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Certification Programs & Policy

ONC HIT Certification Program

Overview

ONC Certified HIT 2014 Logo

The ONC Health Information Technology (HIT) Certification Program is the second part of ONC's two-part approach to establish a transparent and objective certification process, following the Temporary Certification Program (TCP).

The TCP was established to ensure that Certified EHR Technology (CEHRT) be available for adoption by health care providers who sought to qualify for the Centers for Medicare and Medicaid Services (CMS) EHR incentive payments beginning in 2011.

The ONC HIT Certification Program became fully operational on October 4, 2012 and ONC continues to manage the overall program.

In the ONC HIT Certification Program, certification and testing activities are performed by separate entities. Certification is conducted by ONC-Authorized Certification Bodies (ONC-ACBs) and testing is performed by Accredited Testing Laboratories (ATLs). Developers and Vendors first test their product with an ATL, and if their product meets the requirements, they work with an ONC-ACB to certify the product. Once the product is certified, it is submitted to ONC, who posts approved products to the Certified Health IT Product List (CHPL).

It is possible for a single organization to serve as both an ONC-ACB and an ATL, as long as a firewall is established between testing and certification activities.

 

Firewall between the ONC-ACB and ATL

Testing, completed by an Accredited Testing Laboratory (ATL) is separated by a firewall from certification, which is completed by an ONC-Authorized Certification Body (ONC-ACB).

Additional information on certification and testing is available here.

Program Name Change

Per the 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 the name of the Permanent Certification Program was changed to the ONC HIT Certification Program.

A new mark for certified electronic health records (EHR) technology is available for EHR products that have been certified by an ONC-Authorized Certification Body (ONC-ACB) and will indicate that the product meets the 2014 Edition Standards and Certification Criteria.

Criteria and Terms of Use for the ONC Certified HIT Certification and Design Mark [PDF - 1 MB]

Background

In January 2011, ONC issued the Final Rule to establish the Permanent Certification Program for Health Information Technology.

In June 2011, ONC approved the American National Standards Institute (ANSI) as the ONC-Approved Accreditor (ONC-AA) for the PCP. The ONC-AA accredits organizations to certify EHR technology under the ONC HIT Certification Program. Once accredited, these organizations apply to ONC for authorization to certify EHR products. Upon authorization, these organizations become ONC-Authorized Certification Bodies (ONC-ACBs). The National Voluntary Laboratory Accreditation Program (NVLAP) accredits testing laboratories as Accredited Testing Laboratories (ATLs) in the ONC HIT Certification Program.

Additional information about the ONC HIT Certification Program is available in the Establishment of the Permanent Certification Program for Health Information Technology Final Rule [PDF - 413 KB].

Temporary Certification Program and ONC HIT Certification Program Comparison Chart

There are major differences and similarities between the Temporary Certification Program (TCP) and the Permanent Certification Program (PCP). In the TCP, testing and certified are combined, and are performed by the same entity. ONC approves and authorizes testing and certification bodies to become ONC-Authorized Testing and Certification Bodies (ONC-ATCBs). ONC-ATCBs test and certify Complete EHRs and EHR Module(s) based on applicable certification criteria. In the PCP, testing and certification are separate. However, a single organization can operate as both an Accredited Testing Laboratory (ATL) and an ONC-Authorized Certification Body (ONC-ACB) if there is a firewall between testing and certification activities. Testing laboratories are accredited by NVLAP, and certification bodies are accredited by the ONC-Approved Accreditor (ONC-AA). ONC then authorizes accredited certification bodies to serve as ONC-ACBs. ATLs test Complete EHRs and EHR Module(s) based on applicable certification criteria. ONC-ACBs certify Complete EHRs and EHR Module(s) based on applicable certification criteria. Although there are several differences between the Temporary and Permanent Programs, there are also several similarities. These similarities include: both programs are run by ONC; ONC approves test procedures in both; both programs include testing and certification of Complete EHRs and EHR Module(s); and, certified Complete EHRs and EHR Module(s) are listed on the Certified Health IT Product List (CHPL) for both programs.

Program Structure

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

ONC HIT Certification Program Overview

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).