By Evan Sweeney @ Fierce Healthcare
The Food and Drug Administration released three new guidance documents on Thursday with implications for the digital health industry, including one highly anticipated guideline on how the agency plans to regulate clinical decision support tools.
The draft guidance covers decision support technology for both clinicians and patients and builds on several notable exemptions outlined in the 21st Century Cures Act. According to the guidance, analytics technology intended to support clinical diagnoses that provides room for a physician to independently review the basis of the software’s recommendations would not be regulated by the FDA. That includes software that provides current treatment guidelines based on patient information or tools that offer recommendations for a certain intervention, test or drug consistent with clinical guidelines.
Read the entire article: Fierce Healthcare