ONC plans certification well beyond electronic health records

While the majority of the ONC’s rulemaking proposal for the certification of meaningful use EHRs concerns the process of becoming a certifying entity, the 184-page document originally published March 2 is also a compelling look into the future.

Healthcare providers and health information technology leaders take note: according to the proposal, future plans for the specific certification of personal health records is repeatedly stated. Other passages speak to the existing proposal as a framework to certify “other networks designed for the electronic exchange of health information,” and in another passage, “other types of HIT.”

If that sounds overly ambitious given all that must occur for meaningful use stimulus funds to begin flowing next year (or even potentially this year for some state Medicaid incentives plans), the proposal’s foundations in transparency, competitiveness and a maturing of certification and accreditation should – and is meant to – instill faith in providers of ONC’s serious intent in the long-term establishment of a mutually beneficial health information network with population health squarely in mind.

Some assurance of a master plan, so to speak, can be found in the more detailed timelines of the new EHR certification plan as it corresponds to the stages of meaningful use detailed in the December 30 proposals of EHR standards by ONC, and of eligible professional capabilities by the Centers for Medicare and Medicaid Services (CMS).

The March 2 Notice of Proposed Rulemaking (NPRM) establishes a well-publicized temporary and then permanent certification structure, done to meet 2011 stimulus incentives and coincide with Stage 1 (and then Stage 2) meaningful use criteria.

The NPRM predicts that temporary certification largely overseen by ONC can begin this May or June, and be replaced by permanent certification led by the private sector by the first quarter of 2012. May or June could coincide with the final issuance of Stage 1 eligible professional and EHR meaningful use criteria, now that public comment ended March 15, while Stage 2 can begin when permanent certification takes over. That way private sector entities like the Certification Commission for Health Information Technology (CCHIT), the current gold standard in HIT certification, can know just what they are certifying for. And the proposal’s language concerning recertification following the temporary designation is not a repeat process, but an expansion in accordance with meaningful use stages.

And if all goes well, there’s reason to trust that the future certification of personal health records, “other types” and “other networks” can take hold.

To get there, permanent certification entities will be accredited, according to the new proposal, with oversight provided by the National Institute of Standards and Technology (NIST) and the National Voluntary Laboratory Accreditation Program (NVLAP). Likewise, the overall approach to the certification plans has been built by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). I know that sounds like a lot of layers of bureaucracy, but that is the world we are currently in. Speaking of CCHIT, the proposal notes that upon its publishing, only CCHIT has applied for and received “recognized certification body” status as outlined by the guidelines establishing the overall certification program, though the proposal clearly states ONC is seeking a competitive environment of varying temporary and permanent certification entities. (Public comment on the March 2 proposal allows 30 days for the temporary program, and 60 days for the permanent certification language.)

The proposal also estimates that meaningful use certification will remain with the current pricing range of $30,000 to $50,000, and also promises to disclose all eventual certification bodies – and the HIT systems ultimately certified – on HHS websites in another nod to transparency.

Finally, the proposal projects that even within 2010, 45 percent of the estimated 93 complete EHR systems currently available will be certified, followed by 40 percent in 2011 and the remaining 15 percent in 2012.

That is a framework we all hope can be met, all toward comprehensive EHR adoption the meaningful use program is meant to facilitate. At the same time, and while the plan for private sector certification is to be applauded, ongoing vigilance is necessary to ensure that the progress and innovation inherent in our industry does not become subject to over-regulation and truly embraces the private sector during future oversights this document also proposes.

By Justin T. Barnes


Justin Barnes is chairman of the Electronic Health Record Association and vice president of marketing, corporate development and government affairs at Greenway Medical Technologies, Inc.