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Certification for Health IT Stakeholders

Certification Bodies & Testing Laboratories

Overview

Testing Laboratories and Certification Bodies play a key role in the ONC Certification Program. Testing and certifying Electronic Health Record (EHR) technology provides assurance and maintains quality and consistency across the certified products.

In the Temporary Certification Program (TCP), testing and certification are conducted by the same organization, an ONC-Authorized Testing and Certification Body (ONC-ATCB).

In the Permanent Certification Program (PCP), Accredited Testing Laboratories (ATLs) will conduct testing and ONC-Authorized Certification Bodies (ONC-ACBs) will conduct certification. A single organization can be both an ATL and ONC-ACB, but they must maintain a firewall between the two groups.

Getting Involved in the ONC Certification Program

Temporary Certification Program

Information on how to apply to become an ONC-ATCB

ONC-Authorized Testing and Certification Bodies (ONC-ATCBs)

ONC-ATCBs are part of the TCP. ONC-ATCBs include:

  • Surescripts LLC External Links Disclaimer - Arlington, VA
    Date of authorization: December 23, 2010.
    Scope of authorization: EHR Modules: E-Prescribing, Privacy and Security.
  • ICSA Labs External Links Disclaimer - Mechanicsburg, PA
    Date of authorization: December 10, 2010.
    Scope of authorization: Complete EHR and EHR Modules.
  • SLI Global Solutions External Links Disclaimer - Denver, CO
    Date of authorization: December 10, 2010.
    Scope of authorization: Complete EHR and EHR Modules.
  • InfoGard Laboratories, Inc. External Links Disclaimer – San Luis Obispo, CA
    Date of authorization: September 24, 2010.
    Scope of authorization: Complete EHR and EHR Modules.
  • Certification Commission for Health Information Technology (CCHIT) External Links Disclaimer - Chicago, IL
    Date of authorization: September 3, 2010.
    Scope of authorization: Complete EHR and EHR Modules.
  • Drummond Group, Inc. (DGI) External Links Disclaimer - Austin, TX
    Date of authorization: September 3, 2010.
    Scope of authorization: Complete EHR and EHR Modules.

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.

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

ONC-ACBs

Accredited certification bodies must successfully achieve Authorized Certification Body (ONC-ACB) status from ONC to begin certifying EHR technology in the Permanent Certification Program. Qualified applicants may request an application for authorization by contacting ONC at ONC-ACB@hhs.gov.

The following ANSI-Accredited Certification Bodies have achieved ONC-ACB status:

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

A single organization can be both an ATL and an ONC-ACB in the PCP if they have a strong firewall between the two programs.

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).

The application process is highlighted in Establishment of the Permanent Certification Program for Health Information Technology in sections 170.525, 170.530, and 170.535.

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:

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.