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Health IT Regulations

Standards and Certification Regulations

Standards and Certification Criteria

2014 Edition Release 2

The 2014 Edition Release 2 EHR Certification Criteria (2014 Edition Release 2) final rule adopted ten optional 2014 Edition EHR certification criteria and two revised 2014 Edition EHR certification criteria that provide flexibility, clarity, and enhance health information exchange. The final rule also made a few improvements to the ONC Health IT (HIT) Certification Program and removed outdated regulation text from the Code of Federal Regulations.

2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange Final Rule – September, 2014.
Download final rule [PDF - 564 kb].

Proposed Voluntary Edition

We now refer to the previous “Voluntary 2015 Edition Electronic Health Record Certification Criteria; Interoperability Updates and Regulatory Improvements” proposed rule as the “Proposed Voluntary Edition” proposed rule. This prevents confusion with the new naming convention approach for editions of certification criteria as discussed in more detail in the 2014 Edition Release 2 fact sheet and the 2014 Edition Release 2 final rule.

Proposed Voluntary Edition Proposed Rule - 2015 [PDF - 650 KB] [DOCX - 993 KB]

Proposed Voluntary Edition Correction Notice [PDF - 220 KB]

Corrections to Web Links in the Proposed Voluntary Edition Proposed Rule [DOC – 407 KB]

2014 Edition

The 2014 Edition EHR certification criteria (2014 Edition) final rule adopted certification criteria that established the technical capabilities and specified the related standards and implementation specifications that Certified EHR Technology must include to support the Medicare and Medicaid EHR Incentive Programs beginning with the EHR reporting periods in fiscal and calendar year 2015. Please see the Certified EHR Technology Definition section below for recent changes to the Certified EHR Technology definition.

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.

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

Certified EHR Technology Definition

ONC recently revised the Certified EHR Technology definition to permit the use of 2011 Edition EHR technology to meet the definition for fiscal and calendar years 2014.

Medicare and Medicaid Programs; Modifications to the Medicare and Medicaid Electronic Health Record (EHR) Incentive Program for 2014 and Other Changes to the EHR Incentive Program; and Health Information Technology: Revisions to the Certified EHR Technology Definition and EHR Certification Changes Related to Standards; Final Rule [PDF - 434 KB]

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]

Please also review the 2014 Edition final rule and 2014 Edition Release 2 final rule for additional changes to the ONC HIT Certification Program.

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