Health Law and Policy Commons^™

Going Global, Acting Local: How An International Pandemic Convention Can Support Regional And Community Response, Kevin A. Klock, Lawrence O. Gostin, Sam F. Halabi

Georgetown Law Faculty Publications and Other Works

A WHO pandemic convention could set in place an overarching framework needed for strengthening global health security. As the World Health Assembly (WHA) debated the merits of such an agreement, a critically important regional instrument – the Treaty for the Establishment of the African Medicines Agency (AMA Treaty) – entered into force on 5 November 2021. The new agency will, among other things, ensure there is a “common framework” for addressing “emerging issues and pandemics in the event of a public health emergency on the continent with cross border or regional implications.”

An improved worldwide health security strategy is essential …

Toward A More Strategic National Stockpile, Troy Rule

Texas A&M Law Review

The COVID–19 pandemic exposed major deficiencies in the United States’ approach to stockpiling for emergencies. States, cities, and hospitals across the country had meager inventories of critical medical items on hand when the pandemic first reached U.S. soil, and the federal government’s Strategic National Stockpile proved far too small to serve the country’s needs in the first several months of the crisis. As nationwide shortages spread, many state governments were compelled to bid against each other to procure scarce medical supplies—a distribution approach that disadvantaged low-income and minority communities and left countless healthcare professionals and staff ill-equipped to protect themselves …

Title 42, Asylum, And Politicising Public Health, Michael Ulrich, Sondra S. Crosby

Faculty Scholarship

President Biden has continued the controversial immigration policy of the Trump era known as Title 42, which has caused harm and suffering to scores of asylum seekers under the guise of public health.1 The Centers for Disease Control and Prevention (CDC) ordered the policy in March 2020 with the stated purpose of limiting the spread of the coronavirus into the U.S.; though, CDC and public health officials have admitted this policy has no scientific basis and there is no evidence it has protected the public.2,3 Instead, the impetus behind the policy appears to be a desire to keep out or …

Managing Covid-19: Legal And Institutional Issues, Yon-Shik Lee

Minnesota Journal of Law, Science & Technology

No abstract provided.

Problematic Interactions Between Ai And Health Privacy, W. Nicholson Price Ii

Articles

Problematic Interactions Between AI and Health Privacy Nicholson Price, University of Michigan Law SchoolFollow Abstract The interaction of artificial intelligence (AI) and health privacy is a two-way street. Both directions are problematic. This Essay makes two main points. First, the advent of artificial intelligence weakens the legal protections for health privacy by rendering deidentification less reliable and by inferring health information from unprotected data sources. Second, the legal rules that protect health privacy nonetheless detrimentally impact the development of AI used in the health system by introducing multiple sources of bias: collection and sharing of data by a small set …

Pediatric Covid-19 Vaccines: What Parents, Practitioners, And Policy Makers Need To Know, William J. Moss, Lawrence O. Gostin, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

The US Food and Drug Administration (FDA) granted Emergency Use Authorization for Pfizer-BioNTech’s mRNA COVID-19 vaccine (BNT162b2) for children 5 to 11 years of age on October 29, 2021. The Centers for Disease Control and Prevention recommended use of the vaccine among children in this age group on November 2, 2021. Approximately 28 million children are now eligible for vaccination, with only those younger than 5 years remaining excluded from vaccine eligibility. The benefits of pediatric COVID-19 vaccines are clear. Vaccinations protect children, decrease spread to families and communities, and ensure educational continuity. What do parents, practitioners, and policy makers …

The Right To Abortion Access And Reproductive Healthcare, Cardozo Public Interest Law Student Association, If/When/How: Lawyering For Reproductive Justice Cardozo Chapter, Cardozo Women's Law Initiative, Cardozo Students For Human Rights

2021–2022 Flyers

No abstract provided.

Letter In Reply To Bernard Prusak, Et Al., Govind C. Persad

Sturm College of Law: Faculty Scholarship

Scarce medical resource allocation should aim to prevent harm, especially to those who would be most disadvantaged if not helped. Bernard Prusak et al.’s letter reveals a narrow vision of which harms and disadvantages matter, one that overlooks opportunities to simultaneously prevent important harms and avoid exacerbating disadvantage.

