Health Law and Policy Commons^™

Post-Pandemic Privacy Law, Tiffany C. Li

American University Law Review

COVID-19, the global pandemic that began in 2019, altered how we live our lives in just about every way imaginable. Some of those changes were obvious— for example, those who were fortunate enough to be able to work from home began working online—while other changes were more subtle. The latter category included unprecedented levels of data collection by governments and organizations purporting to collect information that would help stop the pandemic’s spread. Given the deadly nature of COVID-19, few would question any public health efforts, no matter their impact on privacy. However, the lack of attention to privacy issues during …

Litigation As Education: The Role Of Public Health To Prevent Weaponizing Second Amendment Rights, Michael Ulrich

Faculty Scholarship

Tobacco litigation was unquestionably successful, but it is dangerous to expect that it can be easily duplicated. An unrealistic reliance on litigation as a regulatory measure can blind public health advocates to other mechanisms of change. And that includes litigation as a means of enabling actual regulation. Firearms and the gun violence epidemic provides a useful case study. The Protection of Lawful Commerce in Arms Act (PLCAA) essentially bars litigation as a regulatory tool for firearms. This legislation means every time someone pulls the trigger, they become the party to blame. Soto v. Bushmaster Firearms presents a rare exception based …

Paying Americans To Take The Vaccine - Would It Help Or Backfire?, Christopher Robertson, Daniel Scheitrum, K. Aleks Schaefer, Trey Malone, Brandon R. Mcfadden, Kent D. Messer, Paul J. Ferraro

Faculty Scholarship

This research investigates the extent to which financial incentives (conditional cash transfers) would induce Americans to opt for vaccination against COVID-19. We performed a randomized survey experiment with a representative sample of 1,000 American adults in December 2020. Respondents were asked whether they would opt for vaccination under one of three incentive conditions ($1,000, $1,500, or $2,000 financial incentive) or a no-incentive condition. We find that—without coupled financial incentives—only 58% of survey respondents would elect for vaccination. A coupled financial incentive yields an 8-percentage-point increase in vaccine uptake relative to this baseline. The size of the cash transfer does not …

National Legal Paradigms For Public Health Emergency Responses, James G. Hodge Jr.

American University Law Review

The COVID-19 pandemic has exposed significant weaknesses of the U.S. federalist system in controlling major infectious disease threats. At the root of American failures to adequately respond is a battle over public health primacy in emergency preparedness and response. Which level of government—federal or state—should actually “call the shots” to quell national emergencies? Constitutional principles of cooperative federalism suggest both levels of government are responsible. Yet real-time applications of these principles, coupled with dubious national leadership, contributed to horrific public health outcomes across America. No one seeks a repeat performance of U.S. COVID-19 response efforts to forthcoming major health threats. …

The Future Of Facts: The Politics Of Public Health And Medicine In Abortion Law, Aziza Ahmed

University of Colorado Law Review

While a great deal of public scrutiny has focused on how information circulates through online outlets including Twitter and Facebook, less attention has been devoted to how more traditional institutions traffic in factual assertions for the sake of setting a particular distributional agenda into motion.1 Of these more traditional institutions, courts play a central role in legitimating legal and factual claims in the process of applying and clarifying legal rules. In public health-related adjudication, courts play at least two important roles: first, judges and juries make decisions between competing sets of public health and medical claims and second, courts legitimate …

Tobacco Reborn: The Rise Of E-Cigarettes And Regulatory Approaches, Daniel G. Aaron

Lewis & Clark Law Review

This Article examines e-cigarettes, FDA-regulated products which heat nicotine-containing fluid into an aerosol to be breathed into the lungs. Recent data show that e-cigarettes are used by about one-fifth of U.S. high school students. Given that we have, in the Surgeon General’s words, reached an epidemic of youth e-cigarette use, it is worth asking how a product within FDA jurisdiction became a serious threat to 3.6 million youth.

This Article reviews the law surrounding e-cigarettes and the history of FDA’s attempts to regulate them. Administrative law doctrines instruct us that increased presidential control will rein in misbehaving agencies by allowing …

A 'Public' Journey Through Covid-19: Donald Trump, Twitter, And The Secrecy Of U.S. Presidents’ Health, Mark Fenster

UF Law Faculty Publications

Donald Trump ignored numerous governance norms in his one term as U.S. President, especially those that prescribe disclosure of official and personal financial information. His brief period of illness from COVID-19, which he broadcast to the world via his Twitter account, revealed the complexity of Trump’s relationship to the concept and norms of transparency that presume information’s necessity for a functional and accountable state. At the same time that Trump offered little in the way of coherent and authoritative information about his health, he also provided an enormous amount of seemingly “inside” and direct accounts of the progress of his …

Covid-19, Abortion, And Public Health In The Culture Wars, Laura D. Hermer

Mitchell Hamline Law Review

No abstract provided.

