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.)
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 writes at HealthBlawg:David Harlow’s Health Care Law Blog, a nationally-recognized health care law and policy blog. He is an attorney and lectures extensively on health law topics to attorneys and to health care providers. Prior to entering private practice, he served as Deputy General Counsel of the Massachusetts Department of Public Health.