Health Law and Policy Commons^™

Addictive By Design: Can States Regulate Social Media Algorithms In The Face Of Free Speech Challenges?, Niamh Kathleen Keane

University of Miami Business Law Review

The foe we did not know, the stranger that stole the show. Social media once presented itself as a friendly way to connect with loved ones through shared pictures and catchy captions. Yet, it has since shown its true colors; intentionally addicting its users—for its own financial benefit—and showing no remorse doing so.

Entranced, users set off on a digital journey, veering down paths they never imagined . . . Today, children as young as eight years old are exposed to extremely harmful content such as medically unsupported dieting techniques, substance abuse, and dangerous, life-threatening social media “trends,” all of …

Chat M.D., Nathan Cortez

Faculty Journal Articles and Book Chapters

Large language models (LLMs) such as Claude and ChatGPT are the most powerful artificial intelligence (AI) systems ever created, and they are being used to diagnose and treat patients. But LLMs have been shown to be unreliable, unpredictable, and unsafe on occasion. New AI guidelines recommend hundreds of standards, such as ‘transparency’, ‘trustworthiness’, and ‘safety’. But there is deep uncertainty whether these are sufficient. The literature focuses mostly on which standards best suit AI models, not on how to transmute standards into law. This article does that by considering AI guidelines as a starting point, then evaluating whether existing frameworks …

Let The Sunshine In: Crafting Constitutional Transparency Regulations For Content Moderation, Caitlin Ring Carlson

Seattle University Law Review

In response to public concern about the impact of social media, legislators in some U.S. states have developed laws to regulate the process of content moderation. Many include mandatory transparency and disclosure requirements, some of which courts have already deemed an unconstitutional infringement on social media platforms’ right to free expression. This article explores the parameters for crafting constitutional social media transparency regulations using existing U.S. media policy and insights from recent legal challenges. The resulting analysis identifies content neutral transparency requirements that mandate the disclosure of purely factual, non-controversial information as those most likely to withstand judicial scrutiny. Specifically, …

This Is Not A Game: The Addictive Allure Of Digital Companions, Nizan Geslevich Packin, Karni Chagal-Feferkorn

Seattle University Law Review

Artificial Intelligence (AI) agents have become an inescapable part of modern childhood, reshaping education, leisure activities, entertainment, and social interaction. From AI-powered tutors that adapt to individual learning styles to emotionally responsive chatbots that simulate human companionship, these systems promise unprecedented personalization, cognitive stimulation, and social support. However, these benefits mask significant risks that remain unregulated and inadequately addressed.

Although adults are also susceptible to forming deep emotional bonds with AI companions—often trusting them as if they possessed genuine understanding and empathy—children are particularly vulnerable. Their misplaced trust can more severely distort social development, weaken critical thinking, and foster unhealthy …

Moral Panic Or Public Health Crisis? Lessons From Drugs And Gambling For “Addictive” Design, Matthew B. Lawrence, Haomin (Kevin) Yan

Seattle University Law Review

Alcohol, automobiles, guns, lottery, loot boxes, meat, music, opioid painkillers, processed foods, prop bets, slot machines, television, tobacco, violent video games. Over the last century each of these has been subject to concerns—some might even say “moral panics”—from parents and policymakers about avoidable harms to kids and adults. In some cases we look back with the benefit of hindsight and dismiss those concerns as naïve or moralistic. In others we look back at them as justified or as having come too late to check an expanding industry before it did unfathomable harm while growing so powerful that it became all …

The Intersection Of Regulation, Quality Care Delivery, And Ethics And Compliance: Look Carefully Before Crossing!, David R. Hoffman, Ilene Warner-Maron

Saint Louis University Journal of Health Law & Policy

Quality and compliant care delivery in nursing homes remains elusive. Four main interests are currently misaligned, thereby putting nursing home residents at risk of harm. Without a clearly defined commitment to quality and compliant care and alignment of these interests, nursing home residents will remain vulnerable to severe harm.

The first key interest concerns nursing home ownership and management. Currently, over seventy percent of nursing homes are owned by for-profit entities. Previous ownership models, including non-profit, religious-based, and county-owned facilities, have largely closed or transitioned to for-profit entities. The shift in ownership significantly impacts quality and compliant care delivery. Unfortunately, …

Does Climate Disclosure Work To Reduce Greenhouse Gas Emissions? Emerging Evidence Suggests Cautious Optimism, Cynthia A. Williams

Seattle University Law Review

Significant regulatory resources have been spent developing global, voluntary climate and sustainability disclosure standards, such as the TCFD, TNRD, and ISSB’s Sustainability and Climate Disclosure standards, or domestically required disclosures, such as in the EU and in the U.S. Thus, it is important to evaluate whether this disclosure, particularly voluntary, qualitative disclosure, will have the power to shift the allocation of capital, will have a significant effect on the management of climate risk within firms, and ultimately will reduce climate change risk and biodiversity loss.

