In a risk-based regulatory framework for health IT released April 3 by federal agencies, clinical decision support software got major billing. In fact, an entire section of the draft report, developed by the Food and Drug Administration in coordination with the Office of the National Coordinator for Health IT and Federal Communications Commission, was devoted to CDS software. However, the level of detail in the report is lacking.
"Frankly, just about everything in the CDS section was already known, except for maybe two or three of the examples that they gave of unregulated CDS. Basically there just wasn't much new there," Bradley Merrill Thompson, an attorney at Washington, D.C.-based law firm Epstein Becker Green who counsels medical device companies on FDA regulatory issues, told Health Data Management.
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