Medical Jurisprudence Commons^™

Trust, Transparency, And The Fragile Promise Of Data Governance In The Era Of Modernization, Fallon Julia Cochlin, Regen Weber-Fares, Jami Crespo, William M. Sage, Cason Daniel Schmit

Faculty Scholarship

Public health data modernization in the United States has accelerated since COVID-19 exposed systemic weaknesses in fragmented data infrastructure and governance. Technical solutions have advanced, but legal and relational barriers still complicate data sharing across jurisdictions. Traditionally, interjurisdictional data sharing has relied on individually negotiated Data Use Agreements (DUAs), a process that is both resource-heavy and often opaque. To address this, the Centers for Disease Control and Prevention have proposed a Core DUA to standardize terms and reduce administrative burden. However, its success depends on trust — a fragile foundation increasingly strained by politicization, perceived lack of transparency, and controversial …

Medical-Legal Partnership As Value-Based Primary Care: Interprofessional Teamwork For Health-Related Social Needs, Jin K. Park, Andrew F. Beck, Keegan D. Warren, William M. Sage

Faculty Scholarship

Today’s primary care physicians are being asked to address patients’ health-related social needs (HRSN) as part of their routine care practices. An aging population, with a growing complement of intersecting medical and social needs, increases this burden on primary care. Medical-legal partnerships (MLP) are interprofessional collaborations that combine clinical and legal expertise to address HRSN involving housing, public benefits, employment, and other domains remediable by civil legal assistance. A value-based approach to integrating MLP into the health system may help primary care practices more effectively address HRSN and, in turn, better balance revenue and expenses. At the practice and healthcare …

Transforming Blood Management Systems In Developing Countries Through Technological And Artificial Intelligence-Driven Innovations, Sandeep Bhargava, Shaun Aaron Abram, Srividhya Ragavan

Faculty Scholarship

It is critical to ensure the safe and quality supply of blood among various stakeholders; however, this remains a significant challenge in today’s world, especially in developing countries. These countries face severe problems, including blood shortages, fragmented regulatory frameworks, and inconsistent quality control measures. To tackle these challenges, countries like India are trying to implement the use of artificial intelligence (AI) and its derivative platforms to transform blood collection, testing, storage, and distribution by enabling interoperability, real-time compliance monitoring, automated donor screening, optimized inventory management, and advanced component separation. The article argues that developing countries must adopt both regulatory reform …

Unwanted Medical Treatment Harms Patients: Taxonomy Of Healthcare Consent Infractions, Thaddeus Pope

Faculty Scholarship

Patients in the United States are subject to an ever-growing “avalanche” of unwanted medical treatment (UMT).  This is ethically, economically, and legally wrong. First, UMT constitutes a serious violation of patient autonomy and self-determination.  Second, it is waste (and often fraud or abuse) of scarce healthcare resources.  Third, but for rare exceptions, administering UMT contravenes settled legal rules and principles around consent and battery.

This article describe four types of unwanted medical treatment and how the law addresses (or fails to address) them.  The four types of UMT are (1) treatment over patient objections, (2) treatment with zero consent, (3) …

Health Truth To Power: Professional Collaboration To Bolster Trust Against Misinformation, William M. Sage, Keegan D. Warren

Faculty Scholarship

This Article is about health, leaving aside more general challenges to shared civic information today. The Article begins by surveying the principal challenges for health information in post-pandemic, arguably post-truth America, and then describes briefly the sources and limits of medical professional authority. Noting the double-edged sword of free speech guarantees under the U.S. Constitution, the Article continues by commenting on speaking truth to government, to industry, and to the crowd. Next, the Article considers the physicians’ role in speaking truth to power from the perspective of standard medical professional ethics and identity, comparing it to that of lawyers. Finally, …

Public Funds, Public Functions, Private Actors: The Cognitive Dissonance Of Us Health Law, William M. Sage

Faculty Scholarship

This chapter begins with the evolution of American medicine from a “sovereign” self-regulating profession focused on direct patient service to a large industry that serves the social sector but that, because of its professional heritage, receives extensive public subsidies without equivalent public accountability. Next, the chapter identifies regulatory dynamics in American health care governance that structurally discourage movement from the prevailing, if dissonant, private law framework to one explicitly grounded in public law. The chapter concludes by highlighting the challenges and opportunities inherent in a private law approach to what is intuitively a public law domain.

