Law Commons^™

Locating Liability For Medical Ai, W. Nicholson Price Ii, I. Glenn Cohen

Articles

When medical AI systems fail, who should be responsible, and how? We argue that various features of medical AI complicate the application of existing tort doctrines and render them ineffective at creating incentives for the safe and effective use of medical AI. In addition to complexity and opacity, the problem of contextual bias, where medical AI systems vary substantially in performance from place to place, hampers traditional doctrines. We suggest instead the application of enterprise liability to hospitals—making them broadly liable for negligent injuries occurring within the hospital system—with an important caveat: hospitals must have access to the information needed …

Covid-19 Pandemic’S Impact On Online Sex Advertising And Sex Trafficking, Coxen O. Julia, Vanessa Castro, Bridgette Carr, Glen Redin

Articles

Disruptive social events such as the COVID-19 pandemic can have a significant impact on sex trafficking and the working conditions of victims, yet these effects have been little understood. This paper examines the effect of the COVID-19 pandemic on sex trafficking in the United States, based on analysis of over one million sexual service advertisements from the online platform Rubratings.com, using indicators of third-party management as potential proxies for trafficking. Our results show that there have been measurable changes in online commercial sexual service advertising, both with and without third-party management indicators, in the United States, with a significant decrease …

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 …

Inequitable By Design: The Patent Culture, Law, And Politics Behind Covid-19 Vaccine Global Access, Ximena Benavides

University of Michigan Journal of Law Reform

COVID-19 vaccine access has been highly inequitable worldwide, with coverage depending largely on a country’s wealth. By the end of 2021, 64.1% of people living in high-income countries had received at least one dose of the vaccine, compared to only 5.4% of those in low-income countries. Similarly, only high- and upper-middle-income countries had received the most effective vaccines.

The uneven distribution of these lifesaving vaccines is made complex due to the convergence of several factors, but it suggests that the extraordinary expanding and ossifying market and political power of a few vaccine manufacturers founded on intellectual property and complementary policies …

Policies For Expanding Hepatitis C Testing And Treatment In United States Prisons And Jails, Tessa Bialek, Dr. Matthew J. Akiyama M.D.

University of Michigan Journal of Law Reform

Hepatitis C virus (HCV) is highly prevalent in United States prisons and jails. In prisons and jails, rates of infection are ten to twenty times greater than national levels. And, more than thirty percent of all people living with HCV in the United States will spend time in prisons and jails in any given year. Rates are especially high among people who inject drugs (PWID), a population whose members are also likely to move between carceral settings and the community. Thus, addressing HCV among incarcerated populations would have a significant effect on the virus’s transmission both in and out of …

The Impact Of Post-Dobbs Abortion Bans On Prenatal Tort Claims, Aviva K. Diamond

Michigan Law Review

In June 2022, the Supreme Court revoked Americans’ fundamental right to abortion in Dobbs v. Jackson Women’s Health Organization. However, the Court said nothing about how its decision would impact tort claims related to reproductive care. Many states have since adopted near-total or early-gestational- age abortion bans, which has not only diminished access to reproductive care, but has also incidentally impaired the ability of plaintiffs to bring long-recognized prenatal tort claims. Prenatal tort claims—wrongful pregnancy, birth, and life—allow victims to recover when a medical professional negligently performs reproductive or prenatal care. This Note identifies the impact that post-Dobbs …

Trading Pain For Gain: Addressing Misaligned Interests In Prescription Drug Benefit Administration, Sheva J. Sanders, Jessica C. Wheeler

University of Michigan Journal of Law Reform

Over the last two decades, Pharmacy Benefit Managers (PBMs), organizations that act as middlemen between health plans and drug manufacturers, have become increasingly powerful players in the healthcare industry. PBMs promise to leverage their expertise and ability to aggregate buying power to negotiate lower drug prices and administer prescription drug benefit plans. In practice, however, PBMs are widely criticized for benefitting from, and contributing to, inefficiencies in the prescription drug market, particularly by imposing restrictions on beneficiary access to drugs in exchange for rebates paid to PBMs by manufacturers. To the extent that the rebates are retained by PBMs, or …

Open-Source Clinical Machine Learning Models: Critical Appraisal Of Feasibility, Advantages, And Challenges, Keerthi B. Harish, W. Nicholson Price Ii, Yindalon Aphinyanaphongs

Articles

Machine learning applications promise to augment clinical capabilities and at least 64 models have already been approved by the US Food and Drug Administration. These tools are developed, shared, and used in an environment in which regulations and market forces remain immature. An important consideration when evaluating this environment is the introduction of open-source solutions in which innovations are freely shared; such solutions have long been a facet of digital culture. We discuss the feasibility and implications of open-source machine learning in a health care infrastructure built upon proprietary information. The decreased cost of development as compared to drugs and …

