Radiologist FDA leader believes generative AI should be evaluated like human docs
A radiologist serving in a key role for the U.S. Food and Drug Administration believes generative artificial intelligence will need to be assessed like a human physicians.
Rick Abramson, MD, director of the FDA’s Digital Health Center of Excellence, recently spoke during a panel held in Boston by industry lobbying group AdvaMed. The Harvard-trained radiologist said the agency may depart from how it currently regulates AI software when evaluating these new advanced gen-AI models, which can create content in response to prompts.
In his new role at the FDA, which started in February, Abramson is wrestling with how to handle regulating AI that behaves more like a human, according to a recap of the panel published by MedCity News. The discussion comes after the FDA also recently asked the public for feedback on how to evaluate gen AI products before they hit the market.
“So let me just say very directly, we intend to go to policy. We intend to draft policy. This is not just an academic paper. It’s not just a thought exercise,” Abramson told attendees at The MedTech Conference on Aug. 20. “I’m not a political appointee, but I can tell you that this administration has made this policy development a priority and I’m talking about at the level of the [HHS] Secretary and the White House.”
The discussion came the day after the public comment period had closed for the new FDA discussion paper. Abramson said the agency has received over 300 responses and will take time to read them. He could not say when the agency would issue proposed regulations, only that it will take time.
“Look, we intend to read the comments. We’re not just going to run them through an AI engine,” Abramson said, according to MedCity. “We’re going to read and we’re going to synthesize. We want to be very thoughtful about this because this is really important.”
The American Medical Association was among those commenting on the request for information Oct. 19. AMA believes physician expertise should inform standards for gen AI (not serve as the safety net) and wants safety and effectiveness of the technology to be prioritized over “regulatory agility.”
“GenAI has the potential to extend the reach of physicians and fundamentally improve how patients receive care. Realizing that potential requires new approaches to evaluating technologies that can perform increasingly consequential clinical functions,” AMA President Willie Underwood, MD, MSc, MPH, said in a statement Oct. 19. “Manufacturers must remain accountable for the performance of their products, and patients and physicians deserve the confidence that these technologies are safe and effective.”
Marty Stempniak has covered healthcare since 2012, with his byline appearing in the American Hospital Association's member magazine, Modern Healthcare and McKnight's. Prior to that, he wrote about village government and local business for his hometown newspaper in Oak Park, Illinois. He won a Peter Lisagor and Gold EXCEL awards in 2017 for his coverage of the opioid epidemic.