FDA digital health leader promises generative AI regulatory guidance is coming | STAT
Skip to Main Content
My Account
Reporting from the frontiers of health and medicine
Search
Log In
Try STAT+
My Account
News
Latest
Series & Investigations
Business
Biotech
Pharma
Health Tech
Health Insurance
Hospitals
Medical Devices
Washington
Policy
FDA
NIH
Science
CRISPR
Gene Therapy
Neuroscience
Public Health
Addiction
Covid-19
Abortion
Health Disparities
Infectious Disease
Mental Health
Disease
Cancer
Cardiovascular Disease
Chronic Disease
Diabetes
Alzheimer's
Obesity
Features
Health Care Costs
The Deadliest Drug
Science, Shattered
Newsletters
Opinion
Columns
Adam Feuerstein
Matthew Herper
Ed Silverman
Reports
E-books
Podcasts
Tools & Trackers
CRISPR Tracker
Breakthrough Device Tracker
Generative AI Tracker
Obesity Drug Tracker
Events
Upcoming Events
Summits
Community
STAT Wunderkinds 2026
Video
Advertise
STAT Brand Studio
What's the word?<br>Test your knowledge with our new weekday mini crossword
Start solving
STAT Plus<br>Exclusive
FDA digital health leader promises generative AI regulatory guidance is coming
As the agency wades toward spelling out rules, it considers a ‘competency-based approach’
Manage alerts for this article
Email this article
Share this article
FDA
By Mario Aguilar<br>Aug. 24, 2026
Health Tech Correspondent
Mario Aguilar
[email protected]
Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.
The Food and Drug Administration says it is developing a plan for how to regulate medical devices that use generative artificial intelligence.
The FDA will eventually release documents spelling out agency policies regarding the technology, Rick Abramson, director of the agency’s Digital Health Center of Excellence, told STAT.<br>Advertisement
“Our goal is formal policy guidance,” he said in an interview. “The ecosystem is expecting clarity. We seek to provide that clarity, and I’ll also throw in that I think the ecosystem can expect not only broad guidance on the overall topic of generative AI, but also some more narrowly constructed specialty guidance on particular generative AI topics of special interest or special complexity.”
STAT+ Exclusive Story
Already have an account? Log in
This article is exclusive to STAT+ subscribers
Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.
Already have an account? Log in
Individual plans
Group plans
Monthly
$39
Totals $468 per year
$39/month<br>Get Started<br>Totals $468 per year
Starter
$30
for 3 months, then $399/year
$30 for 3 months<br>Get Started<br>Then $399/year
Annual
$399
Save 15%
$399/year<br>Get Started<br>Save 15%
11+ Users
Custom
Savings start at 25%!
Request A Quote<br>Request A Quote<br>Savings start at 25%!
2-10 Users
$300
Annually per user
$300/year<br>Get Started<br>$300 Annually per user
View All Plans
To read the rest of this story subscribe to STAT+.
Subscribe
Log In
Artificial intelligence, FDA, health tech, Medical devices, Policy, STAT+
Submit a correction requestReprints
Mario Aguilar
Health Tech Correspondent
Mario covers technology in health care, including FDA regulation of artificial intelligence; how Medicare pays for health tech; the use of AI in clinical care; mental health chatbots; and consumer wearables. He’s also the co-author of the free, twice weekly STAT Health Tech newsletter. You can reach Mario on Signal at mariojoze.13.
Newsletter
Tech is transforming health care and life sciences. Our original reporting is here to keep you ahead of the curve.
Please enter a valid email address.<br>Sign Up
Your data will be processed in accordance with our Privacy Policy and Terms of Service. You may opt out of receiving STAT communications at any time.
Recommended
Exclusive
Exclusive<br>August 18, 2026
STAT Plus: A pill that mimics exercise? Early results on drug designed to maintain both weight loss and muscle mass
Out of Pocket, Out of Reach
Out of Pocket, Out of Reach<br>August 18, 2026
How health care costs are undermining America’s public-sector employers
Advertisement
Exclusive
Exclusive<br>August 17, 2026
STAT Plus: UnitedHealth faces IRS probe over potential tax avoidance
Exclusive
Exclusive<br>August 14, 2026
STAT Plus: Drug-testing lab that has sparked controversy sues group that develops drug standards over criticism
Exclusive
Exclusive<br>August 13, 2026
STAT Plus: Commure terminates payments under its customer referral programs tied to AI products
Subscriber Picks
Back to top