AI and Software in Research: When FDA Rules Apply - On Tech Ethics

Discusses regulatory considerations for research involving medical devices, particularly given the rise of AI and software as a medical device. Our guest today is Lauren Hartsmith, who is a consultant at The HRP Consulting Group and a human subjects protection professional with over 15 years of experience in research compliance, Institutional Review Board oversight, and regulatory affairs. Additional resources: FDA Software as a Medical Device: https://www.fda....