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Health IT Regulations

Standards and Certification Regulations

Standards and Certification Criteria

2015 Edition Proposed Rule

The 2015 Edition Health IT Certification Criteria (2015 Edition) proposed rule serves as a key component in ONC’s commitment to establishing an interoperable nationwide health information infrastructure. The 2015 Edition proposed rule builds on the foundation established with the 2011 and 2014 Editions, and incorporates changes designed to foster innovation, open new market opportunities, and provide more choices to the care community when it comes to electronic health information exchange. The proposed rule is open for public comment from March 30 until May 29, 2015.

2015 Edition Health Information Technology (Health IT) Certification Criteria, Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications Proposed Rule – March 30, 2015; Word version [DOCX - 704 KB]*

*Note: This document is a courtesy copy and is not an official version of the proposed rule. Please refer to the official version of the proposed rule available in the Federal Register.

ONC encourages the public to use the public comment template [DOCX - 163 KB] to submit comments on the proposed certification criteria and associated standards and implementation specifications, respond to specific questions posed in the preamble of the proposed rule, and comment on the proposed modifications to the ONC Health IT Certification Program. While use of the public comment template is entirely voluntary, commenters may find it helpful to use the document in lieu of or in addition to unstructured comments, or to use it as an addendum to narrative cover pages. Public comment should be submitted to regulations.gov.

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 The final rule also made a few improvements to the ONC Health IT (HIT) Certification Program and removed outdated regulation text from the Code of Federal Regulations.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, 10 2014.

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 [DOCX - 993 KB]

Proposed Voluntary Edition Correction Notice

Corrections to Web Links in the Proposed Voluntary Edition Proposed Rule [DOCX – 373 KB][PDF - 160 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

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

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
Proposed Rule – March 7, 2012

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

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

Certified EHR Technology Definition

ONC proposes to remove the Certified EHR Technology (CEHRT) definition from its regulations beginning with the 2015 Edition. The CEHRT definition has always been defined in a manner that supports the EHR Incentive Programs, and as such the CEHRT definition would more appropriately reside solely within the EHR Incentive Programs regulations.

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
Proposed Rule – May 31, 2011

Establishment of the Permanent Certification for Health Information Technology Final Rule – January 7, 2011

Please also review the 2015 Edition proposed rule, 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.