Health IT panel endorses preliminary certification procedure

The federal advisory committee that makes recommendations on electronic health records today approved the concept of establishing a preliminary federal certification process that would begin in October and continue until the fiscal 2011 regulations are in place.

The Health and Human Services Department's Health Information Technology Policy Committee adopted an updated set of proposals from its Certification/Adoption Workgroup.

The policy panel is working on defining the certification and “meaningful use” of EHRs to determine eligibility for $45 billion in incentive payments under the economic stimulus law. Doctors and hospitals who buy the certified systems and whose use of them fits the "meaningful use" standard will qualify for the payments.

Panel members said they foresee a gap developing in managing the transition from the current certification system to a future system to be governed under “meaningful use” rules starting in fiscal 2011. To better manage the transition, the policy committee endorsed the idea of setting up a new, temporary process for vendors to prove their products are capable of supporting meaningful use.

“If approved by [the Office of the National Coordinator for Health IT], the proposed criteria should be used to create a ‘Preliminary Health and Human Services Certification’ that could be offered to vendors by October, 2009,” states the proposal adopted by the committee. “This certification is called 'preliminary' because the meaningful use criteria and the certification criteria will not yet have completed their paths through the regulatory process.”

As envisioned, the preliminary certification process would likely involve the Certification Committee on Health Information Technology, a nonprofit organization of vendors and other groups that has operated since 2004. CCHIT is the only organization currently recognized by HHS as a certifying body for health IT.

Under the plan approved today, CCHIT would be invited to submit a proposal to HHS for developing the preliminary certification process.

The policy panel also approved creating a “gap certification” procedure for vendors that were accredited in 2008 by CCHIT. The process aims to set up a temporary close-the-gap process for certain CCHIT-certified vendors to bring them up to date with the fiscal 2011 regulations. CCHIT already has conducted a “gap analysis” to determine what additional software is needed to meet anticipated criteria under the upcoming regulations.

Once the fiscal 2011 regulations are in place, multiple organizations, presumably including the CCHIT, would spring into action to test and certify health IT systems under the plan, HHS will be coordinating with the National Institute of Standards and Technology to ensure that the certifying organizations comply with basic standards.

“There will be a huge upsurge in this market — that is good,” said Gayle Harrell, committee member and former state representative in Florida. But she wondered whether there is enough time and capacity at HHS to have the fiscal 2011 rule-making in place on schedule with enough time to get the other certifying organizations in place, and for vendors to have the systems ready for sale. “Is it really tenable to have products in place by 2011?” Harrell asked.

The recommended preliminary certification process also will need to go through legal checking by HHS to ensure that it is compatible with Congress’ intent in the stimulus law, David Blumenthal, national coordinator for health IT, said at the meeting.

The certification workgroup is led by Paul Egerman, chief executive of eScription Inc., a health IT vendor, and Marc Probst, chief information officer of Intermountain Healthcare, a care providers group. It outlined several benefits of the current certification approach under CCHIT that included transparency and fairness in judging panels.