Health Law and Policy Commons^™

Considerations In Selecting Venues For The American Thoracic Society International Conference: Balancing Competing Priorities Of The Society's Diverse Membership, Gregory P. Downey, M. Patricia Rivera, Lynn M. Schnapp, Irina Petrache, Jesse Roman, Karen J. Collishaw

Division of Pulmonary, Allergy, and Critical Care Medicine Faculty Papers

No abstract provided.

Femtechnodystopia, Leah R. Fowler, Michael Ulrich

Faculty Scholarship

Reproductive rights, as we have long understood them, are dead. But at the same time history seems to be moving backward, technology moves relentlessly forward. Femtech products, a category of consumer technology addressing an array of “female” health needs, seem poised to fill gaps created by states and stakeholders eager to limit birth control and abortion access and increase pregnancy surveillance and fetal rights. Period and fertility tracking applications could supplement or replace other contraception. Early digital alerts to missed periods can improve the chances of obtaining a legal abortion in states with ever-shrinking windows of availability or prompt behavioral …

Mda Foundation: Mission Of Mercy Moves To Flint In June 2024; Save The Date And Participate, Anne Berquist

The Journal of the Michigan Dental Association

The MDA Foundation is organizing its fifth Mission of Mercy (MOM) in Flint in June 2024. The event aims to provide dental care to those in need, especially those who are uninsured and unable to afford dental services. The MOM will take place at the Dort Financial Center in Flint from June 13 to 17, offering dental care from 6 a.m. to 6 p.m. on June 14 and 15. This initiative has been critical in delivering dental services and improving the lives of those who lack access to proper oral healthcare.

Erisa’S Fiduciary Fantasy And The Problem Of Mass Health Claim Denials, Katherine T. Vukadin

University of Richmond Law Review

Over 100 million Americans face healthcare debt. Most of those in debt have health insurance, with the debt often springing from services people thought were covered. Before and even after receiving care, those seeking coverage must run a gauntlet of obstacles such as excessive pre-authorization requests, burdensome concurrent review of care, and retrospective review, which claws back payment after a treatment is pre-authorized and payment made. Increasingly, this procedural tangle leaves people with unwarranted and unexpected medical bills, quickly spiraling them into debt.

Who polices health insurers’ claims practices? What keeps insurance companies from designing overly burdensome pre-authorization requirements or …

Going The Extra Mile: Expanding The Promoting Affordable Housing Near Transit Act, Emily R. Casey

University of Richmond Law Review

The Promoting Affordable Housing Near Transit Act (“Act”), introduced in Congress in June 2021 and signed into law six months later, proposes a goal of balancing the disproportionately-high costs of housing and transportation felt by lower-income families by combining these resources in one project: transit-oriented housing developments. Middle-income and wealthy suburbanites have ready access to cities by car, but lower-income urbanites lack access to the suburbs without a private vehicle. While the goal of the Act recognizes this disparate outcome, the Act’s failure to include expansion of mass transit into the suburbs will continue to restrict low-income minorities to urban …

Medical-Legal Partnership As A Model For Access To Justice, Yael Cannon

Georgetown Law Faculty Publications and Other Works

The United States is plagued with a “justice gap” that leaves many Americans with unmet civil legal needs. Americans with low income do not receive the legal help they require for as many as 92% of their substantive civil legal problems. The justice gap requires many legal aid agencies to triage, becoming “emergency rooms” for clients with unmet legal needs. This national crisis calls for new innovations so that access to justice (A2J) can function more like primary care, promoting better use of resources and preventing legal crises that can cause long-lasting harm.

Medical-Legal Partnerships (MLPs) embed lawyers in healthcare …

Why Punish Pharma For Making Medicine? Preserving Patent Protections And Cutting Consumer Costs, Alex Wharton

Vanderbilt Journal of Entertainment & Technology Law

The push to lower pharmaceutical drug prices has taken a stronger foothold in legislative and executive actions in recent years. With average prices rising continuously over the past decade, many consumers struggle to pay for the medications they need-—insulin being the most often cited example. Accordingly, a variety of solutions have been suggested. Some solutions support reducing barriers for generic drugs to provide competition to the big brands, others push for greater regulation of manufacturers’ ability to price their drugs, and some proposals seek greater transparency to promote price negotiations, especially when compared to prices abroad. Most concerningly, however, one …

America Is Tripping: Psychedelic Pharmaceutical Patent Reforms Fostering Access, Innovation, And Equity, Quentin Barbosa

Brooklyn Law Review

A resurgence in federally approved psychedelic research has spawned the Psychedelic Renaissance, and with each study it becomes increasingly clear that psychedelics have the potential to revolutionize mental health treatment. However, if Congress fails to reform the industry’s patent procedures, threats to innovation in the budding field of psychedelic medicine will manifest in their ugliest form. Psychedelics are a class of hallucinogenic drugs that primarily trigger substantially altered states of consciousness, including psychological, visual, and auditory changes. Medical research on psychedelics has produced staggering results that indicate psychedelics have the potential to be significantly more effective in treating mental illnesses …