Disease And Data In Society: How The Pandemic Expanded Data Collection And Surveillance Systems, Alan Butler, Enid Zhou

American University Law Review

The COVID-19 pandemic1 is a global tragedy of historic proportions, and its impacts on our families, communities, and social structures will be felt for many years to come. From the significant to the mundane, COVID-19 has changed many aspects of daily life. One of the less obvious but more long-lasting changes may well be the expansion of data collection and surveillance systems adopted both in response to, and as a result of, the pandemic.

Tracing The Invisible: Information Fiduciaries And The Pandemic, Anne L. Washington, Lauren Rhue

American University Law Review

Predictive data technology designed to contain the COVID-19 pandemic was not as successful as promised. Data-centric solutions to providing testing and tracing did little to limit the virus’s spread in part because they served only the most visible parts of society. This Article argues for more robust solutions to protect individuals’ privacy—whether those individuals are currently visible or invisible to pandemic technology—if pandemic technology is to provide the universal coverage necessary for a public health emergency, such as the COVID- 19 pandemic. First, we contend that current pandemic data technology operates under rigid technical and social assumptions that thwart participation …

Setting The Health Justice Agenda: Addressing Health Inequity & Injustice In The Post-Pandemic Clinic, Emily Benfer, James Bhandary-Alexander, Yael Cannon, Medha Makhlouf, Tomar Pierson-Brown

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic surfaced and deepened entrenched preexisting health injustice in the United States. Racialized, marginalized, poor, and hyper-exploited populations suffered disproportionately negative outcomes due to the pandemic. The structures that generate and sustain health inequity in the United States—including in access to justice, housing, health care, employment, and education—have produced predictably disparate results. The authors, law school clinicians and professors involved with medical-legal partnerships, discuss the lessons learned by employing a health justice framework in teaching students to address issues of health inequity during the pandemic. The goal of health justice is to eliminate health disparities that are linked …

At A Covid Crossroads : Public Health, Patient Privacy, And Health Information Confidentiality, Stacey A. Tovino

Faculty Articles

This essay summarizes and assesses the various bulletins, guidance documents, and notices of enforcement discretion released by the federal Department of Health and Human Services regarding the application of the HIPAA Privacy Rule to the COVID-19 pandemic. Among other topics and actions, these authorities address the application of the HIPAA Privacy Rule to the use and disclosure of protected health information for public health activities, waive the application of certain HIPAA Privacy Rule requirements during the COVID-19 pandemic, and announce enforcement discretion regarding certain covered entities’ non-compliance with particular provisions within the HIPAA Privacy Rule. These authorities overwhelmingly, and appropriately, …

Intellectual Property As A Determinant Of Health, Ana S. Rutschman

Vanderbilt Journal of Transnational Law

Public health literature has long recognized the existence of determinants of health, a set of socioeconomic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as “forces and systems” consisting of “factors combin[ing] together to affect the health of individuals and communities.” Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are …

A World Of Their Own: Illiberal Religious Communities Struggle To Comply With Covid-19 Public Health Regulations, Shai Stern

Vanderbilt Journal of Transnational Law

The COVID-19 pandemic did not eliminate existing social tensions; rather, it at times intensified them. Thus, it is unsurprising that. the tension between the liberal state and illiberal religious communities likewise intensified, as those communities were late to comply with COVID-19 public health regulations issued by state authorities. This Article suggests that alongside the behavioral and psychological explanations for individual non-compliance, illiberal religious communities' late response to the COVID-19 threats stems out of these communities' unique characteristics and deeply held norms. It provides five explanations supporting this argument and argues that all result from the interventionist liberal-centric policies embraced by …

Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross

Faculty Scholarship

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

The Need For A Strong And Stable Federal Public Health Agency Independent From Politicians, Jacqueline Salwa, Christopher Robertson

Faculty Scholarship

The COVID-19 pandemic has revealed the precariousness of federal public health institutions in the United States, and how disastrously things can go when those institutions are undermined by political forces. Such institutions can be disbanded, underfunded, populated with incompetent political hacks, manipulated, or sidelined. As a field, public health in particular needs some political space, given that it requires deep scientific expertise and needs to communicate to the public clearly, reliably, and with authority to engender trust. Key public health agencies, such as the Centers for Disease Control and Prevention (CDC) in particular, should be buttressed against future political encroachment, …

Race, Risk, And Personal Responsibility In The Response To Covid-19, Aziza Ahmed, Jason Jackson

Faculty Scholarship

The COVID-19 crisis has tragically revealed the depth of racial inequities in the United States. This Piece argues that the disproportion­ate impact of the pandemic on racial minorities is a symptom of a failing approach to public health, one that privileges individual behaviors over the structural conditions that generate vulnerability and inequitable health outcomes. Despite clear racial disparities in illness and deaths, the neoliberal ideology of personal responsibility shifts the onus for mitigation of risk away from the social and legal determinants of health and onto the individual. To understand how and why these disparate racial outcomes arise, this Piece …

