Medical Jurisprudence Commons^™

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 …

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 …

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 …

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 …

Direct Entry Midwives: Political Factors Shaping Variation In Regulation, Gabrielle Shlikas

The Compass

No abstract provided.

Kidney, Money, And The Shī‘Ah Implementation Of The Rule Of Necessity, Zahra Takhshid

Sturm College of Law: Faculty Scholarship

In the U.S., over 43,000 people die every year waiting for a kidney. In Iran, however, monetary incentives have eliminated such a waitlist. Iran is the only country in the world with an unrelated living kidney donor program that has allowed for monetary incentives in the form of an altruistic gift, which has become known as “the Iranian Model.” Nevertheless, the legal details of the system remain vague and scholars both in and outside of Iran continue to debate the nature of the system. Does the Iranian system consider kidneys a commodity? Can you legally buy a kidney in Iran? …

Protecting Research Data Of Publicly Revealing Participants, Ellen Clayton, B. A. Malin, Kyle J. Mckibbin

Vanderbilt Law School Faculty Publications

Biomedical researchers collect large amounts of personal data about individuals, which are frequently shared with repositories and an array of users. Typically, research data holders implement measures to protect participants’ identities and unique attributes from unauthorized disclosure. These measures, however, can be less effective if people disclose their participation in a research study, which they may do for many reasons. Even so, the people who provide these data for research often understandably expect that their privacy will be protected. We discuss the particular challenges posed by self-disclosure and identify various steps that researchers should take to protect data in these …

Minding The Gaps In Regulation Of Do-It-Yourself Biotechnology, Barbara J. Evans

UF Law Faculty Publications

This Symposium confronts the reality that genetic technologies – not just genetic tests, but tools for altering plant, animal, and human genomes – are rapidly becoming and indeed already are consumer technologies. People can experiment with and apply these technologies in disintermediated formats, potentially without the involvement of national research funding agencies, professional scientists, physicians, genetic counselors, regulators, and traditional medical product manufacturers. The framework of 20th -century medical product and practice regulations assigned each of these parties a role in promoting ethical, safe, and effective biomedical research and health care. Do-it-yourself biotechnology (DIYbio), which includes direct-to-consumer (DTC) and do-it-yourself …

The Waiting Game: How States Can Solve The Organ-Donation Crisis, Meredith M. Havekost

Vanderbilt Law Review

Thousands of patients in the United States live in limbo every day waiting for a lifesaving organ transplant, and the gap between the number of people who need a transplant and the number of available organs widens every year. Every state currently allows individuals to unilaterally indicate their intent to donate their organs upon death, but in practice, family members are frequently allowed to override the express intentions of decedents. In addition, the current U.S. "opt-in" system fails to reach its full potential because many eligible decedents never express their desires to become or not to become organ donors, and …

Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg

Marquette Intellectual Property Law Review

This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …

Should Regulatory Compliance Be A Goal Or A Constraint For Health Care Companies? Finding Effective Methods To Assure Compliance With The Federal Anti-Kickback Statute And The False Claims Act, Roni A. Elias

Florida A & M University Law Review

The stereotypical conception of compliance is reinforced by some of the fundamental assumptions about what the primary objectives of a corporation should be and about how a corporation should accomplish those objectives. According to the prevailing theory of corporate structure, a corporation exists for the sole purpose of earning profits for its shareholders, and all of its actions are to be directed toward that end. If compliance with the law is not an inherently profit making activity, it is to be treated as a constraint on the corporation's efficient operation. According to this view, compliance will generally be considered a …

Fda’S Efforts To Tame The 'Wild West' Of Regenerative Medicine, Christopher M. Holman

Faculty Works

Stem cell-based regenerative therapies hold the potential to address a host of health concerns, particularly congenital, age-related, and trauma-induced injuries, and diseases involving organ and tissue degeneration, conditions that have proven refractory to conventional drug-based approaches. For the time being, however, there is little in the way of solid evidence supporting the safety and efficacy of most cell-based therapeutic approaches (with the notable exception of hematopoietic stem cells used to treat diseases of the blood and immune system). This Holman Report begins with an overview of the current uncertain regulatory status of regenerative medicine in the U.S., including several draft …

The Tip Of The Iceberg: A First Amendment Right To Promote Drugs Off-Label, Christopher Robertson

Faculty Scholarship

Scholars, advocates, and courts have begun to recognize a First Amendment right for the makers of drugs and medical devices to promote their products “off-label,” without proving safety and efficacy of new intended uses. Yet, so far, this debate has occurred in a vacuum of peculiar cases, where convoluted commercial speech doctrine underdetermines the outcome. Juxtaposing these cases against other routine prosecutions of those who peddle unapproved drugs reveals the common legal regime at issue. Review of the seven arguments deployed in the off-label domain finds that, if they were valid, they would undermine the FDA’s entire premarket approval regime. …

Use Of Facial Recognition Technology For Medical Purposes: Balancing Privacy With Innovation, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Adopting An International Convention On Surrogacy—A Lesson From Intercountry Adoption, Seema Mohapatra

Faculty Scholarship

No abstract provided.

Adopting An International Convention On Surrogacy—A Lesson From Intercountry Adoption, Seema Mohapatra

Faculty Scholarship

No abstract provided.

