Health Law and Policy Commons^™

An International Agreement On Pandemic Prevention And Preparedness, Lawrence O. Gostin, Sam F. Halabi, Kevin A. Klock

Georgetown Law Faculty Publications and Other Works

During late 2021, national delegations are, or have, met at the United Nations General Assembly, the G20, and, most importantly, the Special Session of the World Health Assembly in November to determine whether the world needs a new international agreement to address pandemic prevention, preparedness, and response. The current international agreement, the International Health Regulations (2005), failed to work effectively – SARS-CoV-2 was not detected sufficiently early, relevant information was not shared efficiently, and the global response has not been coordinated. Even the most basic investigations were inadequate such as to discover the origins of SARS-CoV-2. Current proposals focus on …

Preventing The Preventable: A Review Of Maternal Mortality Rates In South Carolina, Sydney J. Douglas

South Carolina Law Review

No abstract provided.

9 Steps To End Covid-19 And Prevent The Next Pandemic: Essential Outcomes From The World Health Assembly, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

A year ago, the World Health Assembly (WHA) met virtually for the first time since the creation of the World Health Organization (WHO) in 1948. Last year’s WHA adopted a resolution asking states to intensify action to fight COVID-19. Yet a year on, there have been 3.7 million deaths reported, with the real number estimated as more than 7 million. From May 24-31, 2021, the 74th WHA (WHA74) was again held virtually amidst this historic pandemic. The WHA created a member states working group on strengthening WHO preparedness for and response to health emergencies to make recommendations to next year’s …

Reproductive Justice And Transformative Constitutionalism, Cynthia Soohoo

Cardozo Law Review

No abstract provided.

Lockdowns, Quarantines, And Travel Restrictions, During Covid And Beyond: What’S The Law, And How Should We Decide?, Lawrence O. Gostin, Meryl Chertoff

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic ushered in vast deprivations of liberty previously unthinkable: lockdowns, business closures, travel restrictions, and quarantines. Even witnessing China’s January 2020 lockdown of 11 million people in Wuhan, it seemed wholly implausible that London, Rome, or New York would shut down. But they did, and much more. At the initial height of the pandemic in April 2020, more than 3.9 billion people, about half the world's population, were under stay-at-home orders. That same month, 43 US states were under stay-at-home orders.

What are the scientific, public health, and ethical justifications for various forms of liberty deprivations? Are they …

Fraud Law And Misinfodemics, Wes Henricksen

Faculty Scholarship

No abstract provided.

Covid-19 And Digital Contact Tracing: Regulating The Future Of Public Health Surveillance, Divya Ramjee, Pollyanna Sanderson, Imran Malek

Cardozo Law Review de•novo

Digital surveillance tools are at the forefront of potential public health response strategies for the COVID-19 pandemic. The United States is in desperate need of a national-level contact tracing and exposure notification strategy to supplement traditional public health response efforts. This article addresses data privacy and security concerns, as well as epidemiological considerations, when developing digital contact tracing and exposure notification tools. It is both feasible and prudent that the United States establish a federal network for public health surveillance aided by digital tools, especially considering that waves of COVID-19 are expected to continue well into 2021 and while the …

Difficulty Of Care: Alligning Tax And Health Care Policy For Family Caregiving, Christine S. Speidel

Faculty Publications

In the United States millions of people live with disabilities, many of whom require assistance with activities of daily life to remain in their homes and communities. However, financial support for this assistance is limited. Many caregivers forgo working outside the home in order to provide care to a family member. And while state and federal programs provide some compensation for caregiving, caregivers frequently face problems including poverty, lack of health insurance, lack of Social Security and Medicare credits, and lack of retirement savings. Our nation’s paltry support for caregiving threatens the practical ability of people with disabilities to choose …

Mandating Covid-19 Vaccines, Lawrence O. Gostin, Daniel A. Salmon, Heidi J. Larson

Georgetown Law Faculty Publications and Other Works

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccines hold promise to control the pandemic, and help restore normal social and economic life. The Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for 2 mRNA vaccines and will likely issue full biologics licenses in the coming months. Anticipating vaccine scarcity, the Advisory Committee on Immunization Practice (ACIP) published guidance on vaccine priorities.

