Certification bodies that have obtained accreditation to ISO/IEC 17065 may seek authorization from ONC to participate in the ONC Health IT Certification Program (Certification Program). Once authorized, they are called ONC-Authorized Certification Bodies (ONC-ACBs). ONC-ACBs assess health IT and make certification decisions based on the health IT’s conformity to Certification Program requirements. Once a certification is issued by an ONC-ACB, the ONC-ACB is required by its accreditation and other Certification Program requirements to ensure continued conformity of the certified health IT, which may include surveillance activities. ONC-ACBs also post certified health IT product information and surveillance results on the Certified Health IT Product List (CHPL).
The Certification Process at a Glance
ONC-Authorized Certification Bodies (ONC-ACBs)
The following ONC-ACBs have been accredited by ANSI and authorized by ONC to certify health IT in the Certification Program:
- Drummond Group
- ICSA Labs
- UL LLC
- SLI Compliance, a Division of Gaming Laboratories International, LLC
ONC-ACB applications will be accepted and reviewed on an on-going basis. The application process is described in the Establishment of the Permanent Certification Program for Health Information Technology, Final Rule in sections 170.525, 170.530, and 170.535.