The Office of the National Coordinator for Health Information Technology (ONC) develops the functional and conformance testing requirements for the testing and certification of Health IT Modules to the certification criteria, implementation specifications, and standards adopted by the Health and Human Services (HHS) Secretary.
ONC – Authorized Testing Laboratories (ONC-ATLs)
ONC collaborated with the National Voluntary Laboratory Accreditation Program (NVLAP) to develop and maintain the Healthcare Information Technology Testing Laboratory Accreditation Program administered by NVLAP. NVLAP, administered by the National Institute of Standards and Technology (NIST), is responsible for accrediting and overseeing testing laboratories in the ONC Health IT Certification Program (Certification Program).
Effective December 19, 2016, the ONC Health IT Certification Program: Enhanced Oversight and Accountability Final Rule requires an applicant seeking to participate in the Certification Program as an ONC-ATL to complete and submit an application for authorization to the National Coordinator for Health Information Technology. Once authorized, ONC-ATLs may begin testing under the Certification Program. Pursuant to § 170.511, applicants may seek a scope of authorization for all certification criteria, a subset of the certification criteria (e.g., to support only privacy and security testing), one certification criterion, or a portion of one certification criterion. Applications may be submitted for review to ONC at any time.
The following ONC-ATLs have been accredited by NVLAP and authorized by ONC to test Health IT Modules under the Certification Program:
Only ONC-approved test methods can be used to test products intended for certification in the Certification Program (please note that any individual or organization may submit test methods to ONC for approval). Test methods (test procedures, test data, and test tools) are used by ONC-ATLs and ONC-Authorized Certification Bodies (ONC-ACBs) to evaluate the conformance and functionality of Health IT Modules.