FDA digital health chief: Generative AI may need human-like evaluation

FDA intends to draft policy evaluating generative AI tools akin to human physicians, according to Rick Abramson, MD, a radiologist leading the Digital Health Center of Excellence. The agency received >300 public comments on its discussion paper and will thoughtfully synthesize t…

• Rick Abramson, MD, a Harvard-trained radiologist, is director of FDA’s Digital Health Center of Excellence and says the agency may depart from current AI regulation to evaluate generative AI similarly to human doctors.
• The FDA’s discussion paper on gen-AI evaluation closed public comment with over 300 responses; the American Medical Association urged that physician expertise inform standards, not just serve as a safety net.
• No timeline for proposed regulations was given, but Abramson emphasized policy development is a priority from the HHS Secretary and White House level.

Automated summary

RadPigeon summaries are original and for information only. They are not clinical advice.