Health Law and Policy Commons^™

Evolving Privacy Protections For Emerging Machine Learning Data Under Carpenter V. United States, Emily Nicolella

FIU Law Review

The Fourth Amendment’s third-party doctrine eliminates an individual’s reasonable expectation of privacy in information they willingly turn over to third parties. Government scrutiny of this information is not considered a search under the Fourth Amendment and is therefore not given constitutional protections. In the 2018 case Carpenter v. United States, the Supreme Court created an exception to the third-party doctrine. In Carpenter, a case involving the warrantless use of cell site location information (CSLI) in a criminal investigation, the Court held that individuals do have a reasonable expectation of privacy regarding CSLI. According to Chief Justice Roberts, despite the necessary …

Model Legal Processes For Court Ordered Mental Health Treatment - A Modern Approach, Brian D. Shannon

FIU Law Review

The United States Conference of Chief Justices and Conference of State Court Administrators established the National Judicial Task Force to Examine State Courts’ Response to Mental Illness in 2019. As part of its overall efforts, the National Judicial Task Force then partnered with the Equitas Project of Mental Health Colorado to appoint a select workgroup to develop model statutory language for court-ordered mental health treatment, emergency psychiatric intervention, medication over objection, and criminal matters involving persons with mental illness. This Model Legal Processes Workgroup included judges, psychiatrists, medical school professors, law professors, and others whose goal was to draft model …

The Who’S 75th Anniversary: Who At A Pivotal Moment In History, Lawrence O. Gostin, Danwood Mzikenge Chirwa, Helen Clark, Roojin Habibi, Björn Kümmel, Jemilah Mahmood, Benjamin Mason Meier, Winnie Mpanju-Shumbusho, K. Srinath Reddy, Attiya Waris, Miriam Were

Georgetown Law Faculty Publications and Other Works

The World Health Organisation (WHO) was inaugurated in 1948 to bring the world together to ensure the highest attainable standard of health for all. Establishing health governance under the United Nations (UN), WHO was seen as the preeminent leader in public health, promoting a healthier world following the destruction of World War II and ensuring global solidarity to prevent disease and promote health. Its constitutional function would be ‘to act as the directing and coordinating authority on international health work’. Yet today, as the world commemorates WHO’s 75th anniversary, it faces a historic global health crisis, with governments presenting challenges …

Public Health Product Hops, Michael S. Sinha

All Faculty Scholarship

Pharmaceutical product hops are anticompetitive maneuvers that often represent a last-ditch effort by brand manufacturers to preserve market share in the face of generic competition. An integral part of product life cycle management strategies, product hops may offer marginal benefits to patients but can substantially increase costs to payers and patients alike. Yet industry advocates maintain that this is essential follow-on research and development, resulting in the development of novel products that would otherwise never reach the market.

Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they furthered …

Dobbs In A Technologized World: Implications For Us Data Privacy, Jheel Gosain, Jason D. Keune, Michael S. Sinha

All Faculty Scholarship

In June of 2022, the U.S. Supreme Court issued its opinion in Dobbs v. Jackson Women’s Health Organization, overturning 50 years of precedent by eliminating the federal constitutional right to abortion care established by the Court’s 1973 decision in Roe v. Wade. The Dobbs decision leaves the decision about abortion services in the hands of the states, which created an immediately variegated checkerboard of access to women’s healthcare across the country. This in turn laid bare a profusion of privacy issues that emanate from our technologized world. We review these privacy issues, including healthcare data, financial data, website tracking and …

Federalism And The Right To Travel: Medical Aid In Dying And Abortion, Leslie P. Francis, John Francis

Utah Law Faculty Scholarship

This article explores how rights to movement may limit state efforts to restrict abortions, either directly or indirectly. We use the language of “movement” to encompass short-term visits, longer-term residency changes, and the movement of goods or services across state lines. We prefer “movement” to “travel” or “tourism,” as this language risks trivializing the seriousness of what might be at stake. However, since “travel” is the term used in many U.S. court decisions and other discussions concerning the right,7 we use that term as relevant to these. The centerpiece of our defense is the relationship between freedom of movement and …

The Fall Of Fda Review, Daniel G. Aaron

Utah Law Faculty Scholarship

The U.S. Food and Drug Administration (FDA) is in crisis. FDA can hardly go a single day without an investigation, negative news story, or scholarly critique of the agency’s work. We have increasingly entrusted FDA—today, to the tune of 25% of the U.S. economy—with vetting the products we put in and on our bodies. But the array of problems facing the agency raises questions about whether it is equipped to succeed in the 21st century.

FDA’s core function is to oversee a special legal regime called “premarket review.” Congress has prohibited all marketing of certain types of products (like drugs) …

Reevaluating Regional Law Reform Strategies After Dobbs, Jamie Abrams

Scholarly Articles in Law Reviews & Journals

This article studies the triad of 2016 social media campaigns known as “#AskDr.Kasich,” “#askbevinaboutmyvag,” and “#PeriodsforPence.” While these campaigns, each located in the regional mid-South, were motivated by restrictive state abortion bills, they uniquely positioned menstruation and women’s bodies at the center of their activism—not abortion alone. They leveraged, as a political fault line, the contradiction of these states’ governors’ perceived disgust relating to basic women’s reproductive health, relative to their patriarchal assuredness in regulating and controlling women’s bodies.

