Health Law and Policy Commons^™

Utility Functions For Mild And Severe Health Risks, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

This article reviews economic evidence on health-dependent utility functions and presents new estimates of utility functions for cancer. Estimates of health-dependent utility functions have found that mild adverse health impacts can be treated as monetary equivalents. Severe health consequences also reduce utility levels but have an additional effect of altering the structure of utility functions by reducing the marginal utility of income. The implications of past studies are often misleading when they fail to account for income losses and medical expenses associated with serious ailments. This article’s estimates of the structure of utility functions for cancer indicate a substantially lower …

Evaluating A Concussion Clause: Why The Nfl's Assumption Of Risk Defense Fares No Better As Time Goes On, Ramsey W. Fisher

Vanderbilt Journal of Entertainment & Technology Law

This Article explores the future of National Football League (NFL) concussion litigation. Currently, hundreds of retired NFL players who previously brought negligence claims against the NFL are seeking compensation under a settlement agreement reached in 2012. With many retired players exempting themselves from the 2012 agreement and current players learning more about the long-term risks of football, the potential for future negligence lawsuits against the NFL is still ripe. In any such suit, a key issue will be the NFLs'assumption of risk defense. The allure of the defense is intuitive-when one chooses to play professional football for a living, he …

The Pregnancy Penalty, Jennifer Bennett Shinall

Vanderbilt Law School Faculty Publications

Despite the renaissance of pregnancy-related scholarship over the past decade, 322 very little has been documented empirically regarding the status of pregnant women in the labor market. As such, scholars and advocates have been constrained in their ability to assess both the adequacy of current legislation and the relative urgency for new legislation. Furthermore, in the absence of labor market data, they have been limited in their ability to propose reform measures that can target the pregnant women most in need of assistance. This Article has taken an initial step towards filling these critical gaps in the literature, utilizing a …

A Systematic Literature Review Of Individuals' Perspectives On Privacy And Genetic Information In The United States, Ellen W. Clayton, Colin M. Halverson, Nila A. Sathe, Bradley A. Malin

Vanderbilt Law School Faculty Publications

Concerns about genetic privacy affect individuals' willingness to accept genetic testing in clinical care and to participate in genomics research. To learn what is already known about these views, we conducted a systematic review, which ultimately analyzed 53 studies involving the perspectives of 47,974 participants on real or hypothetical privacy issues related to human genetic data. Bibliographic databases included MEDLINE, Web of Knowledge, and Sociological Abstracts. Three investigators independently screened studies against predetermined criteria and assessed risk of bias. The picture of genetic privacy that emerges from this systematic literature review is complex and riddled with gaps. When asked specifically …

Approaches To Carrier Testing And Results Disclosure In Translational Genomics Research, Ellen Wright Clayton, Kathryn M. Porter, Et Al.

Vanderbilt Law School Faculty Publications

Background: Clinical genome and exome sequencing (CGES) is primarily used to address specific clinical concerns by detecting risk of future disease, clarifying diagnosis, or directing treatment. Additionally, CGES makes possible the disclosure of autosomal recessive and X-linked carrier results as additional secondary findings, and research about the impact of carrier results disclosure in this context is needed.

Methods: Representatives from 11 projects in the clinical sequencing exploratory research (CSER) consortium collected data from their projects using a structured survey. The survey focused on project characteristics, which variants were offered and/or disclosed to participants as carrier results, methods for carrier results …

Neuronal Testimonial: Brain-Computer Interfaces And The Law, Jessica L. Haushalter

Vanderbilt Law Review

Scientific researchers have developed a method of using brainscanning technology to determine if patients in a coma-like condition, known as a "vegetative state," are conscious despite their inability to communicate verbally or via motor actions. While in a brain scanner, patients "answer" yes-or-no questions by envisioning specific scenarios that activate different parts of the brain. A researcher interprets a brain scan image as a yes-or-no response based on which areas of the brain demonstrated activation. Exciting as this technology may be, there are difficulties in terms of the ability to use it within the legal system. This Note considers those …

