right to eighty hours of sick leave at full pay while the employee was in COVID-19-related quarantine, plus an additional eighty hours of sick leave at two-thirds pay to care for another person in quarantine.' Congress felt compelled to pass such legislation because the United States infamously lags behind all other developed countries in guaranteeing paid health-related leave for workers. Of the top twenty-two highest …

Protecting Pregnancy, Jennifer B. Shinall

Vanderbilt Law School Faculty Publications

Laws to assist pregnant women in the workplace are gaining legislative momentum, both at the state and federal levels. Last year alone, four such laws went into effect at the state level, and federal legislation advanced farther than ever before in the House of Representatives. Four types of legislative protections for pregnant workers currently exist-pregnancy accommodation laws, pregnancy transfer laws, paid family leave laws, and state disability insurance programs but very little is known about how each type of legislation performs relative to the others. This Essay provides empirical insight into this question, which is important for setting legislative priorities. …

We Need A Cole Memorandum For Magic Mushrooms, Robert A. Mikos

Vanderbilt Law School Faculty Publications

In fall 2020, as the nation elected Joe Biden to be our Forty-Sixth President, Oregon voters also passed a noteworthy new drug law reform. Known as Measure 109, Oregon’s path-breaking law legalizes the use of psilocybin, a hallucinogenic substance found in magic mushrooms. Measure 109 is designed to unlock the therapeutic potential of psilocybin, which advocates tout as an effective and safe treatment for depression and other psychological conditions.

Given the burgeoning interest in psychedelics, many people are excited to see how Oregon’s psilocybin experiment pans out. But at this point, it remains unclear whether the experiment will even get …

Identifying Meaningful Dietary Intake And Physical Activity Questions For Individual And Population Health, Jennifer Bennett Shinall, David G. Schlundt, Et Al.

Vanderbilt Law School Faculty Publications

We aimed to identify valid screening questions for adults regarding physical activity and dietary behaviours that (a) were correlated with BMI, (b) were deemed by patients and providers to be relevant to clinical care, and (c) have utility for longitudinal understanding of health behaviours in populations. The goal was to identify screening questions that could be implemented at annual health care visits. First, we identified dietary behaviour questions and solicited patient input. Next, we tested both physical activity and dietary behaviour questions in a large sample to test their potential utility. Finally, we used cognitive interviews with patients and physicians …

Detecting Mens Rea In The Brain, Owen D. Jones, Read Montague, Gideon Yaffe

Vanderbilt Law School Faculty Publications

What if the widely used Model Penal Code (MPC) assumes a distinction between mental states that doesn’t actually exist? The MPC assumes, for instance, that there is a real distinction in real people between the mental states it defines as “knowing” and “reckless.” But is there?

If there are such psychological differences, there must also be brain differences. Consequently, the moral legitimacy of the Model Penal Code’s taxonomy of culpable mental states – which punishes those in defined mental states differently – depends on whether those mental states actually correspond to different brain states in the way the MPC categorization …

Pricing The Global Health Risks Of The Covid-19 Pandemic, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

Policies to address the coronavirus disease 2019 (COVID-19) require a balancing of the health risk reductions and the costs of economic dislocations. Application of the value of a statistical life (VSL) to monetize COVID-19 deaths produces a U.S. mortality cost estimate of $1.4 trillion for deaths in the first half of 2020. This article presents worldwide COVID-19 costs for over 100 countries. The total global mortality cost through July 2, 2020 is $3.5 trillion. The United States accounts for 25% of the deaths, but 41% of the mortality cost. Adjustments for the shorter life expectancy and lower income of the …

The Health And Legal Implications Of Early Screening For Developmental Disabilities, Jennifer Safstrom, Jacqueline Safstrom

Vanderbilt Law School Faculty Publications

Child development is a multifaceted process and there are certain milestones to reach that are imperative for healthy, timely growth and development.' Developmental monitoring, screening, and testing can aid in the identification, examination, and follow-up of a child's progress. However, there are a plethora of barriers which inhibit a child's ability to access and receive adequate, quality care. These broader factors, or social determinants of health, can lead to an underutilization of preventive health services, causing a delay in early identification and intervention for children. This can have serious, adverse repercussions, because targeting interventions among children from birth to five …

Electronic Cigarette Risk Beliefs And Usage After The Vaping Illness Outbreak, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

New national survey evidence on electronic cigarette (e-cigarette) risk beliefs indicates that people substantially overestimate the health risks posed by e-cigarettes, both in absolute terms and relative to conventional cigarette risk beliefs. Perceptions of the lung cancer risks and total mortality risks of conventional cigarettes function as prior risk beliefs for e-cigarettes. People believe e-cigarettes are at least 60% as risky as conventional cigarettes. Whether respondents have seen reports of vaping-related illnesses has no significant effect on risk beliefs, but there has been a modest increase in the percentage who believe that e-cigarettes are riskier than cigarettes. Accurate e-cigarette beliefs …