Work

Expert perspectives on recent US digital medicine regulation policy changes and the TEMPO pilot

Year: 2026

Type: article

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.

Source: npj Digital Medicine

DOI: 10.1038/s41746-026-02786-0

Authors: Stephen Gilbert, Tinglong Dai

Institutions: Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden, Johns Hopkins University

Language: English

Topic: Healthcare Regulation

Subfield: Health Information Management

Field: Health Professions

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $4,090