Monday, June 21, 2010

EHR Certification Rule

Provisions of the EHR Certification Rule
HDM Breaking News, June 21, 2010

The new final rule establishing a temporary government-run program for certifying electronic health records becomes effective on June 24, the date of publication in the Federal Register. That's also the first day that organizations can apply to become an Authorized Testing and Certification Body (ATCB), with the goal to have such entities operational this summer and certifying their first EHRs in the fall, according to the Office of the National Coordinator for Health Information Technology.

The final rule is the first of three coordinated final rules, authorized under the HITECH Act, that seek to accelerate the adoption and "meaningful use" of EHRs across the nation. Expected soon are final rules to establish the Medicare and Medicaid incentive programs, including criteria for achieving and demonstrating meaningful use; and adoption of pertinent health information technology standards and EHR certification criteria.

The final rule for a temporary certification program has a number of technical corrections and clarifications, but is very similar to the proposed rule published in March. A reading of the rule makes it clear that ONC is not considering moving the first year of meaningful use back one year to 2012. The rule is designed to get certified EHRs in the market fast enough to enable providers to apply for first year meaningful use incentive payments in 2011.

Under the temporary program, an organization or consortium may submit an application to ONC to become an ATCB. One organization may elect to operate both the testing laboratory and certification functions. Or, two organizations, one specializing in testing and the other in certifying, may apply together. Applicants must be able to test and certify Complete EHRs and/or EHR Modules. "Testing is the process of determining the degree to which a product meets requirements. "Certification" is the assessment and assertion that a product as met all applicable certification criteria. ATCBs under the temporary program must update a list of tested and certified products at least weekly. ONC will maintain on its Web site a master list of certified products.

ONC will make a decision on ATCB applications within 30 days of receiving them. The rule gives ONC authority to suspend ATCBs for specific violations. If ONC determines EHR products were improperly certified, then recertification will be required.

ONC anticipates up to five applicants for ATCB status under the temporary program. The Certification Commission for Health Information Technology on June 21 reiterated that it would apply this week to become an ATCB.

The final rule will sunset on Dec. 31, 2011, of if a permanent EHR certification program is not yet ready, on a subsequent date that ONC will determine. ONC expects this fall to publish a final rule to establish the permanent program. ATCBs under the temporary program will be prohibited from accepting new applications for certification on or after the sunset date. They will be permitted for up to six months to complete testing and certification of products received before the sunset. Products certified under the temporary product will not lose their status when the permanent program begins, but will remain certified through their original expiration date.

--Joseph Goedert

* A copy of the EHR Temporary Certification Program rule is posted below.

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