Health Law and Policy Commons^™

Robots Are Coming: A Discussion Of Choice-Of-Law Issues And Outcomes In Telesurgical Malpractice, Megan Cloud

Texas A&M Law Review

New technology frequently emerges that challenges the legal status quo. Early adopters must then grapple with uncertainty over how the law will apply to novel legal quandaries. There is no better example of this than in medicine; however, the health care field is notoriously risk averse. Despite this, the practice of medicine stands to gain tremendously from these technological advancements. One such advancement is the relatively new ability to perform robotic surgery in which the surgeon is remote from the patient. Widespread use of this technology would improve rural access to surgical care, as well as improve access to more …

Billion Dollar Orphans: Tension Between The Legal Intent And Social Purpose Of The Orphan Drug Act, John Sheridan

Texas A&M Law Review

This Comment examines the extent to which Congress empowered the FDA to address the increase in petitions and the general accessibility of orphan drug remedies. Specifically, this Comment seeks to understand why the FDA’s interpretation of the purpose of the ODA seems to conflict with the statutory intent as interpreted by federal courts. This Comment considers a statute’s ultimate goal or social purpose to be the purpose of the statute, whereas the express mechanisms by which Congress seeks to bring about these goals is best understood as the statute’s intent. To understand the FDA and judiciary’s differing interpretations of the …

Genetic Data Privacy Solutions In The Gdpr, Kristi Harbord

Texas A&M Law Review

The intersection of healthcare and technology is a rapidly growing area. One thriving field at this intersection involves obtaining, processing, and storing genetic data. While the benefits have been great, genetic information can reveal a great deal about individuals and their families. And the information that can be conveyed from genetic data appears limitless and is constantly growing and changing. Many entities have begun storing, processing, and sharing genetic data on a very large scale. This creates many privacy concerns that the current regulatory framework does not account for. The line between patient data and consumer data is blurred; many …

Fifth Indifference: Clarifying The Fifth Circuit's Intent Standard For Damages Under Title Ii Of The Americans With Disabilities Act, Derek Warden

Texas A&M Law Review

The Americans with Disabilities Act prohibits discrimination against people with disabilities. Title II of the ADA applies to public entities. That same Title allows plaintiffs to obtain damages upon a showing that the discrimination was intentional. There are generally two possible standards of intent: (1) deliberate indifference or (2) animus. While most Circuit Courts expressly adopted the deliberate indifference model, the Fifth Circuit has not. Indeed, the Fifth Circuit has not adopted any standard and this has led to confusion. The confusion is not helped, moreover, by the sheer lack of justification offered by a number of the Circuit Courts …

Punishment Without Process: Victim Impact Proceedings For Dead Defendants, Bruce Green, Rebecca Roiphe

Articles & Chapters

After Jeffrey Epstein committed suicide in jail, two judges allowed his accusers to speak in court. This article argues that the proceedings were inappropriate because the criminal case ends when the defendant dies. If the conviction and appeal are not final, there is no finding of guilt, and the defendant is still presumed innocent. Allowing accusers to speak at this time violates the principle of due process and threatens to undermine faith in judges and the criminal justice system in general. While courts are at times legally required to hear from victims of crimes, they were not allowed to do …

The Opioid Crisis: The States' And Local Governments' Response To Bigpharma's Deception And Why The Supremacy Clause May Provide A Cloak For Opioid Manufacturers To Hide Behind, Tracie Childers

Barry Law Review

No abstract provided.

Shadow Health Records Meet New Data Privacy Laws, W. Nicholson Price Ii, Margot E. Kaminski, Timo Minssen, Kayte Spector-Bagdady

Articles

Large sets of health data can enable innovation and quality measurement but can also create technical challenges and privacy risks. When entities such as health plans and health care providers handle personal health information, they are often subject to data privacy regulation. But amid a flood of new forms of health data, some third parties have figured out ways to avoid some data privacy laws, developing what we call “shadow health records”—collections of health data outside the health system that provide detailed pictures of individual health—that allow both innovative research and commercial targeting despite data privacy rules. Now that space …

