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Market Intelligence Resource | December 19, 2025

The Technology-Enabled Meaningful Patient Outcomes For Digital Health Devices Pilot Notice

On December 8, 2025, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) published this notice regarding the Technology-Enabled Meaningful Patient Outcomes For Digital Health Devices pilot. The goal of the pilot is "to promote access to certain digital health devices while safeguarding patient safety . . .

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