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FDA Draft Guidance Paves Way For Collecting Clinical Study Data Via Digital Health Technologies

 
• By Marion Webb

The US FDA released draft guidance on how device makers, investigators and other stakeholders can use digital health solutions to collect data from clinical study participants remotely.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.

Digitalcare
• Source: Alamy

The US Food and Drug Administration released draft guidance on 22 December on how researchers can use smartphones, wearables, and other digital health technologies to remotely collect data from clinical study participants on a continuous basis.

Under the proposed guidance, titled “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,” DHTs, which may be hardware and/or software, would not require FDA device clearance for

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