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Articles 1 - 11 of 11
Full-Text Articles in Law
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
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
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
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 …
German Pharmaceutical Pricing: Lessons For The United States, Marc A. Rodwin, Sara Gerke
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 …
Towards Racial Justice: The Role Of Medical-Legal Partnerships, Medha D. Makhlouf
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.
Privacy Aspects Of Direct-To-Consumer Artificial Intelligence/Machine Learning Health Apps, Sara Gerke, Delaram Rezaeikhonakdar
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 …
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
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 …
Stemming The Shadow Pandemic: Integrating Sociolegal Services In Contact Tracing And Beyond, Medha D. Makhlouf
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 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
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 …
Health Ai For Good Rather Than Evil? The Need For A New Regulatory Framework For Ai-Based Medical Devices, Sara Gerke
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 …
Germany’S Digital Health Reforms In The Covid-19 Era: Lessons And Opportunities For Other Countries, Sara Gerke, Ariel D. Stern, Timo Minssen
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 …