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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.

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

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

CHPL SED Guide [PDF - 758 KB]

Regulation Text Citation

Certification Criterion

Certification Companion Guide (CCG)

Test Procedure

Test Tool

§ 170.315(a)(1)

Computerized provider order entry (CPOE) – medications

Guide

Test Procedure [PDF - 277 KB]

None

§ 170.315(a)(2)

CPOE – laboratory

Guide

Test Procedure [PDF - 342 KB]

None

§ 170.315(a)(3)

CPOE – diagnostic imaging

Guide

Test Procedure [PDF - 200 KB]

None

§ 170.315(a)(4)

Drug-drug, drug-allergy interaction checks for CPOE

Guide

Test Procedure [PDF - 203 KB]

None

§ 170.315(a)(5)

Demographics

Guide

Test Procedure [PDF - 182 KB]

None

§ 170.315(a)(6)

Problem list

Guide

Test Procedure [PDF - 224 KB]

None

§ 170.315(a)(7)

Medication list

Guide

Test Procedure [PDF - 325 KB]

None

§ 170.315(a)(8)

Medication allergy list

Guide

Test Procedure [PDF - 228 KB]

None

§ 170.315(a)(9)

Clinical decision support

Guide

Test Procedure [PDF - 303 KB]

None

§ 170.315(a)(10)

Drug-formulary and preferred drug list checks

Guide

Test Procedure [PDF - 198 KB]

None

§ 170.315(a)(11)

Smoking status

Guide

Test Procedure [PDF - 186 KB]

None

§ 170.315(a)(12)

Family health history

Guide

Test Procedure [PDF - 211 KB]

None

§ 170.315(a)(13)

Patient-specific education resources

Guide

Test Procedure [PDF - 221 KB]

None

§ 170.315(a)(14)

Implantable device list

Guide

Test Procedure [PDF - 242 KB]

None

§ 170.315(a)(15)

Social, psychological, and behavioral data

Guide

 Test Procedure [PDF - 305 KB]

None

§ 170.315(b)(1)

Transitions of care

Guide

CCDS Guide

Test Procedure [PDF - 361 KB]

CCDS Reference [PDF - 295 KB]

Test Tool

§ 170.315(b)(2)

Clinical information reconciliation and incorporation

Guide

Test Procedure [PDF - 270 KB]

Test Tool

§ 170.315(b)(3)

Electronic prescribing

Guide

Test Procedure [PDF - 214 KB]

Test Tool

§ 170.315(b)(4)

Common Clinical Data Set summary record – create

Guide

CCDS Guide

Test Procedure [PDF - 281 KB]

CCDS Reference [PDF - 295 KB]

Test Tool

§ 170.315(b)(5)

Common Clinical Data Set summary record – receive

Guide

CCDS Guide

Test Procedure [PDF - 291 KB]

CCDS Reference [PDF - 295 KB]

Test Tool

§ 170.315(b)(6)

Data export

Guide

CCDS Guide

Test Procedure [PDF - 311 KB]

CCDS Reference [PDF - 295 KB]

Test Tool

§ 170.315(b)(7)

Data segmentation for privacy – send

Guide

Test Procedure [PDF - 259 KB]

Test Tool

§ 170.315(b)(8)

Data segmentation for privacy – receive

Guide

Test Procedure [PDF - 212 KB]

None

§ 170.315(b)(9)

Care plan

Guide

Test Procedure [PDF - 192 KB]

Test Tool

§ 170.315(c)(1)

Clinical quality measures (CQMs) – record and export

Guide

Test Procedure [PDF - 184 KB]

Test Tool

§ 170.315(c)(2)

CQMs – import and calculate

Guide

Test Procedure [PDF - 237 KB]

Test Tool

§ 170.315(c)(3)

CQMs – report

Guide

Test Procedure [PDF - 208 KB]

Test Tool

§ 170.315(c)(4)

CQMs – filter

Guide

Test Procedure [PDF - 248 KB]

Test Tool

§ 170.315(d)(1)

Authentication, access control, authorization

Guide

Test Procedure [PDF - 213 KB] 

None

§ 170.315(d)(2)

Auditable events and tamper-resistance

Guide

Test Procedure [PDF - 284 KB]

