Health Law and Policy Commons^™

Birth Empowerment: Integrating Doula Services Into Our Healthcare System, Rebecca Singer-Miller

Health Matrix: The Journal of Law-Medicine

This law review article explores the role of doulas in improving maternal and infant outcomes and the challenges of integrating doula services into our healthcare system. Part I provides an overview of maternal and infant mortality rates in the United States, highlighting the disparities faced by women of color and low-income women. Part II discusses the benefits of doula services, including reduced rates of cesarean delivery, preterm birth, and other complications. Part III reviews current coverage of doula services in various states, both in the public and private sector. Part IV critiques the current regulatory scheme for doula services and …

A Thousand Views Of The Cathedral: The Law, Politics, And Statistics Of Pandemic Dashboards, Jeff Lingwall, Tj Bliss

Health Matrix: The Journal of Law-Medicine

This Article explores the law, politics, and statistics of communicating data through the thousands of state, county, school district, and higher-education dashboards created in response to the COVID-19 global pandemic. Using a nationally distributed questionnaire and series of interviews with dashboard managers and stakeholders, we offer a wide-ranging view of data visualization practice in response to COVID-19. We pair this evidence with a survey of almost 3,000 entities responsible for public health communication, which resulted in collection of over 1,100 COVID-19 dashboards from a spectrum of government actors and private parties. We evaluate how legal issues were perceived and acted …

Limits On Biomedical Research: Whether, Why, And How, Christine Grady

Health Matrix: The Journal of Law-Medicine

This article examines the limitations of laws and regulations in regulating biomedical research. While laws and regulations can serve as guardrails to limit certain research studies, they are often blunt instruments that struggle to keep up with the rapid pace of scientific progress. Moreover, laws in one jurisdiction may not be binding on others, making it difficult to regulate the global scientific community. The article argues that regulatory parsimony should be exercised, imposing regulations only where they work and not where they are unhelpful. The article also explores the ethical considerations surrounding biomedical research and its impact on society, including …

Eula, Or Eulogy? Reckoning End User License Agreements And Near-Future Cyborgs, Owen Carpenter

Health Matrix: The Journal of Law-Medicine

Integrated biotechnology is a quickly-approaching future legal issue that will blur the line between technology and person. The technology will likely run through some kind of software, and users of the technology will likely need to agree to some type of licensing agreement to use the software. End User License Agreements (“EULAs”) as they exist today have terms and clauses that will be problematic when applied to an implanted artificial heart, a replacement for the human eye that enhances vision, or other types of integrated technology. Current FDA regulation and EULAs are insufficient to deal with the problems that technology …

Splitting Deceased Donor Livers To Double The Transplant Benefits: Addressing The Legal, Ethical, And Practical Challenges, Evelyn M. Tenenbaum, Jed Adam Gross

Health Matrix: The Journal of Law-Medicine

Liver transplantation is different from transplanting other solid organs because some recipients can achieve good long-term outcomes with only half of a donor’s liver (or less). This means that some deceased donor livers can be split, saving two lives instead of one. However, although more than 10 percent of cadaveric livers meet the criteria for splitting, only about 1.5 percent are actually split in the United States. This article identifies a set of ethical, legal, and logistical challenges to a more extensive use of split liver transplantation (SLT) within existing legal frameworks. We then discuss how each of these challenges …

From Roe V. Wade To Dobbs V. Jackson – Between Women’S Rights Discourse And Obligations Discourse, Pnina Lifshitz-Aviram, Yehezkel Margalit

Health Matrix: The Journal of Law-Medicine

Recently, the U.S. Supreme Court published its decision in Dobbs v. Jackson Women’s Health Organization overturning the landmark abortion case, Roe v. Wade. In 1973, two groundbreaking abortion decisions were handed down by the same Court – Roe v. Wade and Doe v. Bolton – recognizing a woman’s fundamental constitutional right to obtain an abortion until fetal viability. The ensuring nationwide judiciary recognition of women’s basic rights was abruptly shaken by the Dobbs v. Jackson’s ruling that “the Constitution does not confer a right to abortion.” Dobbs’ reversal of these prior cases has created a legal, political, and public upheaval. …

Opioid Lawsuits: Is There Any End In Sight?, Richard C. Ausness

Health Matrix: The Journal of Law-Medicine

The opioid epidemic has led to a surge in litigation against opioid manufacturers, distributors, and retail pharmacy chains. This article provides a comprehensive overview of the legal landscape surrounding opioid lawsuits. It discusses the chemical nature of opioids, marketing practices of Purdue Pharma and others, and the largely unsuccessful personal injury cases brought against Purdue by private individuals prior to 2014. The article also examines the public nuisance doctrine—the most popular liability theory invoked by government plaintiffs—and analyzes three of the most important litigation pathways: (1) suits by individual government entities, usually states; (2) multidistrict litigation (MDL); and (3) bankruptcy …

