Law Commons^™

Introduction: Medical-Legal Partnerships: Equity, Evolution, And Evaluation., Katherine L. Kraschel, James Bhandary-Alexander, Yael Z. Cannon, Vicki W. Girard, Abbe R. Gluck, Jennifer L. Huer, Medha D. Makhlouf

Faculty Scholarly Works

The COVID-19 pandemic laid bare systemic inequities shaped by social determinants of health (SDoH). Public health agencies, legislators, health systems, and community organizations took notice, and there is currently unprecedented interest in identifying and implementing programs to address SDoH. This special issue focuses on the role of medical-legal partnerships (MLPs) in addressing SDoH and racial and social inequities, as well as the need to support these efforts with evidence-based research, data, and meaningful partnerships and funding.

Video Endoscopy As Big Data: Balancing Privacy And Progress In Gastroenterology, Eugenia N. Uche-Anya, Sara Gerke, Tyler M. Berzin

Faculty Scholarly Works

Tens of millions of gastrointestinal (GI) endoscopy videos and images are generated annually in the United States (¹). A single 15-minute endoscopic procedure, recorded at 30 frames per second, generates approximately 27,000 high-definition images, representing a treasure trove of potential data. In the era of artificial intelligence (AI) and machine learning (ML), this data stream will not only fuel innovative and clinically impactful research in gastroenterology for both academic and commercial purposes, but also introduce ethical and legal concerns that merit consideration. Gastroenterologists are now faced with navigating new questions around data privacy and data ownership that have …

Decoding U.S. Tort Liability In Healthcare's Black-Box Ai Era: Lessons From The European Union, Mindy Duffourc, Sara Gerke

Faculty Scholarly Works

The rapid development of sophisticated artificial intelligence (“AI”) tools in healthcare presents new possibilities for improving medical treatment and general health. Currently, such AI tools can perform a wide range of health-related tasks, from specialized autonomous systems that diagnose diabetic retinopathy to general-use generative models like ChatGPT that answer users’ health-related questions. On the other hand, significant liability concerns arise as medical professionals and consumers increasingly turn to AI for health information. This is particularly true for black-box AI because while potentially enhancing the AI’s capability and accuracy, these systems also operate without transparency, making it difficult or even impossible …

An Llc By Any Other Name Is Still Not A Corporation, Samantha J. Prince, Joshua P. Fershee

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Business entities have their own unique characteristics. Entrepreneurs and lawyers who represent them select an entity structure based on the business’s current and projected needs. The different needs of each business span myriad topics such as capital requirements, taxation, employee benefits, and personal liability protection. These choices present advantages and disadvantages, many of which are built into the type of entity chosen. It is critically important that people, especially lawyers, recognize the difference between entities such as corporations and limited liability companies (LLCs). It is an egregious, nearly unforgivable, error to call an LLC a “limited liability corporation.” This is …

State Flexibility In Emergency Medicaid To Care For Uninsured Noncitizens, Jin K. Park, Clarisa Reyes-Becerra, Medha D. Makhlouf

Faculty Scholarly Works

No abstract provided.

Artificial Intelligence Tools In Clinical Neuroradiology: Essential Medico-Legal Aspects, Dennis M. Hedderich, Christian Weisstanner, Sofie Van Cauter, Christian Federau, Myriam Edjlali, Alexander Radbruch, Sara Gerke, Sven Haller

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Commercial software based on artificial intelligence (AI) is entering clinical practice in neuroradiology. Consequently, medico-legal aspects of using Software as a Medical Device (SaMD) become increasingly important. These medico-legal issues warrant an interdisciplinary approach and may affect the way we work in daily practice. In this article, we seek to address three major topics: medical malpractice liability, regulation of AI-based medical devices, and privacy protection in shared medical imaging data, thereby focusing on the legal frameworks of the European Union and the USA. As many of the presented concepts are very complex and, in part, remain yet unsolved, this article …

The Proposed Eu Directives For Ai Liability Leave Worrying Gaps Likely To Impact Medical Ai, Mindy Duffourc, Sara Gerke

