Health Law and Policy Commons^™

How Ai Can Learn From The Law: Putting Humans In The Loop Only On Appeal, I. Glenn Cohen, Boris Babic, Sara Gerke, Qiong Xia,, Theodoros Evgeniou, Klaus Wertenbroch

Faculty Scholarly Works

While the literature on putting a “human in the loop” in artificial intelligence (AI) and machine learning (ML) has grown significantly, limited attention has been paid to how human expertise ought to be combined with AI/ML judgments. This design question arises because of the ubiquity and quantity of algorithmic decisions being made today in the face of widespread public reluctance to forgo human expert judgment. To resolve this conflict, we propose that human expert judges be included via appeals processes for review of algorithmic decisions. Thus, the human intervenes only in a limited number of cases and only after an …

The Fall Of Fda Review, Daniel G. Aaron

Utah Law Faculty Scholarship

The U.S. Food and Drug Administration (FDA) is in crisis. FDA can hardly go a single day without an investigation, negative news story, or scholarly critique of the agency’s work. We have increasingly entrusted FDA—today, to the tune of 25% of the U.S. economy—with vetting the products we put in and on our bodies. But the array of problems facing the agency raises questions about whether it is equipped to succeed in the 21st century.

FDA’s core function is to oversee a special legal regime called “premarket review.” Congress has prohibited all marketing of certain types of products (like drugs) …

A Call For Better Abortion Data: Common Ground Amid Dobbs And The Abortion Debate, J. Jackson Hill

Loyola University Chicago Law Journal

There is room for compromise in the U.S. abortion debate. Specifically, improving abortion data is an untapped issue with significant bipartisan appeal. Better data will lead to more-informed abortion policy and promote shared public health priorities, like the reduction of unintended pregnancies. Unfortunately, the current abortion reporting system falls short of providing these benefits. There is no national law governing the collection and reporting of abortion data. Americans must therefore rely on information voluntarily provided to the Centers for Disease Control and Prevention and the Guttmacher Institute. The result is data that is inaccurate, non-uniform, and untimely. To remedy the …

From Conciliation To Conflict: How Dobbs V. Jackson Women's Health Organization Reshapes The Supreme Court's Role In American Polarized Society, Shai Stern

Loyola University Chicago Law Journal

Professor Shai Stern of Bar Ilan University in Israel analyzes the Court’s decision and argues that its approach not only denies a previously recognized constitutional right, but also opens the door for the challenge to other recognized rights. In addition, Professor Stern highlights the Court’s own delegitimization and contribution to rising political polarization.

Research Use Of Electronic Health Records: Patients' Views On Alternative Approaches To Permission, Catherine Hammack-Aviran, Kathleen Brelsford, Kevin Mckenna, Ross Graham, Zachary Lampron, Galen Perdikis

Law Faculty Scholarship

This study examines patients’ perspectives on alternative approaches to notifying individuals and obtaining permission for the research use of electronic health record (EHR) data. As EHR systems increasingly support large-scale health research, questions arise regarding how best to balance scientific progress with patient autonomy, privacy, and trust. Using qualitative interviews with 120 patients across four socioeconomically diverse counties in the southeastern United States, the researchers explored attitudes toward three primary models of permission: General Notification, Broad Permission, and Categorical Permission. Participants evaluated the advantages and disadvantages of each approach from multiple perspectives, including those of patients, researchers, and healthcare organizations. …

Overlapping Surgeries From The Patient's Perspective, Yangzi Liu, Shirley Chen, Catherine Hammack-Aviran, Brian C. Drolet, Galen Perdikis

Law Faculty Scholarship

This study examines patients’ perspectives on alternative approaches to notifying individuals and obtaining permission for the research use of electronic health record (EHR) data. As EHR systems increasingly support large-scale health research, questions arise regarding how best to balance scientific progress with patient autonomy, privacy, and trust. Using qualitative interviews with 120 patients across four socioeconomically diverse counties in the southeastern United States, the researchers explored attitudes toward three primary models of permission: General Notification, Broad Permission, and Categorical Permission. Participants evaluated the advantages and disadvantages of each approach from multiple perspectives, including those of patients, researchers, and healthcare organizations. …

Federalism And The Right To Travel: Medical Aid In Dying And Abortion, Leslie P. Francis, John Francis

Utah Law Faculty Scholarship

This article explores how rights to movement may limit state efforts to restrict abortions, either directly or indirectly. We use the language of “movement” to encompass short-term visits, longer-term residency changes, and the movement of goods or services across state lines. We prefer “movement” to “travel” or “tourism,” as this language risks trivializing the seriousness of what might be at stake. However, since “travel” is the term used in many U.S. court decisions and other discussions concerning the right,7 we use that term as relevant to these. The centerpiece of our defense is the relationship between freedom of movement and …

