Health Law and Policy Commons^™

Medical Marijuana And The Ada: Following The Path Blazed By State Courts To Extend Protection, Stephen M. Scannell

Saint Louis University Journal of Health Law & Policy

Thirty-three states across the country have legalized the use of medical marijuana for disabled individuals. Nevertheless, medical marijuana’s status in the workplace still faces significant uncertainty, because the current understanding of the Americans with Disabilities Act (ADA) categorizes medical marijuana use as an “illegal use of drugs.” Thus, the ADA provides no protection for disabled employees seeking to treat their condition with medical marijuana. In recent years, courts deciding cases involving state medical marijuana and anti-discrimination statutes have brought a more patient-centered and pragmatic approach to the issue. These courts have offered an interpretation of the “illegal use of drugs” …

Unjust Timing Limitations In Genetic Malpractice Cases, Lauren E. Clatch

Law Faculty Publications

As genomic data are increasingly being collected and applied in clinical care, physicians, laboratories, and other health care providers are more frequently being sued for alleged medical malpractice or negligence. Because the genetic underpinnings of an existing or future health condition may not be immediately apparent, such cases sometimes raise unique timing issues involving the applicable statute of limitations, statute of repose, or statutory notification requirements. Although these timing limitations on when a lawsuit can be brought have important policy rationales and justifications, such as helping to protect providers from open-ended liability, their application to genetic liability cases may sometimes …

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 …

Dirty Little Secrets: Fracking Fluids, Dubious Trade Secrets, Confidential Contamination, And The Public Health Information Vacuum, Elliot Fink

Fordham Intellectual Property, Media and Entertainment Law Journal

While the carbon energy industry has frequently claimed that hydraulic fracturing processes and ingredients are proprietary and protected by trade secret laws, their large scale and volume nationwide and the well-documented dangers that they pose to public health have brought fracking under scrutiny. When individuals have been adversely impacted in their own backyards, weak federal and state laws and regulation have generally left these impacted citizens with little to no recourse and part of this problem stems from questionable uses of privacy law, specifically dubious claims of trade secrecy. Focusing specifically on Pennsylvania as a model of insufficient state regulation …

Exploring Legal And Policy Responses To Opioids: America's Worst Public Health Emergency, James G. Hodge Jr., Chelsea Gulinson, Leila F. S. Barraza, Walter G. Johnson, Drew Hensley, Haley R. Augur

South Carolina Law Review

No abstract provided.

"Undue Hardship" And Uninsured Americans: How Access To Healthcare Should Impact Student-Loan Discharge In Bankruptcy, Alexander Gouzoules

Faculty Publications

Student-loan debt has grown to unprecedented heights. Contributing to the severe burden imposed by these debts is the Bankruptcy Code’s unique presumption that they are not dischargeable. To overcome that presumption, a debtor must establish that repayment of her loans would constitute an “undue hardship.” This essay examines the disagreement among bankruptcy courts that have interpreted the “undue hardship” standard in situations where a debtor is unable to afford health insurance—a common occurrence among the economically disadvantaged. After examining recent healthcare reforms, I argue that Congress has expressed a judgment that all Americans should obtain minimum essential healthcare. Though this …

Working 9 To 5? Equal Protection And States' Efforts To Impose Work Requirements For Medicaid Eligibility, David Wasserstein

American University Law Review

No abstract provided.

"You Have The Data"...The Writ Of Habeas Data And Other Data Protection Rights: Is The United States Falling Behind?, Sarah L. Lode

Indiana Law Journal

In Part I of this Note, I will discuss the writ of habeas data that has been developed primarily, but not exclusively, in Latin American countries. I will discuss the intricacies of the writ, how it evolved, and how it is applied today. Using Argentina as an example, I will discuss how the writ would be used by an Argentine citizen to protect her personal data. Part II summarizes the previously employed data protection scheme in the European Union, the Data Protection Directive (“the Directive”), and will also discuss the new EU data protection regulation, the General Data Protection Regulation …

Lgbtq+ Individuals, Health Inequities, And Policy Implications, Heather A. Walter-Mccabe, Killian M. Kinney

Law Faculty Research Publications

No abstract provided.

Health Care Ai: Law, Regulation, And Policy., W. Nicholson Price Ii

Book Chapters

As discussed in previous chapters, artificial intelligence (AI) has the potential to be involved in almost all aspects of the health care industry. The legal landscape for health care AI is complex; AI systems with different intended uses, audiences, and use environments face different requirements at state, federal, and international levels. A full accounting of these legal requirements, or of the policy questions involved, is far beyond the scope of this chapter. Additionally, the legal and regulatory framework for AI in health care continues to evolve, given the nascent stage of the industry.