In so doing, they tapped into meaningful disruptions in the geographies, religiosities, and masculinities of abortion politics. These campaigns achieved regional …

Freedom Not To See A Doctor: The Path Toward Over-The-Counter Abortion Pills, Lewis Grossman

Scholarly Articles in Law Reviews & Journals

American courts and lawmakers are engaged in an epic struggle over the fate of abortion pills. While some anti-abortion activists are attempting to drive the pills off the market entirely, supporters of reproductive rights are striving to make them more easily accessible. This Article advances the latter mission with a bold proposal: FDA should consider allowing abortion pills to be sold over the counter (OTC). Abortion rights supporters argue that FDA should repeal the special distribution and use restrictions it unnecessarily imposes on mifepristone, one of two drugs in the medication abortion regimen. Even if FDA removed these restrictions, however, …

The Ripple Effects Of Dobbs On Health Care Beyond Wanted Abortion, Maya Manian

Scholarly Articles in Law Reviews & Journals

The Supreme Court’s momentous decision in Dobbs v. Jackson Women’s Health Organization to overturn fifty years of precedent on the constitutional right to abortion represents a sea of change, not only in constitutional law, but also in the public health landscape. Although state laws on abortion are still evolving after Dobbs, the decision almost immediately wreaked havoc on the delivery of medical care for both patients seeking abortion care and those not actively seeking to terminate a pregnancy.

This Article also argues that focusing the public’s attention on the deleterious consequences of abortion bans for health care beyond wanted abortion …

On The Appeal Of Drug Patent Challenges, Charles Duan

Scholarly Articles in Law Reviews & Journals

Administrative patent challenge proceedings, the most prominent form of which is inter partes review, have attracted much controversy. In particular, the pharmaceutical industry and its supporters have criticized the proceedings as unfairly biased toward canceling valuable drug patents. Yet there has been little study of the real-world, practical impact of these administrative proceedings on drug patents or pharmaceutical markets.

This Article reviews the universe of administrative challenges on drug patents that have proceeded through appeal to the Federal Circuit. The majority of patents challenged this way are deemed unpatentable at both the agency and appellate levels, and, that administrative cancellation …

Approaches To Sea Level Rise And International Law: A Comparative View Of Emerging Policy Responses By The African And The Americas Regions, Charles Chernor Jalloh

Articles

No abstract provided.

Is There A Fundamental Right To Privacy When An Educational Institution Requires A Student To Disclose Proof Of His Or Her Vaccination Status?, Mary D. Fatscher

Touro Law Review

In 2020, the coronavirus disease (“COVID-19”) dominated the world. Although the public has progressively become more informed about the disease and how to safeguard itself, challenges persist as there is still much unknown. Aside from wearing masks, social distancing, and despite its undetermined consequences, the COVID-19 vaccination has emerged as a primary solution to substantially reducing the incidence and severity of the virus in our country. Many COVID-19 vaccine mandates were initiated once three pharmaceutical and biotechnology companies including Pfizer-BioNTech, Moderna, and Johnson & Johnson received Emergency Use Authorization from the Food and Drug Administration (“FDA”).

New York Mental Hygiene Law Article 81 Proceedings: A Proposal To Better Protect The Best Interests Of An Alleged Incapacitated Person, Casey Marsh

Touro Law Review

Guardianship proceedings under New York Mental Hygiene Law Article 81 are intended to protect the personal needs and property management of an alleged incapacitated person. A guardian appointed for a person is responsible for making decisions in line with the best interests and wishes of his or her ward. While guardians serve a very important purpose, the current procedures of guardianship proceedings allow too much room for family members to bring a proceeding without the alleged incapacitated person’s best interests in mind. Often, people bring guardianship proceedings to fish for information on family members or to circumvent a future Surrogate’s …

Advancing Racial Justice Through Civil And Criminal Academic Medical-Legal Partnerships, Yael Cannon, Vida Johnson

Georgetown Law Faculty Publications and Other Works

The medical-legal partnership (MLP) model, which brings attorneys and healthcare partners together to remove legal barriers to health, is a growing approach to addressing unmet civil legal needs. But MLPs are less prevalent in criminal defense settings, where they also have the potential to advance both health and legal justice. In fact, grave racial health inequities are deeply intertwined with both civil and criminal injustice. In both spheres, health justice is racial justice. Building on the experiences of the authors in their respective civil and criminal law school clinics at Georgetown University in Washington, D.C., this Article argues that academic …

Leveraging Academic-Medical Legal Partnerships To Advance Health Justice, Vicki W. Girard, Yael Cannon, Deborah F. Perry, Eileen S. Moore

Georgetown Law Faculty Publications and Other Works

Unmet legal needs contribute to housing, income, and food insecurity, along with other conditions that harm health and drive health inequity. Addressing health injustice requires new tools for the next generations of lawyers, doctors, and other healthcare professionals. An interprofessional group of co-authors argue that law and medical schools and other university partners should develop and cultivate Academic Medical-Legal Partnerships (A-MLPs), which are uniquely positioned to leverage service, education, and research resources, to advance health justice.

