The new American Law Institute Medical Malpractice Restatement posits a novel rule in § 6(b) that would authorize the use of medical-practice guidelines as a standard of care for medical-malpractice litigation. However, it would only be a “safe harbor” shield; guidelines could not be similarly used by plaintiffs as a sword. For defendants, the rule would transform what heretofore has been indisputably hearsay evidence into prima facie proof that would serve as a substitute for expert testimony, and which would be sufficient to defeat a malpractice claim. Plaintiffs wishing to use practice guidelines would be relegated to the “learned treatise” exception of the hearsay rule.

Practice guidelines are not however the panacea that the Restatement envisions. In the present-day proliferation of guidelines, there are many objectivity and credibility issues, resulting in severe criticism of the guideline promulgation process within the profession. Many guidelines offer inconsistent and conflicting recommendations, contain inherent conflicts of interest and mixed purposes, and some are even blatant attempts to tilt the playing field in favor of defendants.

There is no jurisdictional support for this rule. No case has ever held that practice guidelines constitute a standard of care or that they can be introduced as substantive proof or that their use is different depending on whether they are offered by a defendant or a plaintiff. Nor is there any sound reason or public policy that would support the rule or to believe any guideline is more authoritative than expert testimony, which can be tested in the crucible of the courtroom. The guidelines rule also suffers from practical problems and still requires expert testimony for support. The rule would also violate fundamental principles of equal justice and fairness by compromising the right to cross-examination and by allowing the medical profession to set its own variable standards of care. It is more akin to tort reform that a common law rule of evidence. For those reasons, courts should not accept the invitation to adopt § 6(b).

Over the past three decades, the U.S. health care system has experienced numerous shortages of commonly-used older medicines that are both off-patent and inexpensive. Commentators seeking to explain shortages have often pointed to manufacturing quality and low profit margins as principal causes. These proximate causes, however, do not explain why there was a sudden and dramatic increase in shortages between 2007 and 2012, when shortages almost tripled from 154 to 456, or why they have persisted at similar levels into the 2020s despite repeated efforts to address them. This Article posits that low prices and quality problems derive from underlying shifts in the market environment, and that these shifts in turn are largely the result of Congressional legislation. The role of such well-intentioned legislation over the past fifty years is evaluated, including the 1984 Hatch-Waxman Act, the 2003 Medicare Modernization Act, the 2012 Generic Drug User Fee Act, and the 2015 Bipartisan Budget Act. The analysis reveals these laws have inadvertently squeezed profitability out of the generic drug market and thereby served as a true root cause of many drug shortages. Also considered are the potential effects on drug shortages of more recent legislation, including the 2021 American Rescue Act Plan and the 2022 Inflation Reduction Act.

With more than sixty percent of U.S. adults struggling with at least one diet-related health condition, the relationship between nutrition and public health has never been clearer. Indeed, for the first time in over a century, food has a prominent place on the national political stage and is one of the exceedingly few issues that has garnered bipartisan support. The recent rise in popularity of “Food Is Medicine” initiatives, which seek to provide medically tailored or healthy meals to vulnerable populations, underscores the critical importance of food to public health. Yet, while “Food Is Medicine” is shifting the insurance, business, and nutritional landscape, the Food and Drug Administration (“FDA”) — the primary regulator in charge of both food and drug safety — treats food as anything but medicine. Known and unknown food additives, color dyes categorically banned in other countries, chemicals leaching from paper and plastic, and environmental toxins and pathogens all contaminate our food and sicken children and adults alike. All the while, the FDA acts as if it were powerless to fulfill its mission of protecting the public from unsafe food.

In a time when the political will to reform our food system and rid it of harmful chemicals and ingredients is high, this article offers a blueprint for how to do so in a scientifically grounded, legally consistent, and lasting manner. Starting from the basic premise that food can be medicine, the article explores ways to bring food safety review closer to the much more demanding safety process for pharmaceuticals. Part I defends the premise that food is every bit as important to human health as medicine — both for good and for ill — and posits that food safety should be regulated just as much as (even if not in identical ways to) the safety of medical drugs. Parts II and III offer a comparison between the rigors of drug safety review, albeit with its own set of problems, and the laxity and at times utter lack of food safety review. Finally, Part IV advances a comprehensive package of both legislative and regulatory reforms, all designed to shift the de facto burden of proving the safety of food ingredients from the overtaxed FDA and the overburdened consumers to food manufacturers.

After Dobbs v. Jackson Women’s Health Organization, the United States Supreme Court decision that overturned Roe v. Wade in 2022, OB/GYN residents’ access to abortion training, which is required in all accredited programs, has come under pressure. To receive the foundational training doctors in the field need, many residents in ban states travel to out-of-state programs where abortion is legal. But demand is high, travel for multiple weeks is expensive, and the capacity to train at host sites is limited.

Training by travel could have ripple effects for the quality of patient care. As the number of OB/GYNs continues to decrease, newly-trained providers will have different, and arguably diminished, skills in delivering not just elective but also medically necessary abortion care. And as exceptions for life and health become how legal, procedural terminations take place in one-third of the United States, there is no guarantee that the doctors in those states will feel comfortable providing that care.

This article explores the residency training provided today, providers’ and institutions’ navigation of abortion bans, and what changes in residency programs might mean for patient care in the coming years. Part I surveys the landscape of abortion law after Dobbs; even the strictest bans contemplate instances when abortion is medically required and legally permitted. Part II summarizes the pre- and post-Dobbs expectations for abortion training for OB/GYN residents, describing how graduate medical education has changed for residents in ban states. Part III assesses shorter and longer-term effects of a system that relies on travel and simulation (the use of models) or is out of compliance with national accreditation standards. Part IV concludes with potential paths forward that depend on state and national organizations supporting and funding the networks of health care professionals that facilitate training across the country.

Mental health or psychological forensic assessments are a growing practice in immigration adjudication, but the practice is not well understood. Several studies have measured the impact of medical or mental health forensic reports in immigration adjudication; yet none have documented when mental health forensic reports are sought or how they are conducted in practice. This article undertakes an interdisciplinary empirical documentation of the practice of forensic mental health assessments in immigration adjudication. A core focus of our survey was documenting the role of mental health forensic immigration assessments in substantiating migrants’ trauma and bolstering credibility. Our preliminary findings identify ways to improve the practice of mental health assessments within the immigration context toward practices that are more consistent with the science of trauma and memory.

When someone gets in legal trouble in America, their case is almost invariably decided by a lawyer (a judge), lay people (a jury), or a combination of the two. Professional discipline, however, is a giant unexplained exception. In professional discipline matters, accusations of dangerous or incompetent practice are decided, usually in the first instance but always in the last, by state licensing boards composed of other members of the accused’s profession. These licensing boards wield immense power as labor regulatory institutions, covering ten times as many American workers as the minimum wage and more workers than private and public sector unions combined.

Given how unusual this setup is, there has been surprisingly little study of professional discipline within any academic field—and virtually none within law. This inattention is troubling not only because of professional discipline’s immense footprint, but also because of the potential for widespread social harm. That potential is most obvious in health care, which accounts for approximately two-thirds of licensed professionals. But even in professions outside of health care, like engineering and accountancy, unethical or incompetent practice can cause wide-spread social harm. The decision-makers controlling whether bad actors can continue to practice have no experience in policy, regulation, or adjudication. They are playing lawyers without really knowing how.

This article is the first comprehensive assessment of professional discipline’s regulatory design. It argues that the busy volunteer professionals who handle disciplinary matters lack the regulatory expertise, training, and standards necessary to ensure public safety and provider competence. Fortunately, other jurisdictions offer promising models for reform. We compare the American system to that in the United Kingdom, which demands more legal expertise, decision guidance, and non-professional perspectives. To add rigor to the comparison, we provide two new hand-coded datasets—one from a US state and one for the UK, showing that disciplinary outcomes are more appropriately harsh in the UK. We argue, in conclusion, that a similar model in the United States would be promising step forward.

This paper addresses the comprehensive regulation of artificial intelligence (“AI”) across its entire lifecycle in the health care sector. It builds on a proposal for a True Lifecycle Approach (“TLA”) to address governance gaps across three phases of AI and expands the framework with detailed practical insights for governing health care AI, drawing on pioneering examples from Qatar, Saudi Arabia, and the United Arab Emirates (“UAE”) as models for global implementation. Beginning with the research and development phase, it highlights the urgent need for robust guidelines and certification processes to ensure that AI technologies are developed in compliance with ethical and safety standards. Moving into the approval stage, the discussion explores how AI systems can be effectively regulated under existing medical device frameworks, emphasizing the need for tailored regulations that consider the unique challenges posed by AI. Finally, the paper delves into the deployment of AI in clinical practice, examining the gaps in current laws and the need for a coherent and consistent regulatory framework that can adapt to AI advancements. The paper argues that the existing legal structures are inadequate, often inconsistent, and fail to address the complexities of AI in health care. It argues for a broader regulatory approach focused on patient safety throughout the AI lifecycle.

The United States is one of the largest consumers of meat globally. The traditional production of meat contributes substantially to climate change due to the levels of greenhouse gases emitted and the amount of land, water, feed, and other natural resources required to raise animals used for meat. Conventional meat production is also a major source for the emergence of zoonotic diseases and antimicrobial-resistant pathogens. Nevertheless, Americans consume more meat now than at any time in the nation’s history.

Advocates for policy change aimed at addressing the risks currently associated with meat production have typically focused on reducing meat consumption, alternatives to meat, or improving the standards of conventional meat production. These are laudable goals, but an emerging technology now promises meat production that may avoid these risks entirely. Enter “lab-grown meat” — meat cultivated in an efficient and controlled laboratory environment without the need for fields, feed, or even animals.

The technology has been in development for over 100 years but has seen exponential growth in the past five years. What was previously considered a science fiction fantasy became a reality in the United States in 2023, when UPSIDE Foods and GOOD Meat received approval from USDA for sale of their cultivated chicken to U.S. consumers.

This article highlights the benefits and drawbacks associated with lab-grown meat, assesses the existing regulatory framework, and offers considerations for policy reform as regulators address the emergence and scale-up of this important technology.

The increasing presence of private equity investment in physician practices reveals that current health law practice sites such as in-house, corporate law firms, and Medical Legal Partnerships (MLPs) are ill equipped to address patient harm from health care corporatization. A new type of health law practice is needed to address the adverse impact health care corporatization is having on health care purchasers (primarily employers and patients) and physicians. I label this new health law practice the Wellness Legal Partnership (WLP), modeled after the Medical Legal Partnership (MLP). WLP lawyers can look to systems leadership theory, lawyer fiduciary duties, and health justice frameworks as guides to combat the adverse impacts of health care corporatization. WLPs would work best rooted in corporate health and wellness benefit settings, and they would improve patient wellbeing using a three-fold approach of individual advocacy, organizational change, and systemic change.

Medicaid has been called the “workhorse” of the American health care system, but one would hardly see that in the tenor of political debates. The Program perennially faces political headwinds that at times build to hurricane force with proposals for dramatic structural changes and spending cuts, most recently the draconian cuts enacted by Congress in 2025. In 2024, Medicaid covered more than seventy million Americans, and another ten million were covered by its companion program, the Children’s Health Insurance Program. As formidable as these numbers are, the Program’s impact runs much deeper, affecting the lives of almost everyone in the United States. It serves as an essential support for the entire health care system and, in doing so, helps to sustain almost every hospital, nursing home, and a range of other providers. This support, in turn, generates population-wide benefits that can be seen as public goods on which everyone relies, whether they realize it or not, that the private sector could not provide. These include peace of mind from knowing there is access to inpatient hospital care, emergency rooms, and long-term care when needed, protection from public health threats, improved health care based on continual innovation, greater social stability, enhanced economic productivity, and reduced health inequities. As devastating as proposals to shrink Medicaid would be for millions of low-income Americans who rely on it for access to health care, these repercussions would cause hardship for almost everyone.

This article explains Medicaid’s role in sustaining the overall health care system, the nature of the public goods it produces in doing so, and the widespread harm that would be caused were these public goods to be diminished. By characterizing public debates in this way, the Program’s supporters could reframe political discourse as a matter of universal self-interest.

This Article discusses the design of an innovative approach to the traditional medical-legal partnership. This potentially transformative service model proposes the use of unauthorized practice of law (UPL) reform to embed civil legal problem solving within a patient care setting. Unlike in the traditional medical-legal partnership — a service model which embeds lawyers within patient care settings to address patients’ justice needs — we explore the promise of patient advocacy through community-based justice workers (CBJWs): members of the community who are not lawyers but who have specialized legal training and authorization to provide civil legal help to those who need it most. This work is the result of a partnership between Innovation for Justice, a social justice legal innovation lab housed at both the University of Arizona James E. Rogers College of Law and the University of Utah David Eccles School of Business, and University of Utah Health. The present framework for UPL-reform-based medical-legal partnerships was developed through robust community-engaged research and design work across the 2022–23 academic year. This article discusses the research findings and proposes a framework for replication in other jurisdictions.

Nathan Witkin, in his article The Cost of Closed Doors…, attempts to reframe the question of whether child dependency proceedings should be open or closed to the public and press by positing a balancing test between “dependent families seeking privacy…and the macro-level benefits of a more transparent system.” Witkin’s hypothesis is that opening dependency proceedings educates the public that child welfare spending must be increased, that transparency leads to “greater per capita” spending in open versus closed dependency systems, and finally, that more child welfare spending will result in fewer per capita child welfare fatalities in open court states. This article will examine both sides of Witkin’s proposed balancing test to demonstrate that his approach fails to prove his hypotheses. First, it will discuss how Witkin’s almost total reliance on twenty-five to thirty-year-old psychological studies rather than on contemporary mental health research substantially understates the potential dangers to child abuse victims, especially LGBTQ+ and polyvictimized children, from opening child dependency proceedings. Second, it will present evidence that the welfare budgets did not constantly increase in some closed court states that were later opened to the public, but rather fluctuated through sporadic ups and downs which over time resulted in almost no net longitudinal budgetary increases. Second, those originally closed courts that were later opened had their child fatality rates actually increase which is the opposite of Witkin’s predictions.

Medicaid serves vulnerable populations that experience deep health inequities and significant health-related social needs. In recent years, reforms to Medicaid have sought to respond to those needs, with mixed results. Value based payment methods, which in theory link payment to outcome metrics, are emerging in commercial insurance markets and can be adapted to the needs of Medicaid programs and their beneficiaries. These methods seek to tie payment for services to the forging of connections between medical and social care including housing supports and nutrition services for vulnerable populations. This paper describes the merits and some pitfalls of the attempt to turn Medicaid from its roots as a medical insurance program to a broader health insurance program. It describes the benefits of employing community care hubs – intermediaries between community-based organizations and large payers and hospital systems – as a way to spur the move to social care in Medicaid. It also addresses some of the barriers to this move, including the perceived danger of “medicalizing” society’s failures and the apparent turn by the current federal administration away from commitment to health equity.

There is a seemingly intractable disagreement about whether nonprofit hospitals can be meaningfully differentiated from their for-profit counterparts and are therefore still deserving of exemption from federal income tax. Nonprofit, tax-exempt hospitals are intended to be organized and operated for charitable purposes. What this means and requires has evolved from providing relief for the sick and poor to promoting community health and more. At the same time, these institutions have evolved into complex, highly regulated business organizations, some of which struggle to differentiate themselves from their for-profit competitors. The history of American hospitals from almshouses to today’s complex health care systems includes, and is better understood in the context of, the stories of how women’s hospital auxiliary organizations built, supported, and evolved with hospitals.

While acknowledging the enduring debate regarding exemption, this article attempts to address the question of how to fill the charitable gap if exempt hospitals were to lose or voluntarily relinquish their preferred tax status. The article recommends preserving the ability to address community and individual health needs through charitable hospital auxiliaries. Auxiliaries are uniquely situated in an increasingly commercial healthcare market, due both to their history and community connections, to hold and direct the use of charitable assets, to accept tax-deductible charitable contributions, and to address unmet community needs.

This essay explores central aspects of the relationship between money and national health policy from the passage of Medicare in 1965 to the present, including the two most sweeping attempts at system reinvention during that period: the Patient Protection and Affordable Care Act of 2010 (ACA), and the failed Health Security Act of the early 1990s. Its point is not that ethical professionalism has prevailed, though it survives on the skill and dedication of nurses, physicians, and other health care workers. Rather, its point is that one should not criticize the morality of change without interrogating the morality of the status quo. In the 1990s, Jerome Kassirer wrote that “a system in which there is no equity is, in fact, already unethical.” The same can be said for a system that overfunds medical care and underfunds other essential social investments, including education. A system that, moreover, cannot be justified by the limited morality of competition in the marketplace because it does not — and could not absent radical change — perform as a functioning market would. In terms of robust market competition with its winners and losers, U.S. health care has been, at worst, a sheep in wolf’s clothing.

