FDA & AI  | npj Digital Medicine
By Acacia C. Parks and A. Shick, regulatory consultants |
 Illustration: TherapyTech What the author argues: Regulatory consultants Acacia C. Parks and A. Shick, who have paid ties to digital mental health companies, argue that the FDA's new TEMPO pilot offers a long-missing middle path for AI mental health tools, between costly clearance and today's unregulated consumer market. Key points: - TEMPO, run jointly by the FDA and Medicare's agency CMS, lets selected companies sell to Medicare patients without premarket authorization, collecting real-world data that may later support formal clearance.
- Unlike the FDA's hands-off policy for low-risk apps, participants must run a quality management system, meaning processes to build, monitor and fix products, which the authors say protects patients despite light upfront review.
- The FDA plans to pick up to 10 companies for TEMPO's mental health track, and the authors say that, as far as they know, only tools built on large language models have drawn active FDA interest.
- It's unclear how much real-world data will count toward clearance, and the authors urge developers to engage the FDA now, warning today's regulation-free comfort "may not last forever."
| Why this matters: Many AI tools your clients may already use sit outside FDA oversight, with no required standards for safety, effectiveness or reporting, so a middle path could change which products earn credibility and Medicare payment. Keep in mind that the authors consult for companies in this space, which may color their upbeat view of the pilot. |
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