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ONC Proposes Establishing Health IT Certification Programs

by Astrid Fiano, DOTmed News Writer | March 03, 2010
ONC explains accreditation
The Office of the National Coordinator (ONC) has just released a proposal (to be published in the Federal Register) to establish certification programs for testing and certification of health information technology. Specifically, ONC proposes both a temporary certification program (so that certified electronic health record technology is available prior to when health care providers would need to report demonstrable meaningful use) and a permanent certification program to eventually replace the temporary certification program.

The Notice of Proposed Rulemaking (NPRM) details how how an organization can become an ONC-Authorized Testing and Certification Body (ONC-ATCB) and thereby authorized under the temporary program to perform testing and certification of Complete EHRs and/or EHR Modules. In the temporary certification program, the National Coordinator would assume many of the responsibilities of an accreditation body.

To become an ONC-ATCB, an organization would submit an application to the National Coordinator to demonstrate its competency and ability to both test and certify Complete EHRs and/or EHR Modules. ONC also proposes conditions and requirements applicable to the testing and certification of Complete EHRs and EHR Modules. In the temporary program, the ONC would accept applications for ONC-ATCB status at any time. The temporary program would end once the permanent certification program is established and at least one certification body has been ONC-authorized.

For the permanent program, ONC would move its accreditation responsibilities to others in the private sector. The NPRM proposes the process in the permanent program by which an organization would become an ONC-Authorized Certification Body (ONC-ACB), a status different from the ONC-ATCB above as those with ONC-ACB status would just be required to perform certification.

In the permanent program, an applicant for ONC-ACB status must be accredited prior to submitting an application to the ONC. The NPRM details how the ONC would approve an accreditor (an "ONC-Approved Accreditor" (ONC-AA)) for certification bodies that intend to apply for ONC-ACB status. In addition, for the permanent program, the National Institute of Standards and Technology through the National Voluntary Laboratory Accreditation Program, would perform accreditation of testing laboratories and determine their competency. ONC-ACBs could only accept test results from NVLAP-accredited testing laboratories when evaluating a Complete EHR or EHR Module for certification.