Health Law and Policy Commons^™

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.

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 …

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 …

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 …

Elevating Physician-Patient Relationships In The Shadow Of Metric Mania, Benjamin Sundholm

Faculty Publications

Today, medical and health institutions devote significant time and resources to documenting, measuring, and reporting various metrics. These metrics are used to improve various aspects of care, from efficiency and quality to safety and access. Unfortunately, too often, medical and health institutions overemphasize metrics that are easily captured but too simplistic. As a result, insufficient attention is devoted to crucial, albeit complex and difficult to measure, facets of care. Physician-patient relationships are among the primary casualties resulting from the widespread penchant for overly simplistic metrics. This Article develops a strategy for improving such relationships. I suggest that enhancing physicians' interpersonal …

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 …

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 …

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 …

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 …

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 …

"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 …

Strict Liability For Genetic Privacy Violations In The Age Of Big Data, Benjamin Sundholm

Faculty Publications

(Excerpt)

The ethical issues implicated by the misuse of genetic information have been smoldering for over half a century, and the age of big data has turned them into a five-alarm fire. In recent years, medical researchers and commercial enterprises have been using technological advancements to develop a variety of innovative ways to use genetic information. For example, it is becoming increasingly common for people to learn more about their health and family history by paying direct-to-consumer (“DTC”) companies to analyze their genetic data. DTC companies store the results of these tests electronically and often share them with pharmaceutical companies …

Vaccination Law 101: A Guide For Children’S Lawyers, Christal Cammock, Jennifer Baum

Faculty Publications

(Excerpt)

Today, U.S. children are typically vaccinated against 11 deadly, and formerly common, diseases: diphtheria, Hib disease, hepatitis B, measles, mumps, pertussis (whooping cough), polio, rubella, pneumococcal disease, tetanus, and varicella (chicken pox). But it wasn’t always so. Vaccines are a relatively recent development in medical history. The world’s first vaccine, for smallpox, was discovered in the late 1700s. A hundred years later, Louis Pasteur discovered the second vaccine, for rabies. By the mid-1900s, technological and medical advances drove more rapid vaccine development, and in 1963, the first measles vaccine was approved.

Before the measles vaccine became available, up to …

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.

Step Therapy: Legal And Ethical Implications Of A Cost-Cutting Measure, Sharona Hoffman

Faculty Publications

The very high and ever-increasing costs of medical care in the United States are well-recognized and much discussed. Health insurers have employed a variety of strategies in an effort to control their expenditures, including one that is common but has received relatively little attention: step therapy. Step therapy programs require patients to try less expensive treatments and find them to be ineffective or otherwise problematic before the insurer will approve a more high-priced option. This Article is the first law journal piece dedicated to analyzing this important cost control measure.

The Article explores the strengths and weaknesses of step therapy …

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 …

Big Data Analytics: What Can Go Wrong, Sharona Hoffman

Faculty Publications

It is not uncommon to read that long-held beliefs about medical treatments have been dislodged by new studies. For example, there is now doubt as to whether women should undergo annual mammograms, previously a cornerstone of cancer screening. Hormone replacement therapy for menopausal women, once considered highly suspect in light of worrisome research findings, is now being reconsidered as a beneficial therapy. These reversals trouble and confuse many Americans.

This Article explores why medical research findings can be erroneous and what can go wrong in the process of designing and conducting research studies. It provides readers with essential analytical tools …

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 …

Zika And The Regulatory Regime For Licensing Vaccines For Use During Pregnancy, Sam F. Halabi

Faculty Publications

Microcephaly and other severe fetal brain defects (congenital Zika syndrome) caused by the Zika virus have prompted an urgent effort to develop and license a safe and efficacious vaccine. Yet, that effort has run up against one of the most formidable barriers in vaccine research: pregnant women are almost always excluded from clinical trials for fear that the intervention may harm the fetus. This article analyzes the existing regulatory framework for vaccines intended for use during pregnancy in an effort to identify ways the process may be reconsidered in light of recent public health emergencies that had a disproportionate effect …

