Through the rulemaking process, ASTP/ONC establishes standards for certified health IT required under the ONC Health IT Certification Program. Presently, health IT developers can certify to criteria using standards referenced in 45 CFR Part 170 Subpart B Standards and Implementation Specifications referenced in an active Certification Criterion for Health Information Technology. This page outlines the standards adopted through several Final Rules.
In addition to these standards adopted and referenced in certification criteria, the Standards Version Advancement Process (SVAP) permits health IT developers to voluntarily update health IT products certified under the ONC Health IT 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 ONC Cures Act Final Rule. More information can be found on the SVAP webpage.
Certification Program Standards
Standard | Regulatory Text Citation | Publisher | Certification Criteria in Final Rule |
|---|---|---|---|
| FDA | § 170.315(a)(14) | |
§ 170.210(a)(2) | NIST | § 170.315(d)(7) | |
Applicability Statement for Secure Health Transport, Version 1.2 | § 170.202(a)(2) | The Direct Project | § 170.315(b)(1) |
§ 170.210(h) | ASTM | § 170.315(d)(2) | |
CDC National Center of Immunization and Respiratory Diseases Vaccine NDC Linker, August 17, 2015 Version (Adoption of this standard expires on January 1, 2026.) | § 170.207(e)(4)
§ 170.207(e)(2) | CDC | § 170.315(f)(1) |
CDC Race and Ethnicity Code Set Version 1.0 (March 2000) (Adoption of this standard expires on January 1, 2026.) | § 170.207(f)(2)
§ 170.207(f)(3) | CDC | § 170.315(a)(5) |
§ 170.205(h)(3) | CMS | § 170.315(c)(3) | |
§ 170.205(k)(3) | CMS | § 170.315(c)(3) | |
§ 170.207(b)(3) | ADA | § 170.315(b)(1) | |
Delivery Notification - Implementation Guide for Delivery Notification in Direct v1.0 | § 170.202(e)(1) | The Direct Project | § 170.315(h)(1) |
Electronic Laboratory Reporting (ELR) 2.5.1 Clarification Document for EHR Technology Certification | § 170.205(g) | CDC | § 170.315(f)(3) |
§ 170.210(c)(2) | NIST | § 170.315(d)(8) | |
HL7® 2.5.1 Implementation Guide for Immunization Messaging, Release 1.5 | § 170.205(e)(4) | HL7® | § 170.315(f)(1) |
HL7 CDA® R2 Implementation Guide: Consolidated CDA Templates for Clinical Notes, Release 2.1 | § 170.205(a)(4) | HL7® | § 170.315(b)(1) |
HL7 CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2 (Adoption of this standard expires January 1, 2026.) | § 170.205(a)(5) | HL7® | § 170.315(b)(1) |
§ 170.205(a)(6) | HL7® | § 170.315(b)(1) | |
§ 170.205(t)(2) | HL7® | § 170.315(f)(5) | |
§ 170.205(h)(2) | HL7® | § 170.315(c)(1) | |
§ 170.205(k)(1) | HL7® | § 170.315(c)(4) | |
§ 170.205(k)(2) | HL7® | § 170.315(c)(4) | |
HL7 CDA® R2 Implementation Guide: Reportability Response, Release 1, STU Release 1.1 - US Realm | § 170.205(t)(3) | HL7® | § 170.315(f)(5) |
§ 170.205(i)(2) | HL7® | § 170.315(f)(4) | |
HL7® CDS Hooks Implementation Guide, Version 2.0.1—STU 2 Release 2 | § 170.215(f)(1) | HL7® | § 170.315(j)(20) |
HL7® Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1 | § 170.205(o)(1) | HL7® | § 170.315(b)(7) |
§ 170.215(d)(1) | HL7® | § 170.315(g)(10) | |
HL7 FHIR® Da Vinci—Coverage Requirements Discovery (CRD) Implementation Guide, Version 2.0.1—STU 2 | § 170.215(j)(1)(i) | HL7® | § 170.315(g)(31) |
HL7 FHIR® Da Vinci—Documentation Templates and Rules (DTR) Implementation Guide, Version 2.0.1—STU 2 | § 170.215(j)(2)(i) | HL7® | § 170.315(g)(32) |
HL7 FHIR® Da Vinci Prior Authorization Support (PAS) FHIR Implementation Guide, Version 2.0.1—STU 2 | § 170.215(j)(3)(i) | HL7® | § 170.315(g)(33) |
HL7® FHIR® Implementation Guide: Electronic Case Reporting (eCR) - US Realm, 2.1.0 - STU 2 US | § 170.205(t)(1) | HL7® | § 170.315(f)(5) |
§ 170.215(a)(1) | HL7® | § 170.315(g)(10) | |
HL7 FHIR® SMART Application Launch Framework Implementation Guide Release 1.0.0 (Adoption of this standard expires January 1, 2026.) | § 170.215(c)(1)
§ 170.215(c)(2) | HL7® | § 170.315(g)(10) |
HL7® FHIR® Subscriptions R5 Backport Implementation Guide, Version 1.1.0—Standard for Trial Use | § 170.215(h)(1) | HL7® | § 170.315(j)(21) |
HL7 FHIR® US Core Implementation Guide STU3 Release 3.1.1 (Adoption of this standard expires January 1, 2026) | § 170.215(b)(1)(i)
§ 170.215(b)(1)(ii) | HL7® | § 170.315(g)(10) |
§ 170.205(r)(1) | HL7® | § 170.315(f)(6) | |
§ 170.205(a)(3) | HL7® | § 170.315(b)(1) | |