Medicare Mandates For Shared Decision Making With Patient Decision Aids: Linking Payment To Preference, Thaddeus Pope

Faculty Scholarship

Since 2015, the Centers for Medicare and Medicaid Services (CMS) has increasingly required shared decision making with evidence-based patient decision aids as an essential Medicare condition for payment. CMS is doing this because it recognizes that most healthcare is preference sensitive and value laden. So, whether treatment is “right” or “beneficial” for a patient is not only a matter of clinical expertise. It equally depends on the patient’s values, preferences, and goals. So, CMS wants to ensure that patients understand the risks, benefits, and alternatives to the healthcare that they receive and for which CMS pays. In short, under its …

Patient Access To Health Device Data: Toward A Legal Framework, Charles Duan, Christopher J. Morten

Faculty Scholarship

New health care devices, including at-home diagnostic devices, are generating and aggregating data on patients’ health at a staggering pace. Yet much of that data is inaccessible because it is held in data siloes, most often cloud services controlled by device manufacturers. This proprietary siloing of patient data is problematic from ethical, economic, scientific, and broad public policy perspectives. This chapter frames these concerns and begins to sketch a regulatory framework for patient access to health care device data. As with other consumer data, breaking down siloes and securing patients’ access to their device data safeguards patients’ ownership interests, promotes …

Charging Abortion, Milan Markovic

Faculty Scholarship

As long as Roe v. Wade remained good law, prosecutors could largely avoid the question of abortion. The Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization has now placed prosecutors at the forefront of the abortion wars. Some chief prosecutors in antiabortion states have pledged to not enforce antiabortion laws, whereas others are targeting even out-of-state providers. This post-Dobbs reality, wherein the ability to obtain an abortion depends not only on the politics of one’s state but also the policies of one’s local district attorney, has received minimal scrutiny from legal scholars.

Prosecutors have broad charging discretion, …

(Re)Criminalizing Abortion: Returning To The Political With Stories, George J. Annas

Faculty Scholarship

Abortion stories have always played a powerful role in advancing women’s rights. In the abortion sphere particularly, the personal is political. Following the Court’s reversal of Roe v. Wade, abortion politics, and abortion storytelling, take on an even deeper political role in challenging the bloodless judicial language of Dobbs with the lived experience of women.

Continuous Reproductive Surveillance, Michael Ulrich, Leah R. Fowler

Faculty Scholarship

The Dobbs opinion emphasizes that the state’s interest in the fetus extends to “all stages of development.” This essay briefly explores whether state legislators, agencies, and courts could use the “all stages of development” language to expand reproductive surveillance by using novel developments in consumer health technologies to augment those efforts.

Dobbs V. Jackson Women’S Health: Undermining Public Health, Facilitating Reproductive Coercion, Aziza Ahmed, Dabney P. Evans, Jason Jackson, Benjamin Mason Meier, Cecília Tomori

Faculty Scholarship

Dobbs v. Jackson Women’s Health continues a trajectory of U.S. Supreme Court jurisprudence that undermines the normative foundation of public health — the idea that the state is obligated to provide a robust set of supports for healthcare services and the underlying social determinants of health. Dobbs furthers a longstanding ideology of individual responsibility in public health, neglecting collective responsibility for better health outcomes. Such an ideology on individual responsibility not only enables a shrinking of public health infrastructure for reproductive health, it facilitates the rise of reproductive coercion and a criminal legal response to pregnancy and abortion. This commentary …

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

Faculty Scholarship

No abstract provided.

U.S. Law And Discrimination In Health Care, Kimani Paul-Emile

Faculty Scholarship

No abstract provided.

The Nih-Moderna Vaccine: Public Science, Private Profit, And Lessons For The Future, Christopher J. Morten

Faculty Scholarship

This commentary highlights the scientific history of the NIH-Moderna COVID-19 vaccine and corroborates Sarpatwari’s theme of private capture of value created by the public. The commentary also identifies missteps by the Trump and Biden Administrations and offers policy recommendations: better contracts with and incentives for pharmaceutical manufacturers and a not-for-profit “public option” for pharmaceutical development.