Cruel Dilemmas In Contemporary Fertility Care: Problematizing America's Failure To Assure Access To Fertility Preservation For Trans Youth, Anna Reed

Michigan Journal of Gender & Law

Transgender youth are increasingly able to access gender-affirming healthcare. Because gender-affirming care such as hormone therapy is clinically shown to reduce gender dysphoria and ease physical and social transition, every major U.S. medical association recognizes that gender-affirming healthcare is medically necessary for the treatment of dysphoria. However, an important dimension of gender-affirming care remains under-insured and overpriced: fertility preservation (FP). Several studies indicate that hormone therapies and certain gender-affirming surgeries can have negative, long-term impacts on future fertility. Although these impacts can be mitigated through approved FP methods such as sperm cryopreservation and oocyte cryopreservation, such methods are rarely affordable …

Pregnant Transgender People: What To Expect From The Court Of Justice Of The European Union's Jurisprudence On Pregnancy Discrimination, Hannah Van Dijcke

Michigan Journal of Gender & Law

Pregnant transgender people’s experiences vary: they may identify as male or non-binary and may seek gender-affirming medical care to different degrees. This variety in gender identities and bodies puts additional pressure on CJEU’s pregnancy discrimination case law—a case law that is, as this Article argues, already flawed. Building on a critique of the CJEU’s decision in Dekker, this Article discusses three alternative approaches to addressing pregnancy discrimination in EU law. The first two approaches are different ways of construing pregnancy discrimination as sex discrimination. First, the Article discusses a gender-stereotyping approach to direct sex discrimination, and, second, an indirect sex …

Advancing Reproductive Justice In Latin America Through A Transitional Justice Lens, Rosario Grimà Algora

Michigan Journal of Gender & Law

Reproductive autonomy is a pivotal part of women’s access to equal citizenship, yet it has not been included in any international nor regional human rights treaty. In the past decades, the U.N. Committees, notably the CEDAW Committee, and regional human rights bodies, particularly the Inter-American System for the Protection of Human Rights, have timidly advanced reproductive justice through their jurisprudence, including through the use of reparations. Drawing from the standards of reparations developed in the field of transitional justice, human rights bodies increasingly rely on reparations to enhance the transformative effects of their decisions. These reparations intend to include a …

Reproduction And Gender Self-Determination: Fertile Grounds For Trans Legal Advocacy, Samira Seraji

Michigan Journal of Gender & Law

Current medical constructions of trans identities reflect heterosexist understandings of gender expression—understandings that deny access to gender-affirming healthcare to those who fail to perform normative binary genders. As medical providers establish norms for how to “properly” be trans, the state codifies these norms, basing trans existence on rigidly defined and harshly enforced understandings of binary gender. When this construction of transness is codified on an institutional level, such as with gender reclassification rules for government identification, it forces trans people to conform their bodies to cisgender norms, and dangerously disrupts trans people’s bodily autonomy and diminishes their control over their …

Ai Insurance: How Liability Insurance Can Drive The Responsible Adoption Of Artificial Intelligence In Health Care, Ariel Dora Stern, Avi Goldfarb, Timo Minssen, W. Nicholson Price Ii

Articles

Despite enthusiasm about the potential to apply artificial intelligence (AI) to medicine and health care delivery, adoption remains tepid, even for the most compelling technologies. In this article, the authors focus on one set of challenges to AI adoption: those related to liability. Well-designed AI liability insurance can mitigate predictable liability risks and uncertainties in a way that is aligned with the interests of health care’s main stakeholders, including patients, physicians, and health care organization leadership. A market for AI insurance will encourage the use of high-quality AI, because insurers will be most keen to underwrite those products that are …

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 …

New Innovation Models In Medical Ai, W Nicholson Price Ii, Rachel E. Sachs, Rebecca S. Eisenberg

Articles

In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those that resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those related to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of as …

Fostering Production Of Pharmaceutical Products In Developing Countries, William Fisher, Ruth L. Okediji, Padmashree Gehl Sampath

Michigan Journal of International Law

The ways in which pharmaceutical products are currently developed, manufactured, and distributed fail to meet the needs of developing countries. The recent emergence of new infectious diseases, the associated surge of healthcare nationalism, and the prevalence of substandard and falsified drugs have strengthened substantially the net benefits of augmenting the capacity of developing countries to produce such products locally. Most previous efforts to do so have foundered. The chance of success in the future would be maximized by the adoption of five strategies : (a) clarifying the zones of discretion created by the relevant treaties to ensure that local firms …

Take It With A Grain (Or More) Of Salt: Why Industry-Backed Dietary Guidelines Fail Americans And How To Fix Them, Caroline Farrington

University of Michigan Journal of Law Reform

The U.S. Dietary Guidelines lack oversight and accountability. The result: Guidelines that reflect food industry interests instead of modern science. This deleterious guidance goes on to govern federally-subsidized food assistance programs and to influence dietary choices throughout the private sector and private life. Ultimately, the Guidelines significantly contribute to the endemic chronic disease they seek to address.

