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ONC Health IT Certification Program

About the ONC Health IT Certification Program

The Office of the National Coordinator for Health Information Technology (ONC) Health IT Certification Program is a voluntary certification program established by the Office of the National Coordinator for Health IT to provide for the certification of health IT standards, implementation specifications and certification criteria adopted by the Secretary.  The ONC Health IT Certification Program supports the availability of certified health IT for its encouraged and required use under federal, state and private programs.

Health IT Certification Program Overview [PDF-924KB]

Program Structure

The graphic below shows the organizational structure of the ONC Health IT Certification Program. As illustrated, ONC manages the overall program while working with other agencies and entities in the following capacities:

ONC Program Sctructure

Testing

National Voluntary Laboratory Accreditation Program (NVLAP), as administered by the National Institute of Standards and Technology (NIST) , maintains the Healthcare Information Technology Testing Laboratory Accreditation Program and accredits organizations  to perform health IT conformance testing in the ONC Health IT Certification Program in accordance with the Health Information Technology Standards, Implementation Specifications, and Certification Criteria and Certification Programs for Health Information Technology (45 CFR Part 170).

Effective December 19, 2016, the ONC Health IT Certification Program: Enhanced Oversight and Accountability Final Rule requires an organization seeking to test health IT in the ONC Health IT Certification Program, to complete and submit an application for approval to the National Coordinator for Health Information Technology to become an ONC – Authorized Testing Laboratory (ONC-ATL).

Effective February 3, 2017 the following NVLAP accredited laboratories were granted ONC-ATL status by the National Coordinator to test Complete EHRs and Health IT Modules for conformance with ONC’s standards and certification criteria according to the ONC-approved test method.

Pursuant to 170.511, applicants may seek for the scope of its authorization all certification criteria, a subset of all of the certification criteria (e.g., to support only privacy and security testing), one certification criterion, or a portion of one certification criterion. Applications will be accepted and reviewed on an on-going basis.

Please access application here: ONC-ATL Application and Principles of Proper Conduct

Certification

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). ONC – ACBs make certification determinations and conduct surveillance for Health IT tested and determined to be conformant by an ONC-ATL. ONC-ACBs also post certified Health IT product information and surveillance results on the Certified Health IT Product List (CHPL).

The American National Standards Institute (ANSI) is the current ONC-Approved Accreditor. View more information on the ANSI HIT Accreditation Program here

The following ONC-ACBs have been accredited by ANSI and authorized by ONC to certify Health IT in the ONC Health IT Certification Program:

Qualified applicants may request an application for authorization by contacting ONC at ONC-ACB@hhs.gov. The application process is described in the Establishment of the Permanent Certification Program for Health Information Technology, Final Rule in sections 170.525, 170.530, and 170.535.

For more information on the structure of the ONC Health IT Certification program, please visit our FAQs.

The Certification Process at a Glance

ONC Certification Process Description

Patients & General Public – Health IT makes it possible for patients and their doctors to manage their care through secure use and sharing of health information. For additional information on how ONC is advancing America’s health care, and the benefits Health IT, please visit our Patients and Families section.

To find a certified Health IT Module, visit the Certified Health IT Product List (CHPL).

For answers to commonly asked questions about ONC’s regulations, including the standards and certification criteria, please visit ONC’s regulatory FAQs. For questions about the ONC Health IT Certification Program, please visit the Program FAQs here.

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)

Can’t find the answer to your question? Contact the ONC Health IT Certification Program via ONC.Certification@hhs.gov.

Program Milestones

EventDate

ONC CY16 Surveillance Guidance published

November 5, 2015

2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications; Final Rule published

October 16, 2015

2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications

October 6, 2015
ONC re-authorization of ONC-Authorized Certification Bodies for second 3-year term August 2015
ONC CHPL retired 2011 edition certified products from CHPL display June 2015
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

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