ONC Establishes Temporary Certification Program for EHR Technology

On June 18, the Office of the National Coordinator for Health Information Technology (ONC) issued a final rule [.pdf] establishing a temporary certification program to test and certify health information technology (HIT), including electronic health records (EHRs). This temporary certification program will be used to ensure that "Certified EHR Technology" is available for adoption by eligible professionals, eligible hospitals and critical access hospitals (CAHs) for purposes of qualifying for incentives under the Health Information Technology for Economic and Clinical Health (HITECH) Medicare and Medicaid EHR Incentive Programs, as established under the American Recovery and Reinvestment Act of 2009 (stimulus bill). The final rule describes the process for selecting organizations to test and certify Complete EHRs and EHR Modules as Certified EHR Technology.

ONC will address the specific standards, implementation specifications, and certification criteria required of Certified EHR Technology in a separate final rule to be released in the near future. ONC expects authorized organizations will be testing and certifying EHRs by the end of this summer, which will allow for certified EHR products to be on the market this fall. As more EHR technology products and systems become widely available, adoption of HIT will ideally accelerate as providers and hospitals are able to qualify for federal incentives.

In the final rule, ONC describes how an organization can become an ONC-Authorized Testing and Certification Body (ONC-ATCB), providing details of the application process, application review, testing and certification of Complete EHRs and EHR Modules, testing and certification of “minimum standards,” and authorized testing and certification methods. ONC-ATCBs that are authorized by the National Coordinator will test and certify that certain types of EHR technology (Complete EHRs and EHR Modules) meet the definition of Certified EHR Technology and are compliant with the standards, implementation specifications, and certification criteria adopted by HHS. ONC will consult with the National Institutes of Standards and Technology (NIST), and NIST will develop a test tool and test procedure for each certification criterion. Notably, the final rule does not designate the Certification Commission for Health IT (CCHIT) as a temporary certification entity, despite CCHIT’s role in certifying EHR technology since 2006. Instead, CCHIT will need to apply to become an ONC-ATCB along with other interested organizations. In addition, the final rule does not provide automatic ONC certification (or "grandfathered" status) to existing EHRs, even if the systems had previously received certification from CCHIT.

The temporary certification program was originally scheduled to sunset when ONC had authorized at least one ONC-Authorized Certification Body (ACB) under the permanent certification program, which is expected to be in place by 2012. The sunset date is now December 31, 2011, unless the permanent certification program is not fully constituted by then, in which case the National Coordinator will establish a later date.

ONC plans to issue regulations regarding establishment of the permanent certification program in the fall of 2010.

Source: www.healthcarelawandpolicy.com