Lexology December 15, 2025
The U.S. Food and Drug Administration (FDA) announced the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, or “TEMPO pilot,” on December 5, 2025, alongside a Federal Register notice seeking statements of interest for participation.
The pilot will operate in connection with the Advancing Chronic Care with Effective, Scalable Solutions Model, or “ACCESS model,” from the Centers for Medicare & Medicaid Services (CMS) Center for Medicare and Medicaid Innovation (CMMI). The programs aim to “promote access to certain digital health devices while safeguarding patient safety” and help the agencies “better understand how digital health technologies perform in real-life settings and how they may support efforts to improve care for people living with chronic diseases,” according to FDA’s press release.
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