The 2015 Edition Test Method has been constructed in an outcome-focused format with additional companion guide documents to aid stakeholder development of Health IT Modules. The 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 of the 2015 Edition Health Information Technology (Health IT) Certification Criteria, 2015 Edition Base Electronic Health Record (EHR) Definition, and ONC Health IT Certification Program Modifications final rule as published in the Federal Register on October 16, 2015. The 2015 Edition Test Method includes Test Procedures, Test Tools and Test Data and is listed below by certification criterion number.
The 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule made several changes to the existing 2015 Edition Health IT Certification Criteria. The final rule introduced a small number of new certification criteria, revised several existing certification criteria, and it removed several certification criteria (some immediately and others on a time-limited schedule). These changes constitute the “2015 Edition Cures Update."
Health IT certified under the ONC Health IT Certification Program (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. Materials prepared by ONC to support pre-certification testing, such as the 2015 Edition 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.
2015 Edition 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.
An overview of the public feedback for the 2015 Edition Draft Test Procedures can be found in the Summary of Comments for 2015 Edition NPRM Draft Test Procedures document [PDF - 493 KB].
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 new 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:
|Eligible||Documentation||Visual inspection||Test Tool(s)||Test Data||SVAP|
|Indicates that a Health IT Module is eligible to receive gap certification if previously certified to the 2014 Edition criterion.||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.|
Test tools are designed to be used by health IT developers and implementers during the development of software that implements standards applicable to certification criteria used in the Certification Program. The test tools will be used to evaluate conformance to the referenced standards. 2015 Edition Test Tools for applicable certification criteria are now available and can be accessed at the NIST Healthcare - Standards & Testing site.
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 2015 Edition test tools for related certification criteria.
Certification Companion Guides
ONC provides Certification Companion Guides (CCGs) to accompany the 2015 Edition certification criteria. The CCGs provide development guidance and technical clarifications to complement the 2015 Edition 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.
2015 Edition CCGs will be posted as they become available and will be updated as needed. The CCGs are not undergoing a formal public comment period, but ONC will accept ongoing feedback. Feedback will be considered on a case-by-case basis.