Health Law and Policy Commons^™

Fda's New Approval Plan For Covid-19 Vaccines: An Inquiry Of "Benefit" Rather Than The Statutory Scope Of "Safety, Purity, And Potency"?, Henry Yat-Shing Kwan

Journal of Law and Health

This article analyzes the FDA's proposed policy plan issued in May 2025 regarding the approval of Covid-19 boosters for different groups of persons. It offers two constructive recommendations that will help prevent constitutionality challenge on impermissible intrusion of the freedom of health.

The first is to avoid using the confusing term "benefit" but instead focus on the statutory parameters of "safety, purity, and potency." The affected group can make a strong case that their free choice of vaccination should not be deprived, as long as the vaccine qualifies for the statutory thresholds of being safe, pure, and potent. They are …

Bridging The Rural Telehealth Divide, Deborah Farringer

Law Faculty Scholarship

This article examines the historical development, regulatory landscape, and post-pandemic future of telehealth in the United States, with a particular focus on its original purpose: improving access to care for rural populations. Although Congress first authorized Medicare reimbursement for telehealth in 1997 to alleviate rural health disparities, federal and state regulatory frameworks—especially restrictions on originating sites, licensure rules, and HIPAA-driven technology requirements—significantly limited adoption for more than two decades. The COVID-19 public health emergency triggered sweeping temporary waivers that removed geographic limitations, permitted the use of common communication technologies, liberalized supervision and prescribing rules, and allowed audio-only encounters. These changes …

Unvaccinated By Doubt: How Covid-19 Governance Sparked A Measles Outbreak, Ellen Black

Law Faculty Scholarship

This Article examines how the erosion of public trust in government and public health institutions during the COVID-19 pandemic has contributed to the resurgence of measles in the United States. It argues that pandemic-era governance—marked by inconsistent scientific messaging, politically charged public health mandates, and the federal government’s coordination with social media platforms to suppress dissenting viewpoints—generated widespread skepticism that continues to undermine vaccination uptake. Through a detailed analysis of lockdown policies, vaccine and mask mandates, and the subsequent revelations regarding governmental influence over online content moderation, the Article demonstrates how conflicting guidance and perceived censorship fostered long-lasting public doubt. …

Medicaid Unwinding: Due Process Violations And Impacts In Florida, Emma Page

University of Miami Race & Social Justice Law Review

No abstract provided.

Decriminalizing Disease: A Health Justice Approach To Infectious Diseases And Criminal Law, Sean E. Bland

Arkansas Law Review

Infectious diseases, also called communicable diseases, are largely a public health issue and should not be criminalized. This Article seeks to re-frame the discussion around the legal framework for infectious diseases in a way that moves beyond a punishment mindset and toward a health justice mindset. The focus in this Article is on health justice rather than traditional understandings of public health, defined as the science and practice of improving the health of people and their communities. The Article makes three novel contributions. First, it applies a health justice framework to the critique of infectious disease criminalization. Second, the Article …

Cause Of Death? -- It's Probably Not What's Reported On The Death Certificate, Lauren R. Roth

Lewis & Clark Law Review

In the age of big data, this country has a data problem—inaccurate and incomplete information in death certificates. The problem has long been hidden by the numbers reported—as have the people whose deaths go uncounted, but the COVID-19 pandemic unveiled the scope of the issue. Since the beginning of the pandemic, “excess deaths” (i.e., any deaths above the number predicted by existing mortality models) have increased significantly. Most of these excess deaths are likely attributable to COVID-19 because the decedent was never tested for COVID-19 or it was one of multiple factors contributing to their death. Other deaths are uncounted …

The Courts, Congress, And The Bureau Of Prisons: Using The First Step Act As An Impetus For Accountability And Legal Reform Of The Federal Carceral System, Sarah E. Ryan

Journal of Civil Rights and Economic Development

(Excerpt)

On December 18, 2018, the Formerly Incarcerated Reenter Society Transformed Safely Transitioning Every Person Act, or First Step Act, became law. The Act reflected decades of social, racial, and economic justice advocacy and years of legislative work. In the five years preceding the Act’s passage, lawmakers built a new case for criminal justice reform.

