The ONC Health IT Certification Program (Certification Program) Test Method provides the structure for evaluating conformance of the Health IT Module to the certification criteria defined in 45 CFR Part 170 Subpart II as published in the Code of Federal Regulations. The Certification Program Test Method includes Test Procedures, Test Tools, and Test Data, and is constructed in an outcome-focused format with additional companion guide documents to aid stakeholder development of Health IT Modules. Each Test Method is listed below by certification criterion number.
Health IT certified under the Certification Program must conform to the full scope of the product’s required capabilities, including regulatory/conformance expectation clarifications and interpretations set forth in the applicable Certification Companion Guides (CCGs). Materials prepared by ONC to support pre-certification testing, such as the Certification Program Test Method, should be read and understood on the basis that they have been prepared with the express purpose of evaluating a limited subset of the product’s required capabilities in a controlled environment. As such, this type of guidance is not determinative of the full scope of a product’s required capabilities.
Test Method Feedback
Submit feedback to the Certification Program via the Health IT Feedback and Inquiry Portal. Select the applicable category to enter a ticket.
Test Procedures
The Test Procedures offer objective guidance to ONC-Authorized Testing Laboratories (ONC-ATLs) as they conduct Health IT Module testing in the Certification Program, to provide traceability from the certification criterion or criteria to testing activities, and to ensure consistency throughout the certification process. The Test Procedures format includes a grid of testing components that the ONC-ATLs would use as the test approach for that particular criterion. The key is below:
Documentation | Visual inspection | Test Tool(s) | Test Data | SVAP |
|---|---|---|---|---|
Documentation is an approved method to demonstrate conformance. This may include documents from the health IT developer or third-party that demonstrate/attest to the compliance with the criterion. | Visual inspection is an approved method to demonstrate conformance. Most commonly, this will be accomplished via a live demonstration of functionality that meets the criterion. | Indicates that a test tool(s) exists and must be used to test a portion or all of a Health IT Module’s conformance to the criterion. | Indicates that test data supplied by ONC or as required by the tool(s) must be used during the test. | Indicates that the Standards Version Advancement Process (SVAP) is applicable to the criterion. |
Attestation-Only Criteria
Several criteria do not require testing to complete certification and instead require a developer to attest directly to meeting the requirements outlined in the criterion. In these cases, the ONC-ACB verifies the health IT developer’s attested conformance to the criterion requirements. To determine whether a criterion is attestation-only, please consult the relevant test procedure for that criterion.
Note: Attestations required to demonstrate conformance to a particular criterion are not the same as the bi-annual attestations developers must submit to demonstrate ongoing adherence to the Conditions and Maintenance of Certification requirements. Please refer to the Attestations CCG to learn more about the bi-annual attestation process.
Test Tools
Test tools are designed to be used by health IT developers and implementers during software development that implements standards applicable to certification criteria used in the Certification Program. The test tools are used to evaluate conformance to the referenced standards. Certification Program Test Method test tools for applicable certification criteria are now available and can be accessed on the ONC Conformance Test Tools site.
Test Data
Test data provides a given set of input to verify that expected results are produced from defined functions during the test and accompanies the associated test tools for related certification criteria.
Certification Companion Guides
ONC provides Certification Companion Guides (CCGs) to accompany the certification criteria for health IT. The CCGs provide development guidance and technical clarifications to complement the test procedures in a single, consolidated source for certification criteria clarifications. The CCGs are intended to assist with product development in preparation for Certification Program requirements for testing and certification.
The CCGs do not undergo a formal public comment period, but ONC will accept ongoing feedback. Feedback will be considered on a case-by-case basis. Submit feedback to the Certification Program via the Health IT Feedback and Inquiry Portal. Select the applicable category to enter a ticket.