The Guidelines Advisory Committee is notoriously rife with conflicts of interest, and thus most Guidelines scholarship has focused on reforming the Committee. But the 2015 and 2020 Guidelines show that these reforms are insufficient and agency-level change is necessary. In 2015, the Committee …

Liability For Use Of Artificial Intelligence In Medicine, W. Nicholson Price, Sara Gerke, I. Glenn Cohen

Law & Economics Working Papers

While artificial intelligence has substantial potential to improve medical practice, errors will certainly occur, sometimes resulting in injury. Who will be liable? Questions of liability for AI-related injury raise not only immediate concerns for potentially liable parties, but also broader systemic questions about how AI will be developed and adopted. The landscape of liability is complex, involving health-care providers and institutions and the developers of AI systems. In this chapter, we consider these three principal loci of liability: individual health-care providers, focused on physicians; institutions, focused on hospitals; and developers.

Congressional Myopia In Biomedical Innovation Policy, W. Nicholson Price Ii

Reviews

Innovation policy is hard. Getting it right requires balancing incentives for developers, consumer access, rewards for later innovators, safety concerns, and other factors. This balance is vitally important and wickedly difficult—even when it’s the focus of concerted, careful, informed effort. How well should we expect it to go when innovation policy is made by accident? Enter The Accidental Innovation Policymakers, an illuminating new project by Professor Rachel Sachs. Sachs persuasively shows how Congress has repeatedly made substantial changes to innovation policy, seemingly without talking about, seriously considering, or even recognizing that it is doing so. There’s an asymmetry to this …

Exclusion Cycles: Reinforcing Disparities In Medicine, Ana Bracic, Shawneequa L. Callier, Nicholson Price

Articles

Minoritized populations face exclusion across contexts from politics to welfare to medicine. In medicine, exclusion manifests in substantial disparities in practice and in outcome. While these disparities arise from many sources, the interaction between institutions, dominant-group behaviors, and minoritized responses shape the overall pattern and are key to improving it. We apply the theory of exclusion cycles to medical practice, the collection of medical big data, and the development of artificial intelligence in medicine. These cycles are both self-reinforcing and other-reinforcing, leading to dismayingly persistent exclusion. The interactions between such cycles offer lessons and prescriptions for effective policy.

Structured To Fail: Lessons From The Trump Administration’S Faulty Pandemic Planning And Response, Alejandro E. Camacho, Robert L. Glicksman

Michigan Journal of Environmental & Administrative Law

The Trump Administration’s response to the COVID-19 pandemic is a stark reminder that poorly designed government can be a matter of life and death. This article explains how the Administration’s careless and delayed response to the crisis was made immeasurably worse by its confused and confusing reallocation of authority to perform or supervise tasks essential to reducing the virus’s ravages.

After exploring the rationale for and impact of prior federal reorganizations responding to public health crises, the article shows how a combination of unnecessary and unhelpful overlapping authority and a thoughtless mix of centralized and decentralized authority contributed to the …

Medicare Coverage Of Aducanumab - Implications For State Budgets, Rachel E. Sachs, Nicholas Bagley

Articles

Aducanumab (Aduhelm), the controversial $56,000-per-year Alzheimer’s disease drug approved by the Food and Drug Administration (FDA) in June 2021, has the potential to cost the federal government many billions of dollars — more, by one estimate, than it spends on agencies such as the Environmental Protection Agency or the National Aeronautics and Space Administration. The drug’s extraordinary price tag helps explain why, soon after its approval, the Centers for Medicare and Medicaid Services (CMS) opened a national coverage determination to decide whether and under what circumstances Medicare would pay for it.1

Problematic Interactions Between Ai And Health Privacy, W. Nicholson Price Ii

Articles

Problematic Interactions Between AI and Health Privacy Nicholson Price, University of Michigan Law SchoolFollow Abstract The interaction of artificial intelligence (AI) and health privacy is a two-way street. Both directions are problematic. This Essay makes two main points. First, the advent of artificial intelligence weakens the legal protections for health privacy by rendering deidentification less reliable and by inferring health information from unprotected data sources. Second, the legal rules that protect health privacy nonetheless detrimentally impact the development of AI used in the health system by introducing multiple sources of bias: collection and sharing of data by a small set …

California V. Texas — Ending The Campaign To Undo The Aca In The Courts, Nicholas Bagley

Articles

On June 17, 2021, the U.S. Supreme Court, by a 7-to-2 vote, rejected what will probably be the last major case seeking to uproot the Affordable Care Act (ACA). Although skirmishes over the law and its implementation will persist, the Court’s decision most likely marks an end to Republicans’ efforts to achieve in the courts what they have been unable to achieve in Congress.