Financialization of healthcare drains our current system of resources it needs to provide care. It occurs when money is siphoned off for private profit through mechanisms such as rent seeking, gamesmanship, and exploitative price setting. This is not an ethically neutral activity, and the people profiting in this way ought to justify why they are entitled to this money, given the foreseeable negative effects what they are doing has on people’s health. This important problem is masked by current accounting methods and healthcare billing methods, which need to be changed to allow for a more transparent assessment of what is really occurring.

This commentary analyzes the recent attacks on adolescents’ access to contraception by religious and parental rights activists and the conservative legal movement. Specifically, we focus on Deanda v. Becerra, a 2024 case in which the Fifth Circuit Court of Appeals held that a Texas state law requiring parental consent for minors to access contraception is not preempted by a longstanding policy under Title X of the federal Public Health Service Act that prohibits clinics receiving federal funding from requiring parental consent or notification. We first describe existing laws governing minors’ confidential access to reproductive health care, including the federal constitutional framework for parental rights, state parental notification and consent laws, and Title X, the federal law that provides federal funds to reproductive health care clinics for low-income people. We then examine and critique the Federal District Court ruling in Deanda, which elevated individual religious and parental rights over public health concerns, and the Fifth Circuit Court of Appeals decision in that case, which undermined federal public health authority and jeopardized access to reproductive health care for low-income adolescents. Finally, we assess the public health and reproductive rights implications of restricted access to reproductive health care for minors and consider possible future directions and advocacy opportunities for reproductive, public health and legal advocates to promote continued access to contraception for adolescents despite mounting legal challenges.

The American Law Institute (ALI) recently approved its first ever Restatement of Medical Malpractice law. One Restatement subsection embraces the position that an authoritative clinical practice guideline, if admissible and sufficiently relevant, can be prima facie evidence of a provider’s compliance with the standard of care. This article responds to a forceful critique of that position by two of the Restatement’s advisors, who are nationally esteemed members of the plaintiff’s bar. They argue that caselaw does not support this provision, that it is unsound public policy, and that the provision is unfair because it does not afford the same prima facie proof status to plaintiffs’ use of practice guidelines.

This article addresses each of those critiques. It starts with the observation that, at bottom, this opposition is fundamentally at odds with the primary governing principle of professional liability, namely, that professional standards have greater force in medical liability cases than do industry standards in general negligence cases. Because professional standards determine professional negligence, a relevant clinical practice guideline that speaks with authority for a relevant segment of medical professionals, if admissible, should be sufficient to support a jury finding of non-negligence for a doctor who complies.

The same conclusion does not apply, however, when a plaintiff presents a single relevant guideline that a physician failed to follow, for the simple reason that it is often the case that more than one approach can reasonably apply to a given clinical situation. Also, guidelines often set ideal rather than minimal standards. Thus, this provision’s differential effect is not fundamentally unfair. Instead, it flows directly from a plaintiff’s burden of establishing professional negligence, much like numerous other conventional legal rules can affect opposing sides of a case differently.

As accomplished advocates, it is no surprise these authors have made the strongest possible case against any enhanced legal status for defensive use of exculpatory practice guidelines. Thoughtful inspection and reflection reveal, though, that their analysis significantly misstates or over-states the Restatement’s position, and so their attacks are mostly misdirected. If this Restatement’s position were truly as radical or poorly considered as these authors portray, the ALI likely would not have adopted it. Nevertheless, engaging with this critique can better elucidate reasons that courts might view this Restatement provision as well-considered.

The catchphrase “if you build it, they will come,” from the movie “Field of Dreams,” described an audacious plan to build a small baseball stadium in a remote cornfield. It could also describe the government infrastructure which has drawn in the ever-growing American health care business sector. A series of increasingly complex and expensive programs, first launched just after World War II, continue to provide essential funding and regulatory support for a multitude of private companies that have revolutionized medical care and, in the process, built an industry that represents more than 18% of the country’s economy. This parade of programs includes the Hill-Burton Act of 1946, Medicare and Medicaid in 1965, the initiation of the Human Genome Project in 1990, and 2010’s Patient Protection and Affordable Care Act, all of which created platforms on which private entities rely to provide medical services and products. In the process, these private entities have made and continue to generate substantial profits. And while many of them have improved public wellbeing dramatically, many have also degraded the system’s integrity through fraud and anticompetitive behavior. In its role of keeping this huge and essential private enterprise on track, health law has become an indispensable part of the system, with health lawyers serving as the foundation of its effective operation.