Privacy In The Age Of Medical Big Data, W. Nicholson Price Ii, I. Glenn Cohen

Articles

Big data has become the ubiquitous watch word of medical innovation. The rapid development of machine-learning techniques and artificial intelligence in particular has promised to revolutionize medical practice from the allocation of resources to the diagnosis of complex diseases. But with big data comes big risks and challenges, among them significant questions about patient privacy. Here, we outline the legal and ethical challenges big data brings to patient privacy. We discuss, among other topics, how best to conceive of health privacy; the importance of equity, consent, and patient governance in data collection; discrimination in data uses; and how to handle …

Health Reform And Higher Ed: Campuses As Harbingers Of Medicaid Universality And Medicare Commonality, Sallie Thieme Sanford

Articles

Between 2010 and 2016, the percentage of uninsured higher education students dropped by more than half. All the Affordable Care Act’s key access provisions contributed, but the most important factor appears to be the Medicaid expansion. This article is the first to highlight this phenomenon and ground it in data. It explores the reasons for this dramatic expansion of coverage, links it to theoretical frameworks, and considers its implications for the future of health reform.

Drawing on Medicaid universality scholarship, I discuss potential consequences of including the educationally privileged in this historically stigmatized program. Extending this scholarship, I argue that …

Nobody Knew How Complicated: Constraining The President's Power To Re(Shape) Health Reform, Sallie Thieme Sanford

Articles

Beginning on inauguration day, President Trump has attempted an executive repeal of the Affordable Care Act. In doing so, he has tested the limits of presidential power. He has challenged the force of institutional and non-institutional constraints. And, ironically, he has helped boost public support for the ACA’s central features. The first two sections of this article respectively consider the use of the President’s tools to advance and to subvert health reform.

The final two sections consider the forces constraining the administration’s attempted executive repeal. I argue that the most important institutional constraint, thus far, is found in multifaceted actions …

Note: The Prisoner’S Dementia: Ethical And Legal Issues Regarding Dementia And Healthcare In Prison, David M. N. Garavito

Articles

This Note will give an overview of the political and legal issues that lead to the underdiagnosing of dementias in prison populations and the problems associated with such underdiagnosing. Part I will discuss various forms of dementia that place the prison population at risk, providing general information about both pathology and symptomology of these disorders. Part II will provide an overview of the laws and policies surrounding the healthcare of prisoners and how these policies could lead to underdiagnosing problems specifically with neurological problems like dementia. Part III will describe how the symptomology of dementia, especially for those who remain …

Strict Liability For Genetic Privacy Violations In The Age Of Big Data, Benjamin Sundholm

Faculty Publications

(Excerpt)

The ethical issues implicated by the misuse of genetic information have been smoldering for over half a century, and the age of big data has turned them into a five-alarm fire. In recent years, medical researchers and commercial enterprises have been using technological advancements to develop a variety of innovative ways to use genetic information. For example, it is becoming increasingly common for people to learn more about their health and family history by paying direct-to-consumer (“DTC”) companies to analyze their genetic data. DTC companies store the results of these tests electronically and often share them with pharmaceutical companies …

Vaccination Law 101: A Guide For Children’S Lawyers, Christal Cammock, Jennifer Baum

Faculty Publications

(Excerpt)

Today, U.S. children are typically vaccinated against 11 deadly, and formerly common, diseases: diphtheria, Hib disease, hepatitis B, measles, mumps, pertussis (whooping cough), polio, rubella, pneumococcal disease, tetanus, and varicella (chicken pox). But it wasn’t always so. Vaccines are a relatively recent development in medical history. The world’s first vaccine, for smallpox, was discovered in the late 1700s. A hundred years later, Louis Pasteur discovered the second vaccine, for rabies. By the mid-1900s, technological and medical advances drove more rapid vaccine development, and in 1963, the first measles vaccine was approved.

Before the measles vaccine became available, up to …

On Opioids And Erisa: The Urgent Case For A Federal Ban On Discretionary Clauses, Katherine T. Vukadin

University of Richmond Law Review

The American opioid epidemic cuts across all social divisions, touching the employed and unemployed. Those with private health insurance are one of the fastest-growing affected groups, but this group struggles most to get care. Despite their insured status, the privately-insured received treatment at half the rate of those with Medicaid and at even lower rates than the uninsured. This article focuses on a significant barrier to treatment for those in employer sponsored benefit plans: the discretionary clause. A discretionary clause grants the decision maker broad latitude and ensures that any federal court review is deferential. Claims processing in such a …

Right To A Healthy Prison Environment: Health Care In Custody Under The Prism Of Torture, Juan E. Mendez

Scholarly Articles in Law Reviews & Journals

No abstract provided.

