FDA seeks to regulate digital health software

Mackenzie Bean - Print  | 

The Food and Drug Administration is establishing protocols — and a new digital health unit — to better regulate digital health software, reports Regulatory Focus.

The effort started last October, when the FDA released draft guidance on classifying software as a medical device. Now, the agency is sorting through the nearly 1,400 comments it received on the guidance, Bakul Patel, ‎the FDA's associate center director for digital health, said May 4 at the MedCon conference in Cincinnati.

Mr. Patel said the FDA is discussing "what clinical validation looks like for software" and cited the difficulty of regulating such rapidly evolving software programs, according to Regulatory Focus.

The FDA is also creating a new digital health unit within the Center for Devices and Radiological Health to explore regulatory pathways tailored for digital health technology that relies on real world evidence, according to the report.

More articles on health IT:

Stratasan unveils software to help strengthen population health initiatives
Surgical Care Affiliates to implement HSTpathways software across 200+ facilities: 3 things to know
5 recent vendor contracts, go-lives

© Copyright ASC COMMUNICATIONS 2019. Interested in LINKING to or REPRINTING this content? View our policies by clicking here.

To receive the latest hospital and health system business and legal news and analysis from Becker's Hospital Review, sign-up for the free Becker's Hospital Review E-weekly by clicking here.