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January 07, 2022

FDA Publishes Draft Guidance on Digital Health Technologies

On December 23, the Food and Drug Administration (“FDA”) published draft guidance for industry stakeholders titled, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” In the guidance, the FDA provides recommendations to sponsors, investigators, and other stakeholders on the use of digital health technologies (“DHTs”) to acquire data remotely from participants in clinical investigations evaluating medical products. DHTs can be either hardware or software that is used to gather health-related information, which can be used to evaluate the safety and effectiveness of medical products in clinical investigations. For example, DHTS can be used to track ambulation, sleep, and the performance of everyday tasks, regardless of where participants are located, home, school, work, outdoors. Moreover, they can be used to collect information from participants who are unable to report their experiences to investigators, such as small children and cognitively impaired individuals.

Interested parties may submit comments about the draft guidance until March 23. The FDA will consider any comment submissions as it prepares the final version of its guidance.