Restore, Revert, Repeat: Examining The Decompensation Cycle And The Due Process Limitations On The Treatment Of Incompetent Defendants, Margaret W. Smith

Vanderbilt Law Review

Though correctional facilities are one of the largest providers of mental health care in the country, the treatment provided often fails to address the needs of many mentally ill inmates. Indeed, after receiving treatment at a state mental health facility, many pretrial detainees who have been recently restored to competency revert to an incompetent state-or decompensate-upon their return to jail, at which point they must return to the state treatment facility to be restored to competency once again. This Note is the first to explore this "decompensation cycle," highlighting the significance of the problem and demonstrating how mental health treatment …

Fashioning Worker Protections To Combat The Thin Ideal's Cost On Fashion Models And Public Health, Erin E. Meyers

Vanderbilt Journal of Entertainment & Technology Law

Studies linking thin-obsessed media consumption to poor health outcomes for women have permeated the medical literature for years. The pressures female fashion models face to sacrifice their health for their jobs are perhaps even more disturbing. These harrowing issues are symptoms of the "thin ideal," the social norm glorifying a female body type so thin it is unattainable for most women. Despite the clear harm imposed by the thin ideal, the United States has done little to combat its effect on the working conditions of fashion models and on public health more generally. This Note suggests that the US fashion …

When Trade Secrecy Goes Too Far: Public Health And Safety Should Trump Corporate Profits, Julie E. Zink

Vanderbilt Journal of Entertainment & Technology Law

This Article addresses the historical and ongoing use of trade secrets to withhold critical information from the public. Through its text and footnotes, the Article discusses the positives and negatives of trade secret protection; addresses historical and current examples of trade secret abuse; analyzes the inadequate solutions that have been tried and proposed; and, ultimately, recommends changing trade secret law by incorporating the precautionary principle into the definition of a trade secret to ensure that protection will no longer be available for information that endangers public health.

This Article is both timely and necessary, as the public is continually bombarded …

Ebola Does Not Fall From The Sky: Structural Violence & International Responsibility, Matiangai Sirleaf

Vanderbilt Journal of Transnational Law

This Article challenges the conventional understanding that international crises are limited to instances of direct physical violence. Instead, it argues that the disproportionate distribution of infectious diseases like Ebola is a form of structural violence that warrants international intervention. In the field of global public health, structural violence is a concept used to describe health inequities and to draw attention to the differential risks for infection in the Global South, and among those already infected, for adverse consequences including death, injury, and illness. This Article clarifies how the concept of structural violence can be operationalized in law. It illustrates the …

Cedaw And Treaty Compliance: Promoting Access To Modern Contraception, Katherine Sochacki

Vanderbilt Journal of Transnational Law

Modern contraception is widely recognized as a crucial component of family planning services and is recognized as a reproductive right under international human rights law. However, unmet need for contraception remains high, as many women in the developing world lack access to family planning services. This Note examines the role of the Committee on the Elimination of All Forms of Discrimination Against Women (CEDAW) and its powers as a treaty monitoring body in increasing access to modern contraception. Drawing on empirical research, the example of CEDAW's influence on abortion rights, and the domestic politics theory of treaty compliance, this Note …

Navigating The Research-Clinical Interface In Genomic Medicine: Analysis From The Cser Consortium, Ellen Wright Clayton, Susan M. Wolf, Laura M. Amendola, Et Al.

Vanderbilt Law School Faculty Publications

Purpose: The Clinical Sequencing Exploratory Research (CSER) Consortium encompasses nine National Institutes of Health– funded U-award projects investigating translation of genomic sequencing into clinical care. Previous literature has distinguished norms and rules governing research versus clinical care. This is the first study to explore how genomics investigators describe and navigate the research–clinical interface. Methods: A CSER working group developed a 22-item survey. All nine U-award projects participated. Descriptive data were tabulated and qualitative analysis of text responses identified themes and characterizations of the research–clinical interface. Results: Survey responses described how studies approached the research–clinical interface, including in consent practices, recording …

Prescriptions At A Price: America's Opioid Crisis And The Increasing Toll On Drug Record Privacy, Reem Blaik

