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Code of Federal Regulations Title 45. Public Welfare § 45.170.205 Content exchange standards and implementation specifications for exchanging electronic health information

Current as of January 02, 2025 | Updated by Findlaw Staff

The Secretary adopts the following content exchange standards and associated implementation specifications:

(a) Patient summary record—

(1),(2) [Reserved by 85 FR 25940]

(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).

(5) Standard. HL7 CDA® R2 Implementation Guide:  C–CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2 (incorporated by reference in § 170.299).

(b) Electronic prescribing.

(1) Standard. National Council for Prescription Drug Programs (NCPDP):  SCRIPT Standard Implementation Guide;  Version 2017071 (incorporated by reference in § 170.299).

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

(c) [Reserved by 79 FR 54478]

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

(1) [Reserved by 79 FR 54478]

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

(3) [Reserved by 85 FR 25940]

(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 by 79 FR 54478]

(2) [Reserved by 79 FR 54478]

(3) [Reserved by 85 FR 25940]

(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 by 79 FR 54478]

(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) [Reserved by 85 FR 25940]

(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).

(3) Standard. CMS Implementation Guide for Quality Reporting Document Architecture:  Category I;  Hospital Quality Reporting;  Implementation Guide for 2020 (incorporated by reference in § 170.299).

(i) Cancer information—

(1) [Reserved by 85 FR 25940]

(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) [Reserved by 85 FR 25940]

(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).

(3) Standard. CMS Implementation Guide for Quality Reporting Document Architecture:  Category III;  Eligible Clinicians and Eligible Professionals Programs;  Implementation Guide for 2020 (incorporated by reference in § 170.299).

(l) [Reserved]

(m) [Reserved]

(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]

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Cite this article: FindLaw.com - Code of Federal Regulations Title 45. Public Welfare § 45.170.205 Content exchange standards and implementation specifications for exchanging electronic health information - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-45-public-welfare/cfr-sect-45-170-205/

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