Recent FDA Software Recall Re-Ignites Debate Around HIT Legislation

Recent FDA Software Recall Re-Ignites Debate Around HIT Legislation-insidehealthpolicy: FDA made it clear with its class I recall of McKesson Technologies' anesthesia system -- clinical decision software that is the subject of recent legislative debate -- that it does not plan to just walk away from regulating CDS, Bradley Merrill Thompson, an attorney at Epstein, Becker & Green, said prior to Thursday's release of a tri-agency proposal for risk-based HIT regulation. The debate about how lawmakers should delineate regulatory oversight of health information technology is kicking up as stakeholders review the tri-agency proposal, which says FDA will focus on high-risk technology but leaves several regulatory areas fuzzy.