Through the rulemaking process, 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 outlined in the 2015 Edition Health IT Certification Criteria, 2015 Edition Base Electronic Health Record Definition, and ONC Health IT Certification Program Modifications Final Rule (2015 Edition Final Rule), 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act Final Rule) and Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule. This page outlines the standards adopted through these 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) | |
§ 170.210(h) | ASTM | § 170.315(d)(2) | |
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) | |
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 | § 170.207(r)(1)
§ 170.207(r)(2) | CMS | § 170.315(c)(4) |
§ 170.207(b)(3) | CMS | § 170.315(b)(1) | |
Delivery Notification - Implementation Guide for Delivery Notification in Direct v1.0 | § 170.202(e)(1) | The Direct Project c/o the Office of the National Coordinator for Health Information Technology (ONC) | § 170.315(h)(1) |
Direct Project: ONC Applicability Statement for Secure Health Transport, Version 1.2 August 2015 | § 170.202(a)(2) | The Direct Project c/o the Office of the National Coordinator for Health Information Technology (ONC) | § 170.315(b)(1) |
E.123: Notation for national and international telephone numbers, e-mail addresses and web addresses | § 170.207(q)(1) | International Telecommunication Union | § 170.315(b)(1) |
E.164: The international public telecommunication numbering plan | § 170.207(q)(1) | International Telecommunication Union | § 170.315(b)(1) |
Electronic Laboratory Reporting (ELR) 2.5.1 Clarification Document for EHR Technology Certification | § 170.205(g) | CDC | § 170.315(f)(3) |
§ 170.215(d)(1) | HL7® | § 170.315(g)(10) | |
FHIR® US Core Implementation Guide STU 3.1.1 (Adoption of this standard expires January 1, 2026.) | § 170.215(b)(1) | HL7® | § 170.315(g)(10) |
§ 170.215(a)(1) | HL7® | § 170.315(g)(10) | |
§ 170.205(e)(4) | HL7® | § 170.315(f)(1) | |
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 January 1, 2026.) | § 170.205(a)(5) | HL7® | § 170.315(b)(1) |
§ 170.205(a)(6) | HL7® | § 170.315(b)(1) | |
§ 170.205(h)(2) | HL7® | § 170.315(c)(1) | |
§ 170.205(k)(2) | HL7® | § 170.315(c)(2) | |
HL7® Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1 | § 170.205(o)(1) | HL7® | § 170.315(b)(7) |
§ 170.205(a)(4) | HL7® | § 170.315(a)(9) | |
§ 170.205(s)(1) | HL7® | § 170.315(f)(7) | |
HL7® Implementation Guide for CDA® Release 2 – Level 3: Healthcare Associated Infection Reports | § 170.205(r)(1) | HL7® | § 170.315(f)(6) |
§ 170.205(i)(2) | HL7® | § 170.315(f)(4) | |
§ 170.205(a)(3) | HL7® | § 170.315(a)(9) | |
HL7® Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1 | § 170.205(o)(1) | HL7® | § 170.315(b)(7) |
§ 170.204(b)(3) | HL7® | § 170.315(a)(9) | |
HL7® SMART Application Launch Framework Implementation Guide Release 1.0.0 (Adoption of this standard expires on January 1, 2026.) | § 170.205(c)(1)
§ 170.205(c)(2) | HL7® | § 170.315(g)(10) |
HL7® Standard Code Set CVX— Vaccines Administered, updates through August 17, 2015 (Adoption of this standard expires on January 1, 2026.) HL7® Standard Code Set CVX - Vaccines Administered, updates through June 15, 2022 | § 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, July 2015 | § 170.204(e)(4) | HL7® | § 170.315(f)(1) |
HL7® Version 3 Implementation Guide: Context-Aware Knowledge Retrieval (Infobutton), Release 4 | § 170.204(b)(4) | HL7® | § 170.315(a)(9) |
