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Certification Programs & Policy

Permanent Certification Program

Overview

The Permanent Certification Program (PCP) 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 seek to qualify for the Centers for Medicare and Medicaid Services (CMS) EHR incentive payments beginning in 2011.

The PCP will replace the TCP in summer 2012, and ONC will continue to manage the overall program.

Once the PCP becomes operational, testing and certification activities will be performed by separate entities. Testing will be performed by Accredited Testing Laboratories (ATLs) and certification will be completed by ONC-Authorized Certification Bodies (ONC-ACBs). Developers and Vendors will first test their product with an ATL, and if their product meets the requirements, they will work with an ONC-ACB to certify the product. Once the product is certified, it is submitted to ONC and ONC will post the product on 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 ATL and ONC-ACB

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).

Proposed Program Name Change

The name of the Permanent Certification Program has been proposed to change to the ONC HIT Certification Program.

More information is available in 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, Notice of Proposed Rulemaking (NPRM).

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 will accredit organizations to certify EHR technology under the PCP. Once these organizations are certified by the ONC-AA, they will apply to ONC for authorization to certify EHR products. Upon authorization, these organizations will become ONC-Authorized Certification Bodies (ONC-ACBs). The National Voluntary Laboratory Accreditation Program (NVLAP) accredits testing laboratories, designating them as Accredited Testing Laboratories (ATLs) in the PCP.

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

Differences from the Temporary Certification Program

In the PCP, testing and certification will be performed by separate entities. The graphic below further explains the differences and similarities between the Permanent and Temporary Certification Programs.

The major differences and similarities between the Permanent Certification Program and Temporary Certification Program

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 PCP. As illustrated, ONC manages the overall program.

Permanent 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).