No-One Receives Psychiatric Treatment In A Squad Car, Judy A. Clausen, Joanmarie Davoli

Faculty Scholarship

No abstract provided.

Patient Decision Aids Improve Patient Safety And Reduce Medical Liability Risk, Thaddeus Pope

Faculty Scholarship

Tort-based doctrines of informed consent have utterly failed to assure that patients understand the risks, benefits, and alternatives to the healthcare they receive. Fifty years of experience with the doctrine of informed consent have shown it to be an abject catastrophe. Most patients lack an even minimal understanding of their treatment options. But there is hope. Substantial evidence shows that patient decision aids (PDAs) and shared decision making can bridge the gap between the theory and practice of informed consent. These evidence-based educational tools empower patients to make decisions with significantly more knowledge and less decisional conflict than clinician-patient discussions …

California V. Texas: The Role Of Congressional Procedure In Severability Doctrine, Mary Leto Pareja

Faculty Scholarship

The United States Supreme Court is once again considering a case that challenges the constitutionality of the Affordable Care Act (“ACA”). In this round of litigation, plaintiffs argue that because Congress lowered the individual mandate tax penalty to zero in the 2017 Tax Act that makes the individual mandate itself unconstitutional and that, furthermore, the individual mandate cannot be severed from the rest of the ACA. The District Court agreed with the plaintiffs and struck down the entire ACA, and the Supreme Court granted cert to hear this momentous question. A decision is expected by summer of 2021.

The ACA …

Transparency Of Regulatory Data Across The European Medicines Agency, Health Canada, And Us Food And Drug Administration, Alexander C. Egilman, Amy Kapczynski, Margaret E. Mccarthy, Anita T. Luxkaranayagam, Christopher J. Morten, Matthew Herder, Joshua D. Wallach, Joseph S. Ross

Faculty Scholarship

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

Re-Reading Chevron, Thomas W. Merrill

Faculty Scholarship

Though increasingly disfavored by the Supreme Court, Chevron remains central to administrative law doctrine. This Article suggests a way for the Court to reformulate the Chevron doctrine without overruling the Chevron decision. Through careful attention to the language of Chevron itself, the Court can honor the decision’s underlying value of harnessing comparative institutional advantage in judicial review, while setting aside a highly selective reading that unduly narrows judicial review. This re-reading would put the Chevron doctrine – and with it, an entire branch of administrative law – on firmer footing.

Adolescent Medical Decisionmaking Rights: Reconciling Medicine And Law, Doriane Lambelet Coleman, Philip M. Rosoff

Faculty Scholarship

Dennis Lindberg came into his aunt’s care when he was in the 4th grade because his parents struggled with drug addiction and could not provide for him. At thirteen, he was baptized in his aunt’s faith as a Jehovah’s Witness. Just days after he turned fourteen, on November 6, he was diagnosed with acute lymphoblastic leukemia.

The prognosis was that Dennis had a 75% chance of cure with standard oncology treatment. Consistent with the requirements of his new faith, however, Dennis told his doctors, “I do not want to be treated if the requirement is that I would have to …

Evidence Supporting The Value Of Surgical Procedures: Can We Do Better?, Jonathan J. Darrow, Christopher Robertson, Willard S. Kasoff

Faculty Scholarship

There is an acknowledged need for higher-quality evidence to quantify the benefit of surgical procedures, yet not enough has been done to improve the evidence base. This lack of evidence can prevent fully informed decision-making, lead to unnecessary or even harmful treatment, and contribute to wasteful expenditures of scare health care resources. Barriers to evidence generation include not only the long-recognized technical difficulties and ethical challenges of conducting randomized surgical trials, but also legal challenges that limit incentives to conduct surgical research as well as market-based challenges that make it difficult for those funding surgical research to recoup investment costs. …

The Affordable Care Act: Up For A Final Vote?, Wendy K. Mariner

Faculty Scholarship

For more than a decade, the minimum essential coverage requirement, commonly known as the individual mandate, has been a key point of controversy over the ACA, symbolizing ideological and political disagreements over government assistance to low-income populations, federal regulation of private industry, and the legacy of President Obama. 26 U.S.C. §5000A(a) requires everyone (with exceptions) to be covered by a private or public health benefit program meeting ACA standards. 26 U.S.C. §5000A(b) requires those who are not so covered to pay a fee (“shared responsibility payment”) to the Treasury. 26 U.S.C. §5000A(c) sets forth the amount of that fee.

