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

§ 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).

(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.

(4)Standard. HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use, Volume 1 - Introductory Material, Release 2.1 and HL7 Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes (US Realm), Draft Standard for Trial Use, Volume 2 - Templates and Supporting Material, Release 2.1 (incorporated by reference in § 170.299).

(b)Electronic prescribing.

(1) [Reserved]

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

(c) [Reserved]

(d)Electronic submission to public health agencies for surveillance or reporting.

(1) [Reserved]

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

(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).

(4)Standard. HL7 2.5.1 (incorporated by reference in § 170.299). Implementation specifications. PHIN Messaging Guide for Syndromic Surveillance: Emergency Department, Urgent Care, Inpatient and Ambulatory Care Settings, Release 2.0, April 21, 2015 (incorporated by reference in § 170.299) and Erratum to the CDC PHIN 2.0 Implementation Guide, August 2015; Erratum to the CDC PHIN 2.0 Messaging Guide, April 2015 Release for Syndromic Surveillance: Emergency Department, Urgent Care, Inpatient and Ambulatory Care Settings (incorporated by reference in § 170.299).

(e)Electronic submission to immunization registries.

(1) [Reserved]

(2) [Reserved]

(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).

(4)Standard. HL7 2.5.1 (incorporated by reference in § 170.299). Implementation specifications. HL7 2.5.1 Implementation Guide for Immunization Messaging, Release 1.5 (incorporated by reference in § 170.299) and HL7 Version 2.5.1 Implementation Guide for Immunization Messaging (Release 1.5) - Addendum, July 2015 (incorporated by reference in § 170.299).

(f) [Reserved]

(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 reporting -

(1)Standard. HL7 Implementation Guide for CDA® Release 2: Quality Reporting Document Architecture (incorporated by reference in § 170.299).

(2)Standard. HL7 CDA® R2 Implementation Guide: Quality Reporting Document Architecture - Category I (QRDA I); Release 1, DSTU Release 3 (US Realm), Volume 1 - Introductory Material and HL7 CDA® R2 Implementation Guide: Quality Reporting Document Architecture - Category I (QRDA I); Release 1, DSTU Release 3 (US Realm), Volume 2 - Templates and Supporting Material (incorporated by reference in § 170.299).

(i)Cancer information -

(1)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), Release 1.0 (incorporated by reference in § 170.299).

(2)Standard. HL7 Clinical Document Architecture (CDA), Release 2.0, Normative Edition (incorporated by reference in § 170.299). Implementation specifications. HL7 CDA© Release 2 Implementation Guide: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1; DSTU Release 1.1, Volume 1 - Introductory Material and HL7 CDA© Release 2 Implementation Guide: Reporting to Public Health Cancer Registries from Ambulatory Healthcare Providers, Release 1; DSTU Release 1.1 (US Realm), Volume 2 - Templates and Supporting Material (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 reporting -

(1)Standard. Quality Reporting Document Architecture Category III, Implementation Guide for CDA Release 2 (incorporated by reference in § 170.299).

(2)Standard. Errata to the HL7 Implementation Guide for CDA® Release 2: Quality Reporting Document Architecture - Category III, DSTU Release 1 (US Realm), September 2014 (incorporated by reference in § 170.299).

(l)-(n) [Reserved]

(o)Data segmentation for privacy -

(1)Standard. HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1 (incorporated by reference in § 170.299).

(2) [Reserved]

(p)XDM package processing -

(1)Standard. IHE IT Infrastructure Technical Framework Volume 2b (ITI TF-2b) (incorporated by reference in § 170.299).

(2) [Reserved]

(q) [Reserved]

(r)Public health - antimicrobial use and resistance information -

(1)Standard. The following sections of HL7 Implementation Guide for CDA® Release 2 - Level 3: Healthcare Associated Infection Reports, Release 1, U.S. Realm (incorporated by reference in § 170.299). Technology is only required to conform to the following sections of the implementation guide:

(i) HAI Antimicrobial Use and Resistance (AUR) Antimicrobial Resistance Option (ARO) Report (Numerator) specific document template in Section 2.1.2.1 (pages 69-72);

(ii) Antimicrobial Resistance Option (ARO) Summary Report (Denominator) specific document template in Section 2.1.1.1 (pages 54-56); and

(iii) Antimicrobial Use (AUP) Summary Report (Numerator and Denominator) specific document template in Section 2.1.1.2 (pages 56-58).

(2) [Reserved]

(s)Public health - health care survey information -

(1)Standard. HL7 Implementation Guide for CDA® Release 2: National Health Care Surveys (NHCS), Release 1 - US Realm, HL7 Draft Standard for Trial Use, Volume 1 - Introductory Material and HL7 Implementation Guide for CDA® Release 2: National Health Care Surveys (NHCS), Release 1 - US Realm, HL7 Draft Standard for Trial Use, Volume 2 - Templates and Supporting Material (incorporated by reference in § 170.299).

(2) [Reserved]

[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; 80 FR 62743, Oct. 16, 2015]