Data show 95% efficacy for vaccines granted an EUA, but even highly effective vaccines cannot curb the pandemic without high population coverage and maintenance of other mitigation strategies. Recent data from 1,676 adults surveyed November 30-December …

Untag Me: Why Federal Judges Are Broadly Construing Illinois’S Biometric Privacy Law, Lisa P. Angeles

Cardozo Law Review

No abstract provided.

Oklahoma V. Purdue Pharma: Public Nuisance In Your Medicine Cabinet, Justin Kaufman

Cardozo Law Review

No abstract provided.

Is It Lawful And Ethical To Prioritize Racial Minorities For Covid-19 Vaccines?, Harald Schmidt, Lawrence O. Gostin, Michelle A. Williams

Georgetown Law Faculty Publications and Other Works

Coronavirus disease 2019 (COVID-19) has disproportionately affected racial minorities in the United States resulting in higher rates of infection, hospitalization, and death. With a limited supply after the initial approval of a safe and effective vaccine, difficult legal and ethical choices will have to be made on priority access for individuals. The National Academies of Sciences, Engineering, and Medicine (NASEM) has recommended prioritization of racial minorities who are “worse off” socioeconomically and epidemiologically. TheWorld Health Organization (WHO) similarly cautioned that “colorblind” allocation frameworks could perpetuate or exacerbate existing injustices. Both NASEM and WHO urge policy makers to allocate vaccines in …

When "Things" Go Wrong: Redefining Liability For The Internet Of Medical Things, Bethany A. Corbin

South Carolina Law Review

No abstract provided.

The Kids Are Not Alright: Leveraging Existing Health Law To Attack The Opioid Crisis Upstream, Yael Cannon

Georgetown Law Faculty Publications and Other Works

The opioid crisis is now a nationwide epidemic, ravaging both rural and urban communities. The public health and economic consequences are staggering; recent estimates suggest the epidemic has contracted the U.S. labor market by over one million jobs and cost the nation billions of dollars. To tackle the crisis, scholars and health policy initiatives have focused primarily on downstream solutions designed to help those who are already in the throes of addiction. For example, the major initiative announced by the U.S. Surgeon General promotes the dissemination of naloxone, which helps save lives during opioid overdoses.

This Article argues that the …

Update On Fda Regulation Of Mhealth And Wellness Devices, Barbara Zabawa

Faculty Works

This article provides an update on the evolving regulatory landscape of mobile health (mHealth) and wellness devices, focusing on changes introduced by the Food and Drug Administration (FDA) through its 2017 Draft Guidance. These updates aim to clarify inconsistencies in the definitions and regulatory status of various categories of devices, such as mobile medical apps, general mobile apps, and low-risk wellness devices. The Draft Guidance redefines certain wellness devices, emphasizing that those related to chronic diseases or conditions may now be recognized as medical devices but remain under FDA's enforcement discretion if they pose minimal safety risks. Additionally, the article …

When Popular Culture And The Nfl Collide: Fan Responsibility In Ending The Concussion Crisis, Taylor Simpson-Wood

Faculty Scholarship

No abstract provided.

Fda Regulation Of Mhealth And Wellness Devices: What You Need To Know, Barbara Zabawa

Faculty Works

The integration of mobile health (mHealth) technologies into wellness and healthcare practices presents both opportunities and regulatory challenges. This article explores the role of the U.S. Food and Drug Administration (FDA) in regulating mHealth and wellness devices, particularly as technological advancements blur the lines between general wellness tools and medical devices. It examines the FDA's framework under the Food, Drug, and Cosmetic Act (FDCA) for classifying and overseeing devices based on intended use and associated risks, including the distinctions between medical devices and low-risk wellness products. Guidance documents for mobile medical applications and low-risk wellness devices are analyzed, highlighting their …

The Institutional Case For Partisan Gerrymandering Claims, G. Michael Parsons

Cardozo Law Review de•novo

For voters hoping the Supreme Court’s 2017 Term brings relief from partisan gerrymandering, the end of the 2016 Term was inauspicious. In Cooper v. Harris, the majority assumed the legitimacy of “partisan advantage” arguments while the dissent—including Justice Kennedy—warned about the “serious institutional and federalism implications” of judicial intervention in the redistricting process. If past is prologue, this concern for institutional and structural interests does not bode well.

Constitutionalizing Abortion Rights In Canada, Joanna Erdman

Articles, Book Chapters, & Popular Press

This article endeavours to understand the feminist activism from which constitutional abortion rights in Canada were born in the landmark Supreme Court case of R v Morgentaler 1988, and the influence of these rights on continued feminist activism for reproductive justice. Part I reviews abortion practice in the ‘back-alley’ prior to and immediately after the 1969 criminal reform with attention to the direct service activism of liberation feminists in their campaign to repeal the abortion law as a matter of constitutional justice. Part II turns to adjudication in the courts to study how judicial reasoning channelled these constitutional claims, exploring …

Lessons Learned By An Interdisciplinary Research Team Evaluating Medical-Legal Partnership With The Department Of Veterans Affairs, Margaret Middleton, Jack Tsai, Robert Rosenheck

South Carolina Law Review

No abstract provided.

‘And Miles To Go Before I Sleep’: The Future Of End Of Life Law And Policy In Canada, Jocelyn Downie

Articles, Book Chapters, & Popular Press

This paper reviews the legal status of a number of end-of-life law and policy issues that have, to date, been overshadowed by debates about medical assistance in dying. It suggests that law reform is needed in relation to palliative sedation without artificial hydration and nutrition, advance directives for the withholding and withdrawal of oral hydration and nutrition, unilateral withholding and withdrawal of potentially life-sustaining treatment, and the determination of death. To leave the law in its current uncertain state is to leave patients vulnerable to having no access to interventions that they want or, at the other extreme, being forced …

Is It Time To Adopt A No-Fault Scheme To Compensate Injured Patients?, Elaine Gibson

Articles, Book Chapters, & Popular Press

The tort system is roundly indicted for its inadequacies in providing compensation in response to injury. More egregious is its response to injuries incurred due to negligence in the provision of healthcare services specifically. Despite numerous calls for reform, tort-based compensation has persisted as the norm to date. However, recent developments regarding physician malpractice lead to consideration of the possibility of a move to “no-fault” compensation for healthcare-related injuries. In this paper, I explore these developments, examine programs in various foreign jurisdictions which have adopted no-fault compensation for medical injury, and discuss the wisdom and feasibility of adopting an administratively-based …

Agonizing Identity In Mental Health Law And Policy (Part I), Sheila Wildeman

Articles, Book Chapters, & Popular Press

In this two-part paper, the author explores the significance of identity in mental health law and policy. In this as in other socio-legal domains, identity functions to consolidate dissent as well as to effect social control. The author asks: where do legal experts stand in relation to the identity categories that run so deep in this area of law and policy? More broadly, she asks: is “mental health” working on us — on the mental health disabled, legal scholars, all of us — in ways that are impairing our capacity for social justice? In the first part of the paper, …

Agonizing Identity In Mental Health Law And Policy (Part Ii): A Political Taxonomy Of Psychiatric Subjectification, Sheila Wildeman

Articles, Book Chapters, & Popular Press

This is the second part of a two-part essay exploring the function of identity in mental health law and policy, or more broadly, the function of identity in the politics of mental health. Part one began with the Foucauldian exhortation to undertake a “critical ontology of ourselves,” and adopted the methodology of autoethnography to explore the construction or constructedness of the author’s identity as an expert working in the area of mental health law and policy. That part concluded with a gesture of resistance to identification on one or the other side of the mental health/ illness divide (the divide …

Avoiding Unintended Disclosure: Representing Clients With Hiv And Aids, Lashanda Taylor Adams

Journal Articles

When the HIV/AIDS epidemic was initially recognized in the United States, many attorneys wondered what it would mean to represent a client with HIV. As the number of HIV-infected individuals grew, so did the need for attorneys to represent them. Specifically, attorneys questioned whether or not their duty of confidentiality would expose them to civil liability from failing to protect a third party.1 In response to this concern, several law review articles were written discussing the dilemma faced by attorneys bound by professional rules of conduct.2 These articles focused on the needs of the attorney and the public rather than …

Why Data Privacy Law Is (Mostly) Constitutional, Neil M. Richards

Scholarship@WashULaw

Laws regulating the collection, use, and disclosure of personal data are (mostly) constitutional, and critics who suggest otherwise are wrong. Since the New Deal, American law has rested on the wise judgment that, by and large, commercial regulation should be made on the basis of economic and social policy rather than blunt constitutional rules. This has become one of the basic principles of American Constitutional law. Although some observers have suggested that the Supreme Court’s recent decision in Sorrell v. IMS Health (2011) changes this state of affairs, such readings are incorrect. Sorrell involved a challenge to a poorly-drafted Vermont …

Protecting Rights And Building Capacities: Challenges To Global Mental Health Policy In Light Of The Convention On The Rights Of Persons With Disabilities, Sheila Wildeman

Articles, Book Chapters, & Popular Press

The World Health Organization (WHO) has in the last decade identified mental health as a priority for global health promotion and international development, to be targeted through promulgation of evidence-based medical practices, health systems reform, and respect for human rights. Yet these overlapping strategies are marked by tensions as the historical primacy of expert-led initiatives is increasingly subject to challenge by new social movements — in particular, disabled persons’ organizations (DPOs). These tensions come into focus upon situating the WHO’s contributions to the analysis of global mental health in light of the negotiation and early stages of implementation of the …

The Past And Future Of Deinstitutionalization Litigation, Samuel R. Bagenstos

Law & Economics Working Papers

Two conflicting stories have consumed the academic debate regarding the impact of deinstitutionalization litigation. The first, which has risen almost to the level of conventional wisdom, is that deinstitutionalization was a disaster. The second story does not deny that the results of deinstitutionalization have in many cases been disappointing. But it challenges the suggestion that deinstitutionalization has uniformly been unsuccessful, as well as the causal link critics seek to draw with the growth of the homeless population. This dispute is not simply a matter of historical interest. The Supreme Court’s 1999 decision in Olmstead v. L.C., which held that unjustified …

An Essay On Torts: States Of Argument, Marshall S. Shapo

Pepperdine Law Review

This essay summarizes high points in torts scholarship and case law over a period of two generations, highlighting the “states of argument” that have characterized tort law over that period. It intertwines doctrine and policy. Its doctrinal features include the traditional spectrum of tort liability, the duty question, problems of proof, and the relative incoherency of damages rules. Noting the cross-doctrinal role of tort as a solver of functional problems, it focuses on major issues in products liability and medical malpractice. The essay discusses such elements of policy as the role of power in tort law, the tension between communitarianism …

Consent Requirements For Pelvic Examinations Performed For Training Purposes, Elaine Gibson, Jocelyn Downie

Articles, Book Chapters, & Popular Press

In 2010, The Society of Obstetricians and Gynaecologists of Canada (SOGC) and The Association of Professors of Obstetrics and Gynaecology of Canada (APOG) released an updated policy statement regarding pelvic examinations performed on women under anesthesia. The updated statement, unlike the previous 2006 guideline that applied to “medical trainees” (explicitly including students and residents), for the most part only applies to “medical students”. Pelvic examinations conducted for training purposes presumably constitute a battery in law, subject to the defence of consent. Residents need to be covered by an SOGC and APOG policy statement regarding pelvic examinations for training purposes with …