Law Commons^™

Employers And The Privatization Of Public Health, Sharona Hoffman

Faculty Publications

This Article focuses on the role of employers in public health and argues that they constitute increasingly important actors in the U.S. public health arena. In the aftermath of the COVID-19 pandemic, a series of judicial decisions and newly enacted statutes enfeebled the public health powers of the federal and state governments. In a 2023 statement, Supreme Court Justice Neil Gorsuch clearly articulated his antagonism towards government-initiated COVID-19 interventions, describing them as “the greatest intrusions on civil liberties in the peacetime history of this country.” All too many share his views.

Employers may be highly motivated to safeguard their workers’ …

Patient Autonomy, Public Safety, And Drivers With Cognitive Decline, Sharona Hoffman, Cassandra Burke Robertson

Faculty Publications

With a growing elderly population, cognitive decline in drivers has become a significant public safety concern. Currently, over thirty-two million individuals who are seventy or older have driver’s licenses, and that number is growing quickly. In addition, almost ten percent of U.S. seniors (those sixty-five and older) have dementia, and an additional twenty-two percent have mild cognitive impairment. Between a quarter and a half of individuals with mild to moderate dementia still drive. As cognitive abilities such as memory, attention, and decision-making skills deteriorate, a driver's ability to operate a vehicle safely can be compromised. This not only puts the …

The Patient's Voice: Legal Implications Of Patient-Reported Outcome Measures, Sharona Hoffman, Andy Podgurski

Faculty Publications

In recent years, the medical community has paid increasing attention to patients' own assessments of their health status. Even regulatory agencies, such as the Food and Drug Administration and the Centers for Medicare and Medicaid Services, are now interested in patient self-reports. The legal implications of this shift, however, have received little attention. This Article begins to fill that gap. It introduces to the legal literature a discussion that has been ongoing in the health care field.

Patient-reported outcome measures (PROMs) are reports of patients’ symptoms, treatment outcomes, and health status that are documented directly by patients, typically through electronic …

Segmented Innovation In The Legalization Of Mitochondrial Transfer: Lessons From Australia And The United Kingdom, Myrisha S. Lewis

Faculty Publications

The U.S. is often characterized as a leader in innovation—a home of Nobel Prize‐winning scientists, innovators, and abundant research funding. Yet, in the area of assisted reproduction combined with genetic modification or substitution, what I call “reproductive genetic innovation,” that characterization begins to wane. This Article focuses on the regulation of mitochondrial transfer, a subset of reproductive genetic innovation. While human clinical trials related to mitochondrial transfer go forward in the U.K., the clinical use of the technique remains illegal in the U.S. due to a system of subterranean regulation by the U.S. Food and Drug Administration and a now-recurring …

Due Process, Delegation, And Private Veto Power, B. Jessie Hill

Faculty Publications

Nondelegation doctrine is enjoying a scholarly revival. Some commentators have read the U.S. Supreme Court’s 2019 decision in Gundy v. United States to portend new limitations on Congress’s ability to give away its authority to the executive branch. A recent decision involving Amtrak’s entitlement to exercise regulatory authority raised similar questions about delegation to private entities. Together, these cases may suggest imminent new constraints on the administrative state, generating urgent reconsideration of the purpose and application of the nondelegation doctrine.

This Article is focused on one particular line of nondelegation cases that has received less attention in the nondelegation debate: …

Vulnerable Populations And Vaccine Injury Compensation: The Need For Legal Reform, Katharine A. Van Tassel, Sharona Hoffman

Faculty Publications

This chapter argues that the potential for vaccine-related harms raises acute concerns for vulnerable populations. These harms have a disparate impact on low-income people, who are disproportionately non-White, and who have limited financial resources to obtain medical care, weather job losses, and pursue injury compensation. When a vaccine is given as a countermeasure during a declared public health emergency (PHE), the problem is acute because of the limited availability of injury compensation.

How Analogizing Socio-Legal Responses To Organ Transplantation Can Further The Legalization Of Reproductive Genetic Innovation, Myrisha S. Lewis

Faculty Publications

The Nobel Foundation emphasized the significance of genetic innovation to society, science, and medicine by awarding the 2020 Nobel Prize in Chemistry to “the CRISPR/Cas9 genetic scissors.” This Article focuses on “reproductive genetic innovation,” a term that includes cytoplasmic transfer, mitochondrial transfer, and germline or heritable gene editing techniques that are all categorized as “experimental” in the United States. These techniques all use in vitro fertilization, a legal and widely available practice. Yet reproductive genetic innovation has resulted in controversy and numerous barriers including a recurring federal budget rider, threats of federal enforcement action, and the unavailability of federal funding. …

