Managing Legal Risks of GenAI Tools in Healthcare
Speaker: Prof. Michelle Mello
Affiliation: Stanford
Date: September 2025
Watch the recording on YouTube
Abstract
Generative AI tools using large language models offer the prospect of reducing physician burnout and focusing their attention on patients, not paperwork. However, they also raise legal and regulatory concerns.
This session will explore liability and regulatory issues arising from the use of generative AI tools, and strategies for optimizing the benefit-risk balance. In light of the swift and enormous strides this technology continues to make, policy and legal questions become urgent, especially in critical fields like healthcare. The landscape of relevant questions is complex and nuanced. What should be regulated and how should we define key concepts like medical devices, software or AI tools, wellness and mental health apps? Which entities have the mandate and authority - FDA, CMS, private contractors? Should governance rely on formal legal requirements or softer guidance documents? Who bears liability in the event of an adverse outcome?
Speaker bio
Prof. Michelle Mello, Stanford University
Michelle Mello, Professor of Law at Stanford Law School and Professor of Health Policy at Stanford University School of Medicine, conducts empirical research into issues at the intersection of law, ethics, and health policy. She is the author of more than 270 articles on artificial intelligence, medical liability and patient safety, and ethical and legal issues arising in biomedical research, among other topics - for example, her latest paper is titled ‘Ethical Obligations to Inform Patients About Use of AI Tools’.
She is co-director of the Healthcare Ethical Assessment Lab for Artificial Intelligence ( HEAL-AI ) at Stanford University, which conducts ethical assessments of AI tools proposed for deployment at Stanford Health Care facilities. Prof. Mello holds a Ph.D. in Health Policy and Administration in addition to a law degree. In 2022, Prof. Mello was awarded the John A. Benson Jr., MD, Professionalism Article Prize by the American Board of Internal Medicine Foundation for her article, ‘When Physicians Engage in Practices That Threaten the Nation’s Health’.
Rights and attribution
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