Health Law and Policy Commons^™

Innovation Policy And Chronic Emergencies, Robert Burrell, Catherine Kelly

Vanderbilt Journal of Entertainment & Technology Law

The COVID-19 pandemic has thrust the potential role of the state as a driver of scientific innovation onto center stage. Vaccines have been developed and brought to market in a timescale that seemed almost impossible when the crisis first struck. The pivotal nature of government intervention in this crisis has added to calls from academics and policy makers to adopt a more proactive, mission-oriented approach to innovation policy to tackle other key global challenges.

This Article considers the merits of these calls and argues that an important distinction must be drawn between what this Article terms acute and chronic emergencies. …

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 …

A Zebra's Trust: How Rare Disease Communities' Participation In Data Trusts' Governance Builds Trust And Drives Research, Samantha C. Smith

Vanderbilt Journal of Transnational Law

Data sharing plays an increasingly prominent role in society, but it remains a necessary component of rare disease research. Because rare diseases are--as the name indicates-- rare, researchers have only a small number of patients from whom to collect data, and the expense of cross-border data sharing to increase research data is significant. Nevertheless, the rise of artificial intelligence and precision medicine increases the need for usable rare disease data. Current legislation and regulations aimed at addressing rare diseases fall short in addressing these data sharing needs for rare disease research. While the European Union (EU) has invested in rare …

The Duties Of Occupying Powers In Relation To The Prevention And Control Of Contagious Diseases Through The Interplay Between International Humanitarian Law And The Right To Health, Dr. Marco Longobardo

Vanderbilt Journal of Transnational Law

This Article explores the rules governing the prevention and control of contagious diseases in occupied territory under international law. Although the Article refers to the ongoing COVID-19 pandemic, its scope is broader and encompasses instances of state practice that have occurred over the last two centuries. After a careful analysis of the relevant treaties and episodes of state practice, the Article concludes that occupying powers have duties under international humanitarian law and international human rights law to prevent and control contagious diseases, through cooperating with the local authorities and bringing the necessary medical supplies in the occupied territory. The Article …

Your Body, Your Cells? Direct-To-Consumer Marketing Of Autologous Stem Cell Therapies In The United States, Japan, And Australia, Kathleen C. Laird

Vanderbilt Journal of Transnational Law

Stem cell tourism has relocated; patients in search of stem cell therapies to treat nearly any disease can find clinics selling miracle cures without traveling beyond their national borders. Businesses marketing unproven autologous stem cell therapies are now plentiful in highly regulated, wealthy countries, including the United States, Japan, and Australia. Despite regulatory oversight of stem cell therapies and strong support for scientific innovation in these countries, the internet and social media have facilitated the rapid growth and success of a new industry selling unproven treatments directly to consumers. Clinics selling unproven autologous stem cell therapies have succeeded by developing …

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. …

Make Hay While The Sun Shines: Private Equity And The False Claims Act, Gregory F. Maczko

Vanderbilt Law Review

For years, the federal government has used the False Claims Act to police fraud in the healthcare industry. Every year, the Department of Justice recovers billions of dollars from healthcare companies for their False Claims Act violations, both penalizing wrongdoers and providing incentives for whistleblowers to come forward. Over the past decade, however, private equity activity within the healthcare industry has increased significantly, presenting questions as to how the False Claims Act applies when a private equity firm’s portfolio company is accused of wrongdoing. This Note analyzes the ambiguity in how different courts have previously applied the False Claims Act …

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 …

Equal Protection And Ectogenesis, Brit J. Benjamin

Vanderbilt Journal of Entertainment & Technology Law

Ectogenesis is the gestation of a fetus in an artificial womb. This suite of technologies, now in use to preserve the lives of premature infants, is on the cusp of being a viable method of reproduction from conception to term. This Article argues that an equal protection challenge to a ban on utilizing ectogenetic technologies should be analyzed under intermediate or strict scrutiny. Should the US Supreme Court apply the rational basis or rational basis “with bite” standard of review to such a challenge, the petitioner should prevail.

The nature of ectogenesis is a technological alternative for a sex-specific organ. …

Intellectual Property As A Determinant Of Health, Ana S. Rutschman

Vanderbilt Journal of Transnational Law

Public health literature has long recognized the existence of determinants of health, a set of socioeconomic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are …

Re-Emphasizing African Bioethics In Light Of Potential Crispr-Based Treatment For Hiv And Sickle Cell Disease, Taylor Daniel

Vanderbilt Journal of Transnational Law

Recent genetic studies indicate that CRISPR-Cas9, a biological gene-editing mechanism derived from bacteria, may be capable of curing HIV and Sickle Cell Disease. Clinical research for HIV and SCD is prevalent in African nations because of the high incidence of those diseases in all forms. Because past research studies in Africa demonstrate how Western companies can abuse lax ethics regulations in developing African nations, ethics systems must prevent this new, potentially far-reaching CRISPR technology from being prematurely and unethically used on African research participants. In updating current international bioethics frameworks, drafters should pay particular attention to its application in African …

A World Of Their Own: Illiberal Religious Communities Struggle To Comply With Covid-19 Public Health Regulations, Shai Stern

