A recent article, reporting that NIST awarded a $400,000 contract to Booz Allen Hamilton to develop a framework for electronic health record certification, stirred up lots of questions.
We needed to find out more. It took some time to locate the source document, because the terms “health IT” and “certification” aren’t in the title – instead, it’s entitled “Justification for Other than Free and Open Competition” and it is publicly available by searching fbo.gov for Department of Commerce/NIST documents released January 13, 2010. Or just use this quick link: http://bit.ly/6p2pDD
The NIST document refers to two task areas. First, “develop testing and certification program documents in support of the HHS Health IT Certification Program.” Second, “develop accreditation program documents and a proficiency testing framework to support HHS in authorizing certification and testing organizations.” Note the work product in both cases: documents, not actual programs. We see nothing here to suggest that ONC, NIST, or Booz Allen intend to build and operate a certification program themselves. They do need to develop a well-defined set of policies and processes for accreditation of those programs.
In the Interim Final Rule, ONC said they “decided to proceed with a separate notice and comment rulemaking (which we anticipate publishing shortly after this interim final rule) to establish the policies for the certification of HIT and the process a certification body will need to follow to become an authorized certification body, as determined by the National Coordinator.” [our italics] We think that’s still the most reliable description of what’s underway.
But the NIST document does offer some timing clues. This particular contract, described as a bridge to an upcoming acquisition (i.e. contract) runs 3 months, with a 3 month optional extension. Sounds to us like the soonest the accreditation package would be ready is July 2010, and of course the certifying bodies then have to apply and qualify. By which time, in our opinion, it would be impossible for a provider or hospital to begin shopping for a certified EHR and achieve Stage 1 Meaningful Use in time for the 2011 or 2012 incentives. Let us know if you agree with that assessment.
It appears clearer than ever how crucial our current work is to the health care community and to the practical achievement of the ARRA goals. Next week we’ll release an analysis of the gaps between our current 2011 criteria and the IFR, as well as a plan for promptly closing the gaps.

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I agree with Mark’s point that ONC has a lot of work to do in not a lot of time. And I applaud Mark and his organization, CCHIT, for making every effort to be ready when it comes time to apply to become an outsourced provider of HHS certification services.
In fact, I sincerely hope that every organization aspiring to provide such services to HHS is engaged in the same rigorous preparation that Mark and his organization are doing.
If this is the case, then it’s not clear to me whether starting from scratch with the IFR criteria is better or worse than performing a gap analysis compared to existing criteria, as CCHIT proposes to do.
Regardless, kudos to ONC for recognizing the importance of scrupulously maintaing vendor neutrality in every decision it makes, including this decision to ask Booz for help developing a certification process.
ONC’s concept of “EHR Modules” was a tour-de-force in vendor neutrality, for example, in that these modules help legacy EHR vendors come up to speed quickly on Meaningful Use, AND they permit innovators and specialty product vendors to assemble themselves into something comprehensive and yet transformational in the EHR market (in terms of price points, ease-of-use and so on).
ONC’s decision to work with Booz in developing a certification process is another example of its recognition of the need to be indifferent to the market…including the market for certification services.
Thank you,
Glenn Laffel, MD, PhD
Sr. VP Clinical Affairs
Practice Fusion
http://www.practicefusion.com
Free, Web-based EHR
I agree with that assessment 100 percent! Mark Leavitt stated in a Chicago article in September 2009 that “There is a high risk that providers would not achieve meaningful use to qualify for the ARRA incentives in 2011 and 2012 if they wait until late 2010 to implement certified EHR systems and technologies,”. In short, they probably would not receive any incentives until 2013.
The meaningful use requirements states that the solutions must be used for 90 days continuously in order for the Provider to receive the incentives. That’s 3 months. The average EHR solution takes about 4 months to fully implement. That’s a total of 7 months. This would require the Provider to initiate their implementation in June 2010 in order to qualify for incentives in 2011. It would be wise or recommended that the providers add an additional month for product evaluation and selection. This would suggest that the Provider start the process in May 2010.
If the accreditation package won’t be ready until July 2010, and the vendor can’t test for certification until July, one could easily surmise that the certified apps won’t be available to the Providers until sometime in August 2010. If the Provider needs to get started in May 2010, and the apps are not ready until August, this presents some very interesting challenges.
Regards,
Glenda Williams, VP Marketing
Pristine Technology Solutions, Inc
http://www.pristechsolutions.com
Waiting Room Solutions, SaaS Enterprise EHR
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