The Future Of Facts: The Politics Of Public Health And Medicine In Abortion Law, Aziza Ahmed

Faculty Scholarship

While a great deal of public scrutiny has focused on how information circulates through online outlets including Twitter and Facebook, less attention has been devoted to how more traditional institutions traffic in factual assertions for the sake of setting a particular distributional agenda into motion.[1] Of these more traditional institutions, courts play a central role in legitimating legal and factual claims in the process of applying and clarifying legal rules. In public health-related adjudication, courts play at least two important roles: first, judges and juries make decisions between competing sets of public health and medical claims and second, courts …

The Stellenbosch Consensus On Legal National Responses To Public Health Risks: Clarifying Article 43 Of The International Health Regulations, Roojin Habibi, Steven J. Hoffman, Gian Luca Burci, Thana Cristina De Campos, Danwood Chirwa, Margherita Cinà, Stéphanie Dagron, Mark Eccleston-Turner, Lisa Forman, Lawrence O. Gostin, Benjamin Mason Meier, Stefania Negri, Gorik Ooms, Sharifah Sekalala, Allyn Taylor, Alicia Ely Yamin

Georgetown Law Faculty Publications and Other Works

The International Health Regulations (IHR), of which the World Health Organization is custodian, govern how countries collectively promote global health security, including prevention, detection, and response to global health emergencies such as the ongoing COVID-19 pandemic. Countries are permitted to exercise their sovereignty in taking additional health measures to respond to such emergencies if these measures adhere to Article 43 of this legally binding instrument. Overbroad measures taken during recent public health emergencies of international concern, however, reveal that the provision remains inadequately understood. A shared understanding of the measures legally permitted by Article 43 is a necessary step in …

The Stellenbosch Consensus On The International Legal Obligation To Collaborate And Assist In Addressing Pandemics: Clarifying Article 44 Of The International Health Regulations, Margherita Cinà, Steven J. Hoffman, Gian Luca Burci, Thana Cristina De Campos, Danwood Chirwa, Stéphanie Dagron, Mark Eccleston-Turner, Lisa Forman, Lawrence O. Gostin, Roojin Habibi, Benjamin Mason Meier, Stefania Negri, Gorik Ooms, Sharifah Sekalala, Allyn Taylor, Alicia Ely Yamin

Georgetown Law Faculty Publications and Other Works

The International Health Regulations (IHR), of which the World Health Organization is custodian, govern how countries collectively promote global health security, including prevention, detection, and response to potential global health emergencies such as the ongoing covid-19 pandemic. While Article 44 of this binding legal instrument requires countries to collaborate and assist each other in meeting their respective obligations, recent events demonstrate that the precise nature and scope of these legal obligations are ill-understood. A shared understanding of the level and type of collaboration legally required by the IHR is a necessary step in ensuring these obligations can be acted upon …

Mandatory Quarantine: Administrative Order By The Georgia Department Of Public Health For Public Health Control Measures: Isolation Protocol, Matthew C. Daigle, Carissa L. Lavin

Georgia State University Law Review

The Administrative Order for Public Health Control Measures and its subsequent amendments outlined the Isolation and Quarantine Protocols for individuals who either tested positive for COVID-19 or were suspected of COVID-19 infection based on symptoms or prolonged exposure to the virus.

Public Health State Of Emergency: Executive Order By The Governor Declaring A Public Health State Of Emergency, Rebecca Hu, Ellen Y. Min

Georgia State University Law Review

The Executive Order primarily functions to enumerate the Governor’s emergency powers during a Public Health State of Emergency. The Executive Order allows for the Governor to assist health and emergency management officials by deploying available resources for the mitigation and treatment of COVID-19 within Georgia.

Taxes As Pandemic Controls, Ashley C. Craig, James R. Hines Jr.

Articles

Tax policy can play important roles in limiting the spread of communicable disease and in managing the economic fallout of a pandemic. Taxes on business activities that bring workers or customers into close contact with each other offer efficient alternatives to broad regulatory measures, such as shutdowns, that have been effective but enormously costly. Corrective taxation also helps raise the revenue required to cover elevated government expenditure during a pandemic. Moreover, the restricted consumer choice that accompanies a pandemic reduces the welfare cost of raising tax revenue from higher-income taxpayers, making it a good time for deficit closure. Current U.S. …

Pricing The Global Health Risks Of The Covid-19 Pandemic, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