A Model For Defunding: An Evidence-Based Statute For Behavioral Health Crisis Response, Taleed El-Sabawi, Jennifer J. Carroll

Faculty Publications

Too many Black persons and other persons of color are dying at the hands of law enforcement, leading many to call for the defunding of police. These deaths were directly caused by excessive use of force by police officers, but were also driven by upstream and institutional factors that include structural racism, institutional bias, and a historic culture of racialized violence. Public outcry against racial inequities has increased as the authority of police departments has expanded to include not only the authority to respond to and investigate criminal activity, but also to respond to calls regarding behavioral health issues and …

So Many Have Died: Covid-19 In America's Nursing Homes, David M. English

Faculty Publications

As of the date of this writing in late September 2020, over 77,000 residents and staff of long-term care facilities have died of COVID-19 with more to come. This article will describe the reasons for this mass wave of death and provide practical suggestions for attorneys who represent a resident or family members of residents.

Is Germline Gene Editing Exceptional?, Myrisha S. Lewis

Faculty Publications

Advances in gene editing have recently received significant scientific and media attention. Gene editing, especially CRISPR-Cas9, has revived multiple longstanding ethical debates, including debates related to parental autonomy, health disparities, disability perspectives, and racial and economic inequalities. Germline, or heritable, gene editing generates several newer, neglected bioethical debates, including those about the shared human germline and whether there is a "line" that humans should not cross.

This Article addresses several interrelated ethical and legal questions related to germline gene editing. Those questions address why, if at all, germline gene editing needs to be regulated and, if germline gene editing needs …

Feminist Perspectives On Disaster, Pandemics, And Intimate Partner Violence, Margaret Drew

Faculty Publications

The COVID-19 pandemic brought international awareness to the likelihood of increased abuse of those in abusive intimate partner relationships because of the forced confinement with their abusers (Bettinger-Lopez and Bro, A double pandemic: domestic violence in the age of COVID 19, Council on Foreign Relations. https://www.cfr.org/in-brief/double-pandemic-domestic-violence-age-covid-19, 2020). While this awareness was much discussed, assistance to survivors of abuse was limited because survivors often could not reach out for help, nor could advocates wishing to offer assistance safely reach in to advise them (Taub, A new Covid-19 crisis: domestic abuse rises worldwide. https://www.nytimes.com/2020/04/06/world/coronavirus-domestic-violence.html, 2020). The ever-present influence of the …

Covid-19 And Its Impact On America's Retirement System, David M. English

Faculty Publications

There is a long-standing debate over whether America's retirement system is in crisis. The COVID-19 pandemic has resolved the debate. Perhaps the system was merely challenged prior to March 2020, but it is certainly in crisis now. The pandemic has negatively impacted all four of the principal pillars of retirement: Social Security, employer-sponsored retirement programs, earnings from part-time work, and the worker's own savings. This short article will discuss the impact of the pandemic on the retirement system and discuss possible ways to restore the system to health or at least ameliorate the damage.

The Origins And Future Of Global Health Law: Regulation, Security, And Pluralism, Sam F. Halabi

Faculty Publications

The COVID-19 pandemic has presented a global health crisis unlike any seen in the seventy-five years since the United Nations and the World Health Organization were formed - one that is killing people, spreading human suffering, and upending people's lives. But this is much more than a health crisis. It is a human crisis. The coronavirus disease (COVID-19) is attacking societies at their core. It is therefore a crucial point around which to focus the capability of national and global institutions to address this essential threat to human health and life.

The purposes of this Article are to revisit and …

Keeping Ai Under Observation: Anticipated Impacts On Physicians' Standard Of Care, Iria Giuffrida, Taylor Treece

Faculty Publications

As Artificial Intelligence (AI) tools become increasingly present across industries, concerns have started to emerge as to their impact on professional liability. Specifically, for the medical industry--in many ways an inherently "risky" business--hospitals and physicians have begun evaluating the impact of Al tools on their professional malpractice risk. This Essay seeks to address that question, zooming in on how AI may affect physicians' standard of care for medical malpractice claims.

Complicated Lives: A Look Into The Experience Of Individuals Living With Hiv, Legal Impediments, And Other Social Determinants Of Health, Margaret B. Drew, Jason Potter, Caitlin Stover

Faculty Publications

Those living with HIV continue to have challenges that extend well beyond their medical needs Public misconceptions surrounding HIV transmission and treatment have resulted in systemic and pervasive discrimination against those living with the disease. Common misconceptions include overly optimistic perceptions of the modern state of medical treatment, leading the uninformed to conclude that people living with HIV are minimally impacted by the disease, and misunderstandings regarding how the disease is transmitted from person-to-person, leading to stigma and social prejudice. Because of these misconceptions, three professors from the University of Massachusetts Dartmouth formed a community partnership to determine the unmet …

Essentially Elective: The Law And Ideology Of Restricting Abortion During The Covid-19 Pandemic, B. Jessie Hill

Faculty Publications

During the COVID-19 pandemic, several states adopted orders temporarily suspending elective surgeries and procedures. A subset of those states moved to limit abortions under those orders, provoking emergency litigation to keep abortion clinics open and functioning. No similar lawsuits have been necessary to protect access to other time-sensitive medical procedures. So why was abortion singled out for disparate treatment?