Cryptic Patent Reform Through The Inflation Reduction Act, Arti K. Rai, Rachel E. Sachs, W. Nicholson Price Ii

Faculty Scholarship

If a statute substantially changes the way patents work in an industry where patents are central, but says almost nothing about patents, is it patent reform? We argue the answer is yes — and it’s not a hypothetical question. The Inflation Reduction Act (“IRA”) does not address patents, but its drug pricing provisions are likely to prompt major changes in how patents work in the pharmaceutical industry. For many years scholars have decried industry’s ever-evolving strategies that use combinations of patents to block competition for as long as possible, widely known as “evergreening,” but legislators have not been receptive to …

Increasing Compliance With International Pandemic Law: International Relations And New Global Health Agreements, Matthew M. Kavanagh, Clare Wenham, Elize Massard Da Fonseca, Laurence R. Helfer, Elvin Nyukuri, Allan Maleche, Sam F. Halabi, Adi Radhakrishnan, Attiya Waris

Faculty Scholarship

No abstract provided.

Sanitation: Reducing The Administrative State’S Control Over Public Health, Lauren R. Roth

Scholarly Works

On April 18, 2022, in Health Freedom Defense Fund, Inc. v. Biden, United States District Judge Kathryn Kimball Mizelle vacated the mask mandate issued by the Centers for Disease Control and Prevention. Following a framework laid out in other decisions restricting CDC actions in response to COVID-19, the court found that the agency lacked statutory authority to protect the public from the virus by requiring mask wearing during travel and at transit hubs because Congress did not intend such a broad grant of power. Countering decades of public health jurisprudence, the federal district court failed to defer to experts and …

The Future Of Ivf Post Dobbs, Rebecca Feinberg

Scholarly Works

No abstract provided.

Masking Vulnerability: Including Ppe As A Covered Service In Health Insurance, Mary Leto Pareja

Faculty Scholarship

The COVID-19 pandemic laid bare the shared vulnerability inherent in the human condition, prompting a collective recognition of our physical susceptibility to infectious diseases. While great strides have been made in combating COVID-19 through vaccinations and treatments, a portion of the population remains profoundly vulnerable due to health conditions that make the disease more dangerous, that limit vaccine efficacy, or that prevent vaccination altogether. This article explores a path forward by proposing a solution within health benefit plans—encompassing both private health insurance and public health benefits. Specifically, the article advocates for a coverage mandate for over-the-counter personal protective equipment (PPE) …

An Epidemic In Enforceability: A Growing Need For Individual Autonomy In Health Care Data-Privacy Protection In An Era Of Digital Tracking, Madeline Knight

Vanderbilt Journal of Entertainment & Technology Law

The health care system in the United States is under conflicting pressures. From one angle, there is a demand for the highest standard of care, which includes efficient, confidential communications between doctors and patients. From another, however, the technology that has facilitated such efficiency has outpaced the security mechanisms currently in place to protect a long-recognized right to privacy. In an era of data tracking, the important privacy interest that Congress has recognized since 1996 confronts a growing threat of data commodification. Despite significant potential consequences, however, there is neither guaranteed statutory recovery nor cohesion among states for the process …

Guardianship Before And Following Hospitalization, Jennifer Sullivan, Andrew B. Cohen, Kelly Stolzmann, Elizabeth J. Auguste, Casey C. Catlin, Zachary S. Sager, Rachel E. Weiskittle, Cindy B. Woolverton, Heather L. Connors

Publications

When ethics committees are consulted about patients who have or need court appointed guardians, they lack empirical evidence about several common issues, including the relationship between guardianship and prolonged, potentially medically unnecessary hospitalizations for patients. To provide information about this issue, we conducted quantitative and qualitative analyses using a retrospective cohort from Veterans Healthcare Administration. To examine the relationship between guardianship appointment and hospital length of stay, we first compared 116 persons hospitalized prior to guardianship appointment to a comparison group (n=348) 3:1 matched for age, diagnosis, date of admission, and comorbidity. We then compared 91 persons hospitalized in the …

Experiential Education In Advocacy For Occupational Therapy Students: Didactic Approaches And Learning Outcomes, Aaron Bonsall, Rebecca L. Wolf, Abe Saffer

Journal of Occupational Therapy Education

Advocacy is a foundational value in occupational therapy, but uniformity in teaching and learning advocacy is lacking. This paper proposes and reports on the implementation of an advocacy course based on experiential education. The objective of the study was to evaluate student learning after an advocacy course with an experiential education component using an open-ended survey design. Participants were occupational therapy doctoral students, and the setting was a course taught in a health sciences university. Students voluntarily completed a four-item anonymous survey after participating in an experiential advocacy course. Written responses were coded into themes using an inductive approach. The …