Overview
ASTP/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 ASTP/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 ASTP/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.
Initial Testing Methods
Testing: Certain criteria requires the formal testing of functional and standards requirements with an ONC-Authorized Testing Laboratory (ONC-ATL). Please see the Conformance Test Tools page for a list of the Certification Program 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.
Update Testing Methods
Gap Certification: Certified products with existing certification to specific criteria may be required to make updates to their certifications to ensure their products are up to date with changing requirements. For some of these changes, ASTP/ONC may offer developers the opportunity to meet these requirements via a gap certification method. This method is available for developers with previously certified health IT that has been updated to meet new requirements met by developer attestation to certification updates for criteria that initially required testing for certification.
Inherited Certified Status (ICS): Developers may have multiple reasons to increment their product versions outside of Certification Program required updates. For these scenarios, developers may be able to utilize ICS to maintain certification for the newer versions of their previously certified products.
To learn more about both of these update methods, please review the Applicability of ICS and Gap Certification guidance.
More information regarding the Health IT Certification Programs criteria and associated test methods can be found at the following: