FDA Draft Guidance Paves Way For Collecting Clinical Study Data Via Digital Health Technologies
Executive Summary
The US FDA released draft guidance on how device makers, investigators and other stakeholders can use digital health solutions to collect data from clinical study participants remotely. Comments are due to the agency by 22 March 2022.
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Whether subjects can use their own personal devices, how to manage mid-study technology updates, and the extent to which data gathered will be shared with patients in real-time are all issues that sponsors, investigators and regulators need to consider.