Proposed EHR Certification Rule Changes Game
The Office of the National Coordinator for Health Information Technology has issued for public viewing a proposed rule establishing two certification programs–one temporary and the other permanent–to test and certify electronic health records. The rule soon will be officially published in the Federal Register, which will start the clock for a public comment period.
The Office of the National Coordinator for Health Information Technology has issued for public viewing a proposed rule establishing two certification programs--one temporary and the other permanent--to test and certify electronic health records. The rule soon will be officially published in the Federal Register, which will start the clock for a public comment period. To view the rule and accompanying documents, click here.
The proposed rule describes how an organization would be come 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 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.
So, while CCHIT appears to be able to continue its operations under the proposed temporary certification program, its future isn't clear in the proposed permanent program.
The public comment period for the temporary certification program will be open for 30 days after publication. The public comment period for the permanent certification program will be open for 60 days after publication. While the proposed rule describes two certification programs, ONC anticipates issuing separate final rules for each of the programs.
--Joseph Goedert
The proposed rule describes how an organization would be come 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 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.
So, while CCHIT appears to be able to continue its operations under the proposed temporary certification program, its future isn't clear in the proposed permanent program.
The public comment period for the temporary certification program will be open for 30 days after publication. The public comment period for the permanent certification program will be open for 60 days after publication. While the proposed rule describes two certification programs, ONC anticipates issuing separate final rules for each of the programs.
--Joseph Goedert
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