Lexology April 3, 2023
In brief
On 24 March 2023, a notice was published in the Federal Register announcing that the Food and Drug Administration (FDA) published a framework for the use of digital health technologies (DHTs) in drug and biological product development. DHTs are systems that use computing platforms, connectivity, software, and/or sensors for health care and related uses. FDA previously published draft guidance identifying considerations for use of DHTs to support clinical investigations1 and relating to different aspects of DHT use.2 In the draft guidance, FDA particularly highlighted the importance of verification and validation to ensure the DHTs are for fit-for-purpose for use in the clinical investigation. Further, remote data acquisition through DHTs may raise issues including data privacy and confidentiality concerns.
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