ONC Conformance Test Tools

The following tools are ONC-approved Conformance resources to help developers implement standards to enable health information interoperability. They are organized by tool, criteria and regulatory floor standards. Please visit SITE to find links to all ONC-approved tools and further information on tools and testing for the ONC/ASTP Health IT Certification Program.

Inferno

Test Tools	Use in ONC Health IT Certification Program	Base Standards Under Test for the ONC Health IT Certification Program
Inferno Framework	§ 170.315(g)(10) Standardized API for patient and population services	HL7^® FHIR^® HL7® FHIR® US Core Implementation Guide STU 3.1.1 [Adoption of this standard expires on January 1, 2026] HL7® FHIR® US Core Implementation Guide STU 6.1.0 [This standard is required by December 31, 2025] HL7^® Version 4.0.1 FHIR^® Release 4 October 30, 2019 HL7® SMART Application Launch Framework Implementation Guide Release 1.0.0 [Adoption of this standard expires on January 1, 2026] HL7® SMART App Launch Implementation Guide Release 2.0.0 HL7^® FHIR^®Bulk Data Access (Flat FHIR^®) (V1.0.1: STU 1) Other standards OpenID Connect Core 1.0 incorporating errata set 1 United States Core Data for Interoperability (USCDI), Version 1 [Adoption of this standard expires on January 1, 2026] United States Core Data for Interoperability (USCDI), October 2022 Errata, Version 3 (v3) [This standard is required by December 31, 2025]

Test Tools

Use in ONC Health IT Certification Program

Base Standards Under Test
for the ONC Health IT Certification Program

Inferno Framework

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

HL7^® FHIR^®

HL7® FHIR® US Core Implementation Guide STU 3.1.1 [Adoption of this standard expires on January 1, 2026]
HL7® FHIR® US Core Implementation Guide STU 6.1.0 [This standard is required by December 31, 2025]
HL7^® Version 4.0.1 FHIR^® Release 4 October 30, 2019
HL7® SMART Application Launch Framework Implementation Guide Release 1.0.0 [Adoption of this standard expires on January 1, 2026]
HL7® SMART App Launch Implementation Guide Release 2.0.0
HL7^® FHIR^®Bulk Data Access (Flat FHIR^®) (V1.0.1: STU 1)

Other standards

OpenID Connect Core 1.0 incorporating errata set 1
United States Core Data for Interoperability (USCDI), Version 1 [Adoption of this standard expires on January 1, 2026]
United States Core Data for Interoperability (USCDI), October 2022 Errata, Version 3 (v3) [This standard is required by December 31, 2025]

SITE / Edge Testing Tool (ETT)