Regulate Physician Restrictive Covenants To Improve Healthcare, Judy Ann Clausen

Kentucky Law Journal

No abstract provided.

Using The Ada's 'Integration Mandate' To Disrupt Mass Incarceration, Robert Dinerstein

Scholarly Articles in Law Reviews & Journals

As a result of the disability rights movement's fight for the development of community-based services, the percentage of people with intellectual and developmental disabilities (I/DD) and mental illness living in institutions has significantly decreased over the last few decades. However, in part because of government failure to invest properly in community-based services required for a successful transition from institutions, individuals with disabilities are now dramatically overrepresented in jails and prisons. The Americans with Disabilities Act's (ADA) "integration mandate" -- a principle strengthened by the Supreme Court's 1999 Olmstead v. L.C. decision, entitling individuals with disabilities to receive services in the …

Medical Records And Privacy Rights: The Unintended Consequences Of Aggregated Data In Electronic Health Records, Andrea C. Maciejewski

University of Colorado Law Review

In an era of rapid-pace technological innovation and political focus on healthcare, the federal government is pushing for nationwide interoperability of electronic health records. While there are many benefits from such a program, the lack of federal or state privacy regulations for patients' personal data opens up the possibility of widespread dissemination of private and sensitive information. This inattention to privacy will cause major problems if exploited.

Currently, there are no federal or Colorado laws that protect against potential privacy violations and provide recourse for a patient if a medical professional decides to insert nonmedical information, such as information about …

Mine Reclamation's Reliance On King Coal: Meeting Legacy Environmental Obligations With A Declining Industry, Claire Jarrell

University of Colorado Law Review

Coal mines throughout Appalachia have left the land scarred and the water damaged. Although mine reclamation programs are the only major system of recourse for addressing environmental degradation caused by mining, the downturn of the coal market has put reclamation programs in a precarious position for achieving that end. Funds for coal mine reclamation are derived from the current coal industry's profits. As coal profits continue to atrophy, so too does the pot of money designated for reclamation efforts. These dwindling financial resources are particularly problematic because there is still significant need for reclamation funding throughout Appalachia.

This Comment explores …

Tort Law And Health Law: Intersections And Opportunities, Stacey A. Tovino

Other Faculty Publications

No abstract provided.

The Vaccine Race In The 21st Century, Ana Santos Rutschman

All Faculty Scholarship

In a world in which infectious diseases are spreading increasingly faster, the development of new human vaccines remains a priority in biopharmaceutical innovation. Legal scholars have addressed different aspects of vaccine regulation and administration, but less attention has been paid to the role of laws governing innovation during the stages of research and development (R&D) of vaccines.

This Article explores the race to develop new vaccines from its beginnings through the early 21st century, with a particular focus on the progressively pervasive role of intellectual property in governing vaccine innovation. It describes the insufficiencies of current innovation regimes in promoting …

Exploring The Development Of Three Law-Based Competency Models For Public Health Practitioners, Montrece Mcneill Ransom, Brianne Yassine

Journal of Social, Behavioral, and Health Sciences

As public health promotion and protection become increasingly complex and integrated into various fields, public health law is emerging as an important tool for public health professionals. To ensure that public health professionals are adequately trained public health law, public health law-related competencies should to be integrated into educational and other programming. This article provides three competency models developed by the Public Health Law Program at the Centers for Disease Control and Prevention: (a) the public health emergency law competency model, (b) the public health law competency model, and (c) the legal epidemiology competency model. These competency models provide a …

Redefining "Life": The Constitutional Implications Of Patenting Immortality, Julia Spivak

Cardozo Arts & Entertainment Law Journal

No abstract provided.

