Evolving AI Regulation in Health Care: CDS, Data Privacy and More
Event summary
Artificial intelligence (AI) is transforming healthcare, impacting everything from medical devices and clinical decision support (CDS) to drug application submissions. This half-day virtual conference will explore the evolving approach of the US Food and Drug Administration (FDA) to AI regulation in this broad context. Panelists will discuss AI-enabled medical devices, CDS software, the use of AI in pharmaceutical research and development, and data privacy issues, including state, federal and international regulations on clinical data use. Panelists will also provide practical data management tips.
Featured agenda item
March 26 | 10:45 – 11:45 am
Hot Topics in FDA AI Regulation: Clinical Decision Support Software, Pharmaceutical Development and the New Administration
Cooley associate Wyatt Kernell will speak on this panel, which will provide a brief overview of how AI is used in healthcare, including CDS software, AI-enabled medical devices, and pharmaceutical research and development. Panelists will then share updates on the FDA’s recent AI-related actions, including its January 17 responses to two citizen petitions challenging the agency’s 2022 final guidance on CDS and its January 7 draft guidance on using AI to support regulatory decision-making for drugs and biologics. Panelists will share insights into what to anticipate next from the FDA while analyzing the potential impacts of Loper Bright on the agency’s approach to AI policy and enforcement.
Cooley partner Sonia Nath is on the planning committee for this event.
For more information, please email Caroline Keane.
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