Test Tools	Use in ONC Health IT Certification Program	Base Standards Under Test for the ONC Health IT Certification Program
Direct Testing This tool provides capabilities to validate your Direct implementation to applicable standards-specifications.	§ 170.315(b)(1) Transitions of Care § 170.315(h)(1) Direct Project § 170.315(h)(2) Direct Project, Edge Protocol, and XDR/XDM	HL7^® CDA^® HL7^® Implementation Guide for CDA^® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012 HL7^® Implementation Guide (IG) for CDA^® Release 2 Consolidation CDA^® Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1 C-CDA 2.1, August 2015, June 2019 (with Errata) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2, October 2019, IBR approved for § 170.205(a)(5) [Adoption of this standard expires on January 1, 2026] HL7^® CDA^® R2 Implementation Guide: C-CDA Templates for Clinical Notes STU Companion Guide, Release 4.1 - US Realm [This standard is required by December 31, 2025] Other Standards Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2 June 26, 2018 IHE IT Infrastructure Technical Framework Volume 2b (ITI TF- 2b) ONC Implementation Guide for Direct Edge Protocols, Version 1.1, June 25, 2014 United States Core Data for Interoperability (USCDI), Version 1 [Adoption of this standard expires on January 1, 2026] United States Core Data for Interoperability (USCDI), October 2022 Errata, Version 3 (v3) [This standard is required by December 31, 2025] Delivery Notification: Implementation Guide for Delivery Notification in Direct v1.0 ONC XDR and XDM for Direct Messaging Specification
Message Validators These tools test conformance of artifacts to industry standards and specific criteria, and include: C-CDA, XDM, XDR, and Direct Message validators.	§ 170.315(b)(1) Transitions of Care § 170.315(b)(2) Clinical information reconciliation and incorporation § 170.315(b)(7) Security tags—summary of care—send § 170.315(b)(8) Security tags—summary of care—receive § 170.315(b)(9) Care plan § 170.315(e)(1) View, download, and transmit to 3^rd party § 170.315(g)(6) Consolidated CDA creation performance § 170.315(g)(9) Application access—all data request § 170.315(h)(1) Direct Project § 170.315(h)(2) Direct Project, Edge Protocol, and XDR/XDM	HL7^® CDA^® Health Level 7 (HL7^®) Implementation Guide for CDA^® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012 HL7^® Implementation Guide for CDA Release 2 Consolidation CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1 C-CDA 2.1, August 2015, June 2019 (with Errata) HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2, October 2019, IBR approved for § 170.205(a)(5) [Adoption of this standard expires on January 1, 2026] HL7^® CDA^® R2 Implementation Guide: C-CDA Templates for Clinical Notes STU Companion Guide, Release 4.1 - US Realm [This standard is required by December 31, 2025] HL7^® Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1 Other Standards United States Core Data for Interoperability (USCDI), Version 1[Adoption of this standard expires January 1, 2026] United States Core Data for Interoperability (USCDI), October 2022 Errata, Version 3 (v3) [This standard is required by December 31, 2025] Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2 June 26, 2018
HISP Testing and Delivery Notification These tools provide tests to simulate the role of the Health Information Service Provider (HISP).	§ 170.315(b)(1) Transitions of Care § 170.315(h)(1) Direct Project § 170.315(h)(2) Direct Project, Edge Protocol, and XDR/XDM	HL7^® CDA^® HL7^® Implementation Guide for CDA^® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012 HL7® Implementation Guide for CDA Release 2 Consolidation CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1 C-CDA 2.1, August 2015, June 2019 HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2, October 2019, IBR approved for § 170.205(a)(5) [Adoption of this standard expires on January 1, 2026] HL7^® CDA^® R2 Implementation Guide: C-CDA Templates for Clinical Notes STU Companion Guide, Release 4.1 - US Realm [This standard is required by December 31, 2025] Other Standards Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2 June 26, 2018 IHE IT Infrastructure Technical Framework Volume 2b (ITI TF- 2b) ONC Implementation Guide for Direct Edge Protocols, Version 1.1, June 25, 2014 United States Core Data for Interoperability (USCDI), Version 1 [Adoption of this standard expires on January 1, 2026] United States Core Data for Interoperability (USCDI), October 2022 Errata, Version 3 (v3) [This standard is required by December 31, 2025]
Edge Testing This tool provides various network "Edge" testing capabilities. The term "Edge" is derived from the health IT data exchange paradigm of network "Edge" nodes and health information service providers: Edge -> HISP -> HISP -> Edge. The test cases available allow a user to validate their system’s transport protocols adhere to basic industry standards.	§ 170.315(b)(1) Transitions of Care § 170.315(h)(1) Direct Project § 170.315(h)(2) Direct Project, Edge Protocol, and XDR/XDM

Test Tools

Use in ONC Health IT Certification Program

Base Standards Under Test
for the ONC Health IT Certification Program

Direct Testing

This tool provides capabilities to validate your Direct implementation to applicable standards-specifications.

