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A1. How is the ONC Health IT Certification Program structured?

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

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Issued by: Office of the National Coordinator (ONC) of Health Information Technology

A1. How is the ONC Health IT Certification Program structured?

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:

This graphic summarizes the ONC Permanent Certification Program (PCP) operations. ONC manages the program. The National Voluntary Laboratory Accreditation Program (NVLAP) accredits Accredited Testing Laboratories (ATLs) under the PCP.  The ONC-Approved Accreditor (ONC-AA), the American National Standards Institute (ANSI), accredits ONC-Authorized Certification Bodies (ONC-ACBs).  ONC oversees these two organizations directly for the PCP.  ATLs perform testing against certification criteria and ONC-ACBs certify tested products. Developers and vendors have their product tested with an ATL, and if it passes the testing, then it is certified by an ONC-ACB. Once the product successfully achieves certification, it must be authorized by ONC for posting to the Certified Health IT Product List (CHPL).

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 accredited testing laboratories must seek authorization from ONC to test products under the ONC Health IT Certification Program.  Once authorized, they are called ONC-Authorized Testing Laboratories.  (ONC-ATLs A single organization can serve as both an ONC-ACB and an ONC-ATL, as long as a firewall is established between testing and certification activities.)

Developers or Vendors have their Health IT Module(s) tested by an ONC-ATL. After the Health IT Module has been successfully tested, it can be certified by an ONC-ACB. Products certified by an ONC-ACB are posted to the Certified Health IT Product List (CHPL).

DISCLAIMER: The contents of this database lack the force and effect of law, except as authorized by law (including Medicare Advantage Rate Announcements and Advance Notices) or as specifically incorporated into a contract. The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.