AI-Enabled Medical Devices: Navigating New Liability Risks and Regulatory Frontiers

Defense Research Institute’s Drug and Medical Device Committee Meeting

Overview

Product liability and mass torts counsel Jim Frederick and health care associate Caroline Herion presented to a subgroup of the Defense Research Institute’s Drug and Medical Device Committee about new liability risks and regulatory challenges related to artificial intelligence (AI)-enabled medical devices in the US and EU.

Frederick outlined the product liability risks of AI use in the life sciences sector, focusing on pharmaceutical drug development and medical devices, while Herion addressed regulatory and transactional concerns related to AI use in the health care sector.