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 …

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.

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 …

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 …

Hipaa's Privacy Rule And State Privacy Laws: Roadblocks To Medical Organizations' Self-Policing Expert Medical Testimony, Miles J. Zaremski, Douglas M. Belofsky

Alumni Publications

As part of the wave of medical malpractice reforms over the last several decades, efforts were initiated to ensure the reliability and credibility of expert witness opinion and testimony, which is the sine qua non of necessary proof for any such claim or lawsuit. Governing bodies of professional medical organizations and societies have crafted rules and regulations for their members that wish to provide expert medical witness testimony. Where such testimony does not conform to these organizations’ standards, sanctions can be levied, including membership expulsion. Such self-policing has found favor with courts.

Before sanctions are imposed, however, necessary administrative investigations …

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 …

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 …

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 …

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 …

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 …

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

Faculty Publications

No abstract provided.

Electronic Health Records And Medical Big Data: Law And Policy, Sharona Hoffman

Faculty Publications

This book helps readers gain an in-depth understanding of electronic health record (EHR) systems, medical big data, and the regulations that govern them. It is useful both as a primer for students and as a resource for knowledgeable professionals. The book analyzes the shortcomings and benefits of EHR systems, explores the law's response to the technology’s adoption, highlights gaps in the current legal framework, and develops detailed recommendations for regulatory, policy, and technological improvements. Electronic Health Records and Medical Big Data addresses not only privacy and security concerns, but also other important challenges, such as those related to data quality …

Modernizing The Emergency Medical Treatment & Labor Act To Harmonize With The Affordable Care Act To Improve Equality, Quality And Cost Of Emergency Care, Katharine A. Van Tassel

Faculty Publications

The Emergency Medical Treatment and Active Labor Act (EMTALA) is a federal statute passed almost 30 years ago which was designed to ensure equal access to emergency treatment and to halt the practice of “patient dumping.” Patient dumping is a situation where some patients—typically uninsured, disabled, and minority individuals—receive inferior emergency medical care or are denied emergency medical treatment altogether. The goal of EMTALA is to ensure that everyone coming to the emergency room will receive equal care.

Unfortunately, despite EMTALA, the practice of patient dumping has continued to this day. The most recent case in the news is the …

Taxation Without Representation: The Illegal Irs Rule To Expand Tax Credits Under The Ppaca, Jonathan H. Adler, Michael F. Cannon

Faculty Publications

The Patient Protection and Affordable Care Act (PPACA) provides tax credits and subsidies for the purchase of qualifying health insurance plans on state-run insurance exchanges. Contrary to expectations, many states are refusing or otherwise failing to create such exchanges. An Internal Revenue Service (IRS) rule purports to extend these tax credits and subsidies to the purchase of health insurance in federal exchanges created in states without exchanges of their own. This rule lacks statutory authority. The text, structure, and history of the Act show that tax credits and subsidies are not available in federally run exchanges. The IRS rule is …

The Use And Misuse Of Biomedical Data: Is Bigger Really Better?”, Sharona Hoffman, Andy Podgurski

Faculty Publications

Very large biomedical research databases, containing electronic health records (HER) and genomic data from millions of patients, have been heralded recently for their potential to accelerate scientific discovery and produce dramatic improvements in medical treatments. Research enabled by these databases may also lead to profound changes in law, regulation, social policy, and even litigation strategies. Yet, is “big data” necessarily better data?

This paper makes an original contribution to the legal literature by focusing on what can go wrong in the process of biomedical database research and what precautions are necessary to avoid critical mistakes. We address three main reasons …

Special Topic Introduction: Minerva At The Departure Gate, Robert N. Strassfeld

Faculty Publications

No abstract provided.

Drug-Drug Interaction Alerts: Emphasizing The Evidence, Sharona Hoffman, Andy Podgurski

Faculty Publications

Many analysts and users of contemporary clinical decision support ("CDS") systems have expressed grave concerns about the technology’s efficacy and functionality. Alerts generated by CDS systems are often inaccurate, and an excess of alerts leads some physicians to experience "alert fatigue" and to turn off CDS altogether. This article formulates recommendations to improve drug-drug interaction (DDI) alerts.

The paper comments upon a proposal by Susan Ridgely and Michael Greenberg, who call for the development of a consensus-based "clinically significant drug-drug interaction list" that could generate limited liability protection for users. We argue that instead of creating a list of always-contraindicated …

Introduction - Symposium Issue On Health Data Security Systems, Sharona Hoffman

Faculty Publications

Introduction to the Health Data Security System symposium 2012 Huston, TX.

