Standards Hub

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) and the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule (ONC Cures Act 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 21st Century Cures Act. More information can be found on the SVAP webpage.  

ONC Cures Act Final Rule Standards

Standard

Regulatory Text Citation

Publisher

Certification Criteria in Final Rule

Annex A of the Federal Information Processing Standards (FIPS) Publication 140-2, October 8, 2014 (incorporated by reference in § 170.299).

§ 170.210(a)(2)

NIST § 170.315(d)(12)
ASTM E2147-18 Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems. § 170.210(h) ASTM

§ 170.315(d)(2)
§ 170.315(d)(3)
§ 170.315(d)(10)

CMS Implementation Guide for Quality Reporting Document Architecture: Category I; Hospital Quality Reporting; Implementation Guide for 2020 § 170.205(h)(3)  CMS § 170.315(c)(3)
CMS Implementation Guide for Quality Reporting Document Architecture: Category III; Eligible Clinicians and Eligible Professionals Programs; Implementation Guide for 2020 § 170.205(k)(3) CMS § 170.315(c)(3)
Code on Dental Procedures and Nomenclature (CDT) § 170.207(b)(3) ADA

§ 170.315(b)(1)
§ 170.315(b)(2)
§ 170.315(e)(1)
§ 170.315(f)(5)
§ 170.315(g)(9)

Current Procedural Terminology, Fourth Edition (CPT-4)/Healthcare Common Procedure Coding System (HCPCS) § 170.207(b)(2) AMA

§ 170.315(b)(1)
§ 170.315(b)(2)
§ 170.315(e)(1)
§ 170.315(f)(5)
§ 170.315(g)(9)

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)
FHIR® US Core Implementation Guide STU V3.1.1

§ 170.215(a)(2)

HL7®

§ 170.315(g)(10)

HL7® Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012

§ 170.205(a)(3)

HL7®

§ 170.315(b)(1)
§ 170.315(b)(2)

HL7® Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1 § 170.205(o)(1) HL7®

§ 170.315(b)(7)
§ 170.315(b)(8)

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). § 170.205(a)(4) HL7®

§ 170.315(b)(1)
§ 170.315(b)(2)
§ 170.315(b)(7)
§ 170.315(b)(8)
§ 170.315(b)(9)
§ 170.315(e)(1)
§ 170.315(g)(6)
§ 170.315(g)(9)

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). § 170.205(a)(5) HL7®

§ 170.315(b)(1)
§ 170.315(b)(2)
§ 170.315(b)(9)
§ 170.315(e)(1)
§ 170.315(g)(6)
§ 170.315(g)(9)

HL7® Version 3 Standard, Value Sets for AdministrativeGender and NullFlavor  

§ 170.207(n)(1) HL7® § 170.315(b)(1)
HL7® Version 4.0.1 FHIR® Release 4, October 30, 2019 § 170.215(a)(1) HL7® § 170.315(g)(10)

HL7® SMART Application Launch Framework Implementation Guide Release 1.0.0

§ 170.215(a)(3) HL7® § 170.315(g)(10)
HL7® FHIR® Bulk Data Access (Flat FHIR®) (V1.0.0:STU 1) § 170.215(a)(4) HL7® § 170.315(g)(10)
ICD-10 CM Encounter Diagnoses: Code Set for the following conditions:
Diseases,
Injuries,
Impairments,
Other health problems and their manifestations,
Causes of injury, disease, impairment, or health problems.
§ 170.207(i) CDC

§ 170.315(b)(1)
§ 170.315(f)(5)

IHE IT Infrastructure Technical Framework Volume 2b (ITI TF- 2b) § 170.205(p)(1) IHE § 170.315(b)(1)
International Classification of Diseases ICD-10-PCS 2020 §170.207(b)(4) CMS

§ 170.315(b)(1)
§ 170.315(b)(2)
§ 170.315(e)(1)
§ 170.315(f)(5)
§ 170.315(g)(9)

NCPDP SCRIPT Standard, Implementation Guide, Version 2017071 § 170.205(b)(1) NCPDP § 170.315(b)(3)
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)
OpenID Connect Core 1.0 incorporating errata set 1 § 170.215(b)   § 170.315(g)(10)
(RFC 5905) Network Time Protocol Version 4 § 170.210(g)  Internet Engineering Task Force (IETF)

§ 170.315(d)(2)
§ 170.315(d)(3)
§ 170.315(d)(10)
§ 170.315(e)(1)

RxNorm, September 8, 2015 Full Release Update § 170.207(d)(3) U.S. National Library of Medicine (NLM) § 170.315(b)(3)

Secure Hash Standard, 180-4 (August 2015).