§ 170.315(b)(1) Transitions of Care

§ 170.315(h)(1) Direct Project

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

HL7^® CDA^®

HL7^® Implementation Guide for CDA^® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012
HL7^® Implementation Guide (IG) for CDA^® Release 2 Consolidation CDA^® Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1 C-CDA 2.1, August 2015, June 2019 (with Errata)
HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2, October 2019, IBR approved for § 170.205(a)(5) [Adoption of this standard expires on January 1, 2026]
HL7^® CDA^® R2 Implementation Guide: C-CDA Templates for Clinical Notes STU Companion Guide, Release 4.1 - US Realm [This standard is required by December 31, 2025]

Other Standards

Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2 June 26, 2018
IHE IT Infrastructure Technical Framework Volume 2b (ITI TF- 2b)
ONC Implementation Guide for Direct Edge Protocols, Version 1.1, June 25, 2014
United States Core Data for Interoperability (USCDI), Version 1 [Adoption of this standard expires on January 1, 2026]
United States Core Data for Interoperability (USCDI), October 2022 Errata, Version 3 (v3) [This standard is required by December 31, 2025]
Delivery Notification: Implementation Guide for Delivery Notification in Direct v1.0
ONC XDR and XDM for Direct Messaging Specification

Message Validators

These tools test conformance of artifacts to industry standards and specific criteria, and include: C-CDA, XDM, XDR, and Direct Message validators.

§ 170.315(b)(1) Transitions of Care

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

§ 170.315(b)(7) Security tags—summary of care—send

§ 170.315(b)(8) Security tags—summary of care—receive

§ 170.315(b)(9) Care plan

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

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

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

§ 170.315(h)(1) Direct Project

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

HL7^® CDA^®

Other Standards

United States Core Data for Interoperability (USCDI), Version 1[Adoption of this standard expires January 1, 2026]
United States Core Data for Interoperability (USCDI), October 2022 Errata, Version 3 (v3) [This standard is required by December 31, 2025]
Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2 June 26, 2018

HISP Testing and Delivery Notification

These tools provide tests to simulate the role of the Health Information Service Provider (HISP).

§ 170.315(b)(1) Transitions of Care

§ 170.315(h)(1) Direct Project

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

HL7^® CDA^®

HL7^® Implementation Guide for CDA^® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012
HL7® Implementation Guide for CDA Release 2 Consolidation CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1 C-CDA 2.1, August 2015, June 2019
HL7^® CDA^® R2 IG: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2, October 2019, IBR approved for § 170.205(a)(5) [Adoption of this standard expires on January 1, 2026]
HL7^® CDA^® R2 Implementation Guide: C-CDA Templates for Clinical Notes STU Companion Guide, Release 4.1 - US Realm [This standard is required by December 31, 2025]

Other Standards

Direct Project: ONC Applicability Statement for Secure Health Transport, v1.2 June 26, 2018
IHE IT Infrastructure Technical Framework Volume 2b (ITI TF- 2b)
ONC Implementation Guide for Direct Edge Protocols, Version 1.1, June 25, 2014
United States Core Data for Interoperability (USCDI), Version 1 [Adoption of this standard expires on January 1, 2026]
United States Core Data for Interoperability (USCDI), October 2022 Errata, Version 3 (v3) [This standard is required by December 31, 2025]

Edge Testing

This tool provides various network "Edge" testing capabilities. The term "Edge" is derived from the health IT data exchange paradigm of network "Edge" nodes and health information service providers: Edge -> HISP -> HISP -> Edge. The test cases available allow a user to validate their system’s transport protocols adhere to basic industry standards.