The Impact Covid-19 On The Healthcare Industry’S Systems And Policies: A Case Study, Jameyshia Franklin

West Chester University Doctoral Projects

People worldwide experienced some impacts from the 2019 Coronavirus at various degree. The healthcare industry worldwide was significantly affected by the high volume of patients being infected with the Coronavirus. The COVID-19 virus brought on several challenges for the healthcare industry and the federal government in the United States. Hospitals operated under severe circumstances to treat sick COVID-19 patients and keep their employees safe from contracting the disease. Government mandated social distancing, mask wearing, and cancelation and closing of services to assist with stopping the spread of the virus. This study aimed to identify how the pandemic affected the healthcare …

Microdosing Psychedelics Under Local, State, And Federal Law, Mason Marks, I Glenn Cohen, Jonathan Perez-Reyzin, David Angelatos

Scholarly Publications

Microdosing psychedelic substances ("microdosing') is a growing trend that has gained significant media and scientific attention. The practice typically involves consuming low doses of psychedelics, such as psilocybin or lysergic acid diethylamide ("LSD'), two or three times per week, over the course of weeks or months. Many claim that microdosing improves attention, creativity, or mood. Some say it reduces pain as well as symptoms of anxiety, depression, and migraine or cluster headaches. Others fear it has not been proven safe or effective by randomized controlled trials. Nevertheless, the microdosing trend is growing against the backdrop of a broader psychedelic renaissance …

Playing God In The 21st Century: How The Push For Human Embryonic Germline Gene Editing Sidelines Individual And Generational Autonomy, Anna E. Melo

Catholic University Journal of Law and Technology

Every four and a half minutes a child with a genetic birth defect is born in the United States. For some, these conditions are treatable and manageable, but sadly for others, they are a death sentence. Congenital malformations and chromosomal abnormalities are the leading cause of infant mortality. CRISPR-Cas9 presents hope for the future, a liberation from the heritable genetic shackles that a child would otherwise be trapped in. With such optimism for future applications of germline gene editing, there are also great concerns with what national and global limitations and auditing must be in place to permit “genetic hedging.” …

Forensic Microbiome Evidence: Fourth Amendment Applications And Court Acceptance, Trason Lasley

Catholic University Journal of Law and Technology

No abstract provided.

Table Of Contents

Saint Louis University Journal of Health Law & Policy

No abstract provided.

Masthead

Saint Louis University Journal of Health Law & Policy

No abstract provided.

The Battle For Medicare, Isaac D. Buck

Saint Louis University Journal of Health Law & Policy

America is aging. From 2019 to 2060, the total population of Americans over sixty-five will grow from fifty-four million to ninety-five million. Of all Americans, sixteen percent were aged sixty-five and older in 2019; nearly twenty-two percent are projected to be in this age group by 2040. This shift will put unprecedented pressure on the Medicare program. Its enrollment is already in the midst of an unparalleled boom, growing from forty-eight million in 2010 to eighty-six million by just 2035. As it grows in importance and size, the future of Medicare will be dominated by two competing pressures.

First, Medicare …

Gender Identity, Health, And The Law: An Overview Of Key Laws Impacting The Health Of Transgender And Gender Non-Conforming People, Naomi Seiler, Amanda Spott, Mekhi Washington, Paige Organick-Lee, Aaron Karacuschansky, Gregory Dwyer, Katie Horton, Alexis Osei

Saint Louis University Journal of Health Law & Policy

A growing population of transgender, nonbinary, and other gender non-conforming Americans experience the burden of multiple physical and mental health inequities. Largely rooted in discrimination and stigma, these disparities are compounded by barriers to respectful, appropriate healthcare.