§ 170.210(c)(2)

NIST

§ 170.315(d)(2)
§ 170.315(d)(10)

SNOMED International, Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) U.S. Edition, September 2019 Release

§ 170.207(a)(4) SNOMED CT®

§ 170.315(b)(1)
§ 170.315(b)(2)
§ 170.315(e)(1)
§ 170.315(f)(5)
§ 170.315(g)(9)

Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) International Release July 31, 2012 and US Extension to SNOMED CT® March 2012 § 170.207(a)(3) SNOMED CT® § 170.315(b)(1)
Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®), U.S. Edition, September 2015 Release § 170.207(a)(4) SNOMED CT®

§ 170.315(b)(1)
§ 170.315(f)(5)

United States Core Data for Interoperability (USCDI)

§ 170.213 

ONC

§ 170.315(b)(1)
§ 170.315(b)(2)
§ 170.315(e)(1)
§ 170.315(f)(5)
§ 170.315(g)(6)
§ 170.315(g)(9)
§ 170.315(g)(10)

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)

 

2015 Edition Final Rule Standards

Standard

Regulatory Text Citation

Publisher

Certification Criteria in Final Rule

AccessGUDID   FDA § 170.315(a)(14)
Annex A of the Federal Information Processing Standards (FIPS) Publication 140-2, October 8, 2014 (incorporated by reference in §170.299). § 170.210(a)(2) NIST § 170.315(d)(7)
§ 170.315(d)(9)
CDC Race and Ethnicity Code Set Version 1.0 (March 2000) § 170.207(f)(2) CDC

§ 170.315(a)(5)
§ 170.315(c)(4)

Crosswalk: Medicare Provider/Supplier to Healthcare Provider Taxonomy, April 2, 2015 § 170.207(r)(1) CMS § 170.315(c)(4)
Current Dental Terminology (CDT) § 170.207(b)(3) ADA § 170.315(b)(1)
§ 170.315(b)(6)
§ 170.315(e)(1)
§ 170.315(f)(5)
§ 170.315(g)(6)
§ 170.315(g)(8)
§ 170.315(g)(9)
Current Procedural Terminology/Healthcare Common Procedure Coding System CPT-4/HCPCS § 170.207(b)(2) AMA § 170.315(b)(1)
§ 170.315(b)(6)
§ 170.315(e)(1)
§ 170.315(f)(5)
§ 170.315(g)(6)
§ 170.315(g)(8)
§ 170.315(g)(9)
 
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)
§ 170.315(h)(2)
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)
§ 170.315(h)(1)
§ 170.315(h)(2)
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)

HL7® 2.5.1 Implementation Specifications. HL7 2.5.1 Implementation Guide for Immunization Messaging, Release 1.5, October 2014

§ 170.205(e)(4) HL7® § 170.315(f)(1)

HL7® CDA® Release 2 Implementation Guide for: Quality Reporting Document Architecture – Category I (QRDA I); Release 1, DSTU Release 3 (US Realm), Volume 1

§ 170.205(h)(2) HL7®

§ 170.315(c)(1)
§ 170.315(c)(2)
§ 170.315(c)(3)
§ 170.315(c)(4)

Errata to the HL7® Implementation Guide for CDA® Release 2: Quality Reporting Document Architecture—Category III, DSTU Release 1 (US Realm), September 2014

§ 170.205(k)(2) HL7® § 170.315(c)(2)
§ 170.315(c)(3)
§ 170.315(c)(4)

 

HL7® Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use Release 2.1, August 2015 § 170.205(a)(4)

HL7®

§ 170.315(a)(09)
§ 170.315(b)(1)
§ 170.315(b)(2)
§ 170.315(b)(4)
§ 170.315(b)(5)
§ 170.315(b)(6)
§ 170.315(b)(7)
§ 170.315(b)(8)
§ 170.315(b)(9)
§ 170.315(g)(6)
§ 170.315(g)(9)
§ 170.315(e)(1)

