Digital Health Technologies (DHTs) for Drug Development - fda.gov
Reported by fda.gov · all stories from fda.gov
Editorial digest
The U.S. Food and Drug Administration has released new guidance concerning the use of Digital Health Technologies (DHTs) in the process of drug development.
Digests are written in our own words from the publisher's headline — we never reproduce article text. Read the original for the full reporting.
Read the full story at fda.gov →More like this
Other stories our editors tagged with the same themes.
- Trusted health newsroom9/9/2026
STAT+: ARPA-H to invest $62 million to develop FDA-authorized AI to help treat heart failure
ARPA-H plans to invest $62 million in FDA-authorized AI for heart failure treatment.
- Reputable trade press8/20/2026
FDA-cleared medical AI rarely tested for real-world benefits - News-Medical
FDA-cleared medical AI often lacks real-world benefit testing.
- Official source8/19/2026
Most AI medical devices cleared for use were not tested on patient outcomes - EurekAlert!
Many AI medical devices approved lacked patient outcome testing.
- Reputable trade press8/19/2026
Most AI medical devices cleared for use were not tested on patient outcomes - Medical Xpress
Most cleared AI medical devices lacked patient outcome testing.
- Reputable trade press8/19/2026
Nearly All FDA-Cleared AI Medical Devices Lack Evidence of Patient Benefit - Inside Precision Medicine
Most FDA-approved AI medical devices lack strong evidence of direct patient benefit.
- Trusted health newsroom8/24/2026
STAT+: FDA digital health leader promises generative AI regulatory guidance is coming
FDA digital health head confirms generative AI regulatory guidelines are in development.