§ 170.205(s)(1) | HL7® | § 170.315(f)(7) | |
HL7® Standard Code Set CVX— Vaccines Administered, August 17, 2015 Version (Adoption of this standard expires on January 1, 2026.) HL7® Standard Code Set CVX - Vaccines Administered, June 15, 2022 Version | § 170.207(e)(3)
§ 170.207(e)(1) | HL7® | § 170.315(f)(1) |
§ 170.205(g) | HL7® | § 170.315(f)(3) | |
HL7® Version 2.5.1 Implementation Guide for Immunization Messaging (Release 1.5)—Addendum | § 170.205(e)(4) | HL7® | § 170.315(f)(1) |
HL7® Version 3 Standard (HL7® v3), Value Sets for AdministrativeGender and NullFlavor (Adoption of this standard expires January 1, 2026.) | § 170.207(n)(1) | HL7® | § 170.315(a)(5) |
IHE IT Infrastructure Technical Framework Volume 2b (ITI TF- 2b) | § 170.205(p)(1) | IHE | § 170.315(b)(1) |
Implementation Guide for Direct Edge Protocols, Version 1.1, June 25, 2014 | § 170.202(d) | The Direct Project | § 170.315(b)(1) § 170.315(h)(2) |
International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) | § 170.207(i) | CDC | § 170.315(b)(1) |
International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS 2020) | §170.207(b)(4) | CMS | § 170.315(b)(1) |
§ 170.207(q)(1) | International Telecommunication Union | § 170.315(b)(1) | |
International Classification of Diseases, Tenth Revision, Procedure Coding System (ICD-10-PCS 2020) | § 170.207(q)(1) | International Telecommunication Union | § 170.315(b)(1) |
LOINC® Database Version 2.40, Released July 2012 (Adoption of this standard expires on January 1, 2026.) | § 170.207(c)(2)
§ 170.207(c)(1) | LOINC | § 170.315(f)(3) |
LOINC® Database version 2.52, Released June 2015. (Adoption of this standard expires on January 1, 2026.) | § 170.207(c)(3)
§ 170.207(c)(1) | LOINC | § 170.315(a)(15) |
Medicare Provider and Supplier Taxonomy Crosswalk, April 2015 (Adoption of this standard expires on January 1, 2026.) Medicare Provider and Supplier Taxonomy Crosswalk, October 2021 | § 170.207(r)(1)
§ 170.207(r)(2) | CMS | § 170.315(c)(4) |
§ 170.207(d)(2) | NDC | § 170.315(b)(3) | |
NCPDP SCRIPT Standard, Implementation Guide, Version 2017071 (Adoption of this standard expires on January 1, 2026) NCPDP SCRIPT Standard, Implementation Guide, Version 2023011 | § 170.205(b)(1)
§ 170.205(b)(2) | NCPDP | § 170.315(b)(3) |
NCPDP Real-Time Prescription Benefit Standard Implementation Guide v13 | § 170.205(c)(1) | NCPDP | § 170.315(b)(4) |
§ 170.210(g) | Internet Engineering Task Force (IETF) | § 170.315(d)(2) | |
§ 170.207(g)(2) | Internet Engineering Task Force (IETF) | § 170.315(a)(5) | |
§ 170.207(f)(1) | Office of Management and Budget (OMB) | § 170.315(a)(5) | |
§ 170.215(e)(1) | § 170.315(g)(10) | ||
§ 170.205(d)(4) | CDC | § 170.315(f)(2) | |
Erratum to the CDC PHIN 2.0 Implementation Guide, August 2015 | § 170.205(d)(4) | CDC | § 170.315(f)(2) |
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.) | § 170.207(s)(1)
§ 170.207(s)(2) | National Association of Health Data Organizations (NAHDO)
Public Health Data Standards Consortium (HDSC) | § 170.315(c)(4) |
Reportable Conditions Trigger Codes Value Set for Electronic Case Reporting | § 170.205(t)(4) | Electronic Case Reporting (eCR) | § 170.315(f)(5) |
RxNorm, July 5, 2022 Full Monthly Release RxNorm, December 4, 2023 Full Monthly Release | § 170.210(d)(1)(i)
§ 170.210(d)(1)(ii)
§ 170.210(d)(1)(iii) | U.S. National Library of Medicine (NLM) | § 170.315(b)(3) |
SNOMED CT®, US Edition, September 2015 Release (Adoption of this standard expires on January 1, 2026.) |
§ 170.207(a)(4)
| SNOMED CT® | § 170.315(a)(12) |
§ 170.207(a)(1) | SNOMED CT® | § 170.315(a)(5) | |
The Unified Code of Units of Measure, Version 1.9 (Adoption of this standard expires on January 1, 2026.) | § 170.207(m)(1)
§ 170.207(m)(2) | Regenstrief Institute, Inc. | § 170.315(a)(15) |
United States Core Data for Interoperability (USCDI), Version 1 (July 2020 Errata) (Adoption of this standard expires on January 1, 2026) United States Core Data for Interoperability (USCDI), Version 3 (October 2022 Errata) | § 170.213(a)
§ 170.213(b) | ASTP/ONC | § 170.315(b)(1) |
Web Content Accessibility Guidelines (WCAG) 2.0, Level A Conformance | § 170.204(a)(1) | World Wide Web Consortium (W3C)/MIT | § 170.315(e)(1) |
Web Content Accessibility Guidelines (WCAG) 2.0, Level AA Conformance | § 170.204(a)(2) | World Wide Web Consortium (W3C)/MIT | § 170.315(e)(1) |
§ 170.202(b) | The Direct Project | § 170.315(h)(2) |