HL7® Implementation Guide for CDA Release 2: National Health Care Surveys (NHCS), Release 1 – US Realm, Draft Standard for Trial Use, December 2014 § 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)
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 § 170.205(i)(2) HL7® § 170.315(f)(4)
HL7® Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012 § 170.205(a)(3) HL7® § 170.315(a)(9)
§ 170.315(b)(1)
§ 170.315(b)(2)
HL7® Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1 § 170.205(o)(1)  HL7® § 170.315(b)(7)
§ 170.315(b)(8)
HL7® Standard Code Set CVX— Vaccines Administered, updates through August 17, 2015 § 170.207(e)(3) HL7® § 170.315(f)(1)
HL7® Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm)  § 170.205(g)  HL7® § 170.315(f)(3)
HL7® Version 2.5.1 Implementation Guide for Immunization Messaging (Release 1.5)—Addendum, July 2015 § 170.205(e)(4) HL7® § 170.315(f)(1)
HL7® Implementation Guide: Service-Oriented Architecture Implementations of the Context-aware Knowledge Retrieval (Infobutton) Domain, Release 1 § 170.204(b)(3)  HL7® § 170.315(a)(13)
 
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 § 170.207(n)(1) HL7® § 170.315(a)(5)
§ 170.315(b)(1)
§ 170.315(c)(4)
ICD-10-CM § 170.207(i) CDC § 170.315(b)(6)
§ 170.315(e)(1)
ICD-10 CM Encounter Diagnoses: Code Set for the following conditions: Diseases, Injuries, Impairments, Other health problems and their manifestations, Causes of injury, disease, impairment, or health problems. § 170.207(i) CDC § 170.315(b)(1)
§ 170.315(f)(5)
International Classification of Diseases ICD-10-PCS § 170.207(b)(4) CMS § 170.315(b)(1)
§ 170.315(b)(6)
§ 170.315(e)(1)
§ 170.315(f)(5)
§ 170.315(g)(6)
§ 170.315(g)(8)
§ 170.315(g)(9)

Logical Observation Identifiers Names and Codes (LOINC®) Database version 2.40, Released July 2012.

§ 170.207(c)(2) LOINC® § 170.315(f)(3)
Logical Observation Identifiers Names and Codes (LOINC®) Database version 2.52, Released June 2015. § 170.207(c)(3) LOINC® § 170.315(a)(15)
§ 170.315(f)(4)

National Drug Code (NDC) Directory–Vaccine NDC Linker, updates through August 17, 2015

§ 170.207(e)(4) CDC § 170.315(f)(1)
Office of Management and Budget Standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, Statistical Policy Directive No. 15, as revised, October 30, 1997 § 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)
§ 170.315(h)(2)
ONC XDR and XDM for Direct Messaging Specification

§ 170.202(b) 

The Direct Project
§ 170.315(h)(2)

PHIN Messaging Guide for Syndromic Surveillance: Emergency Department, Urgent, Care, Inpatient and Ambulatory Care, and Inpatient Settings, Release 2.0, April 21, 2015

§ 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) § 170.207(s)(1) National Association of Health Data Organizations (NAHDO) § 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)
§ 170.315(c)(3)
§ 170.315(c)(4)
RxNorm, August 6, 2012 Full Release Update § 170.207(d)(2) U.S. National Library of Medicine (NLM) § 170.315(b)(2)
RxNorm, September 8, 2015 Full Release Update § 170.207(d)(3) U.S. National Library of Medicine (NLM) § 170.315(b)(2)
(RFC 1305) Network Time Protocol § 170.210(g)  Internet Engineering Task Force (IETF) § 170.315(e)(1)
(RFC 5905) Network Time Protocol Version 4 § 170.210(g)  Internet Engineering Task Force (IETF) § 170.315(e)(1)
RFC 5646, “Tags for Identifying Languages,” September 2009 § 170.207(g)(2) Internet Engineering Task Force (IETF) § 170.315(a)(5)

Secure Hash Standard, 180-4 (August 2015).

§ 170.210(c)(2)

NIST § 170.315(d)(8)
§ 170.315(d)(9)
Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) International Release July 31, 2012 and US Extension to SNOMED CT® March 2012 § 170.207(a)(3) SNOMED CT® § 170.315(a)(14)
§ 170.315(b)(1)
§ 170.315(b)(2)
§ 170.315(f)(3)
Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®), U.S. Edition, September 2015 Release § 170.207(a)(4) SNOMED CT® § 170.315(a)(06)
§ 170.315(a)(12)
§ 170.315(b)(1)
§ 170.315(b)(2)
§ 170.315(b)(6)
§ 170.315(c)(4)
§ 170.315(e)(1)
§ 170.315(f)(4)
§ 170.315(f)(5)
§ 170.315(g)(6)
§ 170.315(g)(8)
§ 170.315(g)(9)
The Unified Code of Units of Measure, Revision 1.9 § 170.207(m)(1) Regenstrief Institute, Inc.

§ 170.315(a)(15)

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)