What Is The Meaning Of Health? Constitutional Implications Of Defining 'Medical Necessity' And 'Essential Health Benefits' Under The Affordable Care Act, B. Jessie Hill

Faculty Publications

One consequence of the Affordable Care Act (ACA) is that government will come to play a more extensive role in healthcare decision-making by individuals and their providers. The ACA does not directly regulate access to health services, but by means of a system of funding, mandates, and penalties, it essentially requires many employers to provide, and most individuals to carry, a certain minimum level of health insurance. Governmental decisions about which medical services qualify as medically necessary and appropriate may take on a new and greater importance, because government officials will be required to decide what sorts of procedures must …

Breaking The Cycle Of ‘Unequal Treatment’ With Health Care Reform: Acknowledging And Addressing The Continuation Of Racial Bias, Ruqaiijah Yearby

Faculty Publications

Since the Civil War access to health care in the United States has been racially unequal. This racially unequal access to health care remains even after the passage of Title VI of the Civil Rights Act of 1964 ("Title VI") and the election of an African-American President. Both of these events held the promise of equality, yet the promise has never been fulfilled. Now, many hail the passage of the Patient Protection and Affordable Health Care Act ("ACA") as the biggest governmental step in equalizing access to health care because it has the potential to increase minority access to health …

Balancing Privacy, Autonomy, And Scientific Needs In Electronic Health Records Research, Sharona Hoffman, Andy Podgurski

Faculty Publications

The ongoing transition from paper medical files to electronic health records will provide unprecedented amounts of data for biomedical research, with the potential to catalyze significant advances in medical knowledge. But this potential can be fully realized only if the data available to researchers is representative of the patient population as a whole. Thus, allowing individual patients to exclude their health information, in keeping with traditional notions of informed consent, may compromise the research enterprise and the medical benefits it produces.

This Article analyzes the tension between realizing societal benefits from medical research and granting individual preferences for privacy. It …

The Drugs Stop Here: A Public Health Framework To Address The Drug Shortage Crisis, Sharona Hoffman

Faculty Publications

Drug shortages are emerging as a major public health threat. Grave concern has been expressed by the medical community and government officials, and the crisis has been highlighted in recent media stories. Nevertheless, little has been written to date in the legal literature about the drug shortage crisis, and this timely article begins to fill this gap. It provides a thorough analysis of the origins and implications of the drug shortage problem and formulates a multi-layered approach to addressing it. The article argues that drug shortages result from a combination of market failures and regulatory constraints. It proposes a blend …

All For One And One For All: Informed Consent And Public Health, Jessica Wilen Berg

Faculty Publications

The concept of informed consent is well established in the field of bioethics, but its application is unclear in the area of public health. The increasing prevalence of public health interventions creates a need to analyze the scope of government power as it relates to individual choice. This Article explores three different types of public health measures in which individual choice has been limited: (1) environmental interventions; (2) classic public health interventions to prevent contagious disease; and (3) public health information reporting or use. The reasons for limiting informed consent vary depending on the context, and the implications for the …

Medical Decision Making By And On Behalf Of Adolescents: Reconsidering First Principles, B. Jessie Hill

Faculty Publications

The school nurse cannot give your teenage daughter an aspirin for her headache without your permission, but that same daughter can get an abortion without even informing you. Or can she? The obligations on medical personnel providing care to adolescents are famously indeterminate.

Two common-law presumptions have long lurked in the background, but, far from elucidating matters, those presumptions have contributed to the state of confusion. The first presumption is that, absent any special rule, children lack the legal authority to consent to medical treatment on their own. A parallel and corresponding presumption is that parents have a legal entitlement …

The Individual Mandate And The Taxing Power, Erik M. Jensen

Faculty Publications

This article, prepared for a symposium at the Salmon P. Chase College of Law, Northern Kentucky University, considers whether the Taxing Clause provides an alternative constitutional basis, as some have recently argued, for the individual mandate in the Patient Protection and Affordable Care Act of 21 - the requirement, going into effect in 214, that most individuals acquire satisfactory health insurance or pay a penalty. The article concludes that the Taxing Clause arguments are misguided. At best, the Clause can provide authority for the penalty, not for the mandate as a whole. Furthermore, the article questions whether the penalty will …