In this Article, several interrelated questions will be discussed. First, what does the empirical evidence …

Healthcare Ai's Unlearned Intermediaries, Charlotte A. Tschider

Faculty Publications & Other Works

The U.S. Food & Drug Administration (“FDA”), as the largest and one of the most influential federal agencies, plays a significant role informing downstream tort actions, such as product liability claims against medical product manufacturers.  The contours of the relationship between regulatory behavior and tort law are allocated according to congressional act and through judicial interpretation of agency action.  While artificially intelligent medical devices are technically regulated by the FDA, FDA regulatory approaches may not meaningfully reduce the probability of patient injury.  When, despite inadequate ex ante processes, injured plaintiffs cannot recover in tort due to court perceptions of regulatory …

Just Fix The Damn Payment System!, Frances H. Miller

Faculty Scholarship

This piece takes as a given that we are stuck with our fragmented, inefficient, multi-payor health care system for at least the short run. It then analyzes the deficiencies of three payment mechanisms whereby regulators (including Congress) have invited private sector providers to help ameliorate perceived problems. The first concerns an inadequate supply of nursing home beds in the early ‘70s, the next focuses on Medicare Advantage as a supposedly superior cost containment alternative to traditional Medicare, and the final one involves the ‘devil’s bargain’ struck with the pharmaceutical industry to get prescription drug coverage added to Medicare. All three …

More Than Troubling: The Alarming Absence Of ‘Troubled Teen Industry’ Regulation And Proposals For Reform, Morgan Rubino

Journal of Legislation

This Note will advocate for immediate and wide-reaching legislative action on juvenile residential treatment. Part I will provide a brief history of the origins of the Troubled Teen Industry ("TTI") and the most common types of facilities operating today. Part II will analyze some of the limited state legislation on the TTI, along with the Stop Institutional Child Abuse Act pending before Congress. Finally, Part III will lay out the most pressing injustices and abuses that arise out of the TTI and argue that an integrated framework of local and federal legislation, including the adoption of state bills of rights …

Confronting Cosmetic Carcinogens: A Proposal Regarding The Dangers Of Talcum Powder, Rachael Howell

Helm's School of Government Conference - 2021-2024

The Federal Government needs to stop the import, export, mining, and distribution of talcum powder in the United States. This is an issue that affects all Americans, especially active-duty military members.

Since 2013, there have been over 38,000 lawsuits against Johnson & Johnson, which allege that their talcum-based baby powder caused cancer. The plaintiffs in the very first talc case in the U.S. have died. All four of the plaintiffs from a 2019 suit have died. Yet, the 2019 case has been reversed and remanded. The FDA has redacted the names of scientist(s) that conduct “safety tests” on talc samples. …

Ensnared Care: How Restrictive Healthcare Laws Impact Mothers, Mckenzie Richards

School of Public Policy Capstones

Do restrictive healthcare policies impact whether expectant mothers receive adequate prenatal care? Could such policies also affect access to alternative birthing options for delivery? Through a literature review and a two-way fixed effects model using panel data, this study investigates two categories of state-level restrictive healthcare policies: scope of practice laws and certificate of need laws. The literature demonstrates the detriments of scope of practice care on access to care and maternal health. However, the statistical models presented on scope of practice find no relationship between scope of practice laws and adequate prenatal care or alternative birthing options. Though the …

Market Versus Policy Responses To Novel Occupational Risks, Robert J. Kramer, Elissa Philip Gentry, W Kip Viscusi

Scholarly Publications

The unprecedented occupational risks posed by the COVID-19 pandemic prompted employers to boost wages and federal authorities to propose hazard pay policies. This article estimates a market-based compensating differential for workers facing elevated risks through contact with the public using CPS employment data for 2019–2020 and occupational characteristic data from the US Department of Labor’s Occupational Information Network. The estimated premium for exposure was roughly $820 overall and $1000 for essential workers. These premiums fall short of those proposed—but not enacted—by the federal government and are more commensurate with estimates of the value of a statistical life than were the …

Certificates Of Public Advantage: A Valuable Tool Or Diminishing Allure?, Abdur Rahman Amin

