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June 18, 2010

Final EHR certification rule announced by ONC

A surgeon can’t operate without the proper equipment. A clinician can’t achieve meaningful use of electronic health records without an EHR that is designed to improve patient care and practice efficiency. -- David Blumenthal

Today, 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.)

The technical standards were glossed over on a conference call with ONC this afternoon; the focus, instead, was on getting testing and certification rolling.  Organizations or consortia may apply for recognition as testing and/or certification organizations as soon as the rule is published; the goal is to have these entities approved by the end of the summer, so as to keep this train moving.  Notably, CCHIT will have to apply, along with everyone else, and CCHIT-certified EHRs are not grandfathered (despite the requests of many commenters.) 

Of course, today's action begs the question of when the meaningful use regulation will be finalized (though clearly certification needs to come 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 FDA as well.  I wonder whether FDA will be as willing as ONC to delegate the testing and certification functions out to private entities.  One would hope that this will be addressed in the permanent EHR certification regulations coming out soon. 

David Harlow
The Harlow Group LLC
Health Care Law and Consulting


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"Of course, today's action begs the question of when the meaningful use regulation will be finalized (though clearly certification needs to come first)." Exactly my sentiments when I read the ONC's announcement in my inbox. I have a question, though: why should certification come first?

OK, that's a bit facetious. I think I "know" why certification has to come first, considering the quickly closing timeline on stage 1 and how everyone's been held up (the certification bodies, RECs, providers) by the lack of a certification process.

But my point is that MU and certification are rather interdependent, based on my reading of the rules. Shouldn't both rules be released in their final forms before an EHR can actually be HITECH-certified?

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