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§ 170.315(c)(3)
Clinical quality measures (CQMs) — report
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Certification Companion Guide
Test Procedure
Certification Companion Guide
v1.3
View Changelog
Issued Date:
03-11-2024
08-29-2025
This Certification Companion Guide (CCG) is an informative document designed to assist with health IT product certification. The CCG is not a substitute for the requirements outlined in regulation and related ONC final rules. It extracts key portions of ONC final rules’ preambles and includes subsequent clarifying interpretations. To access the full context of regulatory intent please consult the
Certification Regulations
page for links to all ONC final rules or consult other regulatory references as noted. The CCG is for public use and should not be sold or redistributed.
Archived Version:
§ 170.315(c)(3) Clinical quality measures (CQMs) — report CCG
Quick Overview
Required Updates
None
Design and Performance
Additional Criterion Information
Base EHR Definition
Not Included
Real World Testing
Yes
Insights Condition
No
SVAP Versions
Yes
CLARIFICATIONS
REGULATORY
STANDARDS
DEPENDENCIES
RESOURCES
CHANGELOG
IN THIS SECTION
Certification Clarifications
Technical Explanations and Clarifications
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Technical outcome – Enable a user to electronically create a data file for transmission of CQM data in accordance with the CMS Quality Reporting Document Architecture (QRDA) Category I Implementation Guide (IG) for inpatient measures as adopted in § 170.205(h)(3) and CMS QRDA Category III IG for ambulatory measures as adopted in § 170.205(k)(3).
Clarifications:
The specific version, number, and type of clinical quality measures (CQMs) presented for certification are determined at the developer’s discretion. We recommend developers consult any Centers for Medicare and Medicaid Services (CMS) or other programs’ requirements around the specific version, number, or type of CQMs required for providers in determining the CQMs presented for certification.
Health IT developers are permitted to test and certify to the newest CMS QRDA Category I and Category III IGs, regardless of the versions approved by the National Coordinator via the
Standards Version Advancement Process (SVAP)
Certain CMS programs require or provide the option for electronic CQM (eCQM) reporting. These programs include the Promoting Interoperability Program, the Physician Quality Reporting System, the Hospital Inpatient Quality Reporting Program, the Comprehensive Primary Care (CPC) initiative, CPC Plus, and the Value-Based Payment Modifier Program. Each year, CMS issues annual updates to eCQMs (herein referred to as the “CMS annual measure update(s)”) which are published on the
Electronic Clinical Quality Improvement (eCQI) Resource Center
. The CMS annual measure updates rely upon specific versions of the HL7® Quality Reporting Document Architecture (QRDA) Category I and Category III standards. Each year’s HL7® QRDA Category I and Category III standards are referenced in the corresponding
CMS QRDA Implementation Guides
(IGs) associated with that program year and CMS annual measure update. The CMS QRDA Category I and Category III IGs also contain additional programmatic form and manner requirements necessary for reporting to CMS programs, which make it necessary for the corresponding testing tools to keep pace with these measure updates and CMS reporting requirements.
Compliance with this certification criterion is dependent on the update to the CMS QRDA Category I and Category III IGs. It is ONC's expectation that health IT developers will update Health IT Modules to align with the 2023 CMS QRDA Category I and Category III IGs in a timely fashion that allows users to report eCQMs to CMS in early 2024. Health IT developers should continue to update Health IT Modules to align with the CMS annual update to the CMS QRDA Category I and Category III IGs for continued compliance with this certification criterion.
For details on the latest CMS QRDA Category I and Category III IGs, ONC refers readers to the
eCQI Resource Center website
After technology is certified to specific CQMs for this § 170.315(c)(3) criterion, technology is not required to recertify to the annual measure specification updates CMS issues to maintain certification unless that product is relabeled. Said another way, other programs, such as the Promoting Interoperability Program, may require developers upgrade their technology to the newest CQM specifications, but the technology is not required to be retested or recertified unless explicitly specified in other program requirements. It is expected that all systems will test all measures and standards updates as a best practice. The testing tools are available for each CMS annual measure update and when there are late standards errata or CMS requirement changes to facilitate additional testing.
While health IT developers are not required to re-certify to updated versions of CQMs, they must test and certify to newly added CQMs.
For the purposes of automated testing to meet certification requirements, only errors (but not warnings) generated during testing would constitute a failure to meet certification requirements.