The Three C’S – The Colon, Colonoscopies, And Cancer: A Medical And Legal Overview, Samuel D. Hodge, Calina Noah

Health Matrix: The Journal of Law-Medicine

This article explores the legal implications of colorectal cancer diagnosis and treatment. The article provides an overview of the medical aspects of colorectal cancer, including its symptoms, stages, and available tests for detecting it. It then delves into the legal issues surrounding colonoscopies, including informed consent, medical malpractice claims, and insurance coverage. The article also examines the role of medical documentation in litigation related to colorectal cancer diagnosis and treatment. Finally, it discusses recent legal developments related to colorectal cancer screening guidelines and their impact on healthcare providers and patients. Overall, this law review article provides a comprehensive analysis of …

Disclosing Privacy And Discrimination Protections In Informed Consent, Anya E.R. Prince

Health Matrix: The Journal of Law-Medicine

Recent empirical work shows that providing greater detail about limitations of genetic anti-discrimination protections in informed consent documents is likely to lower individuals’ willingness to participate in research studies. This article presents these empirical findings and analyzes the implications of the findings for clinical care and for privacy and discrimination risks beyond genetic discrimination. While the paper argues that further research is needed to fully understand the potential implications of disclosure of legal protections in the clinical setting, there are clear implications in the research setting. Since individuals are likely to alter their decision to participate in research based on …

Evidence For Community Face Masking To Limit The Spread Of Sars-Cov-2: A Critical Review, Ian T. Liu, Vinay Prasad, Jonathan D. Darrow

Health Matrix: The Journal of Law-Medicine

The use of facemasks in community settings has become an accepted public policy response to decrease disease transmission during the COVID-19 pandemic. Yet evidence of facemask efficacy is based primarily on observational studies that are subject to confounding and on mechanistic studies that rely on surrogate endpoints (such as droplet dispersion) as proxies for disease transmission. The available clinical evidence of facemask efficacy is of low quality and the best available clinical evidence has mostly failed to show efficacy, with fourteen of sixteen identified randomized controlled trials comparing face masks to no mask controls failing to find statistically significant benefit …

“A Solemn Mockery”: Why Texas’S Senate Bill 8 Cannot Be Legitimized Through Comparisons To Qui Tam And Environmental Protection Statutes, Laura Blockman

University of Miami Law Review

On September 1, 2021, the Texas Legislature enacted the Texas Heartbeat Act, an anti-abortion statute popularly known as Senate Bill 8 (“S.B. 8”). Although many states passed anti-abortion legislation in 2021, S.B. 8 received national attention due to the law’s unusual enforcement mechanism: S.B. 8 empowers private citizens, not state actors, to sue individuals who perform or aid in the performance of an abortion after a fetal heartbeat is detected.

Unsurprisingly, the authors of S.B. 8 received extreme back- lash from the public, and many academics and legal scholars viewed the law’s private enforcement mechanism as an effort to evade …

Compassion Fatigue In An Infodemic: A Physician’S Duty To Treat In The Age Of Misinformation, Alessandra Perez

University of Miami International and Comparative Law Review

This Note considers how misinformation has exacerbated the COVID-19 pandemic and the inevitable burden it has placed on the healthcare industry. It explores the intersection between a doctor’s oath of ethics and their right to refuse care by uncovering the obligations that guide their decisions. Justice dictates that physicians provide care to all who seek it, and it is unconstitutional for a physician to refuse to treat patients based on race, ethnicity, gender, religion, or sexual orientation. Even if a patient’s request is antithetical to a physician’s personal beliefs, the unwavering duty to treat generally mandates that physicians treat any …

Cosmetic Crisis: The Obsolete Regulatory Framework Of The Ever-Evolving Cosmetic Industry, Isabelle M. Carbajales

University of Miami Law Review

Cosmetics only first became regulated after a series of tragic events where users were seriously harmed from the use of cosmetic products. These tragic events prompted legislators to enact the Food, Drug, and Cosmetics Act of 1938. Before then, law makers feared that regulating the cosmetic industry would lower the tone of legislation because they considered the cosmetic industry to be inconsequential. At present, the regulatory system in place to protect vulnerable cosmetic consumers is nearly identical to when it was enacted over eighty-six years ago—even though the cosmetic market looks nothing like it did back then. The consumer base …

Vaccine Politics: Law And Inequality In The Pandemic Response To Covid-19, Matthew M. Kavanagh, Renu Singh