Policies to address the coronavirus disease 2019 (COVID-19) require a balancing of the health risk reductions and the costs of economic dislocations. Application of the value of a statistical life (VSL) to monetize COVID-19 deaths produces a U.S. mortality cost estimate of $1.4 trillion for deaths in the first half of 2020. This article presents worldwide COVID-19 costs for over 100 countries. The total global mortality cost through July 2, 2020 is $3.5 trillion. The United States accounts for 25% of the deaths, but 41% of the mortality cost. Adjustments for the shorter life expectancy and lower income of the …

Litigating An Epidemic: California Plaintiffs In The National Opioid Litigation, Samantha T. Pannier

Loyola of Los Angeles Law Review

Can litigation solve a public health epidemic? The opioid epidemic has cost California 24,885 lives, $4.3 billion, and counting. As a result, over 500 California cities, counties, and sovereign Indian tribes are engaged in civil litigation against over twenty different opioid manufacturers, distributors, and pharmacies for their role in creating and profiting from an epidemic of addiction. Cases brought by California plaintiffs account for about 20 percent of all ongoing opioid litigation nationally. This Note situates the claims of three California plaintiffs— the State, the County of Mariposa, and the City of Los Angeles—within the context of the ongoing national …

Tuberculosis, Human Rights, And Law Reform: Addressing The Lack Of Progress In The Global Tuberculosis Response, Matthew M. Kavanagh, Lawrence O. Gostin, John Stephens

Georgetown Law Faculty Publications and Other Works

In 2018, the United Nations General Assembly convened the first-ever high-level meeting (HLM) on tuberculosis (TB). Since that time news on the world’s most lethal infectious disease is not good—the 2019 WHO TB report shows 1.2 million people died from TB, a number that has fallen just 11% since 2015, less than one-third of the way towards the End TB Strategy milestone of a 35% reduction (to about 850 million deaths) by 2020. The same number of people, 10.0 million, are estimated to have fallen ill with TB in 2018 as in 2017. The stubborn persistence of TB is attributable …

A Global Survey Of Potential Acceptance Of A Covid-19 Vaccine, Jeffrey V. Lazarus, Scott C. Ratzan, Adam Palayew, Lawrence O. Gostin, Heidi J. Larson, Kenneth Rabin, Spencer Kimball, Ayman El-Mohandes

Georgetown Law Faculty Publications and Other Works

Several coronavirus disease 2019 (COVID-19) vaccines are currently in human trials. In June 2020, we surveyed 13,426 people in 19 countries to determine potential acceptance rates and factors influencing acceptance of a COVID-19 vaccine. Of these, 71.5% of participants reported that they would be very or somewhat likely to take a COVID-19 vaccine, and 61.4% reported that they would accept their employer’s recommendation to do so. Differences in acceptance rates ranged from almost 90% (in China) to less than 55% (in Russia). Respondents reporting higher levels of trust in information from government sources were more likely to accept a vaccine …

Medicaid's Vital Role In Addressing Health And Economic Emergencies, Nicole Huberfeld, Sidney Watson

Faculty Scholarship

Medicaid plays an essential role in helping states respond to crises. Medicaid guarantees federal matching funds to states, which helps with unanticipated costs associated with public health emergencies, like COVID-19, and increases in enrollment that inevitably occur during times of economic downturn. Medicaid’s joint federal/state structure, called cooperative federalism, gives states significant flexibility within federal rules that allows states to streamline eligibility and expand benefits, which is especially important during emergencies. Federal emergency declarations give the secretary of Health and Human Services temporary authority to exercise regulatory flexibility to ensure that sufficient health care is available to meet the needs …

Expanding Access To Patents For Covid-19, Jorge L. Contreras

Utah Law Faculty Scholarship

Two competing and linked sets of goals must be addressed when considering patent policy in response to a public health emergency. First is the allocation of existing resources among potential users (hospitals, patients, etc.); second is the creation of new technologies over time (innovation). Patents provide financial incentives to develop new technologies. Yet shortages of patented products often plague crisis response. In the case of COVID-19, allocative goals, particularly satisfying demand for patented medical products (e.g., vaccines, ventilators, PPE, and test kits), may be achieved through governmental interventions such as march-in and governmental use rights (compulsory licensing). But in cases …

Upholding Tribal Sovereignty And Promoting Tribal Public Health Capacity During The Covid-19 Pandemic, Heather Tanana, Aila Hoss

Utah Law Faculty Scholarship

Tribes are sovereign nations with authorities and responsibilities over their land and people. This inherent sovereign authority includes the right to promote and protect the health and welfare of their communities. The COVID-19 pandemic has brought national attention to the health inequities experienced by American Indian and Alaska Native communities. The sovereign legal authority for Tribes to respond to this pandemic has received less attention. This Chapter describes some, but not all, of the urgent legal issues impacting Tribal response to the COVID-19 pandemic. It describes and identifies gaps in federal Indian health policies and highlights how Tribes have exercised …