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Title 45

Displaying title 45, up to date as of 9/21/2021. Title 45 was last amended 9/13/2021.

Title 45

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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) [Reserved]

(2) [Reserved]

(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]

(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) [Reserved]

(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]

(2-3) [Reserved]

(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) [Reserved]

(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]

(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]

(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-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; 85 FR 25940, May 1, 2020; 85 FR 70082, Nov. 4, 2020]