The Office of the National Coordinator for Health Information Technology has officially published a proposed rule establishing two certification programs--one temporary and the other permanent--to test and certify electronic health records.
Publication on March 9 in the Federal Register starts the clock for a 30-day public comment period for the temporary program ending on April 9 and a 60-day comment period on the permanent program ending on May 10. While the proposed rule describes two certification programs, ONC anticipates issuing separate final rules for each of the programs.
The proposed rule describes how an organization would become an "ONC-Authorized Testing and Certification Body" under the temporary program. An organization would submit an application and demonstrate "its competency and ability to test and certify Complete EHRs and/or EHR Modules," according to the proposed rule.
The rule mentions the Certification Commission for Health Information Technology, but does not grant it any grandfather status or other advantages over any other organizations to become an ONC-Authorized Testing and Certification Body. CCHIT, however, is the only organization to date that has tested and certified EHRs. Because organizations must be able to both test and certify, ONC expects only a few organizations ultimately will qualify under the temporary certification program.
In the proposed rule published on March 9, ONC notes that the separate final rules will supersede previously issued guidance, called the Certification Guidance Document, which governed the existing EHR certification program.
In the permanent certification program, the testing and certification of EHRs will be done by separate organizations. Upon establishment of the permanent program, ONC will move to the public sector many of the administrative processes and duties it will assume under the temporary program.
The proposed rule lays out a process under the permanent program for organizations to become an "ONC-Authorized Certification Body." These organizations would not test for compliance with certification requirements--ONC's authorization would be valid solely for certification. The National Institute of Standards and Technology would be responsible for accrediting testing laboratories and determining their competency.
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