China's Innovative Turn And The Changing Pharmaceutical Landscape, Peter K. Yu

Faculty Scholarship

For more than a decade, China has been the world's leading supplier of active pharmaceutical ingredients. Today, it is not only the world's second largest pharmaceutical market, behind only the United States, but it also produces about four percent of the world's new pharmaceutical products. Despite these impressive accomplishments, China does not have internationally recognized pharmaceutical brands that are comparable to those found in Europe or the United States, such as Johnson & Johnson, Merck, Novartis, Pfizer, Roche and Sanofi. Nor does China rival India in its status as the "pharmacy of the world," providing generic drugs to needy countries …

Cruzan’S Legacy In Autonomy, Kathy Cerminara

Faculty Scholarship

No abstract provided.

Video Advance Directives: Growth And Benefits Of Audiovisual Recording, Thaddeus Pope

Faculty Scholarship

The key question in Cruzan v. Director, Missouri Department of Health was one of substantiation and evidence: how can the incapacitated patient’s surrogate decision maker prove that the health care decisions she makes on the patient’s behalf are the same health care decisions that the patient would have made for herself? Answering this question, the Court observed that an advance directive would constitute adequate proof because an advance directive constitutes clear and convincing evidence of a patient’s wishes.

Today, clinicians and policymakers no longer focus on the constitutional question of how much evidence state law may require from a patient’s …

Patents, Information, And Innovation, Brenda M. Simon

Faculty Scholarship

Inventors and commercialization partners often rely on patents to facilitate the exchange of sensitive information. Most scholarship in this area has focused on the areas of software and biotechnology. To provide a richer description of the role of patents in the innovative process, this project evaluates the existing literature and sets forth examples drawn from a series of interviews with professionals from the largely-overlooked medical device industry. The limited analysis of the medical device industry has focused on the largest few dozen firms—as publicly-traded entities, a great deal of data about them is readily available. Small medical device companies are …

On Trust, Law, And Expecting The Worst, Elizabeth F. Emens

Faculty Scholarship

This Review has three parts. Part I aims to convey something of the breadth and interest of Hasday’s fascinating new book, foregrounding the role of gender and beginning to touch the subject of trust. Part II delves briefly but widely into the theme of trust, which pervades the book and invites further examination. Part III presents a framework that combines affective trust and epistemic curiosity and applies this framework to illuminate and sort Hasday’s proposals for reform; to critique a recent, dramatic change in the evidentiary treatment of marital confidences; and to devise a novel approach to prenuptial agreements. Throughout, …

Association Between State Policies Using Medicaid Exclusions To Sanction Noncompliance With Welfare Work Requirements And Medicaid Participation Among Low-Income Adults, Atheendar S. Venkataramani, Elizabeth F. Bair, Erica Dixon, Kristin A. Linn, William J. Ferrell, Kevin G. Volpp, Kristen Underhill

Faculty Scholarship

Twenty states have pursued community engagement requirements (ie, work requirements) as a condition for Medicaid eligibility among adults considered able-bodied. Work requirements seek to improve health by incentivizing work, but may result in coverage losses.

The impact of work requirements on Medicaid coverage may extend beyond qualifying beneficiaries, by increasing confusion around benefit rules or deterring individuals from applying for coverage. However, the spillover effects of work requirements on individuals not directly subject to them are difficult to study because these programs have only recently been implemented. To examine this possibility, we studied Temporary Assistance for Needy Families (TANF), the …

Stewart V Azar And The Purpose Of Medicaid: Work As A Condition Of Enrollment, Nicole Huberfeld

Faculty Scholarship

On June 29, 2018, a federal district court found that the US Department of Health and Human Services (HHS) did not properly approve Kentucky’s application for a controversial Medicaid waiver, the first to require work as a condition of eligibility.¹ Because HHS’s approval was vacated, Kentucky’s Medicaid program was required to continue as if no waiver existed, but 3 other states had already received HHS approval to proceed with work requirements. This article provides context for understanding the relevance of work requirements to implementation of Medicaid expansion under the Patient Protection and Affordable Care Act (hereinafter, Affordable Care Act), …