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From 2018 to today, the First Step Act has galvanized discussions about what comes next in criminal justice reform. Most observers have criticized the limited architecture and implementation of the Act, but some have hailed the Act’s utility during the COVID-19 pandemic and …

Equalizing Disproportionate Death And Punishment In Black And Brown Communities: An Emergency Shutdown On Death, Inequality, And Deliberate Indifference, Angela Dixon

Journal of Civil Rights and Economic Development

(Excerpt)

According to an old saying, “death is the great equalizer.” But is it? It may be in the sense that absent a contravening force, it is an appointment that all must keep. Yet data indicates that all do not die equally. Socioeconomic status (“SES”), which includes levels of occupation, education, income, and wealth, all delay or advance mortality. People of a higher SES outlive, generally, people of a lower SES; moreover, such disparities continue to widen as trends of income inequality intensify.

Perhaps predictably, race, just like class, exacerbates inequities. Black Americans in the United States remain the pivotal …

Covid-19 And Access To Healthcare At The Crossing Of Race, Poverty, And Rurality, Shavonnie R. Carthens

Journal of Law and Health

Black Americans make up 7.7 percent of the rural population in the United States. During the COVID-19 pandemic many in this population found themselves at a unique intersection of inequity - being Black, poor, and residing in a rural area. Poverty is a known contributor to negative health outcomes and is a risk factor for death from coronavirus infection. The association between race and poverty, when examining infectivity and mortality rates of COVID-19, have disproportionately devastated Black Americans and other minorities. Further, research indicates the presence of a general “rural mortality penalty” wherein rural Black communities have higher death rates …

Unshackled: Why Eliminating Health Disparities Requires That Our Criminal Justice System Set Incarcerated Mothers And Their Developing Children Free, Angela Dixon

Journal of Law and Health

Incarceration of pregnant nonviolent offenders takes not only the pregnant mother captive but also her unborn child. Kept in unnecessary captivity, these innocent children may experience adverse childhood experiences (“ACES”) or lifelong damage to their physical and mental health. The experiences may be the same for children born already to the mother, as they endure the suffering of parental separation during the mother’s absence. In terms of racial health disparities, such captivity presents at least a triple threat—harm to the health of the mother, harm to the health of the unborn fetus, and harm to the health of children born …

Prescription Practices, Anti-Psychotics, And Covid-19: An Intersectional Examination Of The Long-Term Care Home Setting In Canada, Olivia Ramos

Dalhousie Journal of Legal Studies

Public discourse and concern over the state of long-term care homes in Canada has been ongoing over the last two decades. One of the main sources of these concerns is the off-label prescription of anti-psychotic medications to long-term care home residents. Off-label use of pharmaceuticals is common and can be beneficial in certain contexts, however, there is a risk of anti-psychotics being used as an inappropriate means of managing patients chemically in the long-term care home setting. This paper engages in three lines of inquiry: first, the regulatory landscape of on and off-label prescription in Canada; second, the off-label use …

Blurring Boundaries: A Proposed Research Agenda For Ethical, Legal, Social, And Historical Studies At The Intersection Of Infectious And Genetic Disease, Seethal Jose, Juli Bollinger, Gail Geller, Jeremy Greene, Leslie Meltzer Henry, Brian Hutler, Eric Thomas Juengst, Jeffrey Kahn, Anna Mastroianni, Graham Mooney

Articles

Contemporary understanding of the mechanisms of disease increasingly points to examples of “genetic diseases” with an infectious component and of “infectious diseases” with a genetic component. Such blurred boundaries generate ethical, legal, and social issues and highlight historical contexts that must be examined when incorporating host genomic information into the prevention, outbreak control, and treatment of infectious diseases.

