(a) Certain material is incorporated by reference into this subpart with the approval of the Director of the Federal Register under 5 U.S.C. 552(a) and 1 CFR part 51. To enforce any edition other than that specified in this section, the Department of Health and Human Services must publish notice of change in the Federal Register and the material must be available to the public. All approved material is available for inspection at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030 or go to http://www.archives.gov/federal_ register/code_of_federal_ regulations/ibr_locations.html. Also, it is available for inspection at U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave., SW., Washington, DC 20201, call ahead to arrange for inspection at 202-690-7151, and is available from the sources listed below.
(b) American National Standards Institute, Health Information Technology Standards Panel (HITSP) Secretariat, 25 West 43rd Street--Fourth Floor, New York, NY 10036, http://www.hitsp.org.
(1) HITSP Summary Documents Using HL7 Continuity of Care Document (CCD) Component, HITSP/C32, July 8, 2009, Version 2.5, IBR approved for Sec. 170.205.
(2) [Reserved]
(c) ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA, 19428-2959 USA; Telephone (610) 832-9585 or http://www.astm.org/.
(1) ASTM E2147-01 (Reapproved 2009) Standard Specification for Audit and Disclosure Logs for Use in Health Information Systems, approved September 1, 2009, IBR approved for Sec. 170.210.
(2) ASTM E2369-05: Standard Specification for Continuity of Care Record (CCR), year of adoption 2005, ASTM approved July 17, 2006, IBR approved for Sec. 170.205.
(3) ASTM E2369-05 (Adjunct to E2369): Standard Specification Continuity of Care Record,--Final Version 1.0 (V1.0), November 7, 2005, IBR approved for Sec. 170.205.
(d) Centers for Disease Control and Prevention, 2500 Century Parkway, Mailstop E-78, Atlanta, GA 30333, USA (800-232-4636); http://www.cdc.gov/ehrmeaningfuluse/.
(1) HL7 Standard Code Set CVX--Vaccines Administered, July 30, 2009, IBR approved for Sec. 170.207.
(2) IIS: HL7 Standard Code Set CVX--Vaccines Administered, updates through July 11, 2012, IBR approved for Sec. 170.207.
(3) Implementation Guide for Immunization Data Transactions using Version 2.3.1 of the Health Level Seven (HL7)Standard Protocol Implementation Guide Version 2.2, June 2006, IBR approved for Sec. 170.205.
(4) HL7 2.5.1 Implementation Guide for Immunization Messaging Release 1.0, May 1, 2010, IBR approved for Sec. 170.205.
(5) 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, IBR approved for Sec. 170.205.
(6) 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, IBR approved for Sec. 170.205.
(7) HL7 2.5.1 Implementation Guide for Immunization Messaging, Release 1.4, August 1, 2012, IBR approved for Sec. 170.205.
(8) Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries, HL7 Clinical Document Architecture (CDA), Release 1.0, August 2012, IBR approved for Sec. 170.205.
(9) ELR 2.5.1 Clarification Document for EHR Technology Certification, July 16, 2012, IBR approved for Sec. 170.205.
(e) Centers for Medicare & Medicaid Services, Office of Clinical Standards and Quality, 7500 Security Boulevard, Baltimore, Maryland 21244; Telephone (410) 786-3000
(1) CMS PQRI 2009 Registry XML Specifications, IBR approved for Sec. 170.205.
(2) 2009 Physician Quality Reporting Initiative Measure Specifications Manual for Claims and Registry, Version 3.0, December 8, 2008 IBR approved for Sec. 170.205.
(f) Health Level Seven, 3300 Washtenaw Avenue, Suite 227, Ann Arbor, MI 48104; Telephone (734) 677-7777 or http://www.hl7.org/
(1) Health Level Seven Standard Version 2.3.1 (HL7 2.3.1), An Application Protocol for Electronic Data Exchange in Healthcare Environments, April 14, 1999, IBR approved for Sec. 170.205.
(2) 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, IBR approved for Sec. 170.205.
(3) Health Level Seven Implementation Guide: Clinical Document Architecture (CDA) Release 2--Continuity of Care Document (CCD), April 01, 2007, IBR approved for Sec. 170.205.
(4) HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) HL7 Version 2.5.1: ORU[supcaret]R01, HL7 Informative Document, February, 2010, IBR approved for Sec. 170.205.
(5) HL7 Version 3 Standard: Context-Aware Retrieval Application (Infobutton); Release 1, July 2010, IBR approved for Sec. 170.204.
(6) HL7 Version 3 Implementation Guide: URL-Based Implementations of the Context-Aware Information Retrieval (Infobutton) Domain, Release 3, December 2010, IBR approved for Sec. 170.204.
(7) 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, IBR approved for Sec. 170.204.
(8) HL7 Implementation Guide for CDA[supreg] Release 2: IHE Health Story Consolidation, DSTU Release 1.1 (US Realm) Draft Standard for Trial Use July 2012, IBR approved for Sec. 170.205.
(9) HL7 Clinical Document Architecture, Release 2.0, Normative Edition, May 2005, IBR approved for Sec. 170.205.
(10) 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, IBR approved for Sec. 170.205.
(11) HL7 Version 3 Standard: Clinical Genomics; Pedigree, Release 1, Edition 2011, March 2012, IBR approved for Sec. 170.207.
(12) HL7 Implementation Guide for CDA[supreg] Release 2: Quality Reporting Document Architecture, DTSU Release 2 (Universal Realm), Draft Standard for Trial Use, July 2012, IBR approved for Sec. 170.205.
