United States of America: Consultation opened on draft FDA guidance on digital health technologies in clinical investigations
Description
Consultation opened on draft FDA guidance on digital health technologies in clinical investigations
On 22 December 2021, the US Food and Drug Administration (FDA) published and opened a consultation on a draft guidance on the use of digital health technologies (DHTs), which are used to remotely acquire data about participants, in clinical trials. …
Scope
Policy Area
Data governance
Policy Instrument
Data protection regulation
Regulated Economic Activity
cross-cutting
Implementation Level
national
Government Branch
executive
Government Body
other regulatory body