This Essay provides an overview of the litigation that ensued in the wake of some states’ attempts to limit abortion access under the authority of executive orders banning non-essential or elective procedures. It argues that abortion was singled out in two …

Internet Of Things For Sustainability: Perspectives In Privacy, Cybersecurity, And Future Trends, Abdul Salam

Faculty Publications

In the sustainability IoT, the cybersecurity risks to things, sensors, and monitoring systems are distinct from the conventional networking systems in many aspects. The interaction of sustainability IoT with the physical world phenomena (e.g., weather, climate, water, and oceans) is mostly not found in the modern information technology systems. Accordingly, actuation, the ability of these devices to make changes in real world based on sensing and monitoring, requires special consideration in terms of privacy and security. Moreover, the energy efficiency, safety, power, performance requirements of these device distinguish them from conventional computers systems. In this chapter, the cybersecurity approaches towards …

Specialty Drugs And The Health Care Cost Crisis, Sharona Hoffman, Isaac D. Buck

Faculty Publications

Specialty drugs, often dispensed by specialty pharmacies, are among the most expensive drugs on the market. They are significant contributors to the American health care cost problem, but in many ways they escape public and regulatory scrutiny. Surprisingly, medications are designated as specialty drugs by pharmacy benefit managers (PBMs), entities that are part of the insurance industry, rather than by the Food and Drug Administration or medical authorities.

Specialty drugs have thus far received little attention in the legal literature. Yet, they raise important legal and regulatory questions. For example, there are no federal government rules (and only a handful …

Early Access To Unapproved Medicines In The United States And France, Erika Lietzan

Faculty Publications

In 2018, President Trump signed a federal "right to try" law, claiming that it would give desperately ill patients earlier access to unapproved medicines, by allowing the patient, doctor, and drug company to arrange for access without federal oversight. Critics of the law argued that it would not meaningfully increase access to experimental medicines, because federal oversight was not the obstacle in the first place. And they were correct. U.S. law already permitted companies to provide terminally ill patients with early access to unapproved medicines. The problem was instead that companies did not take advantage of this option. This Article …

Pay Now, Play Later?: Youth And Adolescent Collision Sports, Vivian E. Hamilton

Faculty Publications

The routine and repeated head impacts experienced by athletes in a range of sports can inflict microscopic brain injuries that accumulate over time, even in the absence of concussion. Indeed, cumulative exposure to head impacts—not number of concussions—is the strongest predictor of sports-related degenerative brain disease in later life. The observable symptoms of disease appear years or decades after initial injury and resemble those of other mental-health conditions such as depression and dementia. The years-long interval between earlier, seemingly minor, head impacts and later brain disease has long obscured the connection between the two.

Risk of injury differs across demographics, …

Moving Beyond Medical Debt, Brook E. Gotberg, Michael D. Sousa

Faculty Publications

In recent years it has become clear that medical costs are imposing severe financial burdens on American families, sometimes to the point that bankruptcy becomes the only escape from crippling debt. When evaluating the well-established connection between outstanding medical debt and consumer bankruptcy, most existing empirical studies attempt to quantify the percentage of consumer bankruptcies that are "caused" by unmanageable medical indebtedness. This Article addresses what we believe to be a more significant line of empirical inquiry, namely, the connection between health insurance coverage and consumer bankruptcy as a more precise measurement of how national health insurance programs may or …

American Democratic Deficit In Assisted Reproductive Technology Innovation, Myrisha S. Lewis

Faculty Publications

In many areas of innovation, the United States is a leader, but this characterization does not apply to the United States' position in assisted reproductive technology innovation and clinical use. This article uses a political science concept, the idea of the "democratic deficit" to examine the lack of American public discourse on innovations in ART. In doing so, the article focuses on America's missing public consultation in health care innovation. This missing discourse is significant, as political and ethical considerations may impact regulatory decisions. Thus, to the extent that these considerations are influencing the decisions of federal agency employees, namely …

