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Unpacking FDA’s long-expected Digital Health Technology Framework

As part of the Prescription Drug User Fee program reauthorization, the FDA just published its framework for Digital Health Technologies (DHTs). The document provides a roadmap for the development of DHT policies, including the essential questions it must answer and the guidance, policies and activities it plans to undertake.

Background: Digital Health Technologies (DHT) and policy so far.

DHTs are defined as: “a system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and related uses,” according to an FDA draft guidance from December 2021.

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