In this chapter, we offer an overview …

Constitutional Cohesion And The Right To Public Health, Daniel G. Aaron, James G. Hodge, Haley Augur, Ashley Cheff, C. Joseph Ross Daval, Drew Hensley

Utah Law Faculty Scholarship

Despite years of significant legal improvements stemming from a renaissance in public health law, Americans still face major challenges and barriers in assuring their communal health. Reversals of legal reforms coupled with maligned policies and chronic underfunding contribute to diminished public health outcomes. Underlying preventable morbidity and mortality nationally is an interpretive reality of our existing constitutional infrastructure. In essence there is no general obligation of government to protect or promote the public’s health. Under principles of “constitutional cohesion,” structural facets and rights-based principles interwoven within the Constitution protect individuals and groups from governmental vices (i.e., oppression, overreaching, tyranny, and …

The Humour In My Tumour: Respecting Legal Capacity In Health-Care Decision-Making, Roxanne Mykitiuk, Reshma Valliappan

Articles & Book Chapters

Article 12 CRPD guarantees persons with disabilities the right to equal recognition before the law and the right to enjoy legal capacity on an equal basis with others in all aspects of life. It is the right to have one’s decisions legally recognised. Reshma’s decision not to take medication prescribed for schizophrenia was not accepted and respected by the physician. Instead, the physician implied that Reshma would be denied any further medical care for her current symptoms until she complied with a pharmaceutical-based treatment course for her psychiatric condition. Thus, Reshma would have had to take drugs against her will …

Controlling Biogenic Volatile Organic Compounds For Air Quality, Brian Sawers

Indiana Law Journal

This Article tells a story that is true but seems completely wrong: Trees can make air pollution worse. Smog and ground-level ozone require two chemical ingredients to form: nitrous oxides (NOx) and volatile organic compounds (VOCs). On a warm, sunny day, these two precursors combine to form smog and ground-level ozone, a pollutant. While NOx are pollutants that are largely human-created, VOCs can originate with plants. In fact, emissions of just one type of VOC from trees exceed all human-caused emissions.

This Article presents new research on the impact of plants, especially trees, on air quality. The science is complicated …

Social Work As An Important Collaborator In Transdisciplinary Public Health Law: Why Does It Matter And Where Does It Fit?, Heather A. Walter-Mccabe

Law Faculty Research Publications

No abstract provided.

Developing Product Label Information To Support Evidence-Informed Use Of Vaccines In Pregnancy, Terra A. Manca, Janice E. Graham, Ève Dubé, Melissa Kervin, Eliana Castillo, Natasha S. Crowcroft, Deshayne B. Fell, Michael Hadskis, Jaelene M. Mannerfeldt, Devon Greyson, Noni E. Macdonald, Karina A. Top, On Behalf Of The Canadian Vaccine Product Monograph Working Group

Articles, Book Chapters, & Popular Press

Background: Product labelling information describing the use of vaccines in pregnancy continues to contain cautionary language even after clinical and epidemiological evidence of safety becomes available. This language raises safety concerns among healthcare providers who may hesitate to recommend vaccines during pregnancy.

Purpose: To develop clear evidence-based language about vaccine safety and effectiveness in pregnancy for inclusion in vaccine product labels.

Methods: We conducted a three-stage consensus-methods project with stakeholders, including: healthcare providers, vaccine regulators, industry representatives, and experts in public health, communication, law, ethics, and social sciences. Using qualitative and quantitative methods, we held a nominal group technique (NGT) …

Pharmaceutical Drugs Of Uncertain Value, Lifecycle Regulation At The Us Food And Drug Administration, And Institutional Incumbency, Matthew Herder

Articles, Book Chapters, & Popular Press

Policy Points

• The US Food and Drug Administration (FDA) has in recent years allowed onto the market several drugs with limited evidence of safety and effectiveness, provided that manufacturers agree to carry out additional studies while the drugs are in clinical use.
• Studies suggest that these postmarketing requirements (PMRs) frequently lack transparency, are subject to delays, and fail to answer the questions of greatest clinical importance. Yet, none of the literature speaks directly to the challenges that the FDA—as a regulatory institution—encounters in enforcing PMRs.
• Through a series of interviews with FDA leadership, this article analyzes and situates those challenges …

The Gender Injustice Of Abortion Laws, Joanna Erdman

Articles, Book Chapters, & Popular Press

This commentary is a response to Katarzyna Sękowska-Kozłowska’s article on the treatment of criminal abortion laws as a form of sex discrimination under international human rights law through a study of the communications, Mellet v. Ireland and Whelan v. Ireland. The commentary offers a reading of these communications, and specifically the sex discrimination analysis premised on inequalities of treatment among women, as an engagement with the structural discrimination that characterises abortion laws, and asa radical vision for gender justice under international human rights law.

Refusing Care As A Legal Pathway To Medical Assistance In Dying, Jocelyn Downie, Matthew J. Bowes

Articles, Book Chapters, & Popular Press

Can a competent individual refuse care in order to make their natural death reasonably foreseeable in order to qualify for medical assistance in dying (MAiD)? Consider a competent patient with left-side paralysis following a right-brain stroke who is not expected to die for many years; normally his cause of death would not be predictable. However, he refuses regular turning, so his physician can predict that pressure ulcers will develop, leading to infection for which he will refuse treatment and consequently die. Is he now eligible for MAiD? Consider a competent patient with spinal stenosis (a non-fatal condition) who refuses food …

Incarceration In Canada: Risks To And Opportunities For Public Health, Adelina Iftene

Articles, Book Chapters, & Popular Press

In their introduction to the latest edition of Public Health Law and Policy in Canada, the editors are unequivocal about the importance of this area of growing interest and scholarship. This text, they explain, “explores a range of perspectives that examine how law, in many forms and contexts, plays a critical role in protecting the public from known and emerging threats and promoting conditions for health.”

