Section 170.205 - Content exchange standards and implementation specifications for exchanging electronic health informationThe Secretary adopts the following content exchange standards and associated implementation specifications:
(a)Patient summary record.(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, see § 170.299 ). The adoption of this standard expires on January 1, 2026.(6)Standard. HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes STU Companion Guide, Release 4.1-US Realm (incorporated by reference, see § 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 ).(d)Electronic submission to public health agencies for surveillance or reporting.(2)Standard. HL7 2.5.1 (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.(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 ).(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.(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.(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 ).(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 ).(o)Data segmentation for privacy -(1)Standard. HL7 Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1 (incorporated by reference in § 170.299 ).(p)XDM package processing - (1)Standard. IHE IT Infrastructure Technical Framework Volume 2b (ITI TF-2b) (incorporated by reference in § 170.299 ).(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).(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 ).(t)Public health-electronic case reporting -(1)Standard. HL7® FHIR® Implementation Guide: Electronic Case Reporting (eCR)-US Realm 2.1.0-STU 2 US (HL7 FHIR eCR IG) (incorporated by reference, see § 170.299 ).(2)Standard. HL7 CDA® R2 Implementation Guide: Public Health Case Report-the Electronic Initial Case Report (eICR) Release 2, STU Release 3.1-US Realm (HL7 CDA eICR IG) (incorporated by reference, see § 170.299 ).(3)Standard. HL7® CDA® R2 Implementation Guide: Reportability Response, Release 1, STU Release 1.1-US Realm (HL7 CDA RR IG) (incorporated by reference, see § 170.299 ).(4)Standard. Reportable Conditions Trigger Codes Value Set for Electronic Case Reporting. (incorporated by reference, see § 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; 80 FR 62743, Oct. 16, 2015; 85 FR 25940, May 1, 2020; 85 FR 70082, Nov. 4, 2020 85 FR 25940, 6/30/2020; 85 FR 70082, 12/4/2020; 89 FR 1426, 2/8/2024; 89 FR 8548, 3/11/2024