Safeguarding The Pandemic Agreement From Disinformation, Alexandra Finch, Kevin A. Klock, Lawrence O. Gostin, Sam F. Halabi, Sarah A. Wetter

Georgetown Law Faculty Publications and Other Works

Complicating the negotiation of a global pandemic treaty has been a sustained disinformation campaign worldwide to undermine the agreement by making and amplifying spurious assertions about what it intends to accomplish and how it will do so. Central to the disinformation campaign are erroneous claims about national sovereignty and forcible takings of pandemic countermeasures. Further, legitimate and unfounded unease concern weakened intellectual property (IP) and speech rights. Having followed the negotiations and provided technical assistance to the World Health Organization's (WHO's) leadership, we set the record straight in several key areas.

Shots Fired, Shots Refused: Scientific, Ethical & Legal Challenges Surrounding The U.S. Military's Covid-19 Vaccine Mandate, Shawn Mckelvy, L. William Uhl, Armand Balboni

St. Mary's Law Journal

The COVID-19 pandemic provided uncertain and challenging circumstances under which to lead a nation and the military that protects it. Those in charge and in command faced unique challenges—scientific, ethical, and legal—at our various levels of government to both keep people safe while keeping government and society functioning. While there were many successes to celebrate, there are also many criticisms for how this “whole-of-government approach” may have degraded some of our most cherished liberties along the way. The authors focus on the U.S. military’s vaccine mandate and propose military leaders may have failed to fully consider the evolving science, weigh …

When Governors Prioritize Individual Freedom Over Public Health: Tort Liability For Government Failures, Barbara Pfeffer Billauer Jd, Ma, Phd

Journal of Law and Health

Over half the states have enacted laws diminishing or curtailing the rights of the executive branch (legislatures or governors) to enact laws to preserve, protect, or safeguard public health in the wake of the COVID-19 emergency. Governor DeSantis, of Florida, for example, effectively banned mask mandates in schools during the high point of the epidemic – based on flawed science and erroneous data – and now wants to make that response permanent. The rules effectuating this Executive Order were enacted under an emergency order finding a threat to public health. Nevertheless, the response promulgated by the Florida Department of Health …

How Bodily Autonomy Can Fail Against Vaccination Mandates; The Few Vs. The Many, Jason Yadhram

Journal of Law and Health

Humans have been a communal species since inception and continue to be so to this day. Because of this, if even a small scale of a measured population becomes severely ill, the entire remaining population and surrounding area is thrown into absolute chaos. In fact, we have seen these circumstances throughout history and in the recent COVID-19 pandemic yet, some of us have forgotten that the only way this chaos can be curbed, is by enacting a mandatory vaccination policy. Since COVID-19 however, vaccination mandates have become an uneasy topic of conversation in the United States for essentially one main …

Market Versus Policy Responses To Novel Occupational Risks, Robert J. Kramer, Elissa Philip Gentry, W Kip Viscusi

Scholarly Publications

The unprecedented occupational risks posed by the COVID-19 pandemic prompted employers to boost wages and federal authorities to propose hazard pay policies. This article estimates a market-based compensating differential for workers facing elevated risks through contact with the public using CPS employment data for 2019–2020 and occupational characteristic data from the US Department of Labor’s Occupational Information Network. The estimated premium for exposure was roughly $820 overall and $1000 for essential workers. These premiums fall short of those proposed—but not enacted—by the federal government and are more commensurate with estimates of the value of a statistical life than were the …

Effective Public Health Communication In A Post-Covid-19 America: Lessons From Behavioral Science, Molly J. Walker Wilson

Lewis & Clark Law Review

As we emerge from the worst of the COVID-19 pandemic, Americans are still reeling from the loss of life, the financial fallout, and the deep divide that continues to characterize our social and political institutions. Public health experts who were tasked with communicating facts and advice to the American public faced a daunting challenge, particularly because three distinct groups of Americans received messages differently. One group of Americans was receptive to scientific findings and amenable to taking recommended precautions. A second group was skeptical about the safety and efficacy of available vaccines, and genuinely confused or suspicious about the source …