Vanderbilt Journal of Transnational Law

The COVID-19 pandemic did not eliminate existing social tensions; rather, it at times intensified them. Thus, it is unsurprising that. the tension between the liberal state and illiberal religious communities likewise intensified, as those communities were late to comply with COVID-19 public health regulations issued by state authorities. This Article suggests that alongside the behavioral and psychological explanations for individual non-compliance, illiberal religious communities' late response to the COVID-19 threats stems out of these communities' unique characteristics and deeply held norms. It provides five explanations supporting this argument and argues that all result from the interventionist liberal-centric policies embraced by …

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 …

How Can Law And Policy Advance Quality In Genomic Analysis And Interpretation For Clinical Care?, Ellen W. Clayton, Barbara J. Evans, Gail Javitt, Ralph Hull, Professor, University Of Minnesota Law School, Megan Robertson, Pilar Ossorio, Susan M. Wolf, Thomas Morgan

Vanderbilt Law School Faculty Publications

Delivering high quality care to patients depends on having accurate test results whose clinical implications are understood. While these requirements apply throughout medicine, the question of how best to ensure the quality of genetic tests used in clinical care, in particular, has vexed scientists and regulators alike for roughly two decades. Numerous federal advisory committees, expert scientific bodies, and professional societies have weighed in on the issue, proposed a variety of approaches, and identified a number of governmental and non-governmental entities to regulate the quality of single-gene tests. Over time, the understanding and clinical use of genetic tests have increased …

Online Pediatric Research: Addressing Consent, Assent, And Parental Permission, Ellen Wright Clayton, Kyle B. Brothers, Aaron J. Goldenberg

Vanderbilt Law School Faculty Publications

Research with children lags far behind research with adults, even though research conducted with pediatric participants is critical to developing scientific knowledge that can benefit children. This is particularly apparent in the realm of pharmaceuticals. In a recent study, physicians prescribed an off-label medication to children in 18.5% of pediatric ambulatory care visits. In 74.6% of these cases, the medication was prescribed to treat a condition for which it did not have FDA approval, and in 17.6% of cases the medication was approved for the condition but not in the child’s age group. This widespread practice of using unapproved, and …

The Evolving Federal Response To State Marijuana, Robert A. Mikos

Vanderbilt Law School Faculty Publications

The states have launched a revolution in marijuana policy, creating a wide gap between state and federal marijuana law. While nearly every state has legalized marijuana in at least some circumstances, federal law continues to ban the substance outright. Nonetheless, the federal response to state reforms has been anything but static during this revolution. This Essay, based on my Distinguished Speaker Lecture at Delaware Law School, examines how the federal response to state marijuana reforms has evolved over time, from War, to Partial Truce, and, next (possibly) to Capitulation. It also illuminates the ways in which this shifting federal response …

Returning Results In The Genomic Era: Initial Experiences Of The Emerge Network, Ellen W. Clayton, Georgia L. Wiesner, Alanna K. Rahm, Et Al.

Vanderbilt Law School Faculty Publications

A goal of the 3rd phase of the Electronic Medical Records and Genomics (eMERGE3) Network was to examine the return of results (RoR) of actionable variants in more than 100 genes to consenting participants and their healthcare providers. Each of the 10 eMERGE sites developed plans for three essential elements of the RoR process: Disclosure to the participant, notification of the health care provider, and integration of results into the electronic health record (EHR). Procedures and protocols around these three elements were adapted as appropriate to individual site requirements and limitations. Detailed information about the RoR procedures at each site …

Redefining Lgbtq And Abortion Rights In Latin America: A Transnational Toolkit, Alyssa Julian

Vanderbilt Journal of Transnational Law

Throughout Latin America, the Lesbian, Gay, Bisexual, Trans, and Queer (LGBTQ) and abortion rights movements have progressed at divergent strengths and speeds, with significant variation among countries. The region is home to some of the most restrictive and discriminatory laws when it comes to these contentious issues. This Note explores some of the reasons behind the variation in LGBTQ and abortion rights throughout the region.

This Note traces the economic and political history of Latin America to illustrate the climate in which these social movements are operating. Further, this Note offers a brief snapshot of recent global developments in LGBTQ …

Encomium For Karen Rothenberg, Ellen W. Clayton

Vanderbilt Law School Faculty Publications

Karen is also a zealous advocate in the very best sense of the word. After Struewing's article appeared, she wrote an editorial that appeared in multiple newspapers arguing that women with these variants should not lose their insurance. She became deeply involved in the National Action Plan for Breast Cancer, a powerful grass roots organization. Additionally, she became involved at the National Institutes of Health and addressed, often in leadership roles, such issues to develop strategies to prevent genetic discrimination for individuals with variants that increased the risk of developing cancer, to create tools to obtain meaningful informed consent for …

Risk Guideposts For A Safer Society: Introduction And Overview, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

This symposium issue of the Journal of Risk and Uncertainty addresses wide-ranging policy issues pertaining to risk regulation and the economic underpinnings of these efforts. One such intervention consists of policies to address informational market failures. Whether new information has a positive value is less obvious than economists often assume. When more stringent regulations are required, the structure and evaluation of these efforts often hinges on the value of a statistical life, or the VSL. This symposium reports estimates of the utility functions that generate these local risk-money tradeoffs as well as new estimates of the VSL using both stated-preference …