Health Law and Policy Commons^™

The Regulation Of Human Germline Genome Modification (Hggm) At The National Level: A Call For Comprehensive Legal Reform, Andrea Boggio, Cesare P.R. Romano, Jessica Almqvist

Loyola of Los Angeles International and Comparative Law Review

No abstract provided.

Medicinal Genome Editing In Germany – Tensions Between Safeguarding And Circumventing Ethical And Legal Standards, Timo Faltus

Loyola of Los Angeles International and Comparative Law Review

No abstract provided.

Global Regulation Of Germline Genome Editing: Ethical Considerations And Application Of International Human Rights Law, Scott J. Schweikart

Loyola of Los Angeles International and Comparative Law Review

No abstract provided.

Does Mitochondrial Replacement Therapy Violate Laws Against Human Cloning?, Kerry Lynn Macintosh

Loyola of Los Angeles International and Comparative Law Review

No abstract provided.

Health Information Beyond Pandemic Emergencies: Privacy For Social Justice, Leslie Francis

American University Law Review

The COVID-19 pandemic has forcefully revealed the critical importance of timely information to identify emerging infections, discern patterns of disease, and stop disease spread. Information about individuals both as patients, and as ordinary people in the world is necessary for each of these tasks. Yet the implications for information use and efforts to achieve social justice are significant.

This Article first surveys information needs as revealed by the pandemic. It then articulates different normative approaches to privacy and confidentiality to develop two implications for privacy and justice: that information gleaned in clinical care and information possessed by public health should …

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. …

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.

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 …

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 …

Systemic Racism, The Government’S Pandemic Response, And Racial Inequities In Covid-19, Ruqaiijah Yearby, Seema Mohapatra

All Faculty Scholarship

During the COVID-19 pandemic, the federal and state governments have ignored racial and ethnic minorities’ unequal access to employment and health care that results in racial inequities in COVID-19 infections and deaths. In addition, they have enacted laws that further exacerbate these inequities. Consequently, many racial and ethnic minorities are employed in low-wage essential jobs that lack paid sick leave and health insurance. This lack of benefits causes them to go to work even when they are sick and prevents them from receiving appropriate medical treatment. As a result, racial and ethnic minorities have disproportionately been infected and died from …

Protecting The Rights And Wellbeing Of People With Disabilities During The Covid-19 Pandemic, Elizabeth Pendo

All Faculty Scholarship

The COVID-19 pandemic has exposed and exacerbated significant inequities experienced by people with disabilities. It has also emphasized the value of legal protections against discrimination based on disability. The Americans with Disabilities Act was enacted 30 years ago to eliminate discrimination against people with disabilities and ensure equal opportunity across major areas of American life (ADA, 2008). Together with an earlier law, the Rehabilitation Act of 1973 Rehabilitation Act, 2012), this landmark civil rights law impacts a broad range of issues raised by the COVID-19 pandemic and protects a large and growing number of Americans. This Chapter focuses on application …

Disparities In Health Care: The Pandemic’S Lessons For Health Lawyers, Danielle Pelfrey Duryea, Nicole Huberfeld, Ruqaiijah Yearby

All Faculty Scholarship

Population-level disparities in health and health care came to the forefront of U.S. public consciousness in 2020. As the racial, ethnic, and socioeconomic stratification of COVID-19 infection and death rates emerged with chilling clarity, the Black Lives Matter protests of the summer focused millions of Americans on the complex, structural nature of inequity and its long-lasting effects.

Access to quality health care is a “social determinant of health,” meaning that it is one of the “non-medical factors that influence health outcomes . . . the conditions in which people are born, grow, work, live, and age, and the wider set …

Social Media Self-Regulation And The Rise Of Vaccine Misinformation, Ana Santos Rutschman

All Faculty Scholarship

This essay examines the main characteristics and shortcomings of mainstream social media responses to vaccine misinformation and disinformation. Parts I and II contextualize the recent expansion of vaccine information and disinformation in the online environment. Part III provides a survey and taxonomy of ongoing responses to vaccine misinformation adopted by mainstream social media. It further notes the limitations of current self-regulatory modes and illustrates these limitations by presenting a short case study on Facebook—the largest social media vehicle for vaccine-specific misinformation, currently estimated to harbor approximately half of the social media accounts linked to vaccine misinformation. Part IV examines potential …

Re-Emphasizing African Bioethics In Light Of Potential Crispr-Based Treatment For Hiv And Sickle Cell Disease, Taylor Daniel

Vanderbilt Journal of Transnational Law

Recent genetic studies indicate that CRISPR-Cas9, a biological gene-editing mechanism derived from bacteria, may be capable of curing HIV and Sickle Cell Disease. Clinical research for HIV and SCD is prevalent in African nations because of the high incidence of those diseases in all forms. Because past research studies in Africa demonstrate how Western companies can abuse lax ethics regulations in developing African nations, ethics systems must prevent this new, potentially far-reaching CRISPR technology from being prematurely and unethically used on African research participants. In updating current international bioethics frameworks, drafters should pay particular attention to its application in African …

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 …

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

Utah Law Faculty Scholarship

This paper 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 schoolers. 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 to 3.6 million youth.