Eliding Consent In The Case Of Pandemic Countermeasures Authorized Only For Emergency Use, Lars Noah

UF Law Faculty Publications

Four months after the first vaccines against Covid-19 became available to the public, and just as some universities announced plans to require inoculations, the Boston Globe quoted me as (alone) suggesting that mandates would conflict with federal law. When Congress created a special mechanism for the emergency use of still investigational products, it directed providers to reveal, among other things, that individuals remained free to decline such an intervention; only after full FDA approval of a medical countermeasure would this disclosure obligation become inapplicable. I have watched with dismay over the last three years as nearly everyone—including Executive branch officials, …

Pandemics Of Limitation Of Rights, Rinat Kitai-Sangero

Touro Law Review

This Article discusses the limitation of rights due to pandemics. It analyzes from a constitutional standpoint the holding of the German Federal Constitutional Court (Das BUNDESVERFASSUNGSGERICHT) from April 2022 as a symptom of moral panic disguised through an analytical process. Though it focuses on this case, it sheds light on the moral panic that characterized many countries’ approaches during the COVID-19 pandemic. On April 27, 2022, the German Federal Constitutional Court held that a provision to provide proof of vaccination against COVID-19, recovery from COVID-19, or a medical exemption to COVID-19 vaccination as a condition of employment in the health …

American Star Chamber: Online Misinformation, Government Intervention, And The Intellectual Matrix Of The First Amendment, Emily E. Burton

Catholic University Journal of Law and Technology

Just as monarchs and clerical authorities struggled to respond to seditious and heretical writings enabled by the invention of the printing press, twenty-first century governments are experiencing a similar information revolution as a result of the digital age and a rising tide of what the United States has labeled online misinformation. Like the printing press, the Internet has enabled the spread of information at an exponentially lower cost and an exponentially higher speed as it extends the ability to publish thoughts and opinions to an increasingly diverse array of individuals. Although this was largely celebrated during the first two decades …

Is Jacobson V. Massachusetts Viable After A Century Of Dormancy? A Review In The Face Of Covid-19, Sawan Talwar

Touro Law Review

The COVID-19 pandemic has stretched us into the vast unknowns, emotionally, logically, politically, and legally. Relying on their police power, governments inched into the darkness of the powers’ fullest extent, leaving many to wonder whether the exercise of this power was constitutional. This Article examines the extent of the police power that both the federal and state governments have, and how Jacobson v. Massachusetts1 was the “silver bullet” for governments across the United States. Further, this Article provides an overview of police power, and the status of COVID-19 mandates. This Article additionally examines quarantine case law and provides an analysis …

Intellectual Property And “The Lost Year” Of Covid-19 Deaths, Madhavi Sunder, Haochen Sun

Georgetown Law Faculty Publications and Other Works

Protecting intellectual property (IP) is a question of life and death. COVID-19 vaccines, partially incentivized by IP, are estimated to have saved nearly 20 million lives worldwide during the first year of their availability in 2021. However, most of the benefits of this life-saving technology went to high- and upper-middle-income countries. Despite 10 billion vaccines being produced by the end of 2021, only 4 percent of people in low-income countries were fully vaccinated. Paradoxically, IP may also be partly responsible for hundreds of thousands of lives lost in 2021, due to an insufficient supply of vaccines and inequitable access during …

Telehealth Fraud And Abuse Before And “After” The Pandemic: Are Things Going To Get Better?, Natalia Shamuel

DePaul Journal of Health Care Law

Telehealth and telemedicine have become increasingly useful to both patients and health care providers. The ease and comfort of attending a doctor’s appointment in the comfort of one’s own home made telehealth and telemedicine convenient, safe, and effective options for seeing a doctor during the height of the COVID-19 pandemic. However, with increased usage of telehealth and telemedicine came increased health care fraud and abuse. With increased health care fraud and abuse came increased regulations, both on the federal and state levels. This Note provides a brief analysis of health care fraud and abuse in the telehealth and telemedicine space. …