Preventing Child Maltreatment Through Medical-Legal Partnership, Debra Chopp

Book Chapters

There has been significant attention in recent years to health care delivery models that address social determinants of health. One such model is medical-legal partnership (MLP). MLPs join health care providers with lawyers to address health-harming legal needs in the lives of vulnerable patients. Research on MLPs has demonstrated their success in reducing stress and increasing health and well-being in the patients they serve and in their families. This chapter explores the possibility of using MLP as a tool to prevent child maltreatment.

Catch And Contain Novel Pathogens Early!—Assessing U.S. Medical Isolation Laws As Applied To A Future Pandemic Detection And Prevention Model, April Xiaoyi Xu

University of Michigan Journal of Law Reform Caveat

As of July 2, 2021, there have been 196,553,009 confirmed cases of the Coronavirus Disease (COVID-19), including 4,200,412 deaths, globally. Unfortunately, infectious diseases have been an “unavoidable fact of life” throughout history. While the global community looks forward to a gradual return to normalcy from COVID-19 with an increasing number of individuals getting vaccinated on a daily basis, the COVID-19 public health crisis has exposed significant inadequacies in many countries’ pandemic responses—the United States included. Governing authorities must actively consider more effective solutions to quickly detect and prevent the spread of future pandemics.

One proposed model that offers promising potential, …

Mitochondrial Replacement Therapy: Let The Science Decide, Sabrina K. Glavota

Michigan Technology Law Review

Mitochondrial replacement therapy (MRT) is an in vitro fertilization technique designed to prevent women who are carriers of mitochondrial diseases from passing on these heritable genetic diseases to their children. It is an innovative assisted reproductive technology that is only legal in a small number of countries. The United States has essentially stagnated all opportunities for research and clinical trials on MRT through a rider in H.R.2029 – Consolidated Appropriations Act, 2016. The rider bans clinical trials on all therapies in which a human embryo is intentionally altered to include a heritable genetic modification. This note argues that the rider …

Suicide Prevention And Mood Disorders: Self-Exclusion Agreements For Firearms As A Suicide Prevention Strategy, Melvin G. Mcinnis, Stephen B. Thompson, Sofia D. Merajver, Carl E. Schneider

Articles

Suicide involves a complex set of behaviors and emotions that lead up to actions that may be based on planning and forethought or the result of impulse. While there are a host of antecedent circumstances the presence of a mood disorder, primarily depression, is the most common factor in suicide. While management of depression is recognized as important prevention strategy in depression, the means by which suicide occurs must be a critical element of prevention. Policies that lower access to the means for suicide will decrease the fatality. Guns are associated with half of suicides and the case fatality rate …

Problematic Interactions Between Ai And Health Privacy, W. Nicholson Price Ii

Law & Economics Working Papers

The interaction of artificial intelligence (“AI”) and health privacy is a two-way street. Both directions are problematic. This Article makes two main points. First, the advent of artificial intelligence weakens the legal protections for health privacy by rendering deidentification less reliable and by inferring health information from unprotected data sources. Second, the legal rules that protect health privacy nonetheless detrimentally impact the development of AI used in the health system by introducing multiple sources of bias: collection and sharing of data by a small set of entities, the process of data collection while following privacy rules, and the use of …

The Reincorporation Of Prisoners Into The Body Politic: Eliminating The Medicaid Inmate Exclusion Policy, Mira K. Edmonds

Articles

Incarcerated people are excluded from Medicaid coverage due to a provision in the Social Security Act Amendments of 1965 known as the Medicaid Inmate Exclusion Policy (“MIEP”). This Article argues for the elimination of the MIEP as an anachronistic remnant of an earlier era prior to the massive growth of the U.S. incarcerated population and the expansion of Medicaid eligibility under the Patient Protection and Affordable Care Act of 2010. It explores three reasons for eliminating the MIEP. First, the inclusion of incarcerated populations in Medicaid coverage would signify the final erasure from the Medicaid regime of the istinction between …