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Health IT Regulations

Standards and Certification Regulations

Standards and Certification Criteria

2015 Edition

The 2015 Edition Proposed Rule begins ONC’s shift to a more incremental and frequent approach to publishing proposed and final rules that respond to stakeholder feedback more effectively, make “bug fixes” and regulatory improvements, and enhance interoperability.

The proposed rule was published in the Federal Register on February 26, 2014. ONC will accept comments on the proposed rule through April 28, 2014 via regulations.gov. A voluntary public comment template [DOCX - 99 KB] offers a simple and organized way to submit comments on the proposed certification criteria and associated standards and implementation specifications, and respond to specific questions posed in the preamble of the proposed rule. The final rule is expected to be issued in summer 2014.

Voluntary 2015 Edition Electronic Health Record Certification Criteria; Interoperability Updates and Regulatory Improvements Proposed Rule - 2015 [PDF - 650 KB] [DOCX - 993 KB]*

Voluntary 2015 Edition Electronic Health Record Certification Criteria; Interoperability Updates and Regulatory Improvements Correction Notice [PDF - 220 KB]

Corrections to Web Links in Voluntary 2015 Edition EHR Certification Criteria; Interoperability Updates and Regulatory Improvements Proposed Rule [DOC – 407 KB]

*This is a courtesy copy for the convenience of the public only. To ensure that we are able to understand and respond to your comments, submit narrative explanations of your comments following the instructions in the notice of proposed rulemaking.

2014 Edition

The 2014 Edition adopts certification criteria that establish the technical capabilities and specify the related standards and implementation specifications that Certified EHR Technology will need to include to support the Medicare and Medicaid EHR Incentive Programs beginning with the EHR reporting periods in fiscal and calendar year 2014.

2014 Edition Electronic Health Record Certification Criteria: Revision to the Definition of “Common Meaningful Use (MU) Data Set”  Interim Final Rule – November 4, 2013 [PDF – 235 KB]

Health Information Technology: Revisions to the 2014 Edition Electronic Health Record Certification Criteria; and Medicare and Medicaid Programs; Revisions to the Electronic Health Record Incentive Program Interim Final Rule – December 7, 2012 [PDF - 254 KB]

Health Information Technology: Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology, 2014 Edition; Revisions to the Permanent Certification Program for Health Information Technology Final Rule – September 4, 2012 [PDF - 1 MB] Proposed Rule – March 7, 2012 [PDF - 2.6 MB]

2011 Edition

The 2011 Edition was adopted through a final rule in 2010 and set certification criteria that established the technical capabilities and specify the related standards and implementation specifications that Certified EHR Technology needs to include to support the meaningful use of EHRs Stage 1. The 2014 Edition replaces the 2011 Edition.

Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology Interim Final Rule – October 13, 2010 [PDF - 164 KB]

Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology Final Rule – July 28, 2010 [PDF - 492 KB] Interim Final Rule – January 13, 2010

Certification Programs for Health IT

ONC HIT Certification Program

ONC established the ONC HIT Certification Program to certify health information technology (HIT) pursuant to the authority granted to the National Coordinator for Health Information Technology in the HITECH Act.

Permanent Certification Program for Health Information Technology; Revisions to ONC-Approved Accreditor Processes Final Rule – November 25, 2011 [PDF - 172 KB] Proposed Rule – May 31, 2011 [PDF - 176 KB]

Establishment of the Permanent Certification for Health Information Technology Final Rule – January 7, 2011 [PDF - 537 KB]

Visit Certification Programs and Policy for more information on implementation of these certification criteria.