The Urgent Need for “Nutrition Facts Labels” for AI

August 21, 2023 -
9:00am to 10:00am

Sara Gerke, Dipl-Jur Univ, MA
Assistant Professor of Law
Penn State Dickinson Law

Abstract: Artificial Intelligence (“AI”), particularly its subset Machine Learning (“ML”), is quickly entering medical practice. The US Food and Drug Administration 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.

Sponsored by the Bioethics & Artificial Intelligence Affinity Group of the American Society for Bioethics and Humanities

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