FDA digital health leader promises generative AI regulatory guidance is coming

Ah, marvellous. The FDA's Digital Health Center of Excellence — a name that sounds like a museum wing dedicated to the future, staffed by curators of the status quo — has announced it is 'developing a plan' for regulating medical devices that use generative AI, and will 'eventually' release documents spelling out agency policies. Rick Abramson, the center's director, has thus committed the agency to producing paperwork at some unspecified point in the future. The word 'eventually' is doing heroic lifting, carrying the entire weight of a regulatory agency's response to technology that is already in hospitals. One imagines an internal memo titled 'Plan for a Plan,' currently under review by a subcommittee whose next meeting is itself 'eventually'.

Let us savour the specifics. The FDA is the same body whose premarket pathways for software as a medical device have historically moved at a pace that makes continental drift look zippy, and whose guidance on clinical decision support took years to inch through draft after draft. Meanwhile, generative AI products are being deployed in diagnostics, radiology and clinical documentation, with models that can change their outputs based on new data, the exact property the current regulatory framework is unequipped to assess. Abramson says documents will 'spell out agency policies' — as if the missing ingredient here were a well-worded memo rather than a mechanism to evaluate systems that rewrite themselves. How reassuring. I shall inform my pacemaker to wait for the PowerPoint.

No doubt Abramson is a decent sort stuck inside a machine designed to convert urgency into meetings, and this column is aimed at the machine, not the man. But the gap between 'generative AI is already here' and 'guidance is coming' is precisely the gap in which patients get hurt and manufacturers get away with anything the FDA hasn't gotten around to spelling out. By the time the documents arrive, they will be beautifully formatted, expertly cross-referenced, and comprehensively outdated. The AI, meanwhile, will have moved on to writing its own guidance. Do give my regards to the comments period.