O'Neill Institute Papers

International mechanisms failed to achieve equitable distribution of COVID-19 vaccines—prolonging and deepening the pandemic. To understand why, we conduct process tracing of the first year of international policymaking on vaccine equity. We find that, in the absence of a single venue for global negotiation, two competing law and policy paradigms emerged. One focused on demand and voluntary action by states and firms, while the alternative focused on opening knowledge and expanding production through national and international law. While these could have been complementary, power inequalities between key actors kept the second paradigm from gaining traction on the global agenda. The …

Emotional Distress Claims, Dignitary Torts, And The Medical-Legal Fiction Of Reasonable Sensitivity, Alessandra Suuberg

Journal of Law and Health

Can individuals with a highly sensitive temperament recover in tort for intentional infliction of emotional distress (IIED)? In 2019, an article in the University of Memphis Law Review raised this question, referring to the "Highly Sensitive Person" (HSP) construct in psychology and asking whether the IIED tort’s 'reasonable person' standard discriminates against highly sensitive plaintiffs. Following up on that discussion, the present article considers how the law of IIED has historically treated plaintiffs with diagnosed psychiatric vulnerabilities that are either known or unknown to the defendant. The article also extends this discussion to the law's treatment of temperaments, such as …

Moving To Digitized Health Care: Why Hipaa Coverage Needs To Be Expanded

Connecticut Law Review

The rapid development of personal technology over the past few years has thrust health care online. Most people have used some form of health tracking apps, nutrition apps, or exercise and fitness apps. The expansion of telehealth services and apps during the COVID-19 pandemic accelerated the shift toward online health care. Digitized health care, whether accessed through a mobile app, a web site, or a telehealth service, provides a convenient and efficient means for people to access health care services. But this new access comes with a hidden cost: a risk of unauthorized use of private health information. This Comment …

Death By Detox: Substance Withdrawal, A Possible Death Row For Individuals In Custody, Dorothea R. Carleton

Journal of Law and Health

Suffering through substance withdrawal is a major problem for the majority of individuals in custody, yet there are no guidelines or standards to ensure their safety. Instead, individuals in custody are having their Constitutional rights violated and many die at the hands of the justice system. When their families seek accountability for the lack of adequate care provided by correctional facilities and employees, families are faced with a lack of consistency from one circuit to the next for knowing as to the correct standard to have a successful claim. Strain v. Regalado was a chance for the Supreme Court to …

Rethinking The Civil Protection Of Patients From Misleading Pharmaceutical Marketing Under Saudi Law, Muflih Saud Almughyirah

Maurer Theses and Dissertations

The effect of pharmaceutical marketing on individuals is a universal concern. It can influence patients' health and wealth. Patients, as well as their prescribing medical doctors, have been targeted by such marketing through different means. Many patients are unaware of their position as the most vulnerable party in this context and how these promotional strategies affect their physicians' decisions. When pharmaceutical marketing includes false, misleading, or otherwise negligent statements, patients become potential victims. This research addresses patients' civil protection from misleading pharmaceutical marketing under Saudi law. The study addresses four crucial aspects of patient protection: (i) ex-ante government regulations, (ii) …

Special Issue: Hunger, Nutrition, And Health, Susan Rice

Journal of Food Law & Policy

Everyday millions of Americans face barriers to accessing food, housing, and other supports–––making the impossible decision of whether to put food on the table or cover other essential needs. Food insecurity and diet-related diseases, such as heart disease and diabetes, affect people of all ages and in all communities. It was for this reason that the Biden-Harris Administration hosted the White House Conference on Hunger, Nutrition, and Health in September 2022. As the President said at the Conference, “No child should go to bed hungry. No parent should die of a disease that can be prevented.” It will require all …

Va’S Work To Ensure Veterans’ Food Security, Christine Going

Journal of Food Law & Policy

The Department of Veterans Affairs (VA) is uniquely positioned as the nation’s largest integrated health care system, serving 9 million enrolled Veterans each year, to successfully embrace the power of an interdisciplinary team designed to meet the needs of Veterans challenged by food insecurity. In collaboration with the whole of government approach to ending hunger, VA is addressing food and nutrition security. The Food Security Office within the Veterans Health Administration (VHA) was established and has representation from nutrition, social work, and nursing focusing on the causes of food insecurity among Veterans. VA’s Food Security Office and the Nutrition and …

The Health Care Industry Is Ready For A Revolution: Its Privacy Laws Are Not, Erin Rutherford

