Expert perspectives on recent US digital medicine regulation policy changes and the TEMPO pilot.
expert_opinion · Level V
Where this comes from
- Record sourced from PubMed, PMID 42151566.
- Also identified by DOI 10.1038/s41746-026-02786-0 and PMC identifier 13184310.
- Licence recorded as CC BY-NC-ND.
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Abstract
To enable progress in digital medicine and medical AI, particularly where these technologies extend beyond the usual boundaries of medical devices, new regulatory approaches are needed. In this first article of a three-part interview series with Dr Shantanu Nundy, an advisor on AI in the FDA Commissioner’s Office, we examine the agency’s newly announced TEMPO pilot. The pilot aims to create new pathways for digital health in chronic disease by linking oversight, evidence generation, and reimbursement.