Covid-19 And Its Impact(S) On Innovation, Clark Asay, Stephanie Plamondon Bair

Utah Law Review

In previous work, we explored how certain characteristics of adversity are often more conducive to innovation than others. In this Article, prepared as part of the Lee E. Teitelbaum Utah Law Review Symposium—The Law & Ethics of Medical Research, we review some of that work and apply it specifically to the COVID-19 context. We conclude by assessing certain policy implications in light of how the COVID-19 pandemic has both spurred and hindered innovation.

Problematic Interactions Between Ai And Health Privacy, Nicholson Price

Utah Law Review

The interaction of artificial intelligence (AI) and health privacy is a two-way street. Both directions are problematic. This Essay makes two main points. First, the advent of artificial intelligence weakens the legal protections for health privacy by rendering deidentification less reliable and by inferring health information from unprotected data sources. Second, the legal rules that protect health privacy nonetheless detrimentally impact the development of AI used in the health system by introducing multiple sources of bias: collection and sharing of data by a small set of entities, the process of data collection while following privacy rules, and the use of …

Certificates Of Confidentiality: Mind The Gap, Leslie E. Wolf, Laura M. Beskow

Utah Law Review

Certificates of Confidentiality (“Certificates”) are a federal mechanism designed to protect sensitive, identifiable research data from compelled disclosure in any legal proceeding. The 21st Century Cures Act revised the authorizing statute to address criticisms raised about the Certificates’ coverage and protections. Despite many changes that expanded the scope and reinforced the protection of Certificates, questions remain concerning the robustness of the protection Certificates afford. Here, we briefly review the legal evolution of Certificates and then examine the gaps in protections that remain and their implications. We conclude with recommendations for areas of clarification and future research.

Proceedings Of The 2020 Lee E. Teitelbaum Utah Law Review Symposium, Utah Law Review

Utah Law Review

In the autumn of 2020, the Utah Law Review, in cooperation with the S.J. Quinney College of Law Center for Law and Biomedical Sciences, convened a twoday virtual symposium exploring “The Law and Ethics of Medical Research.” On November 13th, leading scholars from across the country joined us for a panel discussion titled “Sharing Medical Research Data: Privacy and Confidentiality.” On November 20th, a second set of distinguished scholars and practitioners gathered virtually for three more panel discussions: “Clinical Trials—Legal and Ethical Issues in the Age of COVID-19,” “Intellectual Property and Medical Research,” and “Medical Research as a Public Health …

Coronavirus, Compulsory Licensing, And Collaboration: Analyzing The 2020 Global Vaccine Response With 20/20 Hindsight, Arjun Padmanabhan

Student Scholarship

In December 2019, COVID-19, a novel strain of the SARS-2 Virus, appeared in Wuhan, China. Within a year, over ninety million people had been infected, and two million had died. Amid all the death and desolation, humanity's ingenuity and willpower emerged in history's greatest vaccine race. The global community sought to find novel ways to protect innovation and intellectual property while still collaborating to roll out a vaccine in record time. Despite the presence of compulsory licensing provisions like 28 U.S.C. § 1498 and the Bayh-Dole Act in the U.S., and the TRIPS Agreement at the international level, the journey …

Preface, Tammy M. Frisby, Leslie P. Francis

Utah Law Review

When the Utah Law Review editors selected the topic for this symposium issue in early February 2020, we did not anticipate—nor would we have wished for—how exceptionally timely the topic would become over the next year-and-a-half. By the time we were extending invitations to participate in the fall 2020 symposium event, most teaching and learning at the law school, including the annual Lee E. Teitelbaum law review symposium, had moved online. As in so many aspects of life during the pandemic, our conversations turned to COVID-19. The extent and forms of regulation of medical research in the U.S. are sources …

J Mich Dent Assoc November 2021

The Journal of the Michigan Dental Association

Every month, The Journal of the Michigan Dental Association brings news, information, and features about Michigan dentistry to our state's oral health community and the MDA's 6,200+ members. No publication reaches more Michigan dentists!

