Code of Federal Regulations (alpha)

CFR /  Title 45  /  Part 170  /  Sec. 170.205 Content exchange standards and implementation

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 Sec. 170.299). Implementation specifications. The Healthcare Information Technology Standards Panel (HITSP) Summary Documents Using HL7 CCD Component HITSP/C32 (incorporated by reference in Sec. 170.299).

(1) Standard. Health Level Seven Clinical Document Architecture (CDA) Release 2, Continuity of Care Document (CCD) (incorporated by reference in Sec. 170.299). Implementation specifications. The Healthcare Information Technology Standards Panel (HITSP) Summary Documents Using HL7 CCD Component HITSP/C32 (incorporated by reference in Sec. 170.299).

(2) Standard. ASTM E2369 Standard Specification for Continuity of Care Record and Adjunct to ASTM E2369 (incorporated by reference in Sec. 170.299).

(3) Standard. HL7 Implementation Guide for CDA[supreg] Release 2: IHE Health Story Consolidation, (incorporated by reference in Sec. 170.299). The use of the ``unstructured document'' document-level template is prohibited.

(b) Electronic prescribing. (1) [Reserved]

(1) [Reserved]

(2) Standard. NCPDP SCRIPT Standard, Implementation Guide, Version 10.6 (incorporated by reference in Sec. 170.299).

(c) [Reserved]

(d) Electronic submission to public health agencies for surveillance or reporting. (1) [Reserved]

(1) [Reserved]

(2) Standard. HL7 2.5.1 (incorporated by reference in Sec. 170.299).

(3) Standard. HL7 2.5.1 (incorporated by reference in Sec. 170.299). Implementation specifications. PHIN Messaging Guide for Syndromic Surveillance (incorporated by reference in Sec. 170.299) and Conformance Clarification for EHR Certification of Electronic Syndromic Surveillance, Addendum to PHIN Messaging Guide for Syndromic Surveillance (incorporated by reference in Sec. 170.299).

(e) Electronic submission to immunization registries. (1) [Reserved]

(1) [Reserved]

(2) [Reserved]

(3) Standard. HL7 2.5.1 (incorporated by reference in Sec. 170.299). Implementation specifications. HL7 2.5.1 Implementation Guide for Immunization Messaging, Release 1.4, (incorporated by reference in Sec. 170.299).

(f) [Reserved]

(g) Electronic transmission of lab results to public health agencies. Standard. HL7 2.5.1 (incorporated by reference in Sec. 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 Sec. 170.299) with Errata and Clarifications, (incorporated by reference in Sec. 170.299) and ELR 2.5.1 Clarification Document for EHR Technology Certification, (incorporated by reference in Sec. 170.299).

(h) Clinical quality measure data import, export, and electronic submission. Standard. HL7 Implementation Guide for CDA[supreg] Release 2: Quality Reporting Document Architecture, (incorporated by reference in Sec. 170.299).

(i) Cancer information. Standard. HL7 Clinical Document Architecture (CDA), Release 2.0, Normative Edition (incorporated by reference in Sec. 170.299). Implementation specifications. Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries, HL7 Clinical Document Architecture (CDA), (incorporated by reference in Sec. 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 Sec. 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 Sec. 170.299). [75 FR 44649, July 28, 2010, as amended at 75 FR 62690, Oct. 13, 2010; 77 FR 54284, Sept. 4, 2012; 79 FR 54478, Sept. 11, 2014]