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ONC Health IT Certification Program

About the ONC Health IT Certification Program

ONC Certified HIT 2014 Logo

The Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program helps to ensure that health IT conforms to the standards and certification criteria adopted by the Secretary of Health and Human Services.

The Office of Health IT Certification was established to develop and oversee national programs for the certification of health information technology by the Health Information Technology for Economic and Clinical Health (HITECH) Act. For more information about the establishment of the ONC Health IT Certification Program, please see the Establishment of the Permanent Certification Program for Health Information Technology, Final Rule.

Benefits of Certification

Health IT certification provides assurance to purchasers and other users that a system meets the technological capability, functionality, and security requirements adopted by HHS.

Certification also gives providers and patients confidence that the Health IT products and systems they use are secure and can work with other systems to share information (interoperability).

Health IT Certification Program Overview

The graphic below shows the organizational structure of the ONC Health IT Certification Program. As illustrated, ONC manages the overall program.

ONC HIT Certification Program Overview

The ONC-Approved Accreditor (ONC-AA) accredits and oversees certification bodies. Accredited certification bodies must seek authorization from ONC to participate in the ONC Health IT Certification Program - once authorized, they are called ONC-Authorized Certification Bodies (ONC-ACBs).

NVLAP is the accreditor for testing laboratories in the ONC Health IT Certification Program. NVLAP is responsible for accrediting and overseeing Accredited Testing Laboratories (ATLs). A single organization can serve as both an ONC-ACB and an ATL, as long as a firewall is established between testing and certification activities.

The Certification Process at a Glance

The graphic below provides an overview of the certification process.

Graphic: ONC Certification Program Overview

Developers or Vendors have their products tested by an ATL. After the product has been successfully tested, it can be certified by an ONC-ACB. Certified products are submitted to ONC and posted to the Certified Health IT Product List (CHPL). Providers and hospitals use certified health IT in accordance with HHS program requirements, such as the Meaningful Use and EHR Incentive Programs.

Latest News

  • March 20, 2015
    2015 Edition NPRM released 3/20/15 and associated 2015 Edition Draft Test Procedures available for public comment
  • September 11, 2014
    ONC published the 2014 Edition Release 2 EHR Certification Criteria Final Rule in the Federal Register. Read the final rule.
  • July 2014
    ONC launched the Open Test Method Development Pilot Program. For more information and to participate, visit the website here.
  • June 2014 
    Effective June 2014, ANSI began their second 3-year term as the ONC- Approved Accreditor. For more information, please see ONC’s press release.
  • April 28, 2014
    The comment period for the Voluntary 2015 Edition EHR Certification Criteria Proposed Rule closed.
  • February 26, 2014
    ONC published the Voluntary 2015 Edition EHR Certification Criteria Proposed Rule in the Federal Register. Read the proposed rule.
  • July 10, 2013
    A new mark for certified EHR technology will appear on EHR products that have been certified by an ONC-Authorized Certification Body and will indicate that the product meets the 2014 Edition Standards and Certification Criteria. Read the HHS Press release.

Program Milestones

EventDate
Final 2014 Edition Release 2 Test Method approved and published December 24, 2014
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 published September 11, 2014
ONC CY15 Surveillance Guidance [PDF - 263 KB] published July 31, 2014
ONC CY14 Surveillance Guidance [PDF - 490 KB] published July 2, 2013
CHPL 3.0 Operational January 2, 2013

Final 2014 Edition Test Method approved and published

December 14, 2012

ONC HIT Certification Program Operational

October 4, 2012

Temporary Certification Program Sunset

October 4, 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 published

 

September 4, 2012
ONC authorized the first round of certification bodies to serve as ONC-Authorized Certification Bodies (ONC-ACBs) in the ONC HIT Certification Program following their accreditation by ANSI. More information is available here July 2012
NVLAP accredited the first group of testing laboratories to serve as Accredited Testing Laboratories (ATLs) in the ONC HIT Certification Program. More information is available here July 2012
ONC-AA Announcement of ANSI by ONC June 2011

Information on the Temporary Certification Program has been archived here.

Can’t find the answer to your question? Contact the Office of Certification via ONC.Certification@hhs.gov.

Questions about the CMS EHR Incentive Program visit the CMS EHR Incentive Programs website or contact the CMS EHR Information Center.

CMS EHR Information Center Hours of Operation:

  7:30 a.m. – 6:30 p.m. (Central Time) Monday through Friday, except federal holidays.
  1-888-734-6433* (primary number) or 888-734-6563 (TTY number)

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