American Hospital Association December 5, 2025
The Food and Drug Administration announced Dec. 5 that it will launch the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, or TEMPO, an initiative aimed to promote access to certain digital health devices. The voluntary pilot is being launched in conjunction with the Centers for Medicare & Medicaid Services Innovation Center’s Advancing Chronic Care with Effective, Scalable Solutions Model announced Dec. 1. The ACCESS Model is designed for providers offering technology-supported care to patients with Original Medicare for managing common chronic conditions. Under the TEMPO pilot, participating digital device manufacturers would offer devices intended to provide care covered by the ACCESS program and would collect, monitor and report real-world performance data. The FDA also said that under the...
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