2015 Edition Test Method

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.

Health IT certified under the ONC Health IT 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 ONC Health IT Certification Program via ONC.Certification@hhs.gov with “CCG” in the subject line for Certification Companion Guides and “2015 Edition TP” in the subject line for Test Procedures.

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].

Test Procedures

The test procedures offer objective guidance to Accredited Testing Laboratories (ATLs) as they conduct Health IT module testing in the ONC Health IT 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 ATLs would use as the test approach for that particular criterion. The key is below:

gap icon

documentation icon telescope icon test tool icon ONC test tool icon
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.

Test Tools

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 ONC Health IT 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 2015 Edition ONC Health IT Certification 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 2015 Edition Test Tools for related certification criteria. ONC is only providing test data for § 170.315 (g)(1) Automated Numerator Recording and § 170.315 (g)(2) Automated Measure Calculation.

Certification Companion Guides

For the first time, ONC is providing Certification Companion Guides to accompany the 2015 Edition certification criteria. The Certification Companion Guides provide development guidance and technical clarifications to complement the 2015 Edition test procedures in a single, consolidated source for certification criteria clarifications. The Certification Companion Guides are intended to assist with product development in preparation for ONC Health IT Certification Program requirements for testing and certification.

2015 Edition Certification Companion Guides will be posted as they become available and will be updated as needed. The Certification Companion Guides are not undergoing a formal public comment period, but ONC will accept ongoing feedback. Feedback will be considered on a case-by-case basis. Note that links within the CCG’s may not work until all CCG’s have been posted.

Regulation Text Citation Certification Criterion Certification Companion Guide (CCG) CCG Last Updated Sort descending Test Procedure TP Last Updated Testing
§170.315(d)(4) Amendments Guide Test Procedure None
§170.315(a)(3) Computerized provider order entry (CPOE) – diagnostic imaging Guide Test Procedure None
§170.315(d)(1) Authentication, access control, authorization Guide Test Procedure None
§170.315(a)(1) Computerized provider order entry (CPOE) – medications Guide Test Procedure None
§170.315(d)(5) Automatic access time-out Guide Test Procedure None
§170.315(d)(10) Auditing actions on health information Guide Test Procedure None
§170.315(f)(4) Transmission to cancer registries Guide Test Procedure Testing
§170.315(a)(2) Computerized provider order entry (CPOE) – laboratory Guide Test Procedure None
§170.315(a)(7) Medication list Guide Test Procedure None
§170.315(a)(8) Medication allergy list Guide Test Procedure None
§170.315(a)(11) Smoking status Guide Test Procedure None
§170.315(d)(11) Accounting of disclosures Guide Test Procedure None
§170.315(a)(6) Problem list Guide Test Procedure None
§170.315(e)(2) Secure messaging Guide Test Procedure None
§170.315(f)(3) Transmission to public health agencies — reportable laboratory tests and value/results Guide Test Procedure Testing
§170.315(f)(6) Transmission to public health agencies — antimicrobial use and resistance reporting Guide Test Procedure Testing
§170.315(d)(7) End-user device encryption Guide Test Procedure None
§170.315(g)(5) Accessibility-centered design Guide Test Procedure None
§170.315(d)(8) Integrity Guide Test Procedure None
§170.315(e)(3) Patient health information capture Guide Test Procedure None
§170.315(d)(6) Emergency access Guide Test Procedure None
§170.315(b)(3) Electronic prescribing Guide Test Procedure Testing
§170.315(h)(1) Direct Project Guide Test Procedure Testing
§170.315(g)(4) Quality management system Guide Test Procedure None
§170.315(a)(12) Family health history Guide Test Procedure None
§170.315(f)(1) Transmission to immunization registries Guide Test Procedure
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  1. Alt. Test Method updated on 12-18-2017
Testing
§170.315(a)(4) Drug-drug, drug-allergy interaction checks for CPOE Guide Test Procedure None
§170.315(a)(9) Clinical decision support (CDS) Guide Test Procedure None
§170.315(f)(7) Transmission to public health agencies — health care surveys Guide Test Procedure Testing
§170.315(d)(3) Audit report(s) Guide Test Procedure None
§170.315(a)(14) Implantable device list Guide Test Procedure None
§170.315(a)(15) Social, psychological, and behavioral data Guide Test Procedure None
§170.315(c)(2) Clinical quality measures (CQMs) — import and calculate Guide Test Procedure
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  1. Alt. Test Method updated on 06-23-2017
Testing
§170.315(c)(3) Clinical quality measures (CQMs) — report Guide Test Procedure
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  1. Alt. Test Method updated on 06-23-2017
Testing
§170.315(c)(1) Clinical quality measures (CQMs) — record and export Guide Test Procedure Testing
§170.315(f)(5) Transmission to public health agencies — electronic case reporting Guide Test Procedure None
§170.315(f)(2) Transmission to public health agencies — syndromic surveillance Guide Test Procedure Testing
§170.315(a)(13) Patient-specific education resources Guide Test Procedure None
§170.315(d)(9) Trusted connection Guide Test Procedure None
§170.315(a)(5) Demographics Guide Test Procedure None
§170.315(g)(1) Automated numerator recording Guide Test Procedure Testing
§170.315(d)(2) Auditable events and tamper-resistance Guide Test Procedure None
§170.315(h)(2) Direct Project, Edge Protocol, and XDR/XDM Guide Test Procedure Testing
§170.315(g)(3) Safety-enhanced design Guide Test Procedure None
§170.315(g)(7) Application access — patient selection Guide Test Procedure None
§170.315(g)(2) Automated measure calculation Guide Test Procedure Testing
§170.315(a)(10) Drug-formulary and preferred drug list checks Guide Test Procedure None
§170.315(c)(4) Clinical quality measures (CQMs) — filter Guide Test Procedure
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  1. Alt. Test Method updated on 12-01-2017
Testing
§170.315(e)(1) View, download, and transmit to 3rd party Guide Test Procedure Testing
§170.315(b)(2) Clinical information reconciliation and incorporation Guide Test Procedure Testing
§170.315(b)(5) Common Clinical Data Set summary record – receive Guide Test Procedure Testing
§170.315(b)(8) Data segmentation for privacy – receive Guide Test Procedure Testing
§170.315(g)(8) Application access — data category request Guide Test Procedure None
§170.315(b)(6) Data export Guide Test Procedure Testing
§170.315(b)(9) Care plan Guide Test Procedure Testing
§170.315(b)(1) Transitions of care Guide Test Procedure Testing
§170.315(g)(6) Consolidated CDA creation performance Guide Test Procedure Testing
§170.315(b)(4) Common Clinical Data Set summary record – create Guide Test Procedure Testing
§170.315(g)(9) Application access — all data request Guide Test Procedure Testing
§170.315(b)(7) Data segmentation for privacy – send Guide Test Procedure Testing
Content last reviewed on May 1, 2018
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