To prevent unintended burden by tailoring the requirements to the type of measures being tested ONC has provided the following clarifications:  For the updated certification criterion “CQMs—report” in § 170.315(c)(3) a Health IT Module testing only inpatient measures would test only with the CMS QRDA Category I IG and a Health IT Module testing only ambulatory measures would test only with the CMS QRDA Category III IG. A Health IT Module supporting both inpatient and ambulatory measures would be required to test to both the CMS QRDA Category I and Category III IGs.
The following links are references to CMS CQM reporting resources:
CMS and ONC eCQI Resource Center
CMS Quality Measure Basics
CMS Promoting Interoperability Program Resource Page
(contains program requirements, reporting requirements, and other resources for each program year).
Health IT developers can choose to use the flexibility of the SVAP to use more advanced version(s) of standards than the version(s) incorporated by reference in the regulation for this certification criterion.  To comply with the Maintenance of Certification requirement in §170.405(b), a developer that chooses to pursue such updates must include in their Real World Testing plan each Certified Health IT Module updated to newer version(s) of any standard(s) prior to August 31 of the year in which their updates were made and test each Module the following calendar year for conformance to all applicable criteria within its scope, including the newer version(s) of any standard(s).
Health IT developers updating their already Certified Health IT Modules who choose to leverage the SVAP flexibility will be required to provide advance notice to all affected customers and its ONC-ACB. To be open and transparent to the public, health IT developers must also provide its ONC-ACB with a publicly accessible hyperlink to the SVAP Notice to be published with the Module on the ONC Certified Health IT Product List (CHPL).
Regulation Text
§ 170.315(c)(3) Clinical quality measures—report—
Enable a user to electronically create a data file for transmission of clinical quality measurement data:
(i) In accordance with the applicable implementation specifications specified by the CMS implementation guides for Quality Reporting Document Architecture (QRDA), category I, for inpatient measures in § 170.205(h)(3) and CMS implementation guide for QRDA, category III for ambulatory measures in § 170.205 (k)(3); or
(ii) In accordance with the standards specified in § 170.205(h)(2) and § 170.205(k)(1) and (2) for the period until December 31, 2022.
Standards & References
The following standards are referenced within the certification criteria for:
§ 170.315(c)(3) Clinical quality measures (CQMs) — report
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Standard
Paragraph
§ 170.205(h)(3)
CMS Implementation Guide for Quality Reporting Document Architecture: Category I; Hospital Quality Reporting; Implementation Guide for 2020
Referenced in the Following:
Paragraph (c)(3)
SVAP-approved Versions:
2025 CMS QRDA I Implementation Guide for Hospital Quality Reporting
§ 170.205(k)(3)
CMS Implementation Guide for Quality Reporting Document Architecture: Category III; Eligible Clinicians and Eligible Professionals Programs; Implementation Guide for 2020
Referenced in the Following:
Paragraph (c)(3)
SVAP-approved Versions:
2025 CMS QRDA III Implementation Guide for Eligible Clinicians
Paragraph (c)(3)
Applies to Entire Criterion
§ 170.205(h)(3)
CMS Implementation Guide for Quality Reporting Document Architecture: Category I; Hospital Quality Reporting; Implementation Guide for 2020
§ 170.205(k)(3)
CMS Implementation Guide for Quality Reporting Document Architecture: Category III; Eligible Clinicians and Eligible Professionals Programs; Implementation Guide for 2020
Certification Dependencies
§ 170.405
Real World Testing
Products certified to this criterion must complete requirements outlined for the Real World Testing Conditions and Maintenance of Certification.
Note: For calendar year (CY) 2025, a developer is not expected to submit an annual Real World Testing plan to its ONC-Authorized Certification Body (ONC-ACB) for the 2026 Real World Testing year. For CY 2026, ONC only expects a developer with a Health IT Module(s) certified to the (g)(7) through (10) certification criteria, as of August 31, 2024, to submit a CY 2025 Real World Testing results report to its ONC-ACB by March 2026. Please read the full notice outlining the details of the Real World Testing enforcement discretion.
Privacy and Security
This certification criterion was adopted at § 170.315(c)(3). As a result, an ONC Authorized Certification Body (ONC-ACB) must ensure that a product presented for certification to a § 170.315(c) “paragraph (c)” criterion includes the privacy and security criteria (adopted in § 170.315(d)) within the overall scope of the certificate issued to the product.
The privacy and security criteria (adopted in § 170.315(d)) do not need to be explicitly tested with this specific paragraph (c) criterion unless it is the only criterion for which certification is requested.
As a general rule, a product presented for certification only needs to be tested once to each applicable privacy and security criterion (adopted in § 170.315(d)) so long as the health IT developer attests that such privacy and security capabilities apply to the full scope of capabilities included in the requested certification. However, an exception exists for § 170.315(e)(1) “View, download, and transmit to 3rd party (VDT)” and (e)(2) “Secure messaging,” which are explicitly stated.
