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Testing and Test Methods

2015 Edition Test Method

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 - 294 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

Indicates that a Health IT module is eligible to receive gap certification if previously certified to the 2014 Edition criterion.
documentation icon 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.
telescope icon 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.
test tool icon 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.

ONC Supplied Test Data

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.

Additional Resources

Privacy and Security Certification Companion Guide [PDF - 193 KB]

2015 Edition Network Time Protocol (NTP) [PDF - 157 KB]

CHPL SED Guide [PDF - 758 KB]

Master Table of Related and Required Criteria [PDF-251 KB]

Regulation Text Citationsort descending Certification Criterion Certification Companion Guide (CCG) CCG Last Updated Test Procedure TP Last Updated Test Tool
§ 170.315(a)(1)

Computerized provider order entry (CPOE) – medications

Guide

10/22/2015

Test Procedure [PDF - 290 KB]

09/21/2017

None

§ 170.315(a)(2)

CPOE – laboratory

Guide

12/10/2015

Test Procedure [PDF - 355 KB]

09/21/2017

None

§ 170.315(a)(3)

CPOE – diagnostic imaging

Guide

10/22/2015

Test Procedure [PDF - 210 KB]

09/21/2017

None

§ 170.315(a)(4)

Drug-drug, drug-allergy interaction checks for CPOE

Guide

05/08/2017

Test Procedure [PDF - 216 KB]

09/21/2017

None

§ 170.315(a)(5)

Demographics

Guide

09/29/2017

Test Procedure [PDF - 257 KB]

09/21/2017

None

§ 170.315(a)(6)

Problem list

Guide

12/18/2015

Test Procedure [PDF - 209 KB]

09/21/2017

None

§ 170.315(a)(7)

Medication list

Guide

12/18/2015

Test Procedure [PDF - 205 KB]

09/21/2017

None

§ 170.315(a)(8)

Medication allergy list

Guide

12/18/2015

Test Procedure [PDF - 199 KB]

09/21/2017

None

§ 170.315(a)(9)

Clinical decision support

Guide

05/08/2017

Test Procedure [PDF - 265 KB]

09/21/2017

None

§ 170.315(a)(10)

Drug-formulary and preferred drug list checks

Guide

05/08/2017

Test Procedure [PDF - 181 KB]

09/21/2017

None

§ 170.315(a)(11)

Smoking status

Guide

12/18/2015

Test Procedure [PDF - 140 KB]

09/21/2017

None

§ 170.315(a)(12)

Family health history

Guide

03/17/2017

Test Procedure [PDF - 140 KB]

09/21/2017

None

§ 170.315(a)(13)

Patient-specific education resources

Guide

09/29/2017

Test Procedure [PDF - 191 KB]

09/21/2017

None

§ 170.315(a)(14)

Implantable device list

Guide

07/07/2017

Test Procedure [PDF - 226 KB]

09/21/2017

None

§ 170.315(a)(15)

Social, psychological, and behavioral data

Guide

07/07/2017

Test Procedure [PDF - 247 KB]

09/21/2017

None

§ 170.315(b)(1)

Transitions of care

Guide

CCDS Guide

09/29/2017

Test Procedure [PDF - 427 KB]

CCDS Reference [PDF - 360 KB]

10/27/2017

Test Tool

§ 170.315(b)(2)

Clinical information reconciliation and incorporation

Guide

09/29/2017

Test Procedure [PDF - 141 KB]

09/29/2017

Test Tool

§ 170.315(b)(3)

Electronic prescribing

Guide

09/26/2016

Test Procedure [PDF - 252 KB]

09/26/2016

Test Tool

§ 170.315(b)(4)

Common Clinical Data Set summary record – create

Guide

CCDS Guide

09/29/2017

Test Procedure [PDF - 241 KB]

CCDS Reference [PDF - 360 KB]

01/20/2016

Test Tool

§ 170.315(b)(5)

Common Clinical Data Set summary record – receive

Guide

CCDS Guide

09/29/2017

Test Procedure [PDF - 267 KB]

CCDS Reference [PDF - 360 KB]

01/20/2016

Test Tool

§ 170.315(b)(6)

Data export

Guide

CCDS Guide

09/29/2017

Test Procedure [PDF - 219 KB]

CCDS Reference [PDF - 360 KB]

01/20/2016

Test Tool

§ 170.315(b)(7)

Data segmentation for privacy – send

Guide

09/29/2017

Test Procedure [PDF - 300 KB]

01/10/2017

Test Tool

§ 170.315(b)(8)

Data segmentation for privacy – receive

Guide

09/29/2017

Test Procedure [PDF - 311 KB]

12/07/2016

Test Tool

§ 170.315(b)(9)

Care plan

Guide

09/29/2017

Test Procedure [PDF - 177 KB]

01/20/2016

Test Tool

§ 170.315(c)(1)

Clinical quality measures (CQMs) – record and export

Guide

08/04/2017

Test Procedure [PDF - 214 KB]

08/25/2017

Test Tool

§ 170.315(c)(2)

CQMs – import and calculate

Guide

08/04/2017

Test Procedure Option 1 [PDF - 234 KB]

Test Procedure Option 2 [PDF - 154 KB]

01/10/2017

Test Tool Option 1

Test Tool Option 2

§ 170.315(c)(3)

CQMs – report

Guide

08/04/2017

Test Procedure Option 1 [PDF - 217 KB]

Test Procedure Option 2 [PDF - 144 KB]

01/10/2017

Test Tool Option 1

Test Tool Option 2

 

§ 170.315(c)(4)