In this issue, the reader will find the following original content:

• Cover stories with a “Focus on Advocacy: Helping Dentistry Succeed”, including “MDA Dental PAC: What It Is and Why It Matters “, “2021 Advocacy Success — and More to Come “, and “Dental Programs Maintained in 2021-22 State Budget”.
• A feature article on “The Anishinaabe Dental Outreach Program”.
• A feature article, “How Your Website and …

Estimating The Appropriate Size Of Global Pull Incentives For Antibacterial Medicines, Kevin Outterson

Faculty Scholarship

Antibacterial medicines should be foundational for modern medicine—a key part of the infrastructure of contemporary practice. Recently, however, antibacterials have struggled commercially. Even with “push” incentives (grants paid before regulatory approval), antibacterials have failed on the market because revenues are tied to volume sold. There are policy initiatives under way in the United States and United Kingdom that explore paying for exceptional antibacterials with “pull” incentives (paid after regulatory approval) by delinking the payments from volume via other payment formats such as market entry rewards and subscriptions. This article discusses these initiatives but also proposes an expected net present value …

Waive Ip Rights & Save Lives, Srividhya Ragavan

Faculty Scholarship

In October of 2020, when India and South Africa proposed a waiver from certain provisions of the TRIPS agreement, it was meant to increase local manufacturing capacity in these countries. The waiver was proposed as a tool to kick-start prevention, containment and treatment of COVID-19. While there is an imminent need to meet a growing supply-demand gap for all medical products, COVID-19 related products are urgently required in poorer nations to contain the pandemic. The waiver has an additional role to play in the larger trade schema. In enabling vaccination of populations across the globe, the waiver would be critical …

Supported Decisions As The Patient’S Own?, Leslie Francis

Utah Law Faculty Scholarship

This brief commentary addresses what I regard as the thorniest challenge to supported decision making: how to determine if a supported decision really is the decision of the supported person, rather than an insidious form of concealed paternalism or conflicts of interest. The risk that apparent supported decision-making really becomes the decision of the supporter looms as capacities wane. Peterson, Karlawash and Largent (PK&L), who offer a defense of supported decision making in health care for people with dynamic and diminishing capacity, are alert to these problems but skirt their implications. The authors’ model for supported decisionmaking is incomplete; at …

The Ratio Method: Addressing Complex Tort Liability In The Fourth Industrial Revolution, Harrison C. Margolin, Grant H. Frazier

St. Mary's Law Journal

Emerging technologies of the Fourth Industrial Revolution show fundamental promise for improving productivity and quality of life, though their misuse may also cause significant social disruption. For example, while artificial intelligence will be used to accelerate society’s processes, it may also displace millions of workers and arm cybercriminals with increasingly powerful hacking capabilities. Similarly, human gene editing shows promise for curing numerous diseases, but also raises significant concerns about adverse health consequences related to the corruption of human and pathogenic genomes.

In most instances, only specialists understand the growing intricacies of these novel technologies. As the complexity and speed of …

United States V. Texas: Brief Of Legal Scholars Leah Litman, Erwin Chemerinsky, Michael C. Dorf, Barry Friedman, And Fred O. Smith As Amici Curiae In Support Of Petitioner, Leah Litman

Appellate Briefs

Amici curiae are constitutional law scholars who teach and write in the fields of constitutional law and federal courts. They share an interest in promoting the appropriate role of the federal courts in maintaining the supremacy of federal law, and in preserving our federal constitutional system and the rule of law.<\p>

In this case, this Court is asked to consider whether the United States may seek relief in federal court to protect constitutional rights in the face of state subterfuge designed to undercut those rights. Texas’s efforts to evade judicial review of Senate Bill 8 (“S.B. 8”) are central to …

Twenty Years After The Anthrax Terrorist Attacks Of 2001: Lessons Learned And Unlearned For The Covid-19 Response, Lawrence O. Gostin, Jennifer B. Nuzzo

Georgetown Law Faculty Publications and Other Works

The 20th anniversary of the terrorist attacks on September 11, 2001, resulted in deep national reflection. Less remembered are the events that began to unfold 7 days later as anonymous letters laced with deadly anthrax (Bacillus anthracis) spores began arriving at postal facilities, media companies, and congressional offices. The first death from inhaled anthrax exposure occurred on October 5, with an additional 4 deaths and 17 infections over the ensuing months.

