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Standards and Certification Regulations

Standards Hub

This table identifies the standards that are referenced by certification criteria adopted in the 2014 Edition Standards and Certification Criteria final rule and provides links to their respective publishers. Some of these links may be to non-Federal government websites.

This information is made available here for quick reference when referring to the 2014 Edition Standards and Certification Criteria final rule. Visit the Standards and Interoperability page to learn more about ONC’s work in this area.

Publisher

Standard

Regulatory Text Citation

Certification Criteria Referenced In

American Dental Association (ADA)

CDT

§ 170.207(b)(3)

  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries
  • §170.314(b)(7) – Data Portability
  • §170.314(e)(1) – View, download, & transmit to 3rd party
  • §170.314(e)(2) – Clinical Summary

American Medical Association (AMA)

CPT-4

§ 170.207(b)(2)

  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries
  • §170.314(b)(7) – Data Portability
  • §170.314(e)(1) – View, download, & transmit to 3rd party
  • §170.314(e)(2) – Clinical Summary

American National Standards Institute (ANSI)

HITSP Summary Documents Using HL7 Continuity of Care Document (CCD) Component, HITSP/C32, July 8, 2009, Version 2.5

§ 170.205(a)(1)

  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries

ASTM International

ASTM E2147-01 (Reapproved 2009) Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems, approved September 1, 2009

§ 170.210(h)

  • §170.314(d)(2) – Auditable events & tamper resistance
  • §170.314(d)(3) – Audit report(s)

ASTM International

ASTM E2369–05: Standard Specification for Continuity of Care Record (CCR), year of adoption 2005, ASTM approved July 17, 2006

§ 170.205(a)(2)

  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries

ASTM International

ASTM E2369–05 (Adjunct to E2369): Standard Specification Continuity of Care Record,—Final Version 1.0 (V1.0), November 7, 2005

§ 170.205(a)(2)

  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries

Centers for Disease Control and Prevention (CDC)

IIS: HL7 Standard Code Set CVX -- Vaccines Administered, updates through July 11, 2012

§ 170.207(e)(2)

  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries
  • §170.314(f)(2) – Transmission to immunization registries
  • §170.314(b)(7) – Data portability

Centers for Disease Control and Prevention (CDC)

PHIN Messaging Guide for Syndromic Surveillance: Emergency Department and Urgent Care Data, ADT Messages A01, A03, A04, and A08, HL7 Version 2.5.1 (Version 2.3.1 Compatible), Release 1.1, August 2012

§ 170.205(d)(3)

  • §170.314(f)(3) – Transmission to public health agencies - syndromic surveillance

Centers for Disease Control and Prevention (CDC)

Conformance Clarification for EHR Certification of Electronic Syndromic Surveillance, ADT MESSAGES A01, A03, A04, and A08, HL7 Version 2.5.1, Addendum to PHIN Messaging Guide for Syndromic Surveillance: Emergency Department and Urgent Care Data (Release 1.1), August 2012

§ 170.205(d)(3)

  • §170.314(f)(3) – Transmission to public health agencies - syndromic surveillance

Centers for Disease Control and Prevention (CDC)

HL7 2.5.1 Implementation Guide for Immunization Messaging, Release 1.4, August 1, 2012

§ 170.205(e)(3)

  • §170.314(f)(2) – Transmission to immunization registries

Centers for Disease Control and Prevention (CDC)

Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries, HL7 Clinical Document Architecture (CDA), Release 1.0, August 2012

§ 170.205(i)

  • §170.314(f)(6) – Transmission to cancer registries

Centers for Disease Control and Prevention (CDC)

ELR 2.5.1 Clarification Document for EHR Technology Certification, July 16, 2012
(expected to be located on this CDC webpage)

§ 170.205(g)(3)

  • §170.314(f)(4) – Transmission of reportable lab tests & values/results

Centers for Medicare & Medicaid Services (CMS)

ICD-10-CM

§ 170.207(i)

  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries
  • §170.314(b)(7) – Data Portability

Centers for Medicare & Medicaid Services (CMS)

ICD-10-PCS

§ 170.207(b)(4)

  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries
  • §170.314(b)(7) – Data Portability
  • §170.314(e)(1) – View, download, & transmit to 3rd party
  • §170.314(e)(2) – Clinical Summary

Centers for Medicare & Medicaid Services (CMS)

HCPCS

§ 170.207(b)(2)

  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries
  • §170.314(b)(7) – Data Portability
  • §170.314(e)(1) – View, download, & transmit to 3rd party
  • §170.314(e)(2) – Clinical Summary

Health Level Seven (HL7)