§ 170.315(b)(1) Transitions of Care

§ 170.315(h)(1) Direct Project

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

Clinical Quality Measures (CQMs) Testing

Test Tools	Use in ONC Health IT Certification Program	Base Standards Under Test for the ONC Health IT Certification Program
Cypress	§ 170.315(c)(1) Clinical quality measures (CQMs)—record and export	HL7^® CDA^® Health Level 7 (HL7^®) CDA^® R2 Implementation Guide: Quality Reporting Document Architecture - Category I (QRDA I); Release 1, DSTU Release 3 (US Realm), Volume 1
	§ 170.315(c)(2) Clinical quality measures (CQMs)—import and calculate	HL7^® CDA^® Health Level 7 (HL7^®) CDA^® R2 Implementation Guide: Quality Reporting Document Architecture - Category I (QRDA I); Release 1, DSTU Release 3 (US Realm), Volume 1 Quality Reporting Document Architecture Category III, Implementation Guide for CDA Release 2 Errata to the HL7^® Implementation Guide for CDA^® Release 2: Quality Reporting Document Architecture—Category III, DSTU Release 1 (US Realm), September 2014
	§ 170.315(c)(3) Clinical quality measures (CQMs)—report	Other Standards CMS Implementation Guide for Quality Reporting Document Architecture: Category I; Hospital Quality Reporting; Implementation Guide for 2020 CMS Implementation Guide for Quality Reporting Document Architecture: Category III; Eligible Clinicians and Eligible Professionals Programs; Implementation Guide for 2020
	§ 170.315(c)(4) Clinical quality measures (CQMs)—filter	HL7^® CDA^® Health Level 7 (HL7^®) CDA® Release 2 Implementation Guide for: Quality Reporting Document Architecture – Category I (QRDA I); Release 1, DSTU Release 3 (US Realm), Volume 1 Quality Reporting Document Architecture Category III, Implementation Guide for CDA Release 2 Errata to the HL7^® Implementation Guide for CDA® Release 2: Quality Reporting Document Architecture—Category III, DSTU Release 1 (US Realm), September 2014 Other Standards Crosswalk: Medicare Provider/Supplier to Healthcare Provider Taxonomy, April 2, 2015 [Adoption of this standard expires on January 1, 2026] Medicare Provider and Supplier Taxonomy Crosswalk, October 29, 2021[This standard is required by December 31, 2025] Public Health Data Standards Consortium Source of Payment Typology Code Set Version 5.0 (October 2011) [Adoption of this standard expires on January 1, 2026] Public Health Data Standards Consortium Source of Payment Typology Code Set, December 2020, Version 9.2 [This standard is required by December 31, 2025] CDC Race and Ethnicity Code Set Version 1.0 (March 2000) [Adoption of this standard expires on January 1, 2026] CDC Race and Ethnicity Code Set Version 1.2 (July 15, 2021) [This standard is required by December 31, 2025] International Health Terminology Standards Development Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT^®), U.S. Edition, September 2015 Release [Adoption of this standard expires on January 1, 2026] SNOMED CT®, U.S. Edition, March 2022 Release [This standard is required by December 31, 2025] HL7^® Version 3 Standard, Value Sets for AdministrativeGender and NullFlavor [Adoption of this standard expires on January 1, 2026] Sex must be coded in accordance with, at a minimum, the version of SNOMED CT® U.S. Edition codes specified in § 170.207(a)(1)

ELECTRONIC PRESCRIBING (eRx)

Test Tools	Use in ONC Health IT Certification Program	Base Standards Under Test for the ONC Health IT Certification Program
ONC eRX Testing Suite	§ 170.315(b)(3) Electronic prescribing	NCPDP SCRIPT Standard, Implementation Guide, Version 2017071 RxNorm, September 8, 2015 Full Release Update [Adoption of this standard expires on January 1, 2026] RxNorm, a standardized nomenclature for clinical drugs produced by the United States National Library of Medicine, July 5, 2022 Full Monthly Release [This standard is required by December 31, 2025]

