Expert perspectives on recent US digital medicine regulation policy changes and the TEMPO pilot
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.
Fields of Study & Subjects
Artificial Intelligence in Healthcare and Education
Digital Mental Health Interventions
Mobile Health and mHealth Applications
Publication details
- Journal / source
- npj Digital Medicine
- Publisher
- Springer Science and Business Media LLC
- Volume
- 9
- Issue
- 1
- Publication date
- 18 May 2026
- Language
- EN