§ 170.315(d)(2)(i)(C) is not required if the scope of the Health IT Module does not have end-user device encryption features.
For more information on the approaches to meet these Privacy and Security requirements, please download the Privacy and Security CCG below:
Privacy and Security CCG
If choosing
Approach 1
Authentication, access control, and authorization (§ 170.315(d)(1))
Auditable events and tamper-resistance (§ 170.315(d)(2))
Audit reports (§ 170.315(d)(3))
Automatic access time-out (§ 170.315(d)(5))
Encrypt authentication credentials (§ 170.315(d)(12))
Multi-factor authentication (MFA) (§ 170.315(d)(13))
If choosing
Approach 2
For each applicable privacy and security certification criterion not certified for Approach 1, the health IT developer may certify using system documentation which is sufficiently detailed to enable integration such that the Health IT Module has implemented service interfaces that enable the Health IT Module to access external services necessary to meet the requirements of the privacy and security certification criterion. Please see the ONC Cures Act Final Rule at
85 FR 25710
for additional clarification.
Design and Performance
The following design and performance certification criteria (adopted in § 170.315(g)(4) and § 170.315(g)(5)) must also be certified in order for the product to be certified.
Quality management system (§ 170.315(g)(4))
: When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, when different QMS are used, each QMS needs to be separately identified for every capability to which it was applied.
Accessibility-centered design (§ 170.315(g)(5))
: When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively, the developer must state that no accessibility-centered design was used.
Resources
The following resources can offer assistance or additional information:
§ 170.315(c)(3) Clinical quality measures (CQMs) — report
PDF DOCUMENT
Real World Testing Resource Guide
2025-10-01
PDF DOCUMENT
Real World Testing Fact Sheet
Certification Companion Guide Changelog
The following changelog applies to:
§ 170.315(c)(3)Clinical quality measures (CQMs) — report
Changelog functionality is not available.
Revision History
Version #
Description of Change
Version Date
1.0
Initial Publication
03-11-2024
1.1
Standards Referenced updated to reflect 2024 Approved SVAP Standards
08-19-2024
1.2
Added update to Certification Dependencies section to reflect recent Real World Testing enforcement discretion notice.
07-23-2025
1.3
Standards Referenced updated to reflect 2025 Approved SVAP Standards
08-29-2025
Test Procedure
v1.2
View Changelog
Issued Date:
03-11-2024
12-17-2024
This Test Procedure illustrates the test steps required to certify a Health IT Module to this criterion. Please consult the most recent ONC Final Rule on the
Certification Regulations
page for a detailed description of the certification criterion with which these testing steps are associated. ASTP/ONC also encourages developers to consult the Certification Companion Guide in tandem with the test procedure as it provides clarifications that may be useful for product development and testing.
Archived Version:
§ 170.315(c)(3) Clinical quality measures (CQMs) — report TP
Quick Overview
Required Updates
None
Design and Performance
Additional Criterion Information
Base EHR Definition
Not Included
Real World Testing
Yes
Insights Condition
No
SVAP Versions
Yes
TESTING STEPS
TOOLS AND DATA
TESTING COMPONENTS
CHANGELOG
IN THIS SECTION
View Regulation Text
Testing Steps
Note: The test step order does not necessarily prescribe the order in which the tests should take place.
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Testing Steps
System Under Test
CMS Quality Reporting Document Architecture (QRDA) Category III Implementation Guide (IG) Report
The user can generate an aggregate report  with calculated summary data for the patient population of the clinical quality measures calculated in the Execute test (§ 170.315(c)(2)), which at a minimum is in accordance with the standard specified in § 170.205(k)(3). CMS Implementation Guide for Quality Reporting Document Architecture: Category III; Eligible Clinicians and Eligible Professionals Programs; Implementation Guide for 2020, or
Approved
SVAP Version(s)
CMS Implementation Guide for Quality Reporting Document Architecture Category III Eligible Clinicians Programs; Implementation Guide for 2024 (Updated November 2023)
CMS QRDA Category I IG Report
A user can generate a de-duplicated archive of patient documents in the CMS QRDA Category I IG format of the clinical quality measures calculated in the Execute test (§ 170.315(c)(2)), which at a minimum is in accordance with the standard specified in: § 170.205(h)(3). CMS Implementation Guide for Quality Reporting Document Architecture: Category I; Hospital Quality Reporting; Implementation Guide for 2020, or
Approved
SVAP Version(s)
CMS Implementation Guide for Quality Reporting Document Architecture Category I Hospital Quality Reporting; Implementation Guide for 2024 (Updated August 2023)
Data File for Transmission
The health IT developer submits the quality measurement data file consisting of the data created by the generation of the CMS QRDA Category III IG aggregate report(s) and the de-duplicated CMS QRDA Category I IG report(s) for verification.
