The leaders of two federally supported organizationsone tasked with anointing health information technology communications standards and the other with testing and certifying clinical IT systemshave proposed a formal agreement on how to coordinate their activities.
The proposed five-point memorandum of understanding would guide the relationship between the Certification Commission for Healthcare Information Technology and the Healthcare Information Technology Standards Panel. The proposal was worked out between the physician chairmen of the two organizations, Mark Leavitt of CCHIT and John Halamka of the HITSP. It is subject to review and possible amendment by the controlling bodies of the two organizations as well as their approval before it becomes effective, those leaders said. The proposal will be presented to the controlling bodies this month, they said.
The Certification Commission for Healthcare Information Technology was formed in 2004 by the American Health Information Management Association, Healthcare Information and Management Systems Society and the National Alliance for Health Information Technology as a private-sector organization to promote the adoption, particularly by office-based physicians of electronic health-record systems and other IT. In 2005, HHS awarded CCHIT a three-year contract totaling $7.5 million to develop a process to certify health IT products.
The HITSP was created by the American National Standards Institute, which certifies standards development organizations, pursuant to a $3.3 million HHS contract awarded in 2005. Its job is to select appropriate healthcare IT standards to promote the electronic transfer of healthcare information.
The need for the steps outlined in the written agreement became apparent last year after the differences stemming from when the two organizations were created and how they approached their respective tasks sparked a controversy. CCHIT predates the HITSP by more than a year. By querying its own members, which include both users and developers of IT systems, CCHIT developed its first round of 151 certification criteria for ambulatory electronic health records and began testing ambulatory EHR systems in May 2006. With a narrower task list, the HITSP receives its marching orders from the American Health Information Community, an advisory panel first convened by the HHS secretary in October 2005. The HITSP focuses on choosing the most appropriate standards to implement the data transfers specified by discrete "use cases" adopted by the AHIC. HHS Secretary Mike Leavitt didn't formally accept the HITSP's first batch of recommended IT standards until January.
As a result of the timing differences, at least one conflict resulted last year over data standards for the transmission of test results between laboratories and providers' EHR systems. CCHIT accepted for its criteria an older version of the Health Level Seven standard for lab results, a standard that its CCHIT members felt was, while a stretch, still reasonably attainable by the labs and EHR vendors. The HITSP, meanwhile, opted for a newer version, which would be far more of stretch, but would achieve goals set out in the AHIC use case. The HITSP's insistence on the as-yet largely unused and futuristic standard elicited protests from some providers and the national reference lab community.
Leavitt acknowledged the two groups worked their way through the lab standards flap, but, "We don't want it to come up again."
So, the procedure is for CCHIT to ask the HITSP for standards first, and, "If they can't respond, they'll say 'We can't respond, go ahead and work with this (other) standards development organization.' But they don't want that to permanently remove HITSP from doing its work," forcing people to use that temporary work-around permanently, Leavitt said. The process frees CCHIT to respond quickly and "drive the vision into reality at the fastest possible pace without the whole thing breaking down or having the initiative rejected because it's impractical."
For CCHIT's part, its planning document, called a road map, points out to vendors and users what criteria are likely to be worked into the testing regime in the future, giving developers time to write the code and users time to plan for coming functions.
"We'll be declaring our road map early enough that we'll be working with HITSP," Leavitt said. "That's one of the reasons why we need this. We clearly support the use cases, but we have a pulse on the market to see which criteria could be available next year or two years out."
Halamka said putting the agreement in writing was a way "to formalize how a standards harmonization body and a certification body work together. The certification folks want the systems to be interoperable and HITSP wants the standards it chooses for certification.
"Mark and I have a great working relationship," Halamka said. "We're on the phone all the time. But the scope of CCHIT is very large, and what if the certification commission has to certify EKG interoperability and Secretary Leavitt hasn't told HITSP to work on that yet? What do you do?" The memo, Halamka said, "codifies a process so there is no ambiguity."
The proposed agreement has the following points:
"What you're seeing is something the two of us drafted and we're taking to the two organizations," said Leavitt, the CCHIT chairman. "It's a work in progress."
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