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

Empirically Assessing 510(K) Device Safety, George Horvath

Akron Law Faculty Publications

Innovations in medical device technology hold the potential to improve health outcomes across the populace. Nearly half of all medical devices that enter the U.S. market each year are regulated by the Food and Drug Administration (FDA) under the 510(k) pathway. If FDA regulation of 510(k) devices stifles innovation, health outcomes will suffer over time because beneficial devices would not reach patients; on the other hand, if regulation facilitates innovation, health outcomes could improve. Most discussions of innovation under the 510(k) pathway have been either excessively reductionist (such as claims that the pathway stifles innovation) or wholly pessimistic (notably, the …

Health Care Fraud And The Erosion Of Trust, Katrice Bridges Copeland

Northwestern University Law Review

In health care, trust is a foundational concept. Patients must trust that their medical practitioners are competent to treat them. The trustworthiness of medical practitioners encourages patients to disclose intimate facts about their medical issues. Further, patients must trust health care providers to demonstrate impartial concern for the patients’ well-being, also known as fidelity. In providing care, the needs of the patients, rather than financial incentives, must drive medical practitioners. Without this trust, patients may not cooperate with diagnosis and treatment. In addition to trusting providers, care outcomes are better if patients trust the health care system as a whole. …

Is A Child's Life Twice As Valuable As An Adult's?, W. Kip Viscusi

Vanderbilt Law School Faculty Publications

The rise of interest in evidence-based policymaking has created incentives for regulatory agencies to demonstrate the overall benefit-cost merits of their policies. An agency can use evidence to choose more cost-beneficial policies, or it can create the appearance of desirable policies by changing the ground rules by which it assesses a policy's merits.

The Consumer Product Safety Commission (CPSC) recently chose the latter course when monetizing the benefit of mortality risk reductions for children from a proposed safety standard for operating cords on custom window coverings. The cords are currently estimated to be responsible for nine fatal injuries annually. Each …

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 …

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 …

Taking Care Of Business: An Empirical Examination Of The Top S&P 500 Companies And Their Role As Public Health Regulators During The Covid-19 Pandemic, Megan M. O’Malley

University of Miami Business Law Review

Data from the top 15 constituents by weight on the S&P 500 is assembled to identify trends among the policies these companies implemented in the United States during the COVID-19 pandemic. Some policies were fairly consistent across the board, especially in regard to remote work opportunities and health and safety measures for essential and/or in-person employees. Other policies, including vaccination requirements and vaccine incentives, varied across and within industries. Some companies that were examined went beyond the relevant federal, state, or local requirements in effect at the time, while other companies pushed back against public health guidance.

Sb 140 - Treatment Of Gender Dysphoria In Minors, Kathleen Kassa, Alexander J. Merritt

Georgia State University Law Review

The Act adds two new subsections that prohibit licensed physicians, hospitals, and related institutions from performing or providing certain forms of gender‑affirming medical treatment, while also defining mechanisms for promulgating and enforcing new prohibitions and exceptions allowing such treatment.

Cafo’S Are A Public Health Crisis:The Creation Of Covid-19, Helena Masiello

University of Miami Law Review

Concentrated Animal Feeding Operations (“CAFO’s”) are largely unregulated by State or Federal Laws in the United States. As a result of this lack of oversight, they are a breeding ground for deadly infectious diseases. The COVID-19 epidemic has demonstrated the threat that diseases pose to the United State like H1N1, SARS, and Ebola.
The USDA needs to regulate CAFOs under the mandate given to them by congress in the AHPA to ensure that they are not the epicenter of the next wave of deadly infectious diseases. Scientists have been warning about the disease potential of CAFOs for the last decade, …

Risk Regulation And Management Against Illegal Wildlife Trade: Europe And America, Olonyi Bosire

Sustainable Development Law & Policy

Introduction

The source or initial crime in the illegal wildlife trade chain is mostly committed beyond the shores of North America and Europe. However, the two regions continue to be massive destination markets and key transit hubs for illegal wildlife products. Illegal trade networks are shadowy and therefore problematic to study. This helps explain the wide valuation of illegal wildlife trade currently estimated by the Global Environment Facility (“GEF”) as ranging between 7 and 23 billion dollars per annum.