The anthrax attacks exposed a health system ill-equipped to respond to acute emergencies. This article explores the lessons learned, and unlearned, from the anthrax attacks, through to …

Held V. State, Alec D. Skuntz

Public Land & Resources Law Review

On March 13, 2020, a group of 16 Montana children and teenagers filed a complaint in the First Judicial District, Lewis and Clark County against the State of Montana and several state agencies. These young Plaintiffs sought injunctive and declaratory relief against Defendants for their complicity in continuing to extract and release harmful amounts of greenhouse gases which contribute to climate change. Plaintiffs premised their argument on the Montana Constitution’s robust environmental rights and protections. The Defendants filed a motion to dismiss which the District Court granted in-part and denied in-part. Held provides a roadmap for future litigation by elucidating …

Advancing Behavioral Health Literacy, James Scollione

Journal of Social, Behavioral, and Health Sciences

Accessing, comprehending, and using information to make informed decisions and improve one’s overall health or well-being are the foci of health literacy. The concept of behavioral health was introduced in the early 1980s and, since then, it has influenced new ideas (e.g., behavioral health literacy and integrated behavioral health care) and gained research and public attention. My aim is to provide an overview of definitions (i.e., health literacy, mental health literacy, and behavioral health literacy) and their connection to each other. I propose an expanded and honed definition of behavioral health literacy to enhance the behavioral health literacy and well-being …

The Effects Of Missouri's Medicaid Expansion, Chandni Challa

SLU Law Journal Online

A Missouri Supreme Court ordered the Missouri legislature to implement a state constitutional amendment to expand Medicaid. In this article, Chandni Challa argues that this decision will undoubtedly affect the state economy, and based on empirical evidence from Michigan, provide a net benefit.

Covid-19 Vaccine Mandates—A Wider Freedom, Lawrence O. Gostin

Georgetown Law Faculty Publications and Other Works

President Biden has required COVID-19 vaccinations across much of the US workforce, reaching nearly 100 million workers. Opponents call it unconstitutional, a violation of personal freedom, and even “un-American.” The truth is that vaccine mandates are lawful and deeply entrenched in US history and values. They constitute a “wider freedom” so that everyone in society can feel safer where they work, learn, worship, and live.

Jordan's Public Policy Response To Covid-19 Pandemic: Insight And Policy Analysis, Wa’Ed Alshoubaki, Michael Harris

Public Administration Faculty Research

The aim of this study was to gain an understanding of how the Jordanian government has responded and continues to respond to the COVID-19 pandemic. It utilizes the interpretive policy analysis approach through document analysis. The analysis showed that Jordan created social protection policies to assist people who lost their jobs or whose work was suspended due to the coronavirus. The economic policies build solidarity and facilitate the private sector’s recovery. The health care measures firmly applied included lockdown, wearing masks, and restrictions on gatherings and public events. Jordan uses hard power and imposes sanctions on any violation that threatens …

Professional Responsibility, Legal Malpractice, Cybersecurity, And Cyber-Insurance In The Covid-19 Era, Ethan S. Burger

St. Mary's Journal on Legal Malpractice & Ethics

In response to the COVID-19 outbreak, law firms conformed their activities to the Centers for Disease Control and Prevention (CDC), Occupational Safety and Health Administration (OSHA), and state health authority guidelines by immediately reducing the size of gatherings, encouraging social distancing, and mandating the use of protective gear. These changes necessitated the expansion of law firm remote operations, made possible by the increased adoption of technological tools to coordinate workflow and administrative tasks, communicate with clients, and engage with judicial and governmental bodies.

Law firms’ increased use of these technological tools for carrying out legal and administrative activities has implications …

Maternity Rights: A Comparative View Of Mexico And The United States, Roberto Rosas

The Scholar: St. Mary's Law Review on Race and Social Justice

Women play a large role in the workplace and require additional protection during pregnancy, childbirth, and while raising children. This article compares how Mexico and the United States have approached the issue of maternity rights and benefits. First, Mexico provides eighty-four days of paid leave to mothers, while the United States provides unpaid leave for up to twelve weeks. Second, Mexico allows two thirty-minute breaks a day for breastfeeding, while the United States allows a reasonable amount of time per day to breastfeed. Third, Mexico provides childcare to most federal employees, while the United States provides daycares to a small …

Barred By Their Brains: Inmates With Traumatic Brain Injury (Tbi), Claire Mikita

The Scholar: St. Mary's Law Review on Race and Social Justice

Abstract forthcoming.

Mid-Atlantic Ethics Committee Newsletter, Fall 2021

Mid-Atlantic Ethics Committee Newsletter

No abstract provided.