Health Law and Policy Commons^™

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 …

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 …

Identities In Critical Condition: The Urgent Need To Reevaluate The Investigation And Resolution Of Claims Of Medical Identity Theft, Stephanie Lindgren

Mitchell Hamline Law Review

No abstract provided.

Dr. Tele-Corporation: Bridging The Access-To-Care Gap, Nader Amer

Dickinson Law Review (2017-Present)

The United States is currently confronting an access-to-healthcare crisis, which rural regions are experiencing at a disproportionate rate. Many commentators have touted telemedicine as a solution for the access-to-care issue. Telemedicine uses video and telecommunication technology to allow physicians to treat patients from distant locations and thus facilitates a more equal distribution of physicians throughout the United States.

Although the telemedicine industry is quickly growing, the corporate practice of medicine doctrine impedes the industry’s expansion and consequently obstructs a viable solution to the access-to-care crisis. Generally, the corporate practice of medicine doctrine prohibits corporations and limited liability companies from employing …

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 …

Volume 29 (2019), Health Matrix

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Invented Purposes And Blue Sky Predictions: Why The Trump Administration Cannot Win The Medicaid Work Experiment Cases, Sara Rosenbaum

Health Matrix: The Journal of Law-Medicine

No abstract provided.

The Web Of Legal Protections For Participants In Genomic Research, Leslie E. Wolf, Erin Fuse Brown, Ryan Kerr, Genevieve Razick, Gregory Tanner, Brett Duvall, Sakinah Jones, Jack Brackney, Tatiana Posada

Health Matrix: The Journal of Law-Medicine

The identification and arrest of the Golden State Killer using DNA uploaded to an ancestry database occurred shortly before recruitment for the National Institutes of Health’s (NIH) All of Us Study commenced, with a goal of enrolling and collecting DNA, health, and lifestyle information from one million Americans. It also highlighted the need to ensure prospective research participants that their confidentiality will be protected and their materials used appropriately. But there are questions about how well current law protects against these privacy risks. This article is the first to consider comprehensively and simultaneously all the federal and state laws offering …