Student Scholarship

This paper highlights the costs and benefits associated with the gathering, storing, analyzing, and digitizing of health information; examines current privacy laws and their inadequacies in the new and constantly changing digital health world; and then provides a proposal framework to balance encouraging innovation while protecting individual autonomy. The article specifically proceeds as follows. This paper first discusses of the evolution of the health industry, from paper records to the wide array of sources generating health information today. Next, it considers the benefits to the ever-increasing amount of health information, which, while considerable can often be in tension with privacy …

The Effects Of Medical Malpractice Laws In The American States On Healthcare Expenditures, Madison Fulton

Political Science Theses and Capstones

The relationship between medical malpractice laws and healthcare has been an issue battling since the early 1980s. The relationship differs among states because some states have stricter malpractice laws and others have less strict laws, which ultimately affects the healthcare costs within that state. It is argued that because of the risks of lawsuits against doctors, they tend to practice more defensive medicine, affecting health costs and lawsuit rewards. I analyze data from The National Conference of State Legislatures, The Court Statistics Project, and The Kaiser Family Foundation to assess the correlation between state tort laws and their effect on …

Law's Body, Matt Saleh, Hannah Potter, Kendall Foley

Mercer Law Review

How do law’s narratives construct one of its central objects: the human body? This essay explores legal constructions of the human body: both in its idealized form, and in the negative ontological spaces of injury, disability, death, and dehumanization that surround that ideal.

Bodies are “the very ‘stuff’ of law.” There are few areas of law where the human body does not, somewhere, require definition. For instance, without a concept of the body, there can be no consequent constructions of personhood, nakedness, state intrusion, injury, disability, duty of care, aging, or the moment of death, to name only a few.

Finding Calm Amidst Chaos, Lisa Knowles Dds

The Journal of the Michigan Dental Association

This commentary on mindfulness and wellness provides the practitioner with strategies to achieve peace amidst chaos.

J Mich Dent Assoc May 2023

The Journal of the Michigan Dental Association

In this issue, the reader will find the following original content:

• A case study on recognizing the oral signs of Acute Lymphatic Leukemia
• A special pull-out section to assist clinicians in identifying and treating common oral lesions
• Advice on personal Wellness: "Finding Calm Amidst Chaos."
• State of Michigan C.E. Requirements for License Renewal of Dentists, Hygienists, and Registered Dental Assistants.
• A 10Minute EBD contrasting clinical success of composite restorations vs. glass ionomers.
• Guest commentary "Pretty Good Dentistry."
• News you need, Editorial, and an Advocacy Spotlight.

Catalyst Pharms., Inc. V. Becerra: When The Food And Drug Administration Repeatedly Ignores The Plain Language Of The Orphan Drug Act (Oda), Yifan Wang

Journal of Law and Health

In Catalyst Pharms., Inc. v. Becerra, the court held that the scope of orphan drug exclusivity applies to the disease or conditions for which the drug is designated because the plain language of the 21 U.S.C. § 360cc(a) is clear. The decision is in contrast to the practice of the FDA to narrowly construe the exclusivity to apply only to the uses or indications for which the drug is approved. The court correctly reached its holding using a plain language approach and rejected the FDA’s argument based on legislative history and purpose. The FDA has repeatedly ignored courts interpretations …

Abortion Law In A Time Of Judicial Adventurism, Michael Boucai

Other Scholarship

No abstract provided.

The Inherent Monetary Incentive Of Intellectual Property Rights And The Failure Of Intellectual Property Waivers To Recognize This Motive, Ellaheh D. Sims

Barry Law Review

No abstract provided.

Alternative Approaches To Police Interventions When Responding To Mental Health Crises Incidents, Karen Rivera Apolinar

Electronic Theses, Projects, and Dissertations

Purpose: This study explored mental health workers perspectives on alternative approaches in responding to mental health crises.

The study was carried out in Southern California, in collaboration with mental health workers who currently work or previously have worked in mental health crisis. It adopted a post-positivists paradigm and data was gathered through individual interviews with mental health workers who have direct experience with mental health crisis response in the community and with the police. The twenty participants in the study were men and women working in the mental health field, and of various backgrounds, licensures, and ages.

The study found …

Pro-Choice Plans, Brendan S. Maher

Faculty Scholarship

After Dobbs v. Jackson Women’s Health Organization, the United States Constitution may no longer protect abortion, but a surprising federal statute does. That statute is called the Employee Retirement Income Security Act of 1974 (“ERISA”), and it has long been one of the most powerful preemptive statutes in the entire United States Code. ERISA regulates “employee benefit plans,” which are the vehicle by which approximately 155 million people receive their health insurance. Plans are thus a major private payer for health benefits—and therefore abortions. While many post-Dobbs anti-abortion laws directly bar abortion by making either the receipt or provision of …