A range of new policies, including state laws attempting to limit access to gender-affirming care for minors, may further compound health disparities. However, in some states and at the federal level, protective laws seek to prohibit discrimination and support access to care. Meanwhile, the constitutional status of gender identity under the Equal Protection Clause, and the legality of certain federal protections challenged on …

The Future Of Health Care Must Be Harm Reductionist—To Bring It About, We Need Moral Philosophy, Travis N. Rieder

Saint Louis University Journal of Health Law & Policy

In the United States, more than 100,000 people now die each year from drug overdose, but nearly all of these deaths are preventable. The purpose of this Article is to show that harm reduction interventions could go a long way towards saving these lives, but we don’t adopt many of these interventions, or fail to adopt them at the scale needed. Although it is often suggested by opponents of harm reduction that the interventions are unlikely to actually reduce harm, this Article argues that the empirical debate is largely over—decades of data demonstrate that harm reduction saves lives, promotes health, …

Inefficacy Of The Transparency In Coverage Final Rule In Promoting Cost-Effective Choices, Abigail Jaeger

Saint Louis University Journal of Health Law & Policy

The Transparency in Coverage Final Rule requires health plans to provide beneficiaries with financial information such as estimates of their personalized cost-sharing liabilities for items and services offered by different providers, the plan’s negotiated in-network rates with these providers, and the plan’s allowed out-of-network amounts. The Final Rule is designed to enhance consumers’ access to pricing information under their health plan so they have the ability to make well-informed and cost-effective decisions regarding their health care. However, empirical evidence suggests that the Final Rule will not effectuate its intended purpose. Many consumers lack the high level of health insurance comprehension …

Who Pays First?: Medicaid Third-Party Liability In Florida And Virginia’S Birth-Related Neurological Injury Compensation Programs, Alexandra M. Robbins

Saint Louis University Journal of Health Law & Policy

In response to an impending obstetrician shortage and medical malpractice crisis, the states of Florida and Virginia adopted no-fault birth-related neurological injury compensation programs in the 1980s. Both of these programs provide lifetime coverage for eligible children with serious birth-related neurological injuries; however, both programs treated themselves as the payer of last resort and required families to submit claims to Medicaid first based on an inaccurate interpretation of Medicaid third party-liability (“TPL”) laws and the program-enabling statutes. Both programs’ policies treating themselves as the payer of last resort not only violated Federal and State Medicaid laws, they caused harm to …

Eliminating Cash Bail In Washington State—Amending Criminal Rule 3.2, Simran Kaur

Seattle University Law Review

This Note discusses the following three parts. Part I provides an overview of the cash bail system, its history, and its contemporary use in Washington state. Part II presents the effects of bail on pretrial release, analyzing low-income and racial inequalities and the adverse impacts it can have on the accused. Part III focuses on solutions and alternatives to the cash bail system, using other states as case studies.

Selective Patronage, Omari Scott Simmons

Seattle University Law Review

Contemporary academic corporate governance narratives have a blind spot. They focus on institutions, rules, regulations, processes, procedures, intermediaries, and market forces. Yet, missing in this narrative, is the impact of corporate leadership. Ignoring the “black box” of corporate leadership, particularly individual actors, renders an incomplete descriptive assessment as well as potential miscalculations. The examination of key historical figures and their corporate activism provides an important lens through which to identify potential challenges and opportunities related to the contemporary ESG movement.

Generally, this essay examines corporate leadership’s potential to address socio-political issues through the prism of Civil Rights Movement activism. Specifically, …

Promoting Corporate Diversity: The Uncertain Role Of Institutional Investors, Jill Fisch

Seattle University Law Review

Two developments are having an impact on corporate decisions. One is the increased engagement by institutional intermediaries and a shift in the focus of that engagement from corporate governance to environmental and social issues. The other is a heightened societal awareness of diversity, equity, and inclusion (DEI) issues, particularly the importance of diversity in corporate leadership. This Article considers the intersection between the two. It describes how institutional investors have focused their attention on increasing diversity in corporate leadership, the potential motivations for that focus, and the impact of that focus, to date. It highlights the tensions that result from …

America’S Hidden Citizens: The Untold Stories Of The Unconscionable Deportations Of Its International Adoptees, Halley Cody

Seattle University Law Review

This Note addresses how the U.S. should rectify the harms it has perpetrated on non-citizen adoptees by amending the current deportation statutes to prevent their deportation. Part I addresses the history of adoption in the U.S. and related effects on immigration law. Part II highlights the stories of Adam Crapser and Philip Clay, who were adopted by American families who failed to naturalize them as minors, and who were subsequently deported after they sustained criminal records. Part III examines the policy goals behind deportation as a consequence of criminal convictions, as well as remedies instituted to prevent unwarranted deportation and …

Inadequate Privacy: The Necessity Of Hipaa Reform In A Post-Dobbs World, Katherine Robertson

Seattle University Law Review

Part I of this Comment will provide an overview of HIPAA and the legal impacts of Dobbs. Part II will discuss the anticipatory response to the impacts of Dobbs on PHI by addressing the response from (1) the states, (2) the Biden Administration, and (3) the medical field. Part III will discuss the loopholes that exist in HIPAA and further address the potential impacts on individuals and the medical field if reform does not occur. Finally, Part IV will argue that the reform of HIPAA is the best avenue for protecting PHI related to reproductive healthcare.

