Regulatory Issues, Clinical Decision Support and AI with Bradley Merrill Thompson

https://is1-ssl.mzstatic.com/image/thumb/Podcasts116/v4/5e/fd/1c/5efd1c22-520b-6999-2ef2-7db37ce0a3c1/mza_13194991967619733058.jpg/600x600bb.jpg

Yale Certificate in Medical Software and Medical AI: Guest Experts

Yale Biomedical Informatics & Data Science

19 episodes

2 days ago

This is a set of interviews that were recorded as supplementary teaching material for both our new online Yale Certificate Program in Medical Software and Medical AI, and the original Yale/Coursera Class Introduction to Medical Software. The topics cover issues important to medical software and medical artificial intelligence, ranging from regulatory issues, to algorithm development and software engineering, to clinical implementation, and other related areas. We try to keep most of the material at the introductory to intermediate level. We hope that you feel them useful and educational.

These interviews are also available in video form on YouTube -- https://www.youtube.com/watch?v=aeyYc9hCFLE&list=PLF8QgN7ybSHzDGDIPYbQwwdcK9Tqa3Lh7. .

For more information about the Yale Certificate Program in Medical Software and Medical AI please visit https://online.yale.edu/medical-software-ai-program

The audio theme is excerpted from the song "Opening" by Magiksolo.

All content for Yale Certificate in Medical Software and Medical AI: Guest Experts is the property of Yale Biomedical Informatics & Data Science and is served directly from their servers with no modification, redirects, or rehosting. The podcast is not affiliated with or endorsed by Podjoint in any way.

Science

Education,

Courses

Regulatory Issues, Clinical Decision Support and AI with Bradley Merrill Thompson

Yale Certificate in Medical Software and Medical AI: Guest Experts

29 minutes 32 seconds

1 year ago

Regulatory Issues, Clinical Decision Support and AI with Bradley Merrill Thompson

Our guest is Attorney Bradley Merrill Thompson RAC (https://www.linkedin.com/in/bradleymerrillthompson/) who is a partner at Epstein Becker and Green P.C. At the firm, he leads the AI practice and serves in the medical device, digital health, and combination product practices. This video was recorded on Nov 28, 2023.

Further Reading:

Thompson BM, Snyder LS. FDA Oversight of AI Software Developed by Health Care Providers . Epstein, Becker and Green. 2023. Available from: https://www.healthlawadvisor.com/2023/08/10/fda-oversight-of-ai-software-developed-by-health-care-providers/
Thompson BM. FDA’s Final Guidance on Clinical Decision Support Violates the Law. LinkedIn. 2022. Available from: https://www.linkedin.com/pulse/fdas-final-guidance-clinical-decision-support-law-thompson-rac/?trackingId=K7vHT91EEExEN%2BqrezASkg%3D%3D

U.S. Food and Drug Administration (FDA) Center for Devices, Radiological Health. Clinical Decision Support Software - Guidance for Industry and Food and Drug Administration Staff. 2022. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software

This episode is also available to watch on Youtube: https://www.youtube.com/watch?v=58-2IG9aY2U