Equitable Health Savings Accounts, Samuel Estreicher, Clinton G. Wallace

Faculty Publications

This Article offers the first comprehensive legal-policy critique of existing Health Savings Accounts (HSAs), arguing that the current approach is redistributively regressive, thus exacerbating inequality, and also fails to accomplish stated healthcare goals. We propose an alternative—Equitable Health Savings Accounts—which uses cash grants as a tool to address both of these problems. Equitable HSAs are a market-based social program that calibrates size and delivery of a government subsidy to help the least well off and to facilitate participation in healthcare markets. Equitable HSAs can serve as a model for using cash grants to bridge the gap between Republican social policy …

Healing The Healers: Legal Remedies For Physician Burnout, Sharona Hoffman

Faculty Publications

A career as a doctor was long considered to be among the best professional paths that one could pursue. But medicine may no longer be the sought-after career that it once was. All too often, doctors, struggling with the demands of electronic health record systems and a myriad of administrative and regulatory responsibilities, find that they fail to derive much joy from their work and become victims of burnout. Physician burnout is an acute concern in the medical community, with over half of doctors reporting that they suffer from it. Physician burnout is a public health threat. Doctors who are …

What Genetic Testing Teaches About Long-Term Predictive Health Analytics Regulation, Sharona Hoffman

Faculty Publications

The ever-growing phenomenon of predictive health analytics is generating significant excitement, hope for improved health outcomes, and potential for new revenues. Researchers are developing algorithms to predict suicide, heart disease, stroke, diabetes, cognitive decline, future opioid abuse, and other ailments. The researchers include not only medical experts, but also commercial enterprises such as Facebook and LexisNexis, who may profit from the work considerably. This Article focuses on long-term disease predictions (predictions regarding future illnesses), which have received surprisingly little attention in the legal and ethical literature. It compares the robust academic and policy debates and legal interventions that followed the …

Portable Medical Order Sets (Polst®): Ethical And Legal Landscape, Sharona Hoffman

Faculty Publications

Anyone who has observed the dying of a loved one or who has thought about medical care in the final months of life may be concerned about end-of-life care. How can individuals ensure that their care fits their needs and preferences if they cannot express these because of dementia, confusion, or other frailties? Some worry that they will receive care that is painful and aggressive in the last stages of disease even though they would prefer comfort care only. By contrast, others worry that physicians will withhold therapeutic care because they assume that such care is unwanted by patients who …

"Undue Hardship" And Uninsured Americans: How Access To Healthcare Should Impact Student-Loan Discharge In Bankruptcy, Alexander Gouzoules

Faculty Publications

Student-loan debt has grown to unprecedented heights. Contributing to the severe burden imposed by these debts is the Bankruptcy Code’s unique presumption that they are not dischargeable. To overcome that presumption, a debtor must establish that repayment of her loans would constitute an “undue hardship.” This essay examines the disagreement among bankruptcy courts that have interpreted the “undue hardship” standard in situations where a debtor is unable to afford health insurance—a common occurrence among the economically disadvantaged. After examining recent healthcare reforms, I argue that Congress has expressed a judgment that all Americans should obtain minimum essential healthcare. Though this …

The Private Insurance Market: Not Very Big And Not Insuring Much, Either, Jacqueline R. Fox

Faculty Publications

Creating a single national health insurance pool is not likely to destabilize the economy by supplanting the private health insurance industry. This industry insures a relatively small percentage of the population and holds very little of the risk such insurance implies. In effect, insurance companies function as middlemen, bundling risk packages to distribute to other, larger companies and so serve a limited purpose. Were insurers to handle claims for a national pool as they do for the Medicare program, any destabilization to the economy more broadly would be further minimized.

Personal Health Records As A Tool For Transparency In Health Care (Draft), Sharona Hoffman

Faculty Publications

This chapter explores the benefits and limitations of personal health records (PHRs) as a tool to promote transparency in health care. A PHR can be defined as “an electronic application through which individuals can access, manage and share their health information . . . in a private, secure, and confidential environment.” PHRs can enhance efficiency, communication, data accuracy, and health outcomes. At the same time, they can disrupt the physician-patient relationship and raise liability concerns. For example, PHRs may induce patients and physicians to rely on electronic communication when office visits would be far more appropriate. The chapter analyzes the …

Faith-Based Emergency Powers, Noa Ben-Asher

Faculty Publications

This Article explores an expanding phenomenon that it calls Faith-Based Emergency Powers. In the twenty-first century, conservatives have come to rely heavily on Faith-Based Emergency Powers as a leading legal strategy in the Culture Wars. This strategy involves carving faith-based exceptions to rights of women and LGBT people. The concept of Faith-Based Emergency Powers is developed in this Article through an analogy to the “War on Terror.” In the War on Terror, conservatives typically have taken the position that judges, legislators, and the public must defer to the President and the executive branch in matters involving national security. This argument …