Test Lab Verification
Test Lab Setup
Prior to beginning this test, the tester creates and exports data using Cypress, and the health IT developer imports the data into its Health IT Module.
CMS QRDA Category III IG Report
Using the Cypress supplied XML Schema validation, the tester:
uploads the aggregate report(s) submitted by the health IT developer; and
runs the Cypress supplied XML schema validation for each aggregate report.
The tester verifies that all of the QRDA Category III aggregate report(s) submitted by the health IT developer are at a minimum in accordance with the standard specified in § 170.205(k)(3) through evaluation of the Cypress validation report.
CMS QRDA Category I IG Report
The tester verifies all of the de-duplicated CMS QRDA Category I IG report(s), submitted by the health IT developer are at a minimum in accordance with the standard specified in § 170.205(h)(3) through evaluation of the Cypress validation report.
Data File for Transmission
The tester verifies via visual inspection that the data file for transmission submitted with clinical quality measurement data includes both de-duplicated CMS QRDA Category I IG and aggregate CMS QRDA Category III IG report(s).
TEST TOOL DOCUMENTATION
Testing Tools
§ 170.315(c)(3) Clinical quality measures (CQMs) — report
Cypress
Rigorous & repeatable testing of Electronic Health Records
Cypress is the rigorous and repeatable testing tool of Electronic Health Records (EHR) and EHR modules in calculating eCQMs used by CMS’s Quality Reporting Programs. The Cypress tool is open source and freely available for use or adoption by the health IT community including EHR vendors and testing labs. Cypress serves as the official testing tool for the EHR Certification program supported by the Office of the National Coordinator for Health IT (ONC).
Test Data
Test data for implementation and validation.
(c)(3)
Cypress Gold Standard Test Data created using Cypress
- generated to match the submitted exported CMS QRDA Category I IG files created during section (c)(1)(ii) and generated CMS QRDA Category I IG files created as a result of section (c)(2)(i) Import of Clinical Quality Measures (CQMs).
Testing Components
§ 170.315(c)(3) Clinical quality measures (CQMs) — report
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
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.
Testing Tools
Testing tools indicate 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.
SVAP
Indicates that the Standards Version Advancement Process (SVAP) is applicable to the criterion.
Test Data
The test data for this criterion is provided within the testing tools tab. Click the link below to be directed to the testing tools tab.
Review Test Data
Test Method Changelog
The following changelog applies to:
§ 170.315(c)(3)Clinical quality measures (CQMs) — report
Changelog functionality is not available.
Revision History
Version #
Description of Change
Version Date
1.0
Initial publication
03-11-2024
1.1
Updated tests with 2024 SVAP adopted standards.
11-14-2024
1.2
Corrected reference to 2024 SVAP adopted standards in test steps.
12-17-2024
The following design and performance certification criteria (adopted in § 170.315(g)(4) and § 170.315(g)(5)) must also be certified in order for the product to be certified.
Additional Criteria:
§ 170.315(g)(4)
Quality management system
Description:
When a single quality management system (QMS) is used, the QMS only needs to be identified once. Otherwise, when different QMS are used, each QMS needs to be separately identified for every capability to which it was applied.
§ 170.315(g)(5)
Accessibility-centered design
Description:
When a single accessibility-centered design standard is used, the standard only needs to be identified once. Otherwise, the accessibility-centered design standards need to be identified for every capability to which they were applied; or, alternatively, the developer must state that no accessibility-centered design was used.
Loading Privacy & Security content...
Standards Version Advancement Process (SVAP)
The Standards Version Advancement Process (SVAP) permits health IT developers to voluntarily update health IT products certified under the ONC Health IT Certification Program (Certification Program) to newer versions of adopted standards as part of the "Real World Testing" Condition and Maintenance of Certification requirement (§ 170.405) of the 21st Century Cures Act.
Learn More About SVAP
SVAP Approved Version:
UPDATED MAY 2024
2025 CMS QRDA I Implementation Guide for Hospital Quality Reporting
Related to standard reference: § 170.205(h)(3)
UPDATED DECEMBER 2024
2025 CMS QRDA III Implementation Guide for Eligible Clinicians
Related to standard reference: § 170.205(k)(3)
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