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.

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 (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 Program via the Centralized Feedback System. 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].

Test Procedures

The test procedures offer objective guidance to ONC-Authorized Testing Laboratories (ONC-ATLs) as they conduct Health IT module testing in the 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 gap icon Documentation documentation icon Visual inspectiontelescope icon Test Tool(s)test tool icon Test DataONC 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 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 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) Test Procedure Status
§170.315(a)(1) Computerized provider order entry (CPOE) – medications

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(a)(2) Computerized provider order entry (CPOE) – laboratory

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(a)(3) Computerized provider order entry (CPOE) – diagnostic imaging

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(a)(4) Drug-drug, drug-allergy interaction checks for CPOE

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(a)(5) Demographics

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(a)(9) Clinical decision support (CDS)

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(a)(10) Drug-formulary and preferred drug list checks

2015 Edition CCG

2015 Edition Test Procedure

Time Limited Certification
§170.315(a)(12) Family health history

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(a)(13) Patient-specific education resources

2015 Edition CCG

2015 Edition Test Procedure

Time Limited Certification
§170.315(a)(14) Implantable device list

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(a)(15) Social, psychological, and behavioral data

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(b)(1) Transitions of care

2015 Edition Cures Update CCG

2015 Edition CCG

2015 Edition Cures Update Test Procedure

2015 Edition Test Procedure

Revised
§170.315(b)(2) Clinical information reconciliation and incorporation

2015 Edition Cures Update CCG

2015 Edition CCG

2015 Edition Cures Update Test Procedure

2015 Edition Test Procedure

Revised
§170.315(b)(3) Electronic prescribing

2015 Edition Cures Update CCG

2015 Edition CCG

2015 Edition Cures Update Test Procedure

2015 Edition Test Procedure

Revised
§170.315(b)(6) Data export

2015 Edition CCG

2015 Edition Test Procedure

Time Limited Certification
§170.315(b)(7) Data segmentation for privacy – send—

2015 Edition Cures Update CCG

2015 Edition CCG

2015 Edition Cures Update Test Procedure

2015 Edition Test Procedure

Revised
§170.315(b)(8) Data segmentation for privacy – receive—

2015 Edition Cures Update CCG

2015 Edition CCG

2015 Edition Cures Update Test Procedure

2015 Edition Test Procedure

Revised
§170.315(b)(9) Care plan

2015 Edition Cures Update CCG

2015 Edition CCG

2015 Edition Cures Update Test Procedure

2015 Edition Test Procedure

Revised
§170.315(b)(10) Electronic Health Information export

2015 Edition CCG

2015 Edition Test Procedure

New
§170.315(c)(1) Clinical quality measures (CQMs) — record and export

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(c)(2) Clinical quality measures (CQMs) — import and calculate

2015 Edition CCG

2015 Edition Test Procedure

  1. Alt. Test Method updated on 02-28-2020
Unchanged
§170.315(c)(3) Clinical quality measures (CQMs) — report

2015 Edition Cures Update CCG

2015 Edition CCG

2015 Edition Cures Update Test Procedure

2015 Edition Test Procedure

  1. Alt. Test Method updated on 02-28-2020
Revised
§170.315(c)(4) Clinical quality measures (CQMs) — filter

2015 Edition CCG

2015 Edition Test Procedure

  1. Alt. Test Method updated on 02-28-2020
Unchanged
§170.315(d)(1) Authentication, access control, authorization

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(d)(2) Auditable events and tamper-resistance

2015 Edition Cures Update CCG

2015 Edition CCG

2015 Edition Test Procedure

Revised
§170.315(d)(3) Audit report(s)

2015 Edition Cures Update CCG

2015 Edition CCG

2015 Edition Test Procedure

Revised
§170.315(d)(4) Amendments

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(d)(5) Automatic access time-out

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(d)(6) Emergency access

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(d)(7) End-user device encryption

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(d)(8) Integrity

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(d)(9) Trusted connection

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(d)(10) Auditing actions on health information

2015 Edition Cures Update CCG

2015 Edition CCG

2015 Edition Test Procedure

Revised
§170.315(d)(11) Accounting of disclosures

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(d)(12) Encrypt authentication credentials

2015 Edition CCG

2015 Edition Test Procedure

New
§170.315(d)(13) Multi-factor authentication

2015 Edition CCG

2015 Edition Test Procedure

New
§170.315(e)(1) View, download, and transmit to 3rd party

2015 Edition Cures Update CCG

2015 Edition CCG

2015 Edition Cures Update Test Procedure

2015 Edition Test Procedure

Revised
§170.315(e)(2) Secure messaging

2015 Edition CCG

2015 Edition Test Procedure

Time Limited Certification
§170.315(e)(3) Patient health information capture

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(f)(1) Transmission to immunization registries

2015 Edition CCG

2015 Edition Test Procedure

  1. Alt. Test Method updated on 12-18-2017
Unchanged
§170.315(f)(2) Transmission to public health agencies — syndromic surveillance

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(f)(3) Transmission to public health agencies — reportable laboratory tests and value/results

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(f)(4) Transmission to cancer registries

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(f)(5) Transmission to public health agencies — electronic case reporting

2015 Edition Cures Update CCG

2015 Edition CCG

2015 Edition Cures Update Test Procedure

2015 Edition Test Procedure

Revised
§170.315(f)(6) Transmission to public health agencies — antimicrobial use and resistance reporting

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(f)(7) Transmission to public health agencies — health care surveys

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(g)(1) Automated numerator recording

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(g)(2) Automated measure calculation

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(g)(3) Safety-enhanced design

2015 Edition CCG

2015 Edition Test Procedure

Revised
§170.315(g)(4) Quality management system

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(g)(5) Accessibility-centered design

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(g)(6) Consolidated CDA creation performance

2015 Edition Cures Update CCG

2015 Edition CCG

2015 Edition Cures Update Test Procedure

2015 Edition Test Procedure

Revised
§170.315(g)(7) Application access — patient selection

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(g)(8) Application access — data category request

2015 Edition CCG

2015 Edition Test Procedure

Time Limited Certification
§170.315(g)(9) Application access — all data request

2015 Edition Cures Update CCG

2015 Edition CCG

2015 Edition Cures Update Test Procedure

2015 Edition Test Procedure

Revised
§170.315(g)(10) Standardized API for patient and population services

2015 Edition CCG

2015 Edition Test Procedure

New
§170.315(h)(1) Direct Project

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
§170.315(h)(2) Direct Project, Edge Protocol, and XDR/XDM

2015 Edition CCG

2015 Edition Test Procedure

Unchanged
Removed
Regulation Text Citation Certification Criterion Certification Companion Guide (CCG) Test Procedure Status
§170.315(a)(6) Problem list

2015 Edition CCG

2015 Edition Test Procedure

Removed
§170.315(a)(7) Medication list

2015 Edition CCG

2015 Edition Test Procedure

Removed
§170.315(a)(8) Medication allergy list

2015 Edition CCG

2015 Edition Test Procedure

Removed
§170.315(a)(11) Smoking status

2015 Edition CCG

2015 Edition Test Procedure

Removed
§170.315(b)(4) Common Clinical Data Set summary record – create

2015 Edition CCG

2015 Edition Test Procedure

Removed
§170.315(b)(5) Common Clinical Data Set summary record – receive

2015 Edition CCG

2015 Edition Test Procedure

Removed
Content last reviewed on July 13, 2020
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