Health Law and Policy Commons^™

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 …

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 …

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. …

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. …

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 …

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 …

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 …

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.

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 …

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 …

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 …

Health Information Ownership: Legal Theories And Policy Implications, Lara Cartwright Smith, Elizabeth Gray, Jane H. Thorpe

Vanderbilt Journal of Entertainment & Technology Law

This Article explores the nature and characteristics of health information that make it subject to federal and state laws and the existing legal framework that confers rights and responsibilities with respect to health information. There are numerous legal and policy considerations surrounding the question of who owns health information, including whether and how to confer specific ownership rights to health information. Ultimately, a legal framework is needed that reflects the rights of a broad group of stakeholders in the health information marketplace, from patients to providers to payers, as well as the public's interest in appropriate sharing of health information.

Confronting Legal And Technological Incongruity: Remote Testimony For Child Witnesses, Elizabeth A. Mulkey

Vanderbilt Journal of Entertainment & Technology Law

Child victims are often the only eyewitnesses in cases against their abusers. A child's testimony may be necessary for a prosecutor to secure a conviction. However, the child must often face his or her abuser and relive the traumatic experience while giving this testimony. Any accommodations or protection of a child witness at trial must be balanced against the defendant's rights under the Confrontation Clause. The Supreme Court's decision in Maryland v. Craig allows child victims to testify via one-way, closed-circuit television in some circumstances, but the Court has not addressed two-way, closed-circuit testimony or remote testimony. In the absence …

Kickbacks And Contradictions: The Anti-Kickback Statute And Electronic Health Records, Daniel E. Rheiner

Vanderbilt Journal of Entertainment & Technology Law

The Obama Administration has made the universal adoption of electronic health records a major policy priority, passing the Health Information Technology for Economic and Clinical Health (HITECH) Act, which creates incentives for physicians and hospitals to computerize their medical records. This effort has been largely successful, as evidenced by the significant increase in medical providers who have adopted electronic health records. However, for the President to achieve his goal of computerizing all medical records in the United States, he will need to ensure that other federal laws do not conflict with the incentive structure created by the HITECH Act. The …

Late Fathers' Later Children: Reconceiving The Limits Of Survivor's Benefits In Response To Death-Defying Reproductive Technology, Jeffrey W. Sheehan

Vanderbilt Journal of Entertainment & Technology Law

When Congress instructed the Social Security Administration to begin paying a social insurance benefit to "widows and orphans" in the 1930s, it simplified the process of determining an applicant's relationship to an insured decedent in two significant ways: First, Congress ordered the agency to honor the intestate laws of each state when determining whether an applicant was actually the child of a decedent, and second, it ordered the agency to treat any child who could qualify as an intestate heir as if that child actually depended on the parent financially at the time of the parent's death. Three-quarters of a …

Electronic Medical Records: A Prescription For Increased Medical Malpractice Liability?, Blake Carter

Vanderbilt Journal of Entertainment & Technology Law

The cost and quality of health care is and most likely will continue to be one of the most important issues that the United States faces in the coming decade. Although no powerful antidote exists to cure this industry of all of its ailments, one potential suggestion to treat some of the symptoms is the introduction of electronic medical records (EMRs).

Members of the medical community, patients, and even politicians all agree that EMRs offer promising opportunities to improve the overall quality of health care. However, lost in the discussion of these opportunities, is a consideration of the potential side …

There Will Be Blood ... Testing: The Intersection Of Professional Sports And The Genetic Information Nondiscrimination Act Of 2008, Jesse A. Bland

Vanderbilt Journal of Entertainment & Technology Law

Genetic testing, professional baseball, and employment discrimination seldom intersect. This Note changes that. Thanks to scientific breakthroughs in genetic research over the past half-century, genetic testing is a powerful tool for producing rich, individualized information. Progress comes at a price, however. As genetic testing has advanced and become more prevalent, so too has the potential misuse of genetic information. A recently enacted federal law--the Genetic Information Nondiscrimination Act of 2008 (GINA)--seeks to eliminate one such threat by prohibiting the improper use of genetic information in employment decisions. While the law gained congressional momentum after tales of abuse in blue-collar industries, …

Allocating Liability For Deficient Warnings On Generic Drugs: A Prescription For Change, Sarah C. Duncan

Vanderbilt Journal of Entertainment & Technology Law

Brand-name pharmaceutical companies create pioneer drugs that cure diseases around the world. However, because research and development costs are very high, brand-name drugs are expensive. In response to escalating costs, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 ("Hatch-Waxman Act") to promote generic competition. As generics become more prominent in the pharmaceutical marketplace, individuals injured by generic drugs are suing the manufacturers with more frequency. The cases often turn on which company should bear the liability for failing to warn--the brand-name manufacturer or the generic drug maker. Although the injured person took the generic drug, …

Access This: Why Institutions Of Higher Education Must Provide Access To The Internet To Students With Disabilities, Nina Golden

Vanderbilt Journal of Entertainment & Technology Law

No one questions whether the ADA applies to institutions of higher education. Title II applies to public colleges and universities, while Title III applies to private ones. With some exceptions, colleges and universities must make their programs and services accessible by providing reasonable accommodations to students with disabilities. What is significantly less clear, and thus the topic of dispute among courts and commentators, is whether the ADA requires colleges and universities to provide access to the Internet to students with disabilities. Much of the dispute revolves around the meaning of the term "place of public accommodation." Some courts have required …

Taking One For The Team: Should Colleges Be Liable For Injuries Occurring During Student Participation In Club Sports?, Nick White

Vanderbilt Journal of Entertainment & Technology Law

Since the 1970s, colleges have not been liable for their adult students' actions or injuries, but courts have since delineated many exceptions to this rule. This Note will analyze the effect of college involvement in club sports as to whether it creates a duty for a college to protect its club athletes and those they might injure. This Note will also examine whether such a duty might exist in the future if the current trends in the law and college policy continue unchecked. Finally, this Note will address the effectiveness of the current defenses to liability and the effect of …