The CDS Coalition, a group of software developers and medical device manufacturers, has released final guidelines on the design of medium-risk clinical decision support that it hopes will serve to self-regulate the industry as the Food and Drug Administration looks to publish its own guidance on high-risk CDS early next year.

“The coalition wanted to do its part to assure the safety of unregulated CDS by developing guidelines that would ensure that medium-risk CDS either leaves the decision-making in the hands of qualified users or is properly validated,” says Bradley Merrill Thompson, general counsel for the group. “We also wanted to leave low-risk CDS untouched to avoid burdening innovation in that area.”

Register or login for access to this item and much more

All Health Data Management content is archived after seven days.

Community members receive:
  • All recent and archived articles
  • Conference offers and updates
  • A full menu of enewsletter options
  • Web seminars, white papers, ebooks

Don't have an account? Register for Free Unlimited Access