Vanderbilt Journal of Entertainment & Technology Law

How should the US Constitution govern patient privacy in the face of a public health emergency? Declaring the United States' opioid crisis as a public health emergency may put the already-compromised integrity of drug record privacy at higher risk by virtue of emerging administrative responses, existing Supreme Court precedent, and acquiescent state laws. The White House convened a summit on opioids where the then-US attorney general discussed law enforcement responses to the crisis. Although the Fourth Amendment protects against unreasonable searches and seizures, the Supreme Court's third-party doctrine generally grants state and federal actors access to records released to third …

The Net Effects Of Medical Malpractice Tort Reform On Health Insurance Losses, W. Kip Viscusi, Patricia H. Born, J. Bradley Karl

Vanderbilt Law School Faculty Publications

In this paper, we examine the influence of medical malpractice tort reform on the level of private health insurance company losses incurred. We employ a natural experiment framework centered on a series of tort reform measures enacted in Texas in 2003 that drastically altered the medical malpractice environment in the state. The results of a difference-in-differences analysis using a variety of comparison states, as well as a difference-in-difference-in-differences analysis, indicate that ameliorating medical malpractice risk has little effect on health insurance losses incurred by private health insurers.

Intersectional Complications Of Healthism, Jennifer B. Shinall

Vanderbilt Law School Faculty Publications

For Americans in the labor market with health conditions that fall outside the scope of the ADA, the rehabilitation Act, and GINA, antihealthism legislation, like the kind proposed by Roberts and Leonard, 9would unquestionably serve as a critical first step in increasing their legal protections in the workplace. Moreover, to the extent that such legislation would also operate outside the workplace, it could expand legal protections even for individuals who presently enjoy coverage by disability and genetic discrimination laws solely inside the workplace. Yet, as this article has argued, simple healthism-discriminatory animus based solely on health-may be surprisingly rare. Existing …

Reading Remedially: What Does "King V. Burwell" Teach Us About Modern Statutory Interpretation, And Can It Help Solve The Problems Of Cercla § 113(H)?, Benjamin Raker

Vanderbilt Law Review

In the latter half of the twentieth century, Congress drafted a law to solve a problem. As decades passed, that problem became increasingly complex. In the new millennium, Congress became increasingly polarized, and increasingly unproductive. In the face of that inaction, the executive branch decided to rely on a provision of that earlier law to address a modern facet of that earlier problem. Or litigants decided to ask a court to rely on a provision of that earlier law to address a modern facet of that earlier problem. The Congress that drafted the law might not have understood this modern …

No Vip Treatment: Acos Should Not Get Waiver Protection From The Prohibition On Beneficiary Inducement, Soraya Ghebleh

Vanderbilt Law Review

Virgil is known for saying "the greatest wealth is health."' Based on the astronomical amount spent on healthcare, the United States has taken his idea literally-spending more "wealth" will lead to greater "health." In 2006, the United States spent over seven thousand dollars per person annually on healthcare. While that number may not seem very high to spend on an individual level, the total amounted to approximately 2.1 trillion dollars in 2006. In 2014, that number hit three trillion, or seventeen percent of the country's Gross Domestic Product ("GDP"). One justification for spending nearly one-fifth of the United States GDP …

Public Attitudes Towards Consent And Data Sharing In Biobank Research, Ellen Wright Clayton, Saskia C. Sanderson, Kyle B. Brothers, Nathaniel D. Mercaldo, Other Contributers

Vanderbilt Law School Faculty Publications

Individuals participating in biobanks and other large research projects are increasingly asked to provide broad consent for open-ended research use and widespread sharing of their biosamples and data. We assessed willingness to participate in a biobank using different consent and data sharing models, hypothesizing that willingness would be higher under more restrictive scenarios. Perceived benefits, concerns, and information needs were also assessed. In this experimental survey, individuals from 11 US healthcare systems in the Electronic Medical Records and Genomics (eMERGE) Network were randomly allocated to one of three hypothetical scenarios: tiered consent and controlled data sharing; broad consent and controlled …

