FDA's unannounced chatbot session gave select tech firms an early say in health-AI guidance

The invitation stated what the session was for. "This is a great opportunity to support HHS' goals and share your state-of-the-art understanding of safe Conversational AI development and monitoring to help FDA shape future guidance," CMS senior policy adviser Morgan Taylor wrote in the Slack workspace ^[7]. The FDA is the agency that regulates health apps as medical devices ^[4]. Any guidance that comes out of that work would apply to every company selling a patient chatbot, including those that never saw the invitation.

Regulation and payment are being discussed in the same place. A CMS adviser announced the FDA session in Slack ^[6][7], so the agency that regulates these products and the agency that runs Medicare reached industry through one channel ^[17]. "We wanted to give industry a chance to play in the sandbox of government-supported healthcare," CMS Administrator Mehmet Oz said in September, at the launch of an initiative that lets health apps bill Medicare for AI services such as wearable device tracking ^[9]. KFF Health News, in reporting published by CBS News, describes the direction as a loosely regulated future in which the government reimburses AI health apps for services as it does medical professionals ^[14].

The firms in that channel include the largest consumer platforms. Apple and Google were among the businesses invited to the February session ^[3]. KFF Health News built its account from thousands of Slack messages, meeting transcripts and video recordings ^[8]. That record establishes who got an early hearing on chatbot guidance, though the published account does not show what any company said in the session or whether those views will reach the FDA's text.

CMS's answer is that the arrangement is open. "The Health Technology Ecosystem is an open, voluntary technical collaboration," Gleason said in a statement sent by email; Gleason is chief product officer of the Office of Health Technology and Products, a unit CMS recently set up ^[20]. The February meeting did not appear on the FDA's public calendar or in its regulatory notices, and the public was not invited ^[6]. Legal experts cited by KFF Health News said the chat room resembles a federal advisory panel, a body that would be required to operate in public view ^[19].

Doctors are the group most openly uneasy. They are increasingly worried about how patients use and share their medical records with these tools, KFF Health News reported ^[15]. "Some of these tools just aren't ready for primetime," said John Whyte, CEO of the American Medical Association. "We don't have enough data about them. We don't understand how they work, how they're using the information. There's no liability if these tools get things wrong." ^[12] Health and Human Services Secretary Robert F. Kennedy Jr. has said AI is "much better informed than any doctor in the country" ^[11].

For vendors, the trade-off is early access against durable rules. A seat in the workspace gives sight of what FDA and CMS officials want before anything is written down. I would expect guidance shaped in a forum that legal experts liken to an advisory panel to be the guidance most open to challenge once the process is public ^[19]. The companies that built to it first would carry the cost of any rework.