This article will review 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 …

Public Health In The Opioid Litigation, Daniel G. Aaron

Utah Law Faculty Scholarship

Today, the opioid crisis is playing out in the nation’s courts. Litigants have taken a microscope to defendant opioid companies whose misconduct ignited and exacerbated the opioid crisis. As the litigation continues, one could imagine numerous ways its resolution could contribute to the end of a multi-decade overdose crisis and prevent future ones. Options include holding defendant companies accountable, releasing previously secret information for research on root causes of the epidemic, and prohibiting future misconduct through injunctive relief. Unfortunately, to date, the litigation has not been so capacious. Rather, the participants—judge included—have been preoccupied with rapid monetary settlement. Though understandable, …

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 …

Difficulty Of Care: Aligning Tax And Health Care Policy For Family Caregiving, Christine Speidel

Scholarly Articles in Law Reviews & Journals

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 …

Family Law During Covid-19: Virtual Hearings, Family Court Proceedings, And The Future: Editors' Notes, Lisa Grumet

Articles & Chapters

No abstract provided.

Inherent Powers And The Limits Of Public Health Fake News, Michael Goodyear

Articles & Chapters

The world has changed dramatically over the past year. The COVID-19 pandemic has presented unprecedented challenges and has caused a catastrophic loss of over 300,000 U.S. lives. This crisis has been compounded by an infodemic, an effusion of misinformation and fake news about COVID-19. This incorrect information has flooded social media and online platforms, confusing and misleading the American public. Yet U.S. constitutional law largely upholds fake news as protected free speech under the First Amendment. This legal reality has significantly compounded the COVID-19 crisis.

But U.S. law is not limited to only constitutional enumerated powers. An underexamined approach to …

Becoming Visible, Jennifer Bennett Shinall

Oklahoma Law Review

No abstract provided.

An Update On Gambling Disorder, Neuroscience, And The Law, Stacey A. Tovino

Faculty Articles

No abstract provided.

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, …

Second Thoughts On Fda's Covid-Era Mental Health App Policy, Michael Mattioli

Articles by Maurer Faculty

As the coronavirus pandemic swept across the globe in April 2020, the US Food and Drug Administration (FDA) made an unusual decision. The agency announced that it would relax its enforcement of compliance rules for “digital therapeutics”—smartphone apps designed to address mental health disorders. The measure was a response to widely reported upticks in symptoms of anxiety, depression, and substance abuse brought on by the pandemic. As an added benefit, the agency explained, digital therapeutics could promote social distancing by removing patients’ need to visit health care providers.

This essay explores the possible lasting effects of the FDA’s temporary suspension …

Drivers Of Health Policy Adoption: A Political Economy Of Hiv Treatment Policy, Matthew M. Kavanagh, Kalind Parish, Somya Gupta

Georgetown Law Faculty Publications and Other Works

Why do some countries rapidly adopt policies suggested by scientific consensus while others are slow to do so? Through a mixed methods study, we show that the institutional political economy of countries is a stronger and more robust predictor of health policy adoption than either disease burden or national wealth. Our findings challenge expectations in scholarship and among many international actors that policy divergence is best addressed through greater evidence and dissemination channels. Our study of HIV treatment policies shows that factors such as the formal structures of government and the degree of racial and ethnic stratification in society predict …

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 …

(Un)Masking The Truth - The Cruel And Unusual Punishment Of Prisoners Amidst The Covid-19 Pandemic, Ariel Berkowitz

Touro Law Review

No abstract provided.

Closing The Health Justice Gap: Access To Justice In Furtherance Of Health Equity, Yael Cannon

Georgetown Law Faculty Publications and Other Works

A massive civil “justice gap” plagues the United States. Every day, low-income Americans—and disproportionately people of color—go without the legal information and representation they need to enforce their rights. This can cost them their homes, jobs, food security, or children. But unmet civil legal needs in housing, employment, and public benefits, for example, are not simply injustices—they are well-documented drivers of poor health, or social determinants of health. Those marginalized by virtue of both race and socioeconomic status are particularly harmed by inaccessibility to justice and also by chronic health conditions and lower life expectancy. When a tenant walks into …

Adolescent Medical Decisionmaking Rights: Reconciling Medicine And Law, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

Dennis Lindberg came into his aunt’s care when he was in the 4th grade because his parents struggled with drug addiction and could not provide for him. At thirteen, he was baptized in his aunt’s faith as a Jehovah’s Witness. Just days after he turned fourteen, on November 6, he was diagnosed with acute lymphoblastic leukemia.

The prognosis was that Dennis had a 75% chance of cure with standard oncology treatment. Consistent with the requirements of his new faith, however, Dennis told his doctors, “I do not want to be treated if the requirement is that I would have to …