Genome Editing And The Jurisprudence Of Scientific Empiricism, Paul Enriquez

Vanderbilt Journal of Entertainment & Technology Law

Humankind has reached, in tow by the hand of a scientific breakthrough called CRISPR, the Rubicon of precise genetic manipulation first envisioned over fifty years ago. Despite CRISPR's renown in science and its power to transform the world, it remains virtually unaddressed in legal scholarship. In the absence of on-point law, the scientific community has attempted to reach some consensus to preempt antagonistic regulation and prescribe subjective standards of use under the guise of a priori scientific empiricism. Significant and complex legal issues concerning this technology are emerging, and the void in legal scholarship is no longer tolerable.

This Article …

Following Footsteps: How Federal District Court Jurisprudence Protects Health Data In The Workplace, J. T. Parisi

Vanderbilt Journal of Entertainment & Technology Law

With the growing popularity of fitness tracking technology, employers have started to provide their employees with fitness tracking devices in order to obtain a subsidy on employer group health plans. Access to this data creates an opportunity to abuse the data by using it when making employment decisions. This Note analyzes how the current legal framework does not adequately protect the data and employees. The solution suggests using a recent case to provide the Equal Employment Opportunity Commission with authority to regulate employers' use of the health data until adequate privacy and data security laws can address the problem.

The American Bar Association's Criminal Justice Mental Health Standards: Revisions For The Twenty-First Century, Christopher Slobogin

Vanderbilt Law School Faculty Publications

In 1981, the American Bar Association ("ABA"), bolstered by a grant from the John D. and Catherine T. MacArthur Foundation, decided to develop standards for governing the involvement of persons with mental disabilities in the criminal justice system. To accomplish this task the ABA established six task forces, each focused on a different topic, and each composed of judges, prosecutors, defense attorneys, law professors, and mental health professionals well-known for their expertise about criminal mental health law. The result, promulgated in 1984 by the ABA's House of Delegates, was more than eighty black letter Criminal Justice Mental Health Standards, accompanied …

Health Insurance Mandates, Mammography, And Breast Cancer Diagnoses, Christopher K. Carpenter, Marianne P. Bitler

Vanderbilt Law School Faculty Publications

We examine the effects of state health insurance mandates requiring coverage of screening mammograms. We find evidence that mammography mandates significantly increased mammography screenings by 4.5-25 percent. Effects are larger for women with less than a high school degree in states that ban deductibles, a policy similar to a provision of federal health reform that eliminates cost-sharing for preventive care. We also find that mandates increased detection of early stage in-situ precancers. Finally, we find a substantial proportion of the increased screenings were attributable to mandates that are not consistent with 2014 recommendations of the American Cancer Society.

Unfulfilled Promises: Discrimination And The Denial Of Essential Health Benefits Under The Affordable Care Act, Jennifer B. Shinall

Vanderbilt Law School Faculty Publications

The passage of the ACA is a source of great pride for President Barack Obama's Administration, and the President undoubtedly hopes that the ACA will be his greatest legacy. 285 As a result, it is difficult to understand why, under his administration, HHS has relinquished its rulemaking authority to the states regarding the core guarantees of the Act. For the individuals living in states in which promised essential health benefits have not yet become a reality, HHS has offered a glimmer of hope. In 2012, the agency released a bulletin stating that it would "revisit" its approach of allowing states …

The Relationship Between The Markets For Health Insurance And Medical Malpractice Insurance, W. Kip Viscusi, J. Bradley Karl, Patricia H. Born

Vanderbilt Law School Faculty Publications

This article evaluates the interdependence of medical malpractice insurance markets and health insurance markets. Prior research has addressed the performance of these markets, individually, without specifically quantifying the extent to which they are linked. Increasing levels of health insurance losses could increase the scale of potential malpractice claims, boosting medical malpractice losses, or could embody an improvement in medical care quality, which will reduce malpractice losses. Our results for a state panel data set from 2002 to 2009 demonstrate that health insurance losses are negatively related to medical malpractice insurance losses. An additional dollar of health insurance losses is associated …

