45 CFR 170.205 - Content exchange standards and implementation specifications for exchanging electronic health information.

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§ 170.205 Content exchange standards and implementation specifications for exchanging electronic health information.
The Secretary adopts the following content exchange standards and associated implementation specifications:
(a) Patient summary record—
(1) Standard. Health Level Seven Clinical Document Architecture (CDA) Release 2, Continuity of Care Document (CCD) (incorporated by reference in § 170.299). Implementation specifications. The Healthcare Information Technology Standards Panel (HITSP) Summary Documents Using HL7 CCD Component HITSP/C32 (incorporated by reference in § 170.299).
(2) Standard. ASTM E2369 Standard Specification for Continuity of Care Record and Adjunct to ASTM E2369 (incorporated by reference in § 170.299).
(b) Electronic prescribing—
(1) Standard. The National Council for the Prescription Drug Programs (NCPDP) Prescriber/Pharmacist Interface SCRIPT standard, Implementation Guide, Version 8, Release 1 (Version 8.1) October 2005 (incorporated by reference in § 170.299)
(2) Standard. NCPDP SCRIPT Standard, Implementation Guide, Version 10.6 (incorporated by reference in § 170.299).
(c) Electronic submission of lab results to public health agencies. Standard. HL7 2.5.1 (incorporated by reference in § 170.299). Implementation specifications. HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) (incorporated by reference in § 170.299).
(d) Electronic submission to public health agencies for surveillance or reporting. (1) Standard. HL7 2.3.1 (incorporated by reference in § 170.299).
(2) Standard. HL7 2.5.1 (incorporated by reference in § 170.299).
(e) Electronic submission to immunization registries—
(1) Standard. HL7 2.3.1 (incorporated by reference in § 170.299). Implementation specifications. Implementation Guide for Immunization Data Transactions using Version 2.3.1 of the Health Level Seven (HL7) Standard Protocol Implementation Guide Version 2.2 (incorporated by reference in § 170.299).
(2) Standard. HL7 2.5.1 (incorporated by reference in § 170.299). Implementation specifications. HL7 2.5.1 Implementation Guide for Immunization Messaging Release 1.0 (incorporated by reference in § 170.299).
(f) Quality reporting. Standard. The CMS Physician Quality Reporting Initiative (PQRI) 2009 Registry XML Specification (incorporated by reference in § 170.299). Implementation specifications. Physician Quality Reporting Initiative Measure Specifications Manual for Claims and Registry (incorporated by reference in § 170.299).
[75 FR 44649, July 28, 2010, as amended at 75 FR 62690, Oct. 13, 2010]
Effective Date Note:
At 77 FR 54284, Sept. 4, 2012, § 170.205 was amended by adding paragraphs (a)(3), (d)(3), (e)(3), and (g) through (k), effective Oct. 4, 2012. For the convenience of the user, the added text is set forth as follows:
§ 170.205 Content exchange standards and implementation specifications for exchanging electronic health information.
The Secretary adopts the following content exchange standards and associated implementation specifications:
(a) * * *
(3) Standard. HL7 Implementation Guide for CDA® Release 2: IHE Health Story Consolidation, (incorporated by reference in § 170.299). The use of the “unstructured document” document-level template is prohibited.
(d) * * *
(3) Standard. HL7 2.5.1 (incorporated by reference in § 170.299). Implementation specifications. PHIN Messaging Guide for Syndromic Surveillance (incorporated by reference in § 170.299) and Conformance Clarification for EHR Certification of Electronic Syndromic Surveillance, Addendum to PHIN Messaging Guide for Syndromic Surveillance (incorporated by reference in § 170.299).
(e) * * *
(3) Standard. HL7 2.5.1 (incorporated by reference in § 170.299). Implementation specifications. HL7 2.5.1 Implementation Guide for Immunization Messaging, Release 1.4, (incorporated by reference in § 170.299).
(g) Electronic transmission of lab results to public health agencies. Standard. HL7 2.5.1 (incorporated by reference in § 170.299). Implementation specifications. HL7 Version 2.5.1 Implementation Guide: Electronic Laboratory Reporting to Public Health, Release 1 (US Realm) (incorporated by reference in § 170.299) with Errata and Clarifications, (incorporated by reference in § 170.299) and ELR 2.5.1 Clarification Document for EHR Technology Certification, (incorporated by reference in § 170.299).
(h) Clinical quality measure data import, export, and electronic submission. Standard. HL7 Implementation Guide for CDA® Release 2: Quality Reporting Document Architecture, (incorporated by reference in § 170.299).
(i) Cancer information. Standard. HL7 Clinical Document Architecture (CDA), Release 2.0, Normative Edition (incorporated by reference in § 170.299). Implementation specifications. Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries, HL7 Clinical Document Architecture (CDA), (incorporated by reference in § 170.299).
(j) Electronic incorporation and transmission of lab results. Standard. HL7 Version 2.5.1 Implementation Guide: S&I Framework Lab Results Interface, (incorporated by reference in § 170.299).
(k) Clinical quality measure aggregate electronic submission. Standard. Quality Reporting Document Architecture Category III, Implementation Guide for CDA Release 2 (incorporated by reference in § 170.299).

Title 45 published on 2013-10-01

The following are only the Rules published in the Federal Register after the published date of Title 45.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-09-11; vol. 79 # 176 - Thursday, September 11, 2014
    1. 79 FR 54430 - 2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary
      Final rule.
      This rule is effective October 14, 2014, except for the amendments to the amendatory instruction number 3 amendment to § 170.102, the amendments to §§ 170.205, 170.207, 170.210, 170.302, 170.304, 170.306, and the amendatory instruction number 18 amendment to § 170.550, which are effective on March 1, 2015. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of October 14, 2014.
      45 CFR Part 170

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United States Code

Title 45 published on 2013-10-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 45 CFR 170 after this date.

  • 2014-09-11; vol. 79 # 176 - Thursday, September 11, 2014
    1. 79 FR 54430 - 2014 Edition Release 2 Electronic Health Record (EHR) Certification Criteria and the ONC HIT Certification Program; Regulatory Flexibilities, Improvements, and Enhanced Health Information Exchange
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Office of the Secretary
      Final rule.
      This rule is effective October 14, 2014, except for the amendments to the amendatory instruction number 3 amendment to § 170.102, the amendments to §§ 170.205, 170.207, 170.210, 170.302, 170.304, 170.306, and the amendatory instruction number 18 amendment to § 170.550, which are effective on March 1, 2015. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of October 14, 2014.
      45 CFR Part 170