Health Level Seven Messaging Standard Version 2.5.1 (HL7 2.5.1), An Application Protocol for Electronic Data Exchange in Healthcare Environments, February 21, 2007

§ 170.205(d)(3)
§ 170.205(e)(3)
§ 170.205(g)(3)

  • §170.314(f)(2) – Transmission to immunization registries
  • §170.314(f)(3) – Transmission to public health agencies - syndromic surveillance
  • §170.314(f)(4) – Transmission of reportable lab tests & values/results

Health Level Seven (HL7)

Health Level Seven Implementation Guide: Clinical Document Architecture (CDA) Release 2—Continuity of Care Document (CCD), April 01, 2007

§ 170.205(a)(1)

  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries

Health Level Seven (HL7)

HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) HL7 Version 2.5.1: ORU^R01, HL7 Informative Document, February, 2010

§ 170.205(g)(3)

  • §170.314(f)(4) – Transmission of reportable lab tests & values/results

Health Level Seven (HL7)

HL7 Version 3 Standard: Context-Aware Retrieval Application (Infobutton); Release 1, July 2010

§ 170.204(b)

  • §170.314(a)(8) – Clinical decision support
  • §170.314(a)(15) – Patient-specific education resources

Health Level Seven (HL7)

HL7 Version 3 Implementation Guide: URL-Based Implementations of the Context-Aware Information Retrieval (Infobutton) Domain, Release 3, December 2010

§ 170.204(b)(1)

  • §170.314(a)(8) – Clinical decision support
  • §170.314(a)(15) – Patient-specific education resources

Health Level Seven (HL7)

HL7 Version 3 Implementation Guide: Context-Aware Knowledge Retrieval (Infobutton) Service-Oriented Architecture Implementation Guide, Release 1, HL7 Draft Standard for Trial Use, March 2011

§ 170.204(b)(2)

  • §170.314(a)(8) – Clinical decision support
  • §170.314(a)(15) – Patient-specific education resources

Health Level Seven (HL7)

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)

  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries
  • §170.314(b)(7) – Data Portability
  • §170.314(e)(1) – View, download, & transmit to 3rd party
  • §170.314(e)(2) – Clinical Summary

Health Level Seven (HL7)

HL7 Clinical Document Architecture, Release 2.0, Normative Edition, May 2005

§ 170.205(i)

  • §170.314(f)(6) – Transmission to cancer registries

Health Level Seven (HL7)

HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, Release 1 - US Realm [HL7 Version 2.5.1: ORU^R01] Draft Standard for Trial Use, July 2012

§ 170.205(j)

  • §170.314(b)(5) – Incorporate lab tests & values/results
  • §170.314(b)(6) – Transmission of electronic lab tests & values/results to ambulatory providers

Health Level Seven (HL7)

HL7 Version 3 Standard: Clinical Genomics; Pedigree, Release 1, Edition 2011, March 2012

§ 170.207(j)

  • §170.314(a)(13) – Family health history

Health Level Seven (HL7)

HL7 Implementation Guide for CDA® Release 2: Quality Reporting Document Architecture, DTSU Release 2 (Universal Realm), Draft Standard for Trial Use, July 2012

§ 170.205(h)

  • §170.314(c)(1)-(3) – Clinical quality measures

Health Level Seven (HL7)

HL7 v2.5.1 IG: Electronic Laboratory Reporting to Public Health (US Realm), Release 1 Errata and Clarifications, September, 29, 2011

§ 170.205(g)

  • §170.314(f)(4) – Transmission of reportable lab tests & values/results

Health Level Seven (HL7)

HL7 Implementation Guide for CDA® Release 2: Quality Reporting Document Architecture—Category III, DSTU Release 1 (US Realm) Draft Standard for Trial Use, November 2012

§ 170.205(k)

  • §170.314(c)(3) – Clinical quality measures

Internet Engineering Task Force (IETF)

RFC 1305: Network Time Protocol (Version 3) Specification, Implementation and Analysis, March 1992

§ 170.210(g)

  • §170.314(a)(16) – Electronic medication administration record
  • §170.314(d)(2) – Auditable events & tamper resistance
  • §170.314(d)(3) – Audit report(s)
  • §170.314(e)(1) – View, download, & transmit to 3rd party

Internet Engineering Task Force (IETF)

RFC 5905: Network Time Protocol Version 4: Protocol and Algorithms Specification, June 2010

§ 170.210(g)

  • §170.314(a)(16) – Electronic medication administration record
  • §170.314(d)(2) – Auditable events & tamper resistance
  • §170.314(d)(3) – Audit report(s)
  • §170.314(e)(1) – View, download, & transmit to 3rd party

Library of Congress

ISO 639-2. Codes for the Representation of Names of Languages Part 2: Alpha-3 Code, April 8, 2011