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Two newly proposed Directives impact liability for artificial intelligence in the EU: a Product Liability Directive (PLD) and an AI Liability Directive (AILD). While these proposed Directives provide some uniform liability rules for AI-caused harm, they fail to fully accomplish the EU’s goal of providing clarity and uniformity for liability for injuries caused by AI-driven goods and services. Instead, the Directives leave potential liability gaps for injuries caused by some black-box medical AI systems, which use opaque and complex reasoning to provide medical decisions and/or recommendations. Patients may not be able to successfully sue manufacturers or healthcare providers for some …

The Role Of The Aba’S “Summits” In Facilitating Global Networks And International Cross-Border Legal Practice, Laurel Terry

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This Article was written for a Symposium honoring recently-retired Professor Bob Lutz. It describes fourteen gatherings that were organized by either the ABA Section of International Law’s Transnational Legal Practice Committee or by the predecessor entities to the ABA Standing Committee on International Trade in Legal Services. Professor Lutz was a driving force behind these gatherings, which were held between 2004 and 2014, and were referred to by the organizers as “Summits.” This Article examines the impact of these Summits and explains why they played a critical role in helping establish global legal profession networks among U.S. legal profession stakeholders …

Burning Down The House: How Libertarian Philosophy Was Corrupted By Delusion And Greed (Book Review), Julie Tedjeske Crane

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No abstract provided.

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

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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 …

Interagency Dynamics In Matters Of Health And Immigration, Medha D. Makhlouf

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When Congress delegates authority to an executive agency, it tells us something important about the expertise that Congress wishes to harness in policymaking on an issue. In the legal literature on interagency dynamics and cooperation, issues at the nexus of health and immigration are largely understudied. This Article extends this literature by examining how delegations of authority on issues at the intersection of health and immigration influence policymaking. In an analysis of how administrative law models apply to three topics in the shared regulatory space of the Department of Health and Human Services (“HHS”) and the Department of Homeland Security …

Deducting Dobbs: The Tax Treatment Of Abortion-Related Travel Benefits, Samantha J. Prince

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In 2022, Dobbs v. Jackson Women's Health Organization overturned both Roe v. Wade and Planned Parenthood v. Casey thereby giving the states carte blanche to do as they wish regarding abortion access. The decision created upheaval in the United States. However, it also provided the impetus for the creation of a new employee benefit, abortion-related travel benefits.

Thirteen states had anti-abortion trigger bans that were unenforceable until Dobbs. Several other states have passed legislation that criminalizes, or significantly restricts, abortion access. Women residing in these states will now endure greater financial, health, and temporal challenges to travel out of state …

Comments On Worker Classification Proposed Rule For Flsa Purposes Rin 1235-Aa43, Samantha J. Prince, Taylor Haberle, Lauren E. Stahl

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No abstract provided.

Trademark Confusion Revealed: An Empirical Analysis, Daryl Lim

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The likelihood of confusion standard defines the scope of trademark infringement. Likelihood of confusion examines whether there is a substantial risk that consumers will be confused as to the source, identity, sponsorship, or origin of the defendants’ goods or services. This Article presents a contemporary empirical analysis of the various factors and how they interact. Conventional wisdom teaches us that courts should comprehensively traverse each factor and that likelihood of confusion cases generally require jury determination. However, the data reveals that neither is true. Instead, courts provide early off-ramps to litigants by “economizing,” and analyzing only a handful of factors …

Book Review: This Is How They Tell Me The World Ends: The Cyberweapons Arms Race (2020) By Nicole Perlroth, Amy Gaudion

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In the book, Perlroth traces the development and use of cyber capabilities, focusing on the U.S. government’s unintended role in creating a market for these cyber goods. Her purpose is a straightforward one: to illuminate. Perlroth explains that her goal is to “help shine even a glimmer of light on the highly secretive and largely invisible cyberweapons industry so that we, a society on the cusp of this digital tsunami called the Internet of Things, may have some of the necessary conversations now, before it is too late.”7 She seeks to accomplish this purpose by offering a treatise-like treatment of …

Towards Racial Justice: The Role Of Medical-Legal Partnerships, Medha D. Makhlouf

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Medical-legal partnerships (MLPs) integrate knowledge and practices from law and health care in pursuit of health equity. However, the MLP movement has not reached its full potential to address racial health inequities, in part because its original framing was not explicitly race conscious. This article aims to stimulate discussion of the role of MLPs in racial justice. It calls for MLPs to name racism as a social determinant of health and to examine how racism may operate in the field. This work sets the stage for the next step: operationalizing racial justice in the MLP model, research, and practice.