Written and edited by leading health law scholars and featuring contributions from legal and health experts from across the country, this book provides a comprehensive overview of our Canadian public health law and policy …

The Intersection Of Indigenous Public Health With Law And Policy In Canada, Constance Macintosh

Articles, Book Chapters, & Popular Press

This chapter presents an overview of the law, policy and governance practices that are most directly implicated in the population health of Indigenous people who reside in Canada. The first section provides a general description of the socio-legal categories that are drawn upon in health policy, programming and legislation regarding Indigenous peoples. It briefly describes roles in funding and delivering community health services and programming, as well as disputes about responsibilities and some shortcomings.

The second section provides an overview of the population health status of Indigenous peoples. Epidemiological data is presented, and select social determinants of health are also …

Purchasing Health? The Promise And Limits Of Public Health Insurance, Kristen Underhill

Faculty Scholarship

The 2010s have been a momentous decade for Medicaid. With enrollment of over seventy-two million people (19% of the country’s population), Medicaid is the nation’s largest public health insurance program, and it is the primary or sole source of health insurance for vulnerable groups such as low-income children and pregnant women, adults with disabilities, and people in need of long-term care. Since 2014, the pendulum of Medicaid policy has swung from an unprecedented expansion of coverage under the Affordable Care Act (ACA), toward more recent federal regulations and state policy innovations that are instead predicted to limit uptake of benefits. …

The Federalism Challenges Of Protecting Medical Privacy In Workers' Compensation, Ani B. Satz

Faculty Articles

This Article is the first to address the challenges of federalism in protecting medical privacy in workers’ compensation after the promulgation of the HPR and to propose legal change. The Article argues that workers’ compensation programs must align with the federal privacy protections of the HPR and proposes actions for the U.S. Department of Health and Human Services (HHS) and states to remedy departures. Part I discusses the complex relationship between the HPR and workers’ compensation. This relationship is often misunderstood by legislatures and courts, compounding the challenges of federalism in this area. Specifically, Part I addresses the HPR’s § …

Regulatory Gaps In Drug Compounding: Implications For Patient Safety, Innovation, And Fraud, Joanna Shepherd

Faculty Articles

Drug compounding is the practice of mixing, combining, or altering drug ingredients to create a product that meets the medical needs of a patient whose needs cannot otherwise be met with commercially-available products. Compounding is essential for patients that are allergic to certain ingredients or cannot tolerate the route of administration or dosage form of a commercially-available drug. Compounding may also enable pharmacists to supply medications when there is a shortage of commercially-available drugs. For example, amid the nationwide shortage of generic liquid Tamiflu and growing flu deaths in early 2018, pharmacists around the country used Tamiflu capsules to compound …

Deputizing Family: Loved Ones As A Regulatory Tool In The “Drug War” And Beyond, Matthew B. Lawrence

Faculty Articles

Many laws use family members as a regulatory tool to influence the decisions or behavior of their loved ones, i.e., they deputize family. Involuntary treatment laws for substance use disorder are a clear example; such laws empower family members to use information shared by their loved ones to petition to force their loved ones into treatment without consent. Whether such deputization is helpful or harmful for a patient’s health is a crucial and dubious question discussed in existing literature, but use of family members as a regulatory tool implicates important considerations beyond direct medical impacts that have not been as …

An Analysis And Critique Of Mental Health Treatment In American State Prisons And Proposal For Improved Care, Shelby Hayne

Scripps Senior Theses

Mental health treatment in state prisons is revealed to be highly variable, under-funded, and systematically inadequate. Existing literature exposes this injustice but fails to provide a comprehensive proposal for reform. This paper attempts to fill that gap, outlining a cost-effective, evidence-based treatment proposal, directly addressing the deficits in care revealed through analysis of our current system. In addition, this paper provides historical overviews of the prison system and mental health treatment, utilizing theoretical perspectives to contextualize this proposal in the present state of affairs. Lastly, the evidence is provided to emphasize the potential economic and social benefits of improving mental …

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 …

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 …

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.

A Dangerous Concoction: Pharmaceutical Marketing, Cognitive Biases, And First Amendment Overprotection, Cynthia M. Ho

Faculty Publications & Other Works

This Article argues that pharmaceutical marketing to doctors should be more critically evaluated and entitled to less First Amendment protection, contrary to a trend dating back to the Supreme Court's 2011 decision in Sorrell. In particular, the Article argues that more information to doctors in the form of pharmaceutical marketing does not necessarily result in better patient outcomes. The Article adds a significant critique based on the existence and impact of cognitive bias literature that has thus far not been recognized in this area. If courts fully embrace this understanding, they should recognize that the government, through the Food and …