Cyberattacks: An Underlying Condition Exacerbated By The Covid-19 Pandemic, Kaitlyn Palmeter

The Journal of Business, Entrepreneurship & the Law

COVID-19 continues to change the world in unforeseen ways triggering a new era of corporate data breaches. This article will illustrate how cyberattacks have increased in severity during the pandemic, how current laws and government officials are trying to evolve with the current threats and technology, how victims of cyberattacks risk sanctions and potential lawsuits, and concludes by suggesting solutions throughout to increase Cybersecurity.

Compassion Fatigue In An Infodemic: A Physician’S Duty To Treat In The Age Of Misinformation, Alessandra Perez

University of Miami International and Comparative Law Review

This Note considers how misinformation has exacerbated the COVID-19 pandemic and the inevitable burden it has placed on the healthcare industry. It explores the intersection between a doctor’s oath of ethics and their right to refuse care by uncovering the obligations that guide their decisions. Justice dictates that physicians provide care to all who seek it, and it is unconstitutional for a physician to refuse to treat patients based on race, ethnicity, gender, religion, or sexual orientation. Even if a patient’s request is antithetical to a physician’s personal beliefs, the unwavering duty to treat generally mandates that physicians treat any …

The Inherent Monetary Incentive Of Intellectual Property Rights And The Failure Of Intellectual Property Waivers To Recognize This Motive, Ellaheh D. Sims

Barry Law Review

No abstract provided.

Liberating Legal Aid: Reducing Covid-19'S Justice Gap And Promoting Health By Removing The Legal Services Corporation's Class Action And Advocacy Restrictions, Molly C. Schmidt

Cleveland State Law Review

The Legal Services Corporation (LSC) is the single-largest funder of civil legal services, or legal aid, in the United States. The COVID-19 pandemic underscored a longstanding and growing problem faced by ow-income Americans served by LSC-funded legal aid organizations: the growing "justice gap." The justice gap represents the unmet civil legal needs of low-income Americans. The justice gap perpetuates poverty, conceals health-harming legal problems, and furthers racial disparities. Despite the LSC’s essential role in reducing the justice gap and promoting “equal access to justice,” Congress consistently underfunded the LSC before and during COVID-19. Congress has also prohibited the LSC-funded legal …

Shifting Into “Neutral”: Evaluating Mediation As A Peaceful Alternative To The Forceful Resolution Of The 2022 Canada–Freedom Convoy Dispute, Teresa (Tessa) Griego

Pepperdine Dispute Resolution Law Journal

In early 2022, the Canadian government found itself confronted by a group of truck drivers—in what came to be known as the “Freedom Convoy”—protesting government-imposed restrictions related to the COVID-19 pandemic. This article evaluates how mediation could—and should—have been used as an effective means for the government and protestors to resolve their dispute. It begins by defining the government health and safety measures that prompted the protests and describing the ensuing protest movement by the Freedom Convoy. The article then discusses the protest’s implications on commerce and on the communities where it was located. Next, the article describes the unilateral …

Taking Care Of Business: An Empirical Examination Of The Top S&P 500 Companies And Their Role As Public Health Regulators During The Covid-19 Pandemic, Megan M. O’Malley

University of Miami Business Law Review

Data from the top 15 constituents by weight on the S&P 500 is assembled to identify trends among the policies these companies implemented in the United States during the COVID-19 pandemic. Some policies were fairly consistent across the board, especially in regard to remote work opportunities and health and safety measures for essential and/or in-person employees. Other policies, including vaccination requirements and vaccine incentives, varied across and within industries. Some companies that were examined went beyond the relevant federal, state, or local requirements in effect at the time, while other companies pushed back against public health guidance.