Health Law and Policy Commons^™

Dying In Isolation: Public Health Implications Of Transportation And Burial Of Human Remains During A Pandemic A Fifty State Survey, Christopher Ogolla

Faculty Scholarship

No abstract provided.

Genetic Technologies: Patent Protections & The Case For Technology Transfer, Smitha Gundavajhala

Washington Journal of Law, Technology & Arts

Genetic technologies range in scope from agricultural to medical applications. Most recently, during the COVID-19 pandemic, companies like Moderna developed and patented genetic technologies for diagnostic and therapeutic purposes, like the mRNA vaccine. However, patent protection provides these companies with a monopoly that ultimately limits domestic production of generic versions, thus limiting access to life-saving diagnostics and therapeutics. When a company located in one country files a patent for recognition in another country, it effectively places a hold on production of any technologies covered by that patent’s reach, whether that patent is enforced or not. However, the TRIPS Agreement, the …

“Tiktok Told Me I Have Adhd”: Regulatory Outlook For The Telehealth Revolution, Kaitlin Campanini

Washington Journal of Law, Technology & Arts

Telehealth’s expansion during the COVID-19 pandemic has drastically changed the approach to healthcare in the United States. This is particularly true in the behavioral health sector where several behavioral telehealth companies have emerged to treat Attention-Deficit/Hyperactivity Disorder (“ADHD”). These companies utilize a direct-to-consumer (“DTC”) model with a virtual platform that connects subscribing patients to medical providers who can treat them for ADHD. Although this telemedicine model emphasizes convenience and efficiency, the reality is that those benefits come at the cost of patient care. The federal regulations promulgated in the Ryan Haight Online Pharmacy Consumer Protection Act of 2008 to curtail …

The Origins Of Covid-19 — Why It Matters (And Why It Doesn’T), Lawrence O. Gostin, Gigi K. Gronvall

Georgetown Law Faculty Publications and Other Works

When Health emergencies arise, scientists seek to discover the cause — such as how a pathogen emerged and spread — because this knowledge can enhance our understanding of risks and strategies for prevention, preparedness, and mitigation. Yet well into the fourth year of the Covid-19 pandemic, intense political and scientific debates about its origins continue. The two major hypotheses are a natural zoonotic spillover, most likely occurring at the Huanan Seafood Wholesale Market, and a laboratory leak from the Wuhan Institute of Virology (WIV). It is worth examining the efforts to discover the origins of SARS-CoV-2, the political obstacles, and …

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 and Critical Care Medicine Faculty Papers

No abstract provided.

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 …

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 …

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 …

Abortion In America After Roe: An Examination Of The Impact Of Dobbs V. Jackson Women’S Health Organization On Women’S Reproductive Health Access, Natalie Maria Caffrey

Senior Theses and Projects

This thesis will examine the limitations in access to abortion and other necessary reproductive healthcare in states that are hostile to abortion rights, as well as discuss the ongoing litigation within those states between pro-choice and pro-life advocates. After analyzing the legal landscape and the different abortion laws within these states, this thesis will focus on the practical consequences of Dobbs on women’s lives, with particular attention to its impact on women of color and poor women in states with the most restrictive laws. The effect of these restrictive laws on poor women will be felt disproportionately due to their …

Drug Ideologies Of The United States, Macy Montgomery

Helm's School of Government Conference

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.