Public Health Testing Suites

Test Tools	Use in ONC Health IT Certification Program	Base Standards Under Test for the ONC Health IT Certification Program
NIST HL7^® v2 Immunization Test Suite	§ 170.315(f)(1) Transmission to immunization registries	HL7^® v2 Health Level 7 (HL7^®) 2.5.1 Implementation Specifications. HL7^® 2.5.1 Implementation Guide for Immunization Messaging, Release 1.5, October 2014 HL7^® Version 2.5.1 Implementation Guide for Immunization Messaging (Release 1.5)—Addendum, July 2015
NIST HL7^® v2 Syndromic Surveillance Test Suite	§ 170.315(f)(2) Transmission to public health agencies—syndromic surveillance	HL7^® v2 Health Level 7 (HL7^®) Implementation specifications. PHIN Messaging Guide for Syndromic Surveillance: Emergency Department, Urgent, Care, Inpatient and Ambulatory Care, and Inpatient Settings, Release 2.0, April 21, 2015 Erratum to the CDC PHIN 2.0 Implementation Guide, August 2015
NIST Electronic Laboratory Reporting (ELR) Validation Suite	§ 170.315(f)(3) Transmission to public health agencies—reportable laboratory tests and value/results	HL7^® v2 HL7^® Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) with Errata and Clarifications ELR 2.5.1 Clarification Document for EHR Technology Certification
HL7^® CDA^® Cancer Registry Reporting Validation Tool	§ 170.315(f)(4) Transmission to cancer registries	HL7^® CDA^® HL7^® Implementation Guide for CDA^© Release 2: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1, DSTU Release 1.1, April 2015
Antimicrobial use and resistance HL7® CDA® validator	§ 170.315(f)(6) Transmission to public health agencies — antimicrobial use and resistance reporting	HL7^® CDA^® Health Level 7 (HL7^®) Implementation Guide for CDA^® Release 2 – Level 3: Healthcare Associated Infection (HAI) Reports, Release 1, U.S. Realm, August 2013 HL7® CDA® R2 Implementation Guide: Healthcare Associated Infection (HAI) Reports, Release 3 - US Realm, December 2020
HL7^® CDA^® National Health Care Surveys Validator	§ 170.315(f)(7) Transmission to public health agencies—health care surveys	HL7^® CDA^® Health Level 7 (HL7^®) Implementation Guide for CDA^© Release 2: National Health Care Surveys (NHCS), Release 1 – US Realm, Draft Standard for Trial Use, December 2014 HL7^® CDA^® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3 - US Realm HL7^® CDA^® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3.1 - US Realm

Alternative Test Methods

Test Tools	Use in ONC Health IT Certification Program	Base Standards Under Test for the ONC Health IT Certification Program
HIMSS Immunization Integration Test Suite	§ 170.315(f)(1) Transmission to immunization registries	HL7^® v2 HL7^® 2.5.1 Implementation Specifications. HL7^® 2.5.1 Implementation Guide for Immunization Messaging, Release 1.5, October 2014 HL7^® Version 2.5.1 Implementation Guide for Immunization Messaging (Release 1.5)—Addendum, July 2015

Test Tools

Use in ONC Health IT Certification Program

Base Standards Under Test
for the ONC Health IT Certification Program

HIMSS Immunization Integration Test Suite

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

HL7^® v2

Other Testing Tools

Test Tools
CPOE Evaluation Tool—Please note that links on this page to any non-federal sites do not constitute an endorsement by HHS or any of its employees of the information and products presented. Source code for ONC projects, tools and utilities can be found at: https://github.com/siteadmin. New testing tools can be added to this list by emailing: SITTeam@hhs.gov.
IHE Testing Tools—IHE has developed a growing body of software tools to facilitate testing and implementation of IHE Integration Profiles in healthcare information technology systems. These tools are available for download and licensed by their developers for free use.

Note: The above resources provide the base standards adopted in regulation for the ONC Health IT Certification Program. Through the Standards Version Advancement Process (SVAP), health IT developers may 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. For the full list of base and SVAP approved standards, please refer to the Standards Version Advancement Process (SVAP) | HealthIT.gov.

Key Links

ONC Conformance Test Tools

Inferno

SITE / Edge Testing Tool (ETT)

Clinical Quality Measures (CQMs) Testing

ELECTRONIC PRESCRIBING (eRx)

Public Health Testing Suites

Alternative Test Methods

Other Testing Tools