07-24-2012
The American National Standards Institute (ANSI) is pleased to announce the selection by the U.S. Department of Health and Human Services' (HHS) Office of the National Coordinator for Health Information Technology (ONC) as the ONC-Approved Accreditor (ONC-AA) for the Permanent Certification Program for Health Information Technology. ONC's Permanent Certification Program seeks to enhance the certification of health information technology in the United States by increasing comprehensiveness, transparency, reliability, and efficiency of the current processes used for the certification of electronic health record (EHR).
ONC's Permanent Certification Program was established by regulation in a final rule published in the Federal Register on January 7, 2011. ONC is the principal federal entity charged with coordination of nationwide efforts to implement and use the most advanced health information technology and the electronic exchange of health information.
ANSI will assess applicant certification bodies against the requirements set forth in ISO/IEC Guide 65: General requirements for bodies operating product certification systems along with the technical specification detailed by published Final Rule (CRF 170).
As an approved ONC-AA, ANSI will offer accreditation for product certification bodies in order to achieve ONC recognition by:
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Meeting ONC requirements as set forth in the CFR 170; and
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Being accredited by a third-party accreditation body to ISO/IEC Guide 65 General Requirements for Bodies Operating Product Certification Systems.
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Furthermore, the ONC requires that third-party accreditation bodies operate in accordance with ISO/IEC 17011, Conformity assessment - General requirements for accreditation bodies accrediting conformity assessment bodies. Accreditation bodies must also be signatories to the International Accreditation Forum (IAF) Multilateral Recognition Arrangement (MLA) for Product Certification which ANSI is currently a U.S. signatory to the IAF MLA for Product Certification.