Digital Commons Network^™

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

Faculty Scholarly Works

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 …

Institutional Antiracism And Critical Pedagogy: A Quantum Leap Forward For Legal Education And The Legal Academy, Danielle M. Conway

Faculty Scholarly Works

A fundamental launchpad for redeeming American society is to look to the historical and contextual goals of the Second Founding—the Reconstruction Amendments—and grasp the lessons about justice and equality for all by focusing on the principles of institutional antiracism. While our nation should deploy teaching and learning strategies at all levels of the American system of education, legal education must be out front leading the way to incorporate institutional antiracism through critical pedagogy.

This article provides the historical context in which legal education developed in the antebellum and postbellum periods and up to what might be deemed the “Third Founding” …

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.

Ethical Perspectives On Surgical Video Recording For Patients, Surgeons And Society: Systematic Review, Ross Walsh, Emma C. Kearns, Alice Moynihan, Sara Gerke, Mindy Duffourc, Marcelo Corrales Compagnucci, Timo Minssen, Ronan A. Cahill

Faculty Scholarly Works

Background

Operating-room audiovisual recording is increasingly proposed, although its ethical implications need elucidation. The aim of this systematic review was to examine the published literature on ethical aspects regarding operating-room recording.

Methods

MEDLINE (via PubMed), Embase, and Cochrane databases were systematically searched for articles describing ethical aspects regarding surgical (both intracorporeal and operating room) recording from database inception to the present (the last search was undertaken in July 2022). Medical subject headings used in the search included ‘operating room’, ‘surgery’, ‘video recording’, ‘black box’, ‘ethics’, ‘consent’, ‘confidentiality’, ‘privacy’, and more. Title, abstract, and full-text screening determined relevance. The quality of …

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

Faculty Scholarly Works

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

Faculty Scholarly Works

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 …

Comment Re: Non-Compete Clause Rulemaking, Matter No. P201200, Samantha J. Prince, Benjamin Edwards, Matthew T. Bodie, Chaz D. Brooks, Doron Dorfman, Joshua P. Fershee, Christine Hurt, Juliet Moringiello, Francis J. Mootz Iii, Griffin Toronjo Pivateau, Daiquiri Steele, Tim Azizkhan, Sarah Donley, Cassidy Eckrote, Taylor Haberle, Kathryn L. James, Julia Martinez, Tamia M. Perez, Serena T. Ruedas, Austin A. Thummel

Faculty Scholarly Works

Within signed law professors and law students submitted this letter to the Federal Trade Commission, writing in their individual capacities, not as agents of their affiliated institutions, in support of the Federal Trade Commission’s proposed rule to ban most non-compete clauses (the “Proposal”) as an unfair method of competition.

This letter offers comments in response to areas where the FTC has requested public comment. To make our views clear, this letter contains the following sections:

I. Summary of the Proposal;

II. The Commission Should Consider Expanding Its Definition of Non-Compete Clauses to Prevent Employers from Requiring Workers to Quit Before …

“Nutrition Facts Labels” For Artificial Intelligence/Machine Learning-Based Medical Devices—The Urgent Need For Labeling Standards, Sara Gerke

Faculty Scholarly Works

Artificial Intelligence (“AI”), particularly its subset Machine Learning (“ML”), is quickly entering medical practice. The U.S. Food and Drug Administration (“FDA”) has already cleared or approved more than 520 AI/ ML-based medical devices, and many more devices are in the research and development pipeline. AI/ML-based medical devices are not only used in clinics by health care providers but are also increasingly offered directly to consumers for use, such as apps and wearables. Despite their tremendous potential for improving health care, AI/ML-based medical devices also raise many regulatory issues.

This Article focuses on one issue that has not received sustained attention …

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

Faculty Scholarly Works

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 …

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

Faculty Scholarly Works

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

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 …

Privacy Shield 2.0: A New Trans-Atlantic Data Privacy Framework Between The European Union And The United States, Sara Gerke, Delaram Rezaeikhonakda

Faculty Scholarly Works

This Article is the first to thoroughly examine the new adequacy decision for the Trans-Atlantic Data Privacy Framework (also known as “Privacy Shield 2.0”), including the relevant events and milestones ultimately leading to its adoption. The European Commission adopted the new Privacy Shield on July 10, 2023, to restore transatlantic data flows and commercial exchanges between the European Union and the United States. This Article first explores the holdings of the Court of Justice of the European Union in the groundbreaking cases Schrems I and Schrems II and elaborates on the reasons for the invalidation of the Safe Harbor Decision …

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

Faculty Scholarly Works

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 …

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

Faculty Scholarly Works

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 …

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

Faculty Scholarly Works

No abstract provided.

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 …

Trademark Confusion Revealed: An Empirical Analysis, Daryl Lim

Faculty Scholarly Works

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 …

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

Faculty Scholarly Works

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.

The Shoe Is About To Drop For The Platform Economy: Understanding The Current Worker Classification Landscape In Preparation For A Changed World, Samantha J. Prince

Faculty Scholarly Works

Whether a worker is an independent contractor or employee is of great significance in many countries, including the United States. This label drives whether a worker is entitled to many protections and benefits, including, minimum wage, overtime, workers’ compensation, unemployment compensation, anti-discrimination protection, NLRA protection, etc. The difficulty inherent in accurately classifying workers as either independent contractors or employees cannot be overstated. First, there are so many tests spanning all levels of our government. Second, there are so many ways that people work and with the increased popularity of app-based work, classification becomes even more difficult. Simply, some of the …

To Explain Or Not To Explain?—Artificial Intelligence Explainability In Clinical Decision Support Systems, Julia Amann, Dennis Vetter, Stig Nikolaj Blomberg, Helle Collatz Christensen, Megan Coffee, Sara Gerke, Thomas K. Gilbert, Thilo Hagendorff, Sune Holm, Michelle Livne, Andy Spezzatti,, Inga Strümke, Roberto V. Zicari, Vince Istvan Madai

Faculty Scholarly Works

Explainability for artificial intelligence (AI) in medicine is a hotly debated topic. Our paper presents a review of the key arguments in favor and against explainability for AI-powered Clinical Decision Support System (CDSS) applied to a concrete use case, namely an AI-powered CDSS currently used in the emergency call setting to identify patients with life-threatening cardiac arrest. More specifically, we performed a normative analysis using socio-technical scenarios to provide a nuanced account of the role of explainability for CDSSs for the concrete use case, allowing for abstractions to a more general level. Our analysis focused on three layers: technical considerations, …

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 …

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 …

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

Faculty Scholarly Works

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.

The Ab5 Experiment - Should States Adopt California’S Worker Classification Law?, Samantha J. Prince

Faculty Scholarly Works

A worker's classification as either independent contractor or employee drives whether a worker is entitled to minimum wage, overtime, worker's compensation, unemployment compensation, anti-discrimination protection, National Labor Relations Act protections, and many other safety-net protections. During the COVID-19 pandemic, unemployment protections were extended to independent contractors, but this is not the norm and is not slated to continue post-pandemic. Classifying certain workers, particularly those who work in the app-based economy, is challenging, so states are looking for an answer - either through their own innovation or through that of other states. California's answer was AB5.

AB5 's goals were to …