HL7® Version 3 Standard, Value Sets for AdministrativeGender and NullFlavor (Adoption of this standard expires on January 1, 2026.) | § 170.207(n)(1) | HL7® | § 170.315(a)(5) |
HL7® FHIR® Implementation Guide: Electronic Case Reporting (eCR) | § 170.205(t)(1) | HL7® | § 170.315(f)(5) |
§ 170.205(t)(2) | HL7® | § 170.315(f)(5) | |
§ 170.205(t)(3) | HL7® | § 170.315(f)(5) | |
ICD-10 CM Encounter Diagnoses: Code Set for the following conditions: | § 170.207(i) | CDC | § 170.315(b)(1) |
IHE IT Infrastructure Technical Framework Volume 2b (ITI TF- 2b) | § 170.205(p)(1) | IHE | § 170.315(b)(1) |
§170.207(b)(4) | CMS | § 170.315(b)(1) | |
Logical Observation Identifiers Names and Codes (LOINC®) Database version 2.40, Released July 2012 (Adoption of this standard expires on January 1, 2026.) Logical Observation Identifiers Names and Codes (LOINC®) Database Version 2.72, February 16, 2022 | § 170.207(c)(2)
§ 170.207(c)(1) | LOINC | § 170.315(f)(3) |
Logical Observation Identifiers Names and Codes (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) |
National Drug Code (NDC) Directory– Vaccine NDC Linker, updates through August 17, 2015 (Adoption of this standard expires on January 1, 2026.) National Drug Code Directory (NDC) - Vaccine NDC Linker, updates through July 19, 2022 | § 170.207(e)(4)
§ 170.207(e)(2) | CDC | § 170.315(f)(1) |
NCPDP SCRIPT Standard, Implementation Guide, Version 2017071 | § 170.205(b)(1) | NCPDP | § 170.315(b)(3) |
§ 170.210(g) | Internet Engineering Task Force (IETF) | § 170.315(d)(2) | |
§ 170.207(f)(1) | Office of Management and Budget (OMB) | § 170.315(a)(5) | |
ONC Implementation Guide for Direct Edge Protocols, Version 1.1, June 25, 2014 | § 170.202(d) | The Direct Project c/o the Office of the National Coordinator for Health Information Technology (ONC) | § 170.315(b)(1) |
§ 170.202(b) | The Direct Project | § 170.315(h)(2) | |
§ 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) |
Quality Reporting Document Architecture Category III, Implementation Guide for CDA Release 2 | § 170.205(k)(1) | HL7® | § 170.315(c)(2) |
Reportable Conditions Trigger Codes Value Set for Electronic Case Reporting | § 170.205(t)(4) | Electronic Case Reporting (eCR) | § 170.315(f)(5) |
§ 170.207(g)(2) | Internet Engineering Task Force (IETF) | § 170.315(a)(5) | |
RxNorm, September 8, 2015 Full Release Update (Adoption of this standard expires on January 1, 2026.) | § 170.207(d)(3)
§ 170.210(d)(1) | U.S. National Library of Medicine (NLM) | § 170.315(b)(3) |
§ 170.210(c)(2) | NIST | § 170.315(d)(2) | |
Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) International Release July 31, 2012 and US Extension to SNOMED CT® March 2012 (Adoption of this standard expires on January 1, 2026.) | § 170.207(a)(3) | SNOMED CT® | § 170.315(a)(5) |
Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®), U.S. 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, Revision 1.9 (Adoption of this standard expires on January 1, 2026.) Unified Code for Units of Measure, Revision 2.1, November 21, 2017 | § 170.207(m)(1)
§ 170.207(m)(2) | Regenstrief Institute, Inc. | § 170.315(a)(15) |
United States Core Data for Interoperability (USCDI), July 2020 Errata, Version 1 (v1) (Adoption of this standard expires on January 1, 2026.) United States Core Data for Interoperability Version 3 (USCDI v3) | § 170.213(a)
§ 170.213(b) | 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) |