STAT+: Federal regulators invite industry, researchers, and lobbyists to closed-door meetings on clinical AI
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- FDA and CMS officials hosted a closed-door 'clinical AI demo day' on July 8 at FDA's White Oak headquarters, inviting leaders from 10 companies to demonstrate AI doctor technology firsthand
- The 10 participating companies were Anthropic, Counsel Health, Curai, K Health, Microsoft AI, Amazon One Medical, Doctronic, Ellipsis Health, Hippocratic AI, and Welldoc
- STAT spoke with four attendees — Counsel Health, K Health, Hippocratic AI, and Ellipsis Health — who summarized their comments to regulators from the meeting
- The event was designed to give federal health officials direct experience with clinical AI as it exists today, beyond white papers and policy abstracts
- Several participating startups are backed by Andreessen Horowitz and Khosla Ventures, giving influential investors a direct line into health AI rulemaking
- The meeting offered companies a chance to help shape policy as officials wrestle with two open questions: how to regulate health AI and how to pay for it
Why it matters: By inviting 10 AI companies — including major tech players and VC-backed startups — into a closed-door FDA setting, federal regulators are gathering hands-on intelligence before writing rules on clinical AI. The companies that secured a seat gain early influence over how the FDA and CMS approach both safety oversight and reimbursement for AI doctor tools.
