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.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd 
• FDA Clinical Decision Support Software Guidance: https://www.fda.gov/media/109618/download 
• HRP Consulting Resources: https://thehrpconsultinggroup.com/resources/ 
• CITI Program’s Tech Ethics solution: https://about.citiprogram.org/solutions/tech-ethics/