§ 170.207(g)

  • §170.314(a)(3) – Demographics
  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries
  • §170.314(b)(7) – Data portability
  • §170.314(e)(1) – View, download, & transmit to 3rd party
  • §170.314(e)(2) – Clinical summary

National Council for Prescription Drug Programs (NCPDP)

SCRIPT Standard, Implementation Guide, Version 10.6, October, 2008, (Approval date for ANSI: November 12, 2008)

§ 170.205(b)(2)

  • §170.314(b)(3) – Electronic prescribing

National Institute of Standards and Technology (NIST)

Annex A: Approved Security Functions for FIPS PUB 140-2, Security Requirements for Cryptographic Modules, Draft, May 30, 2012

§ 170.210(a)(1)

§ 170.210(f)

  • §170.314(d)(7) – End-user device encryption
  • §170.314(e)(1) – View, download, & transmit to 3rd party
  • §170.314(e)(3) – Secure messaging

Office of Management and Budget (OMB)

OMB standards for Maintaining, Collecting, and Presenting Federal Data on Race and Ethnicity, Statistical Policy Directive No. 15, Oct 30, 1997

§ 170.207(f)

  • §170.314(a)(3) – Demographics
  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries
  • §170.314(b)(7) – Data portability
  • §170.314(e)(1) – View, download, & transmit to 3rd party
  • §170.314(e)(2) – Clinical summary

Office of the National Coordinator for Health Information Technology (ONC)

DIRECT: Applicability Statement for Secure Health Transport, Version 1.1, July 10, 2012

§ 170.202(a)

  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries
  • §170.314(e)(1) – View, download, & transmit to 3rd party

Office of the National Coordinator for Health Information Technology (ONC)

XDR and XDM for Direct Messaging Specification, Version 1, March 9, 2011

§ 170.202(b)

  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries

Office of the National Coordinator for Health Information Technology (ONC)

Transport and Security Specification, Version 1.0, June 19, 2012

§ 170.202(c)

  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries

Regenstrief Institute, Inc

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

§ 170.207(c)(2)

  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries
  • §170.314(b)(5) – Incorporate lab tests & values/results
  • §170.314(b)(6) – Transmission of electronic lab tests & values/results to ambulatory providers
  • §170.314(b)(7) – Data portability
  • §170.314(e)(1) – View, download, & transmit to 3rd party
  • §170.314(e)(2) – Clinical summary
  • 170.314(f)(4) – Transmission of reportable lab results & values/results
  • §170.314(f)(6) – Transmission to cancer registries

U.S. National Library of Medicine (NLM)

International Health Terminology Standards Development Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT®) International Release July 31, 2012

§ 170.207(a)(3)

  • §170.314(a)(5) – Problem list
  • §170.314(a)(13) – Family health history
  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries
  • §170.314(b)(7) – Data portability
  • §170.314(e)(1) – View, download, & transmit to 3rd party
  • §170.314(e)(2) – Clinical summary
  • §170.314(f)(4) – Transmission of reportable lab results & values/results
  • §170.314(f)(6) – Transmission to cancer registries

U.S. National Library of Medicine (NLM)

US Extension to SNOMED CT® March 2012 Release

§ 170.207(a)(3)

  • §170.314(a)(5) – Problem list
  • §170.314(a)(13) – Family health history
  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries
  • §170.314(b)(7) – Data portability
  • §170.314(e)(1) – View, download, & transmit to 3rd party
  • §170.314(e)(2) – Clinical summary
  • §170.314(f)(4) – Transmission of reportable lab results & values/results
  • §170.314(f)(6) – Transmission to cancer registries

U.S. National Library of Medicine (NLM)

RxNorm, August 6, 2012 Full Release Update

§ 170.207(d)(2)

  • §170.314(b)(1) – Transitions of care: receive, display, & incorporate transition of care/referral summaries
  • §170.314(b)(2) – Transitions of care: create and transmit transition of care/referral summaries
  • §170.314(b)(3) – Electronic prescribing
  • §170.314(b)(7) – Data portability
  • §170.314(e)(1) – View, download, & transmit to 3rd party
  • §170.314(e)(2) – Clinical summary

U.S. National Library of Medicine (NLM)

Data Element Catalog, Version 1.1 October 2012

§ 170.204(c)

  • §170.314(c)(1) – Clinical quality measures

World Wide Web Consortium (W3C)/MIT

Web Content Accessibility Guidelines (WCAG) 2.0, December 11, 2008

§ 170.204(a)

  • §170.314(e)(1) – View, download, & transmit to 3rd party

Last updated: Tuesday, November 12, 2013