Immigration Reforms As Health Policy, Medha D. Makhlouf, Patrick J. Glen

Faculty Scholarly Works

The 2020 election, uniting control of the political branches in the Democratic party, opened up a realistic possibility of immigration reform. Reform of the immigration system is long overdue, but in pursuing such reform, Congress should cast a broad net and recognize the health policies embedded in immigration laws. Some immigration laws undermine health policies designed to improve individual and population health. For example, immigration inadmissibility and deportability laws that chill noncitizens from enrolling in health-promoting public benefits contribute to health inequities in immigrant communities that spill over into the broader population—a fact highlighted by the still-raging COVID-19 pandemic. Restrictions …

Antiracist Lawyering In Practice Begins With The Practice Of Teaching And Learning Antiracism In Law School, Danielle M. Conway

Faculty Scholarly Works

I was honored by the invitation to deliver the 2021 Lee E. Teitelbaum keynote address. Dean Teitelbaum was a gentleman and a titan for justice. I am confident the antiracism work ongoing at the S.J. Quinney College of Law would have deeply resonated with him, especially knowing the challenges we are currently facing within and outside of legal education, the legal academy, and the legal profession. I am fortified in this work by Dean Elizabeth Kronk Warner’s commitment to antiracism and associated diversity, equity, and inclusion work. Finally, I applaud the students who serve on the Utah Law Review for …

De-Gentrified Black Genius: Blockchain, Copyright, And The Disintermediation Of Creativity, Tonya M. Evans

Faculty Scholarly Works

In a 2016 acceptance speech during the Black Entertainment Television (BET) Awards, actor and activist Jesse Williams used the phrase “gentrifying our genius” to refer to the insidious process of misappropriating the cultural and artistic productions of Black creators, inventors, and innovators. In that speech, he poignantly and unapologetically condemned racial discrimination and cultural misappropriation. This Article chronicles the nefarious history of the creative disempowerment of creators of color and then imagines an empowering future for those who successfully exploit their creations by fully leveraging copyright ownership and transfer termination. To that end, I reference the considerable scholarship of Professor …

Megacompany Employee Churn Meets 401(K) Vesting Schedules: A Sabotage On Workers' Retirement Wealth, Samantha J. Prince

Faculty Scholarly Works

Retirement wealth inequality and retirement security are issues that the United States has been grappling with for years. Low-paid and minority workers are most likely to be unable to accumulate retirement savings over time. This Article spotlights Amazon, one of America’s largest employers and one that has very high employee turnover. To be vested in Amazon’s 401(k) matching contributions, an employee must be there for three years—a requirement that is not being met given the much quicker turnover in their low-paid, predominantly minority warehouse workforce.

Until now, there has not been discussion about the grossly unfair result of mixing high …

German Pharmaceutical Pricing: Lessons For The United States, Marc A. Rodwin, Sara Gerke

Faculty Scholarly Works

To control pharmaceutical spending and improve access, the United States could adopt strategies similar to those introduced in Germany by the 2011 German Pharmaceutical Market Reorganization Act. In Germany, manufacturers sell new drugs immediately upon receiving marketing approval. During the first year, the German Federal Joint Committee assesses new drugs to determine their added medical benefit. It assigns them a score indicating their added benefit. New drugs comparable to drugs in a reference price group are assigned to that group and receive the same reimbursement, unless they are therapeutically superior. The National Association of Statutory Health Insurance Funds then negotiates …

Exploring Race And Racism In The Law School Curriculum: An Administrator's View On Adopting An Antiracist Curriculum, Amy Gaudion

Faculty Scholarly Works

This article provides a candid assessment of the demanding, and rewarding, work that is required to put into action the written words of institutional support for implementing an Antiracist curriculum. This article starts by describing the two Penn State Dickinson Law faculty resolutions that committed the faculty to condemn racism and bias against our Black and Brown brothers and sisters, while committing to teach and learn according to Antiracist pedagogy and best practices. It then describes the resolve to become Antiracist teachers, discusses the investments in curricular policy and reform, and details the bureaucratic processes to accomplish the following: adding …

Privacy Aspects Of Direct-To-Consumer Artificial Intelligence/Machine Learning Health Apps, Sara Gerke, Delaram Rezaeikhonakdar

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Direct-To-Consumer Artificial Intelligence/Machine Learning health apps (DTC AI/ML health apps) are increasingly being made available for download in app stores. However, such apps raise challenges, one of which is providing adequate protection of consumers' privacy. This article analyzes the privacy aspects of DTC AI/ML health apps and suggests how consumers' privacy could be better protected in the United States. In particular, it discusses the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the Federal Trade Commission (FTC) Act, the FTC's Health Breach Notification Rule, the California Consumer Privacy Act of 2018, the California Privacy Rights Act of 2020, the …

A Black Woman Law Dean Speaks About The Precarity Of Leadership, Danielle M. Conway

Faculty Scholarly Works

No abstract provided.