The Disability Docket, Jasmine E. Harris, Karen M. Tani, Shira Wakschlag

American University Law Review

The monumental changes emanating from the contemporary Supreme Court have now generated abundant commentary—but it remains possible to glean new insights if we review the Court’s work from an alternative perspective, one that does not often inform mainstream accounts. Drawing on insights from Disability Legal Studies and other critical approaches to law, as well as from the trenches of disability advocacy and civil litigation, this Article applies a “disability lens” to the Supreme Court’s 2021 and 2022 Terms. Our review of the Court’s published decisions and broader docket suggests three themes. We highlight (1) the role of disability cases in …

Disability Reproductive Justice During Covid-19 And Beyond, Robyn M. Powell

American University Law Review

The United States is experiencing the convergence of two crises threatening the reproductive freedom of people with disabilities and other historically marginalized groups: the COVID-19 pandemic and a rising assault on reproductive rights, including the U.S. Supreme Court’s recent Dobbs v. Jackson Women’s Health Organization decision. This convergence has created a perfect storm, revealing the depth of existing reproductive injustices endured by disabled people and forcing a reckoning with the consequences of permitting such inequities to persist. As such, urgent attention by activists, scholars, legal professionals, and policymakers is necessary.

This Article proposes a vision for addressing the deeply entrenched …

Public Health Product Hops, Michael S. Sinha

American University Law Review

Pharmaceutical product hops are anticompetitive maneuvers that often represent a last-ditch effort by brand manufacturers to preserve market share in the face of generic competition. An integral part of product life cycle management strategies, product hops may offer marginal benefits to patients but can substantially increase costs to payers and patients alike. Industry advocates, however, maintain that product hops represent essential follow-on research and development, resulting in the development of novel products that would otherwise never reach the market.

Is there a middle ground between these two diametrically opposed views? Might certain product hops be considered beneficial, perhaps if they …

Buck As (Anti) Canon: The Misuse Of Eugenics Rhetoric In Selective-Abortion Jurisprudence And The Dangers For Tort Law, Samantha C. Smith

American University Law Review

America’s notorious eugenics case Buck v. Bell is being resurrected as anticanon in abortion jurisprudence. Buck became one of the Court’s worst decisions by upholding eugenic practices, but these recent anticanonical citations also prove harmful by misidentifying eugenics. This Article joins critics of this misuse of “eugenics” labeling and warns that the rhetorical use of Buck in abortion cases has dangerous implications for reproductive medicine. It draws on Buck as the leading precedent for eugenics under the law and demonstrates that selective-abortion cases are distinguishable because of two failures of the Buck Court: the failure to recognize state interference with …

Covid-19, Free Exercise, And Most Favored Nation Status, Mark Strasser

Lewis & Clark Law Review

Commentators and some Justices suggest that religious activity is accorded a kind of Most Favored Nation status under free exercise guarantees—if a statutory exception is made for a relevantly similar secular activity, then an exception must also be made for religious activity. Such an approach would require a careful consideration of which secular activities were relevantly similar to religious activities to warrant protecting the latter. But the Most Favored Nation approach involves a mischaracterization of the past jurisprudence. Further, as is evidenced in the COVID cases, the U.S. Supreme Court does not engage in a nuanced consideration of which activities …

More Than The Minimum: Why States Should Enact Better Fmla Equivalents, Matt Heldt

Lewis & Clark Law Review

For many workers, taking time off from work for a serious health condition or to care for a family member’s serious health condition is complicated. Since 1993, the Family Medical Leave Act (FMLA) has provided job protection for workers who take leave. However, not all workers are covered. This Comment looks at where the FMLA comes up short, how some states are providing broader coverage and more robust benefits, and advocates for states to continue improving upon the FMLA baseline.

Training A Public Accommodations Lens On Vaccine Passports, Paul Diller

Lewis & Clark Law Review

The Covid pandemic and the rise of smartphone technology enabled the use of “vaccine passports”—that is, a requirement to show proof of vaccination against Covid—on a scale unmatched before in human history. In the United States, many public accommodations such as restaurants, coffee shops, stadiums, and movie theaters required patrons to show proof of vaccination in order to enter or consume food and drink on the premises. In approximately two dozen local jurisdictions as well as the District of Columbia and Puerto Rico, government mandated that public accommodations do this, with varied carveouts for religious objections and medical or age-based …