Policies and strategies to pre-empt or respond to illegal wildlife trade keep evolving as appreciation grows for the previously underestimated complexities, …

Underserved Communities Trashed By Plastic: Slowing The Proliferation Of Petroleum Based Products Through Stewardship Laws And Enhanced Back-End Regulatory Solutions, Joan F. Chu

Sustainable Development Law & Policy

Introduction

Plastic pollution has attracted a tremendous amount of attention and press coverage in early 2021 as evidenced in news stories; an episode of John Oliver’s show, “Last Week Tonight”; and a viral tweet from Greta Thunberg highlighting a study linking plastic pollution to human penises shrinking. These eye-catching pieces stemmed from Dr. Shanna H. Swan’s work that culminated in her book, Count Down: How Our Modern World Is Threatening Sperm Counts, Altering Male and Female Reproductive Development, and Imperiling the Future of the Human Race. Other articles have highlighted plastic pollution’s impact on polar bears, which causes their penis …

Distributed Governance Of Medical Ai, W. Nicholson Price Ii

Law & Economics Working Papers

Artificial intelligence (AI) promises to bring substantial benefits to medicine. In addition to pushing the frontiers of what is humanly possible, like predicting kidney failure or sepsis before any human can notice, it can democratize expertise beyond the circle of highly specialized practitioners, like letting generalists diagnose diabetic degeneration of the retina. But AI doesn’t always work, and it doesn’t always work for everyone, and it doesn’t always work in every context. AI is likely to behave differently in well-resourced hospitals where it is developed than in poorly resourced frontline health environments where it might well make the biggest difference …

Opioid Accountability, Daniel G. Aaron

Utah Law Faculty Scholarship

The opioid crisis has steadily killed Americans for twenty years. In total, we have lost 450,000 American lives since the 1990s, and countless more suffer from chronic addiction.

After years of piecemeal efforts to address this massive loss of life and health, the opioid litigation, largely centralized in Ohio federal district court, has brought significant hope for change. But there is a notable divide between the popular sense of the litigation and its reality. A full 57% of Americans believe that opioid companies should be held accountable for precipitating a public health crisis. However, the litigation has been dedicated to …

On What Basis Did Health Canada Approve Oxycontin In 1996? A Retrospective Analysis Of Regulatory Data, Jessie Pappin, Itai Bavli, Matthew Herder

Articles, Book Chapters, & Popular Press

The marketing and sale of oxycodone (OxyContin) by Purdue Pharma has commanded a great deal of legal and policy attention due to the drug’s central role in the ongoing overdose crisis. However, little is known about the basis for OxyContin’s approval by regulators, such as Health Canada in 1996. Taking advantage of a recently created online database containing information pertaining to the safety and effectiveness of drugs, we conducted a retrospective analysis of Purdue Pharma’s submission to Health Canada, including both published and unpublished clinical trials. None of the trials sponsored by Purdue Pharma sought to meaningfully assess the risks …

The Limits Of Regulation By Insurance, Kenneth S. Abraham, Daniel Benjamin Schwarcz

Indiana Law Journal

Insurance is an enormously powerful and beneficial method of spreading risk and compensating for loss. But even insurance has its limits. A new and misleading aspiration for insurance—that it also can and often does substitute for or significantly complement health and safety regulation—is increasingly in vogue. This vision starts from the uncontroversial recognition that insurers typically adopt measures designed to counteract “moral hazard,” the tendency of insurance to blunt policyholders’ incentives to take care. But proponents of this vision go on to contend that the risk-reducing potential of insurance is significantly more extensive than is traditionally imagined, because insurers are …

The Challenges Of Applying Computational Legal Analysis To Mhealth Security And Privacy Regulations, Brian Tung

McKelvey School of Engineering Graduate Student Theses & Dissertations

As our world has grown in complexity, so have our laws. By one measure, the United States Code has grown over 30x as long since 1935, and the 186,000-page Code of Federal Regulations has grown almost 10x in length since 1938. Our growing legal system is too complicated; it’s impossible for people to know all the laws that apply to them. However, people are still subject to the law, even if they are unfamiliar with it. Therein lies the need for computational legal analysis. Tools of computation (e.g., data visualization, algorithms, and artificial intelligence) have the potential to transform civic …

Lockdowns, Quarantines, And Travel Restrictions, During Covid And Beyond: What’S The Law, And How Should We Decide?, Lawrence O. Gostin, Meryl Chertoff

Georgetown Law Faculty Publications and Other Works

The COVID-19 pandemic ushered in vast deprivations of liberty previously unthinkable: lockdowns, business closures, travel restrictions, and quarantines. Even witnessing China’s January 2020 lockdown of 11 million people in Wuhan, it seemed wholly implausible that London, Rome, or New York would shut down. But they did, and much more. At the initial height of the pandemic in April 2020, more than 3.9 billion people, about half the world's population, were under stay-at-home orders. That same month, 43 US states were under stay-at-home orders.

What are the scientific, public health, and ethical justifications for various forms of liberty deprivations? Are they …