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.
Gilbert et al. (2026) studied this question.