Clicking Away Consent: Establishing Accountability And Liability Apportionment In Direct-To-Consumer Healthcare Artificial Intelligence, Stephanie L. Lee

Brooklyn Law Review

Artificial Intelligence (AI) and machine learning are making sweeping changes across all industries, and health care is no exception. AI promises to revolutionize patient treatment with the development of algorithm-driven tools to improve efficiency in clinical care. As alluring as machine-driven learning may be given its potentialities, however, the incorporation of AI into the healthcare field has also been received with trepidation. This fear is understandable given the lack of transparency to the public surrounding the exact mechanisms for creating algorithms and the reasoning followed by the software. Indeed, AI in the healthcare system is aptly known as “black-box medicine.” …

Telehealth Fraud And Abuse Before And “After” The Pandemic: Are Things Going To Get Better?, Natalia Shamuel

DePaul Journal of Health Care Law

Telehealth and telemedicine have become increasingly useful to both patients and health care providers. The ease and comfort of attending a doctor’s appointment in the comfort of one’s own home made telehealth and telemedicine convenient, safe, and effective options for seeing a doctor during the height of the COVID-19 pandemic. However, with increased usage of telehealth and telemedicine came increased health care fraud and abuse. With increased health care fraud and abuse came increased regulations, both on the federal and state levels. This Note provides a brief analysis of health care fraud and abuse in the telehealth and telemedicine space. …

The Future Of Healthcare Is Generic: Expanding Hatch-Waxman To Equitably Regulate The Healthcare Products Industry, George Encarnacion Jr.

DePaul Journal of Health Care Law

This article serves to address the statutory disconnect in the healthcare industry regarding generic products. There has been marked success in the generics market pertaining to pharmaceutical drugs, but the same cannot be said for medical devices and, in more recent times, biosimilars. The end result for consumers is higher product prices, limited access of care, and a more burdensome healthcare system. This article explores the statutory history of drug and medical device approval and production. It also explores differences between modern regulation of generic drugs and generic medical devices, focusing on key issues of FDA approval, consumer safety and …

The Relevance Of Fda Regulation In Medical Device Product Defect Cases, Edward Correia

DePaul Journal of Health Care Law

Medical device product cases typically involve a jury determination whether a product is unreasonably dangerous. If the product has been cleared for marketing by the Food and Drug Administration, it has been through an extensive regulatory process in which the safety of the product is potentially reviewed by experts. Nevertheless, a number of courts have concluded that juries should not hear about FDA regulation in making factual findings regarding liability and damages.

What the FDA concludes about the safety of a product can be extremely relevant to juries in deciding whether to find there was a defective product and whether …

Fool Me Once … Why The American Data Privacy Act Proposal Fails To Adequately Deter Data Privacy Violations, Melissa Mann

SLU Law Journal Online

The recent Supreme Court decision of Dobbs v. Jackson Women's Health Organization raises many questions regarding the privacy of health data. In this article, Melissa Mann discusses some concerns that may arise with the use health applications to track personal data and potential privacy laws that could be enacted to protect these users.

Blue Water Navy Veterans And The Agent Orange Rulings: A Lifeboat For The Veterans; A Storm Warning For The Vba, Jennifer Howley

Catholic University Law Review

Agent Orange was a herbicidal chemical used by the U.S. military for tactical use during the Vietnam War. Although initially told by the government not to worry about exposure to the chemical, veterans, their wives, and their offspring began having severe health and reproductive issues. In the early 1990’s, Congress passed the Agent Orange Act and the government directed the Institute of Medicine to report on the health effects of Agent Orange. Through this approach, Vietnam Veterans could claim benefits for illnesses listed in connection with Agent Orange. But only some Vietnam Veterans.

Initially, only veterans who served on-shore or …

It Is What It Is... Enduring The Never-Ending: The Lived Experiences Of Parenting Adult Children With Developmental/Intellectual Disabilities, Siri Gurunam Kaur Khalsa

Nursing ETDs

The parental home is the principal place of residence for adults with developmental disabilities/ intellectual disabilities (DD/ID) (Heller et al., 2007). More than 75% of the adult population with DD/ID living in the U.S. continue to have their basic needs provided by their parents (Williamson & Perkins, 2014). This is based on the estimated statistic that 1.0 to 1.58% of the U.S. adult population has a developmental disability (Anderson et al., 2019; Fox et al., 2015). About 2.9 million adults with DD/ID live with a parent of 55 years (Byun et al., 2006), with more than 25% of these parents …