Risk Beliefs And Preferences For E-Cigarettes, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

Drawing on evidence from a new nationally representative survey, this article examines several measures of risk beliefs for e-cigarettes. For both lung cancer mortality risks and total smoking mortality risks, respondents believe that e-cigarettes pose risks that are lower than the risks of conventional tobacco cigarettes. However, people greatly overestimate the risk levels of e-cigarettes compared with the actual risk levels. Risk beliefs for conventional cigarettes receive at least a two-thirds informational weight in the formation of e-cigarette risk beliefs. Public perceptions of nicotine levels of e-cigarettes are closer to the beliefs for conventional cigarettes than are their health risk …

The Fatality And Morbidity Components Of The Value Of Statistical Life, W. Kip Viscusi, Elissa Philip Gentry

Vanderbilt Law School Faculty Publications

The fatality risk–money tradeoff that is the value of a statistical life (VSL) may vary with the nature of the fatality event. While all fatalities involve loss of future life expectancy, the morbidity effects and their duration may differ. This article analyzes fatality risks accompanied by morbidity effects of different duration to disentangle the mortality and morbidity components of VSL using data from the Census of Fatal Occupational Injuries (CFOI). The VSL is comprised of the sum of the value of the fatality risk and the value of the morbidity risk. Labor market valuations of morbidity risks are positive, even …

Instrumental And Transformative Medical Technology, Nicole Huberfeld Professor Of Law

Vanderbilt Journal of Entertainment & Technology Law

This Article considers how medical technologies impact universality in health care. The universality principle, as embodied in the Patient Protection and Affordable Care Act (ACA), eliminated widespread discriminatory practices and provided financial assistance to those otherwise unable to become insured--a democratizing federal act that was intended to stabilize health care policy nationwide. This Article posits that medical technology, as with all of medicine, can be universalizing or exclusionary and that this status roughly correlates to its being "instrumental technology" or "transformative technology." Instrumental technology acts as a tool of medicine and often serves an existing aspect of health care; in …

Power To The People: Data Citizens In The Age Of Precision Medicine, Barbara J. Evans

Vanderbilt Journal of Entertainment & Technology Law

Twentieth-century bioethics celebrated individual autonomy but framed autonomy largely in terms of an individual's power to make decisions and act alone. The most pressing challenges of big data science in the twenty-first century can only be resolved through collective action and common purpose. This Article surveys some of these challenges and asks how common purpose can ever emerge on the present bioethical and regulatory landscape. The solution may lie in embracing a broader concept of autonomy that empowers individuals to protect their interests by exercising meaningful rights of data citizenship. This Article argues that twentieth-century bioethics was a paternalistic, top-down …

Will The Internet Of Things Transform Healthcare?, Nicolas P. Terry, Professor Of Law,

Vanderbilt Journal of Entertainment & Technology Law

Emerging technologies like health apps on mobile computing platforms and wearable devices are believed to have the potential to improve individual and population health. Increasingly, however, attention should extend to a far larger cohort of connected devices known as the Internet of Things (IoT), an environment in which devices communicate with each other, health apps, and wearables. The resulting Internet of Health Things promises to do things conventional health providers either cannot do or do them faster and cheaper. First, services are "always on, "providing twenty-four/seven monitoring of the patient or pre-patient. Second, the multiple sensors contained in smartphones or …

Making International Health Regulations Work: Lessons From The 2014 Ebola Outbreak, Tsung-Ling Lee

Vanderbilt Journal of Transnational Law

Many legal scholars believe that the lack of enforcement mechanisms provided by the International Health Regulations (IHR) in part explains the slow containment of the deadly Ebola virus disease outbreak in West Africa in 2014. In contrast, some global health practitioners deem funding for global health emergencies as a key remedy to the ineffective international infectious disease control regime. Such belief underpinned the creation of the Pandemic Emergency Facility (PEF), the World Bank's new financing initiative, aiming to finance global disaster response. Some commentators hope that the establishment of the PEF will resuscitate international interest in global health security and …