None

§ 170.315(d)(3)

Audit report(s)

Guide

Test Procedure [PDF - 211 KB]

None

§ 170.315(d)(4)

Amendments

Guide

Test Procedure [PDF - 207 KB]

None

§ 170.315(d)(5)

Automatic access time-out

Guide

Test Procedure [PDF - 173 KB]

None

§ 170.315(d)(6)

Emergency access

Guide

Test Procedure [PDF - 164 KB]

None

§ 170.315(d)(7)

End-user device encryption

Guide

Test Procedure [PDF - 219 KB]

None

§ 170.315(d)(8)

Integrity

Guide

Test Procedure [PDF - 284 KB]

None

§ 170.315(d)(9)

Trusted connection

Guide

Test Procedure [PDF - 194 KB]

None

§ 170.315(d)(10)

Auditing actions on health information

Guide

Test Procedure [PDF - 281 KB] 

None

§ 170.315(d)(11)

Accounting of disclosures

Guide

Test Procedure [PDF - 176 KB] 

None

§ 170.315(e)(1)

View, download, and transmit to 3rd party

Guide

CCDS Guide 

Test Procedure [PDF - 468 KB]

CCDS Reference [PDF - 295 KB]

Test Tool

§ 170.315(e)(2)

Secure messaging

Guide

Test Procedure [PDF - 180 KB]

None

§ 170.315(e)(3)

Patient health information capture

Guide

Test Procedure [PDF - 248 KB]

None

§ 170.315(f)(1)

Transmission to immunization registries

Guide

Test Procedure [PDF - 229 KB]

Test Tool

§ 170.315(f)(2)

Transmission to public health agencies – syndromic surveillance

Guide

Test Procedure [PDF - 166 KB]

Test Tool

§ 170.315(f)(3)

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

Guide

Test Procedure [PDF - 227 KB]

Test Tool

§ 170.315(f)(4)

Transmission to cancer registries

Guide

Test Procedure [PDF - 179 KB]

Test Tool

§ 170.315(f)(5)

Transmission to public health agencies – electronic case reporting

Guide

CCDS Guide

Pending CDC development of trigger tables

None

§ 170.315(f)(6)

Transmission to public health agencies – antimicrobial use and resistance reporting

Guide

Test Procedure [PDF - 176 KB]

Test Tool

§ 170.315(f)(7)

Transmission to public health agencies – health care surveys

Guide

Test Procedure [PDF - 203 KB]

Test Tool

§ 170.315(g)(1)

Automated numerator recording

Guide

*HOLD on testing and certifying. Pending CMS finalization of NPRM

Test Procedure [PDF - 534 KB]

Test Data [XLSX - 95 KB]

None

§ 170.315(g)(2)

Automated measure calculation

Guide

*HOLD on testing and certifying. Pending CMS finalization of NPRM

Test Procedure [PDF - 579 KB]

Test Data [XLSX - 95 KB]

None

§ 170.315(g)(3)

Safety-enhanced design

Guide

Test Procedure [PDF - 224 KB]

None

§ 170.315(g)(4)

Quality system management

Guide

Test Procedure [PDF - 221 KB]

None

§ 170.315(g)(5)

Accessibility-centered design

Guide

Test Procedure [PDF - 167 KB]

None

§ 170.315(g)(6)

Consolidated CDA creation performance

 Guide

CCDS Guide

Test Procedure [PDF - 229 KB]

CCDS Reference [PDF - 295 KB]

Test Tool

§ 170.315(g)(7)

Application access – patient selection

Guide

Test Procedure [PDF - 270 KB]

None

§ 170.315(g)(8)

Application access – data category request

Guide

CCDS Guide

Test Procedure [PDF - 247 KB]

CCDS Reference [PDF - 295 KB]

None

§ 170.315(g)(9)

Application access – all data request

Guide

CCDS Guide

Test Procedure [PDF - 239 KB]

Test Tool

§ 170.315(h)(1)

Direct Project

Guide

Test Procedure [PDF - 205 KB]

Test Tool

§ 170.315(h)(2)

Direct Project, Edge Protocol, and XDR/XDM

 Guide

Test Procedure [PDF - 512 KB]

Test Tool