(13) HL7 v2.5.1 IG: Electronic Laboratory Reporting to Public Health (US Realm), Release 1 Errata and Clarifications, September, 29, 2011, IBR approved for Sec. 170.205.
(14) HL7 Implementation Guide for CDA[supreg] Release 2: Quality Reporting Document Architecture--Category III, DSTU Release 1 (US Realm) Draft Standard for Trial Use, November 2012, IBR approved for Sec. 170.205.
(g) Internet Engineering Task Force (IETF), University of Delaware, Newark, DE 19716, Telephone (302) 831-8247, http://www.ietf.org/rfc.html.
(1) Network Time Protocol (Version 3) Specification, Implementation and Analysis, March 1992, IBR approved for Sec. 170.210.
(2) Network Time Protocol Version 4: Protocol and Algorithms Specification, June 2010, IBR approved for Sec. 170.210.
(h) Library of Congress, Network Development and MARC Standards Office, Washington, DC 20540-4402, Tel: (202) 707-6237 or http://www.loc.gov/standards/iso639-2/.
(1) ISO 639-2. Codes for the Representation of Names of Languages Part 2: Alpha-3 Code, April 8, 2011, IBR approved for Sec. 170.207.
(2) [Reserved]
(i) National Council for Prescription Drug Programs, Incorporated, 9240 E. Raintree Drive, Scottsdale, AZ 85260-7518; Telephone (480) 477-1000; and Facsimile (480) 767-1042 or http://www.ncpdp.org.
(1) National Council for Prescription Drug Programs Prescriber/Pharmacist Interface SCRIPT Standard, Implementation Guide, Version 8, Release 1, October 2005, IBR approved for Sec. 170.205.
(2) SCRIPT Standard, Implementation Guide, Version 10.6, October, 2008, (Approval date for ANSI: November 12, 2008), IBR approved for Sec. 170.205.
(j) National Institute of Standards and Technology, Information Technology Laboratory, National Institute of Standards and Technology, 100 Bureau Drive, Gaithersburg, MD 20899-8930, http://csrc.nist.gov/groups/ STM/cmvp/standards.html.
(1) Annex A: Approved Security Functions for FIPS PUB 140-2, Security Requirements for Cryptographic Modules, Draft, January 27, 2010, IBR approved for Sec. 170.210.
(2) Annex A: Approved Security Functions for FIPS PUB 140-2, Security Requirements for Cryptographic Modules, Draft, May 30, 2012, IBR approved for Sec. 170.210.
(k) Office of the National Coordinator for Health Information Technology (ONC), 200 Independence Avenue SW., Suite 729-D, Washington, DC 20201, http://healthit.hhs.gov.
(1) Applicability Statement for Secure Health Transport, Version 1.1, July 10, 2012, IBR approved for Sec. 170.202; available at http://healthit.hhs.gov/portal/ server.pt/community/healthit_ hhs_gov__direct_project/3338.
(2) XDR and XDM for Direct Messaging Specification, Version 1, March 9, 2011, IBR approved for Sec. 170.202; available at http://healthit.hhs.gov/portal/ server.pt/community/healthit_ hhs_gov__direct_project/3338.
(3) Transport and Security Specification, Version 1.0, June 19, 2012, IBR approved for Sec. 170.202.
(4) ONC Implementation Guide for Direct Edge Protocols, Version 1.1, June 25, 2014, IBR approved for Sec. 170.202; available at http://www.healthit.gov/sites/ default/files/implementationguide fordirectedgeprotocolsv1_1.pdf.
(l) Regenstrief Institute, Inc., LOINC[supreg] c/o Medical Informatics The Regenstrief Institute, Inc 410 West 10th Street, Suite 2000 Indianapolis, IN 46202-3012; Telephone (317) 423-5983 or http://loinc.org/.
(1) Logical Observation Identifiers Names and Codes (LOINC[supreg]) version 2.27, June 15, 2009, IBR approved for Sec. 170.207.
(2) Logical Observation Identifiers Names and Codes (LOINC[supreg]) Database version 2.40, Released June 2012, IBR approved for Sec. 170.207.
(m) U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894; Telephone (301) 594-5983 or http://www.nlm.nih.gov/.
(1) International Health Terminology Standards Development Organization Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT[supreg]), International Release, July 2009, IBR approved for Sec. 170.207.
(2) International Health Terminology Standards Development Organisation (IHTSDO) Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT[supreg]) International Release July 31, 2012, IBR approved for Sec. 170.207.
(3) US Extension to SNOMED CT[supreg] March 2012 Release, IBR approved for Sec. 170.207.
(4) RxNorm, August 6, 2012 Full Release Update, IBR approved for Sec. 170.207.
(5) Data Element Catalog, Version 1.1, October 2012, IBR approved for Sec. 170.204.
(n) World Wide Web Consortium (W3C)/MIT, 32 Vassar Street, Room 32-G515, Cambridge, MA 02139 USA, http://www.w3.org/standards/
(1) Web Content Accessibility Guidelines (WCAG) 2.0, December 11, 2008, IBR approved for Sec. 170.204.
(2) [Reserved] [75 FR 44649, July 28, 2010, as amended at 75 FR 62690, Oct. 13, 2010; 77 FR 54285, Sept. 4, 2012; 77 FR 72991, Dec. 7, 2012; 79 FR 54478, Sept. 11, 2014]