Employee Turnover & Partial Plan Terminations, Samantha J. Prince

Faculty Scholarly Works

Who would have expected that a pandemic would bring Congressional awareness of an oft-overlooked concept called Partial Plan Terminations? Congress codified a temporary (and now expired) partial termination safe harbor for qualified retirement plans in the Consolidated Appropriations Act, 2021. This was necessary because qualified plans can experience a partial termination due to layoffs resulting from an economic downturn. The pandemic created such an upheaval for many businesses that without such relief, an overwhelming number of plans would have partially terminated. However, even with businesses reopening, the economy continues to be in flux, and this can portend more employee turnover. …

The Alchemy Of Effective Auditor Regulation, Sarah J. Williams

Faculty Scholarly Works

The audit profession has repeatedly failed in its obligation to accurately opine on financial statements prepared by companies that trade in U.S. markets. The list of entities that have contributed to the quest for effective regulation of these auditors is long; it includes the American Institute of Certified Public Accountants (AICPA), the U.S. Securities and Exchange Commission (SEC), Congress, outside directors of public companies, and the Public Company Accounting Oversight Board (PCAOB), a recent congressional creation. Yet, despite 50 years of effort, the formula for efficacious oversight of the audit profession remains elusive.

In 2020, then-president Donald Trump proposed to …

When Is A Change Significant? The Update Problem Of Apps In Medical And Behavioral Research, Carmel Shachar, Sara Gerke, Walker Morrell, Aaron Kirby, I. Glenn Cohen, Barbara E. Bierer

Faculty Scholarly Works

Digital applications (apps) are commonly used across the research ecosystem. While apps are frequently updated in the course of clinical and behavioral research, there is limited guidance as to when an app update should trigger action related to human research participant protections and who should be responsible for monitoring and reviewing these updates. We term this the “update problem” and argue that, while it is the principal investigator's duty to track all relevant updates, the level of involvement and re-review by the institutional review board (IRB) of an approved research protocol should vary depending on whether the update may be …

The Assault On Critical Race Theory As Pretext For Populist Backlash On Higher Education, Danielle M. Conway

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The rightwing is carrying out its most recent effort to install an authoritarian regime in America, which has been boosted by Donald Trump’s white supremacist rhetoric and actions before, during, and after his four years holding the Office of the President of the United States. Resolute in the effort to destabilize American Democracy by forcing on to the populist, among other messages, “The Big Lie,” the rightwing is committed to a coordinated strategy of attacking and delegitimizing democratic institutions for the purpose of retaining economic and political power.

The attack on Critical Race Theory (“CRT”) is one element of the …

Stemming The Shadow Pandemic: Integrating Sociolegal Services In Contact Tracing And Beyond, Medha D. Makhlouf

Faculty Scholarly Works

The COVID-19 pandemic has shed light on the challenges of complying with public health guidance to isolate or quarantine without access to adequate income, housing, food, and other resources. When people cannot safely isolate or quarantine during an outbreak of infectious disease, a critical public health strategy fails. This article proposes integrating sociolegal needs screening and services into contact tracing as a way to mitigate public health harms and pandemic-related health inequities.

The (Unnoticed) Revitalization Of The Doctrine Of Equivalents, Daryl Lim

Faculty Scholarly Works

Over the past century, few patent issues have been considered so often by the Supreme Court of the United States as the doctrine of equivalents (“DOE”). This judge-made rule deals with a question that lies at the heart of patent policy—what is the best way to define property rights in an invention? The doctrine gives patentees an opportunity to ensnare an accused device that does not literally infringe a patent claim if the accused device is substantially similar to each claim limitation. Patentees enjoy this advantage, but it comes at a cost to the public, who must face the uncertainty …