Drug Ideologies Of The United States, Macy Montgomery

Helm's School of Government Conference - 2021-2024

The United States has been increasingly creating lenient drug policies. Seventeen states and Washington, the District of Columbia, legalized marijuana, and Oregon decriminalized certain drugs, including methamphetamine, heroin, and cocaine. The medical community has proven that drugs, including marijuana, have myriad adverse health side effects. This leads to two questions: Why does the United States government continue to create lenient drug policies, and what reasons do citizens give for legalizing drugs when the medical community has proven them harmful? The paper hypothesizes that the disadvantages of drug legalization outweigh its benefits because of the numerous harms it causes, such as …

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

Law & Economics Working Papers

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 …

A Case Study Of California's Maternal Health Landscape And Recommendations For Mississippi, Kinley Miller

Honors Theses

This paper is a case study of California’s maternal health landscape, reflecting its exceptional approach to the maternal health crisis. I review several policies: the creation of the Maternal Quality Care Collaborative, the Maternal Data Center, and the Maternal Mortality Review Committee, maternal health toolkits, Medicaid expansion, extended postpartum Medicaid coverage, paid family leave, C-Section Honor Roll, and maternal mental health measures. The case study suggests that all of these policies in conjunction with one another correlates with a decrease maternal mortality. California’s proactive approach and ability to mobilize public and private entities are key attributors to its success in …

Cyberattacks: An Underlying Condition Exacerbated By The Covid-19 Pandemic, Kaitlyn Palmeter

The Journal of Business, Entrepreneurship & the Law

COVID-19 continues to change the world in unforeseen ways triggering a new era of corporate data breaches. This article will illustrate how cyberattacks have increased in severity during the pandemic, how current laws and government officials are trying to evolve with the current threats and technology, how victims of cyberattacks risk sanctions and potential lawsuits, and concludes by suggesting solutions throughout to increase Cybersecurity.

Advancing Equity In The Pandemic Treaty, Lawrence O. Gostin, Kevin A. Klock, Katherine Ginsbach, Sam F. Halabi, Taylor Hall-Debnam, Janelle Lewis, Vanessa S. Perlman, Katie Robinson

Georgetown Law Faculty Publications and Other Works

There is a broad consensus around equity’s importance. Even countries that hoarded supplies during the acute phase of COVID-19 seem to understand that the international community must find a means to ensure fairer allocation of medical resources when the next health crisis hits. But there has been little agreement about the concrete steps needed to operationalize fairer access and benefit sharing. That is, what are the workable mechanisms that could reduce the divide between richer and poorer populations? The World Health Assembly, the governing body of the World Health Organization, has appointed an Intergovernmental Negotiating Body to develop a pandemic …

Disaster Risk In The Carceral State, Saptarishi Bandopadhyay, Joshua R. Coene

Journal Articles

The overlap between prisoner vulnerability and disasters in the United States is undeniable. During 2020 and 2021, the United States endured a series of natural hazards such as wildfires, floods, and hurricanes, many of which exposed the country’s 2.1 million inmates to additional risks and compounded the danger posed by COVID-19. Yet policymakers and scholars are only beginning to appreciate the centrality and magnitude of disaster risk management for the millions of people currently held in penal institutions around the country. Unsurprisingly, the production of “lessons learned” documents that follow in the aftermath of disasters overlook how prisoner vulnerability is …

The Exacerbating Role Of Technological And Connectivity Challenges On Older Detroiters’ Health In A Pandemic, Nicholas Schroeck, Carrie Leach

Seattle Journal of Technology, Environmental, & Innovation Law

The COVID-19 pandemic hit communities of color hard. The City of Detroit was particularly vulnerable to COVID-19 due to racial, socioeconomic, and environmental health factors. To analyze the exacerbating role of technology and connectivity challenges on older Detroiters' health in a pandemic, we first examined Detroit’s demographics. This analysis involved looking at the continued evolution of the City's population toward older adults, as well as the impact of COVID-19 and the healthcare services on Detroit’s elder population. Next, we examined Detroit’s internet access challenges, including the presence of digital exclusion among older adults in Detroit, the impact of COVID-19 on …

Pooling Patents For Pandemic Progress: Mrna Vaccines And The Broader Context Of Modernatx Inc V. Pfizer Inc., Francis Brefo

DePaul Journal of Art, Technology & Intellectual Property Law

No abstract provided.

Masthead, Case Western Reserve University School Of Law

Health Matrix: The Journal of Law-Medicine

No abstract provided.

State Constitutional Law: The Future Of Abortion Rights?, Gabriella Wittbrod

Health Matrix: The Journal of Law-Medicine

No abstract provided.

Volume 33 (2023), Case Western Reserve University School Of Law

Health Matrix: The Journal of Law-Medicine

No abstract provided.

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 …