For The Love Of The Game: The Case For State Bans On Youth Tackle Football, Adam Bulkley

University of Michigan Journal of Law Reform Caveat

This football season, millions of Americans enjoying their favorite pastime might feel pangs of a guilty conscience. Years of scientific research into the long-term neurological effects of tackle football and a recent settlement between the National Football League (NFL) and thousands of retired NFL players have made football-related traumatic brain injuries (TBI) a topic of national conversation. Current and former NFL players and even President Obama have participated in the conversation, saying that they would hesitate to let their sons play the game for fear of possible brain injury. Because research has uncovered signs of permanent brain damage in players …

Hodgson V. Minnesota: Chipping Away At Roe V. Wade In The Aftermath Of Webster, Selina K. Hewitt

Pepperdine Law Review

No abstract provided.

Beyond Abortion: Human Genetics And The New Eugenics, John R. Harding Jr.

Pepperdine Law Review

No abstract provided.

The Policy Against Federal Funding For Abortions Extends Into The Realm Of Free Speech After Rust V. Sullivan, Loye M. Barton

Pepperdine Law Review

No abstract provided.

The Fda Sends Smoke Signals To Big Tobacco: Will The Fda Suffer Backlash, Will Alcohol Be Regulated Next, And Will The Health Of Americans Prevail?, Angela Turriciano

Pepperdine Law Review

No abstract provided.

Can Law Improve Prevention And Treatment Of Cancer?, Roger Magnusson, Lawrence O. Gostin, David Studdert

O'Neill Institute Papers

The December 2011 issue of Public Health (the Journal of the Royal Society for Public Health) contains a symposium entitled: Legislate, Regulate, Litigate? Legal approaches to the prevention and treatment of cancer. This symposium explores the possibilities for using law and regulation – both internationally and at the national level – as the policy instrument for preventing and improving the treatment of cancer and other leading non-communicable diseases (NCDs). In this editorial, we argue that there is an urgent need for more legal scholarship on cancer and other leading NCDs, as well as greater dialogue between lawyers, public health practitioners …

Can Speech By Fda-Regulated Firms Ever Be Noncommercial?, Nathan Cortez

Faculty Journal Articles and Book Chapters

This Article considers whether speech by pharmaceutical, medical device, and other FDA-regulated companies can ever be noncommercial and thus subject to heightened protection under the First Amendment. Since the U.S. Supreme Court first recognized a right to commercial speech in 1976, there have been 24 published federal judicial opinions in which an FDA-regulated firm has argued that its speech was protected. Courts have categorized the speech as commercial in all but two cases, neither of which involved FDA rules or enforcement.

I examine the tests and factors courts claim they use when making this threshold distinction, then identify the various …

The Money Blind: How To Stop Industry Bias In Biomedical Science, Without Violating The First Amendment, Christopher Robertson

Faculty Scholarship

The pharmaceutical and medical device industries use billions of dollars to support the biomedical science that physicians, regulators, and patients use to make healthcare decisions—the decisions that drive an increasingly large portion of the American economy. Compelling evidence suggests that this industry money buys favorable results, biasing the outcomes of scientific research. Current efforts to manage the problem, including disclosure mandates and peer reviews, are ineffective. A blinding mechanism, operating through an intermediary such as the National Institutes of Health, could instead be developed to allow industry support of science without allowing undue influence. If the editors of biomedical journals …

A Complete Property Right Amendment, John H. Ryskamp

ExpressO

The trend of the eminent domain reform and "Kelo plus" initiatives is toward a comprehensive Constitutional property right incorporating the elements of level of review, nature of government action, and extent of compensation. This article contains a draft amendment which reflects these concerns.

Drugged, Carl E. Schneider

Articles

The Supreme Court's recent decision in Gonzales v. Oregon, like its decision last year in Gonzales v. Raich (the "medical marijuana" case), again raises questions about the bioethical consequences of the Controlled Substances Act. When, in 1970, Congress passed that act, it placed problematic drugs in one of five "schedules," and it authorized the U.S. attorney general to add or subtract drugs from the schedules. Drugs in schedule II have both a medical use and a high potential for abuse. Doctors may prescribe such drugs if they "obtain from the Attorney General a registration issued in accordance with the …

Internet Pharmacies: Why State Regulatory Solutions Are Not Enough, Linda C. Fentiman

Elisabeth Haub School of Law Faculty Publications

Internet pharmacies are an economic and communications miracle--and a regulatory nightmare. It is estimated that Americans spent some $3.2 billion in 2003 on medications from the Internet, but Internet pharmacies permit consumers to evade long-standing regulatory protections, particularly those that rely on the oversight of drug prescribing and dispensing by licensed physicians and pharmacists.

Bioethics With A Human Face, Carl E. Schneider

Articles

This Article and the successor article I will shortly publish grow out of one reaction I have had to years of reading bioethical and legal literature. Let me begin by putting the point in its simplest, even crudest, form: That literature too often discusses the problems of health care in so disembodied and denatured a way that the patients and physicians, the family and friends, the dread and the disease are quite abstracted from the scene. The result is a literature that critically limits itself and that crucially oversimplifies the issues it confronts. There are, of course, reasons bioethical and …

Governmental Regulation Of The Drug Industry, J. Mark Hiebert

Cleveland State Law Review

In today's world of increased government participation in business, certain industries are frequently spotlighted for particular attention. The communications industry is one, the drug industry is another. In both cases the special attention is fitting, for the communications industry, like the drug industry, each in its own way, reaches the very fiber of American life. Each has the inherent capability of changing our political and social order. At any rate two points are basic: first, the drug industry directly affects the foundations of our society and therefore is a reasonable concern of government. Secondly, the drug industry has a legitimate …