This week David Blumenthal, Steve Posnack and Carol Bean of the ONC announced the publication of the final (albeit temporary) EHR certification rule. The actual publication date in the Federal Register will be June 24. (Here is the display copy of the EHR Certification Rule; a permanent rule will be forthcoming later this year.)
Thetechnical standards were glossed over on a conference call with ONCthis afternoon; the focus, instead, was on getting testing andcertification rolling. Organizations or consortia may apply forrecognition as testing and/or certification organizations as soon asthe rule is published; the goal is to have these entities approved bythe end of the summer, so as to keep this train moving. Notably, CCHITwill have to apply, along with everyone else, and CCHIT-certified EHRsare not grandfathered (despite the requests of many commenters.)
Ofcourse, today's action begs the question of when the meaningful useregulation will be finalized (though clearly certification needs tocome first).
The question I didn't get to ask on the conference call today (snubbed again!) was whether ONC has been collaborating with the FDA (which has asserted jurisdiction over EHRs as "devices")so that certification under ONC standards will ultimately satisfy FDAas well. I wonder whether FDA will be as willing as ONC to delegatethe testing and certification functions out to private entities. Onewould hope that this will be addressed in the permanent EHRcertification regulations coming out soon.
June 19, 2010 in Certification, ONCView the Original article
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