The TEMPO program and the future of digital mental health regulation in the US
The high burden of traditional FDA clearance drives many novel, AI-enabled mental health devices into unregulated consumer markets. The new FDA-CMS TEMPO pilot program establishes a vital regulatory middle ground, allowing companies to commercialize using a Quality Management System without immediate premarket authorization. This commentary explores how TEMPO serves as a sandbox for real-world data, offering a blueprint to reshape the future of US digital health regulation.
Authors
- Acacia C. Parks (ORCID: https://orcid.org/0000-0001-6643-0116)
- Aubrey Shick (ORCID: https://orcid.org/0000-0002-6945-2369)
Institutions
- Launchpad Central (United States) (US)
Publication Details
- Journal
- npj Digital Medicine
- Published
- 2026-11-03
- DOI
- https://doi.org/10.1038/s41746-026-03464-x
- Primary Topic
- Healthcare Regulation
- Type
- article
- Field-Weighted Citation Impact
- 0.00