• Overview
• Getting Involved in the ONC Certification Program

Overview

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

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

In the Temporary Certification Program (TCP), testing and certification were conducted by the same organization, an ONC-Authorized Testing and Certification Body (ONC-ATCB). Following the sunset of the Temporary Certification Program on October 4, 2012, ONC-ATCBs have six months to complete testing and certification activities for products already in the testing pipeline.

Getting Involved in the ONC Certification Program

ONC HIT Certification Program

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.

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

ONC-ACBs

In July 2012, ANSI accredited the following certification bodies, which then applied to ONC for authorization to certify Electronic Health Records (EHR) technologies in the ONC HIT Certification Program. ONC has authorized the following certification bodies to serve as ONC-ACBs in the ONC HIT Certification Program: 

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

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

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

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

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 ONC HIT Certification Program. In July 2012, NVLAP accredited the following test laboratories, as Accredited Testing Laboratories (ATLs), qualified to test EHR technology under the ONC HIT 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). ATLs are authorized to test Complete EHRs and/or EHR Modules according to the 2011 and/or the 2014 Edition Standards and Certification Criteria. The test tools and test procedures that align with the 2011 Edition Standards and Certification Criteria are available here , and the test tools and test procedures that align with the 2014 Edition are available here.

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, under the ONC HIT Certification Program, other entities can submit test tools and test procedures to the National Coordinator for approval.

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:

• ICSA Labs  - Mechanicsburg, PA
  Date of authorization: December 10, 2010.
  Scope of authorization: Complete EHR and EHR Modules.

• SLI Global Solutions  - Denver, CO
  Date of authorization: December 10, 2010.
  Scope of authorization: Complete EHR and EHR Modules.

• InfoGard Laboratories, Inc.  – 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)  - Chicago, IL
  Date of authorization: September 3, 2010.
  Scope of authorization: Complete EHR and EHR Modules.

• Drummond Group, Inc. (DGI)  - Austin, TX
  Date of authorization: September 3, 2010.
  Scope of authorization: Complete EHR and EHR Modules.