EMR Certification Revisited

The Office of the National Coordinator for Health IT (ONC) continues its work on a Notice of Proposed Rule Making (NPRM) on EMR certification that is expected to be released by the end of next month. Numerous stakeholders are anxiously awaiting this information. The process for EMR certification was set on a course for a major revision after publication of the February 2009 ARRA legislation. The Certification Commission for Health Information Technology (CCHIT) was the only government recognized certification agency prior to ARRA. Since July, comments from the National Coordinator, David Blumenthal, and his staff indicate there will probably be more than one federally recognized certification body in the future. This is an extremely important topic because use of a certified EMR will be one of the major requirements for Meaningful Use that will enable providers to qualify for incentives for EMR adoption and use after 2011.

Coming in the middle of the uncertainty about certification, the Chairman of CCHIT, Dr. Mark Leavitt, announced his retirement effective March 2010. One can ponder the reasons for this timing. There have been six years of demanding work in previously unexplored territory. Dr. Leavitt should be proud of his accomplishments. The success of CCHIT is reflected in the approximately 85% of EMR systems that have voluntarily certified, without a government mandate. I wish him well in his future pursuits. Perhaps he has achieved most or all of his personal goals that were established during the initiation of CCHIT. But I think there may be other reasons.

Government plans will axe at least fifty percent of CCHIT's mission and work output. Previously, CCHIT as an organization had two arms. Over 200 volunteers organized in a number of workgroups have developed the criteria for EMR certification and they have developed test scripts for testing EMR systems to ensure the criteria are met. The Department of Health and Human Services and the National Institute of Standards and Technology will take over these duties in the future. The second arm has consisted of jurors, representing a cross section of organizations, who perform the actual testing. No overlap of membership in the two arms is allowed to avoid conflicts of interest. It now appears that the ONC will encourage competition for the roles compliance testing and certification of EMRs. These decisions challenge both arms of the CCHIT purpose. The government's stance must have been especially disappointing for the Chairman of CCHIT who has worked tirelessly for the past six years.

There are those who have challenged the approximately 30% vendor representation on CCHIT workgroups. The vendors represent a wide cross section of the vendor community. Their representatives provide invaluable insight about the capabilities and experience from the vendor perspective. This does not constitute vendor bias. In fact, it probably has just the opposite effect because work group members must function in a collaborative environment. We should ask: will the ONC will have the resources to match the intellectual output of the 200 plus volunteer CCHIT work group members when it develops the future certification criteria and test scripts? Furthermore, there should be concern among vendors and purchasers of EMR systems about how consistency will be guaranteed when multiple organizations are involved in certifying systems. Finally, recognize that it took CCHIT a few years to develop the organization and to recruit participants for its certification effort. Although the rules have not yet been published, there can be little doubt that the mandates for Meaningful Use will require that any new certification organizations be operational and ready to test no later than mid-2010 for the 2011 criteria. To say the least, this will be a very challenging timeline.

For another viewpoint, see: http://geekdoctor.blogspot.com/2009/11/certification-verses-meaningful-use.html