Re-posted with permission from Today’s Wound Clinic.
On Thursday, Dec. 7th 2017, the FDA issued draft guidance explaining which clinical decision support (CDS) tools won’t be considered devices (and thus will NOT require FDA clearance). This draft guidance provides much-needed clarity for electronic health record (EHR) vendors.
I have good news. Two months in a row, the U.S. Wound Registry (USWR) and Intellicure, Inc. had ground breaking papers