Permitted Incentives For Workplace Wellness Plans Under The Ada And Gina: The Regulatory Gap, Elizabeth Pendo, Brandon Hall

All Faculty Scholarship

Although workplace wellness plans have been around for decades, they have flourished under the Patient Protection and Affordable Care Act (“PPACA”) into a $6 billion-dollar industry. Under PPACA, a “wellness plan” is a program of health promotion or disease prevention offered by an employer that is designed to promote health or prevent disease and which meets the other applicable requirements of that subsection. Employers look to these programs to promote healthy lifestyles, improve the overall health of employees and beneficiaries, and reduce rising healthcare costs. PPACA’s amendments to the Health Insurance Portability and Accountability Act (“HIPAA”) permit employers to offer …

On The Judicialization Of Health, Ana Santos Rutschman

All Faculty Scholarship

The provision of health care has long been at the forefront of domestic and international debates, philosophical inquiries, and political agendas. A growing body of legal scholarship has added to the debate by examining the role of judicial review in the context of health-related litigation. What role, if any, should courts play in compelling the provision of health care or in furthering access to potentially life-saving medicines?

This question intersects with multiple strands of the law. For instance, it has an institutional component that interrogates the function(s) of courts within systems of checks and balances. It ties into constitutional design …

The Shadows Of Life: Medicaid's Failure Of Health Care's Moral Test, Barak D. Richman, Kushal T. Kadakia, Shivani A. Shah

Faculty Scholarship

North Carolina Medicaid covers one-fifth of the state’s population and makes up approximately one-third of the budget. Yet the state has experienced increasing costs and worsening health outcomes over the past decade, while socioeconomic disparities persist among communities. In this article, the authors explore the factors that influence these trends and provide a series of policy lessons to inform the state’s current reform efforts following the recent approval of North Carolina’s Section 1115 waiver by the Centers for Medicare and Medicaid Services. The authors used health, social, and financial data from the state Department of Health and Human Services, the …

Manufactured Emergencies, Robert Tsai

Scholarly Articles in Law Reviews & Journals

Emergencies are presumed to be unusual affairs, but the United States has been in one state of emergency or another for the last forty years. That is a problem. The erosion of democratic norms has led to not simply the collapse of the traditional conceptual boundary between ordinary rule and emergency governance, but also the emergence of an even graver problem: the manufactured crisis. In an age characterized by extreme partisanship, institutional gridlock, and technological manipulation of information, it has become exceedingly easy and far more tempting for a President to invoke extraordinary power by ginning up exigencies. To reduce …

Acting Differently: How Science On The Social Brain Can Inform Antidiscrimination Law, Susan Carle

Scholarly Articles in Law Reviews & Journals

Legal scholars are becoming increasingly interested in how the literature on implicit bias helps explain illegal discrimination. However, these scholars have not yet mined all of the insights that science on the social brain can offer antidiscrimination law. That science, which researchers refer to as social neuroscience, involves a broadly interdisciplinary approach anchored in experimental natural science methodologies. Social neuroscience shows that the brain tends to evaluate others by distinguishing between "us" versus "them" on the basis of often insignificant characteristics, such as how people dress, sing, joke, or otherwise behave. Subtle behavioral markers signal social identity and group membership, …

Direct-To-Consumer Ads Are Misleading: Concise Statements Of Effectiveness Should Be Required, Robert A. Bohrer

Faculty Scholarship

Direct-to-consumer (DTC) advertising of prescription pharmaceuticals has been the subject of much criticism and the issue has become even more pressing with the Trump administration’s proposal to require the disclosure of prices in DTC ads. In this article I argue that a more powerful approach to the problem of DTC ads would require the disclosure of the effectiveness of the advertised drugs, at least as found in the clinical trials submitted for FDA approval. To support the need for an effectiveness disclosure, I describe the problem of DTC ads and examine representative ads to illustrate the potential of such ads …

Legal Considerations In Pediatric And Adolescent Obstetrics And Gynecology, Steven R. Smith

Faculty Scholarship

Providing gynecologic and obstetric care for minors raises important legal issues and it is critical that health-care providers understand those legal issues. State laws are often somewhat complicated and unsettled in the areas minors’ of consent to treatment, privacy and information, and abuse reporting requirements. State statutes commonly give minors the authority to consent to treatment for STIs, pregnancy, and contraception. There are, however, many variations among states in these areas. Most states limit the ability of minors to consent to abortion without some parental (or court) involvement. In some circumstances, a physician may provide information to parents if it …