Zika And The Failure To Act Under The Police Power, Jacqueline Fox

Faculty Publications

Zika is a mosquito-borne and sexually transmitted disease that is a dangerous threat to pregnant women, causing catastrophic birth defects in a large percentage of fetuses when their mothers become infected while pregnant. It raises numerous issues related to abortion, birth control, poverty, and women’s control over their procreative choices. While the United States received ample warning from January 2016 onward that it was at risk of local transmission of this virus and public health officials at all levels generally behaved properly, the state and federal legislative responses in the summer of 2016 were entirely inadequate. For example, no state …

Exploitation In Medical Research: The Enduring Legacy Of The Tuskegee Syphilis Study, Ruqaiijah Yearby

Faculty Publications

No abstract provided.

Assessing The Relative Influence And Efficacy Of Public And Private Food Safety Regulation Regimes: Comparing Codex And Global Gap Standards, Sam F. Halabi, Ching-Fu Lin

Faculty Publications

An extensive global system of private food regulation is under construction, one that exceeds conventional regulation, thought of as being driven by public authorities like FDA and USDA in the U.S. or the Food Standards Agency in the UK. Agrifood and grocer organizations, in concert with some farming groups, have been the primary designers of this new food regulatory regime. These groups have established alliances that compete with national regulators in complex ways. This article analyzes the relationship between public and private sources of food safety regulation by examining standards adopted by the Codex Alimentarius Commission, a food safety organization …

Big Data And The Americans With Disabilities Act, Sharona Hoffman

Faculty Publications

While big data offers society many potential benefits, it also comes with serious risks. This Essay focuses on the concern that big data will lead to increased employment discrimination. It develops the novel argument that the Americans with Disabilities Act (ADA) should be amended in response to the big data phenomenon in order to protect individuals who are perceived as likely to develop physical or mental impairments in the future. Employers can obtain medical data about employees not only through the traditional means of medical examinations and inquiries, but also through the non-traditional mechanisms of social media, wellness programs, and …

A Global Vaccine Injury Compensation System, Sam F. Halabi, Saad B. Ommer

Faculty Publications

Vaccines are extremely safe and harm is rare. Worldwide, more than 30000 vaccine doses are delivered per second through routine immunization programs, which, in turn, prevent an estimated 2 million to 3 million deaths annually. Yet the specter of vaccine injury plays a central role in vaccine access and will continue to do so as vaccine technologies evolve.

Zika, Pregnancy, And The Law, Sam F. Halabi

Faculty Publications

This Essay situates a crucial component of the public health response to Zika - the effort to develop a safe and effective vaccine - within the broader literature. It does so in an effort to highlight the need to revisit the relationship between law and pregnancy - not only in the areas legal scholars have prioritized so far, but also in the context of routine and emergency maternal health, which has heretofore been largely assumed to be governed by straightforward norms and practices based on medical evidence and physician ethics. In fact, whereas the current literature tends to assume or …

Regulatory Obstacles To Harm Reduction: The Case Of Smoking, Jonathan H. Adler

Faculty Publications

The inability of many smokers to quit is a significant public health problem. The demand for a product that can help smokers kick the habit is an entrepreneurial opportunity. In surveys, a majority of smokers express concern for their health and a desire to kick the habit.

Electronic cigarettes (“e-cigarettes” or “e-cigs”) appear to be the most promising smoking alternative to enter the market to date. E-cigarettes have the potential to satisfy smokers’ craving for nicotine in a less dangerous way. The available evidence suggests e-cigarettes expose smokers (and others) to a fraction of the health risks posed by combustible …

Category Errors And Executive Power, Jonathan H. Adler

Faculty Publications

The purpose of this brief essay is to provide some clarity in the muddled discussion over executive power. Specifically, the aim is to help clarify what sorts of actions taken by the executive branch can be properly characterized as “enforcement” actions—where the President’s inherent authority to exercise prosecutorial discretion applies—and what sorts of actions cannot. Specifically, this essay seeks to explain why some particularly controversial actions—such as the Administration’s decision to delay the so-called employer mandate imposed by the Affordable Care Act (ACA) and to “tailor” the application of federal regulations governing greenhouse gas emissions under the Clean Air Act …