CQMs – filter

Guide

08/04/2017

Test Procedure Option 1 [PDF - 264 KB]

Test Procedure Option 2 [PDF - 327 KB]

01/10/2017

Test Tool Option 1

Test Tool Option 2

§ 170.315(d)(1)

Authentication, access control, authorization

Guide

10/22/2015

Test Procedure [PDF - 186 KB]

09/21/2017

None

§ 170.315(d)(2)

Auditable events and tamper-resistance

Guide

10/27/2017

Test Procedure [PDF - 228 KB]

09/21/2017

None

§ 170.315(d)(3)

Audit report(s)

Guide

05/26/2017

Test Procedure [PDF - 215 KB]

09/21/2017

None

§ 170.315(d)(4)

Amendments

Guide

10/22/2015

Test Procedure [PDF - 180 KB]

09/21/2017

None

§ 170.315(d)(5)

Automatic access time-out

Guide

10/22/2015

Test Procedure [PDF - 161 KB]

09/21/2017

None

§ 170.315(d)(6)

Emergency access

Guide

07/20/2016

Test Procedure [PDF - 164 KB]

09/21/2017

None

§ 170.315(d)(7)

End-user device encryption

Guide

03/24/2016

Test Procedure [PDF - 198 KB]

09/21/2017

None

§ 170.315(d)(8)

Integrity

Guide

04/20/2016

Test Procedure [PDF - 211 KB]

09/21/2017

None

§ 170.315(d)(9)

Trusted connection

Guide

09/29/2017

Test Procedure [PDF - 199 KB]

09/21/2017

None

§ 170.315(d)(10)

Auditing actions on health information

Guide

10/26/2015

Test Procedure [PDF - 211 KB]

09/21/2017

None

§ 170.315(d)(11)

Accounting of disclosures

Guide

12/18/2015

Test Procedure [PDF - 248 KB]

09/21/2017

None

§ 170.315(e)(1)

View, download, and transmit to 3rd party

Guide

CCDS Guide

09/29/2017

Test Procedure [PDF - 327 KB]

CCDS Reference [PDF - 360 KB]

09/29/2017

Test Tool

§ 170.315(e)(2)

Secure messaging

Guide

01/05/2016

Test Procedure [PDF - 180 KB]

09/21/2017

None

§ 170.315(e)(3)

Patient health information capture

Guide

07/06/2016

Test Procedure [PDF - 261 KB]

09/21/2017

None

§ 170.315(f)(1)

Transmission to immunization registries

Guide

12/15/2017

Test Procedure [PDF - 329 KB]

12/15/2017

Test Tool Option 1

Test Tool Option 2

§ 170.315(f)(2)

Transmission to public health agencies – syndromic surveillance

Guide

08/25/2017

Test Procedure [PDF - 105 KB]

05/05/2016

Test Tool

§ 170.315(f)(3)

Transmission to public health agencies – reportable laboratory tests and value/results

Guide

01/29/2016

Test Procedure [PDF - 224 KB]

01/20/2016

Test Tool

§ 170.315(f)(4)

Transmission to cancer registries

Guide

10/29/2015

Test Procedure [PDF - 175 KB]

04/28/2016

Test Tool

§ 170.315(f)(5)

Transmission to public health agencies – electronic case reporting

Guide

CCDS Guide

08/11/2017

Test Procedure [PDF - 218 KB]

09/21/2017

None

§ 170.315(f)(6)

Transmission to public health agencies – antimicrobial use and resistance reporting

Guide

02/19/2016

Test Procedure [PDF - 160 KB]

01/20/2016

Test Tool

§ 170.315(f)(7)

Transmission to public health agencies – health care surveys

Guide

05/26/2017

Test Procedure [PDF - 155 KB]

10/06/2016

Test Tool

§ 170.315(g)(1)

Automated numerator recording

Guide

09/29/2017

Test Procedure [PDF - 617 KB]

02/01/2018

None

§ 170.315(g)(2)

Automated measure calculation

Guide

02/01/2018

Test Procedure [PDF - 697 KB]

02/01/2018

None

§ 170.315(g)(3)

Safety-enhanced design

Guide

02/01/2018

Test Procedure [PDF - 252 KB]

07/25/2016

None

§ 170.315(g)(4)

Quality management system

Guide

01/27/2017

Test Procedure [PDF - 156 KB]

01/20/2016

None

§ 170.315(g)(5)

Accessibility-centered design

Guide

03/24/2016

Test Procedure [PDF - 151 KB]

01/20/2016

None

§ 170.315(g)(6)

Consolidated CDA creation performance

Guide

CCDS Guide

09/29/2017

Test Procedure [PDF - 188 KB]

CCDS Reference [PDF - 360 KB]

01/20/2016

Test Tool

§ 170.315(g)(7)

Application access – patient selection

Guide

02/01/2018

Test Procedure [PDF - 172 KB]

09/21/2017

None

§ 170.315(g)(8)

Application access – data category request

Guide

CCDS Guide

02/01/2018

Test Procedure [PDF - 181 KB]

CCDS Reference [PDF - 360 KB]

03/08/2016

None

§ 170.315(g)(9)

Application access – all data request

Guide

CCDS Guide

02/01/2018

Test Procedure [PDF - 236 KB]

03/08/2016

Test Tool

§ 170.315(h)(1)

Direct Project

Guide

10/07/2016

Test Procedure [PDF - 221 KB]

05/26/2017

Test Tool

§ 170.315(h)(2)

Direct Project, Edge Protocol, and XDR/XDM

Guide

11/29/2017

Test Procedure [PDF - 444 KB]

09/29/2017

Test Tool