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.

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

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 …

Digital Home Health During The Covid-19 Pandemic Challenges To Safety, Liability, And Informed Consent, And The Way To Move Forward, Sara Gerke

Faculty Contributions to Books

In this chapter, I will first give an overview of the promise of digital home health. I will then discuss the regulation of digital home health before and during COVID-19 in the context of the US Federal Food, Drug, and Cosmetic Act (FDCA). This will be followed by a discussion of three digital home health challenges during the pandemic: 1) safety, 2) liability, and 3) informed consent. In this context, I will also make suggestions on how to move forward.

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.

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.

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 …

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 …

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 …

Feres: The “Double-Edged Sword”, Kaitlan Price

Dickinson Law Review (2017-Present)

In Feres v. United States, the Supreme Court barred service members from suing the Government under the Federal Tort Claims Act if the injuries occurred “incident to military service.” In establishing this doctrine, the Court discussed the necessity of protecting the military from lawsuits to ensure effective decision-making by military leaders.

Scholars have harshly criticized Feres in the modern era, arguing Feres must be overturned to provide service members with a greater opportunity for recovery. Specifically, many scholars admonish Feres because the Supreme Court failed to provide a clear definition of “incident to military service.” Lacking a clear definition …

Finding Parity Through Preclusion: Novel Mental Health Parity Solutions At The State Level, Ryan D. Kingshill

Dickinson Law Review (2017-Present)

Recently, the federal government has taken numerous steps to promote the equal treatment (also known as parity) of mental and physical health issues. The two most impactful actions are the Mental Health Parity and Addiction Act of 2008 and the Affordable Care Act. These acts focus on the traditional avenue for parity change—insurance regulation. While these acts have improved parity, major gaps in coverage and treatment between mental health/substance use disorder treatment and medical/surgical treatment persist. ERISA Preemption, evasive insurer behavior, lack of enforcement, and lack of consumer education continue to plague patients and healthcare professionals. On its own, federal …

Achieving Better Care In Pennsylvania By Allowing Pharmacists To Practice Pharmacy, Travis Murray

Dickinson Law Review (2017-Present)

Traditionally, state legislatures implemented Prescription Drug Monitoring Programs (“PDMPs”) to assist prescribers, pharmacists, and law enforcement in identifying patients likely to misuse, abuse, or divert controlled substances. PDMP databases contain a catalog of a patient’s recent controlled substances that pharmacies have filled, including the date, location, the quantity of medication filled, and the prescribing health care provider. Prescribers in Pennsylvania have a duty to query the PDMP before prescribing controlled substances in most clinical settings. Pharmacists have a similar duty in Pennsylvania to dispense safe and effective medication therapy to patients and to screen patients for potential signs of misuse, …

Health Ai For Good Rather Than Evil? The Need For A New Regulatory Framework For Ai-Based Medical Devices, Sara Gerke

Faculty Scholarly Works

Artificial intelligence (AI), especially its subset machine learning, has tremendous potential to improve health care. However, health AI also raises new regulatory challenges. In this Article, I argue that there is a need for a new regulatory framework for AI-based medical devices in the U.S. that ensures that such devices are reasonably safe and effective when placed on the market and will remain so throughout their life cycle. I advocate for U.S. Food and Drug Administration (FDA) and congressional actions. I focus on how the FDA could - with additional statutory authority - regulate AI-based medical devices. I show that …

The Need For A System View To Regulate Artificial Intelligence/Machine Learning-Based Software As Medical Devices, Sara Gerke, Boris Babic, Theodoros Evgeniou, I. Glenn Cohen

Faculty Scholarly Works

Artificial intelligence (AI) and Machine learning (ML) systems in medicine are poised to significantly improve health care, for example, by offering earlier diagnoses of diseases or recommending optimally individualized treatment plans. However, the emergence of AI/ML in medicine also creates challenges, which regulators must pay attention to. Which medical AI/ML-based products should be reviewed by regulators? What evidence should be required to permit marketing for AI/ML-based software as a medical device (SaMD)? How can we ensure the safety and effectiveness of AI/ML-based SaMD that may change over time as they are applied to new data? The U.S. Food and Drug …

Germany’S Digital Health Reforms In The Covid-19 Era: Lessons And Opportunities For Other Countries, Sara Gerke, Ariel D. Stern, Timo Minssen

Faculty Scholarly Works

Reimbursement is a key challenge for many new digital health solutions, whose importance and value have been highlighted and expanded by the current COVID-19 pandemic. Germany’s new Digital Healthcare Act (Digitale–Versorgung–Gesetz or DVG) entitles all individuals covered by statutory health insurance to reimbursement for certain digital health applications (i.e., insurers will pay for their use). Since Germany, like the United States (US), is a multi-payer health care system, the new Act provides a particularly interesting case study for US policymakers. We first provide an overview of the new German DVG and outline the landscape for reimbursement of digital health solutions …

Dr. Tele-Corporation: Bridging The Access-To-Care Gap, Nader Amer

Dickinson Law Review (2017-Present)

The United States is currently confronting an access-to-healthcare crisis, which rural regions are experiencing at a disproportionate rate. Many commentators have touted telemedicine as a solution for the access-to-care issue. Telemedicine uses video and telecommunication technology to allow physicians to treat patients from distant locations and thus facilitates a more equal distribution of physicians throughout the United States.

Although the telemedicine industry is quickly growing, the corporate practice of medicine doctrine impedes the industry’s expansion and consequently obstructs a viable solution to the access-to-care crisis. Generally, the corporate practice of medicine doctrine prohibits corporations and limited liability companies from employing …