Conformance Methods

Overview

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.

Health IT Developers certify their Health IT Modules by demonstrating conformance to certification criteria, using conformance methods (that may have associated testing, test tools and/or test data) approved by the National Coordinator. Conformance methods are how certified health IT products demonstrate their ability to meet Certification Program requirements.

Test Methods

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-Authorized Testing Laboratories (ONC-ATLs) and ONC-Authorized Certification Bodies (ONC-ACBs) to evaluate the conformance and functionality of Health IT Modules.

Testing: Certain criteria requires the formal testing of functional and standards requirements with an ONC-Authorized Testing Laboratory (ONC-ATL).  Please see ONC Conformance Test Tools page for a list of the ONC testing tools and associated criteria.

Attestation: Some criteria require attestation to a developer’s ONC-Authorized Certification Body as a demonstration of their conformance with the requirements. For more details regarding the attestation approach, please see Attestation Approach for ONC-Approved Conformance Methods.

More information regarding the Health IT Certification Programs criteria and associated test methods can be found at the following: