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.

The transition from the Temporary Certification Program to the Permanent Certification Program will have no impact on the certifications issued to EHR technology in the temporary program. All EHR technology in the pipeline to be completed under the Temporary Certification Program must be completed within six months after the sunset of the program. ONC-ATCBs (Authorized Testing and Certification Bodies under the Temporary Certification Program) will not have any standing in the Permanent Certification 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.

When the processes are in place for the Permanent Certification Program to become fully operational, the Temporary Certification Program will sunset. Additional information regarding the sunset date will be announced by ONC.

The transition from the Temporary Certification Program to the Permanent Certification Program will have no impact on the certifications issued to EHR technology in the temporary program. All EHR technology in the pipeline to be completed under the Temporary Certification Program must be completed within six months after the sunset of the program. ONC-ATCBs (Authorized Testing and Certification Bodies under the Temporary Certification Program) will not have any standing in the Permanent Certification Program.

Certification

In June 2011, the Office of the National Coordinator for Health IT selected the American National Standards Institute (ANSI) as the ONC-Approved Accreditor (ONC-AA) for certification bodies. The ONC-AA was selected through a competitive process. The competitive process for the ONC-AA will repeat every three years.

In July, 2012 ANSI accredited the following certification bodies, which may apply to ONC for authorization to certify Electronic Health Records (EHR) technologies in the ONC Permanent Certification Program.

• Certification Commission for Health Information Technology (CCHIT)
• Drummond Group, Inc.
• ICSA Laboratories, Inc.
• InfoGard Laboratories, Inc.
• Orion Register, Inc.

For more information on the ANSI HIT Accreditation Program, please visit https://www.ansica.org/wwwversion2/outside/PROpilotONCHIT.asp?menuID=1.

Accredited certification bodies must receive authorization from ONC to begin certifying EHR technology in the Permanent Certification Program. Qualified applicants may request an application for authorization, please contact ONC at ONC-ACB@hhs.gov.

ONC-ACBs are required by regulation to renew their ONC-ACB status every three years.

Gap Certification

When the Secretary adopts new and/or updated certification criteria through rulemaking processes, gap certification will be available. Gap certification serves as a more efficient certification process to have previously certified Complete EHRs and EHR Modules tested and certified to only the applicable new and/or updated certification criteria.

Testing

The National Voluntary Laboratory Accreditation Program (NVLAP) has been acknowledged by ONC, by regulation, as the Accreditation Body for Test Labs in the Permanent Certification Program. In July, 2012 NVLAP accredited the following test laboratories, as Accredited Testing Laboratories (ATLs), qualified to test EHR technology under the Permanent Certification Program:

• Drummond Group
• Certification Commission for Health Information Technology (CCHIT)
• ICSA Laboratories, Inc.
• InfoGard Laboratories, Inc.
• SLI Global Solutions

For more information on the NVLAP HIT Laboratory Accreditation Program (LAP), please visit www.nist.gov/nvlap.

Only test tools and test procedures that have been approved by the National Coordinator can be used to test Complete EHRs and/or EHR Modules in order for them to be eligible for certification by an ONC-Authorized Certification Body (ONC-ACB).

ONC plans to continue to collaborate with NIST to develop test tools and test procedures as needed for the testing of new and/or revised certification criteria adopted by the Secretary in the future. However, as under the temporary EHR technology certification program, other entities can submit test tools and test procedures to the National Coordinator for approval.

• Final Rule for Permanent Certification Program Press Release
• Read the Final Rule for Permanent Certification Program [PDF - 412kb]