United States of America: FDA guidance on digital health technologies in clinical investigations including data governance
Progress
Current status
processing consultation
23 Mar 2022 processing consultation
22 Dec 2021 in consultation
Scope
Implementers
United States of America
Policy Area
Data governance
Policy Instrument
Data protection regulation
Regulated Economic Activity
cross-cutting
Government Branch
executive
Government Body
other regulatory body
Implementation Level
national
Timeline of events
Consultation closed on draft FDA guidance on digital health technologies in clinical investigations
On 23 March 2022, the US Food and Drug Administration (FDA) closed its consultation on a draft guidance on the use of digital health technologies (DHTs), which are used to remotely acquire data about participants, in clinical trials. In providing gu…
SourceEvent type
outline
Action type
consultation closed
Government branch
executive
Government body
other regulatory body
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On 22 December 2021, the US Food and Drug Administration (FDA) published and opened a consultation on a draft guidance on the use of digital health technologies (DHTs), which are used to remotely acquire data about participants, in clinical trials. …
SourceEvent type
outline
Action type
consultation opened
Government branch
executive
Government body
other regulatory body