Healthcare IT News December 8, 2025
With the Technology-Enabled Meaningful Patient Outcomes initiative, some digital health developers will offer devices for care covered by the CMS ACCESS model while monitoring for real-world performance.
The U.S. Food and Drug Administration has launched a new initiative, the Technology-Enabled Meaningful Patient Outcomes for Digital Health Devices Pilot, or TEMPO. It’s designed as a voluntary effort to improve the health of chronic disease patients by promoting safe access to specific digital health devices.
WHY IT MATTERS
The new pilot, developed by the FDA’s Center for Devices and Radiological Health seeks to explore what agency officials are a calling a “risk-based enforcement approach” that supports digital health tools that could improve patient outcomes for cardio-kidney-metabolic, musculoskeletal, and behavioral health conditions.
“Digital health...
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