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.”
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