§ 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, 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). The Secretary's adoption of this standard expires on January 1, 2028.
( 2 ) *Standard.* NCPDP SCRIPT Standard, Implementation Guide, Version 2023011 (incorporated by reference in § 170.299).
( c ) *Real-time prescription benefit* — ( 1 ) *Standard.* NCPDP Real-Time Prescription Benefit Standard, Implementation Guide, Version 13 (incorporated by reference in § 170.299).
( 2 ) [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]
( 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).
( u ) *Formulary and benefit* — ( 1 ) *Standard.* NCPDP Formulary and Benefit Standard Version 60 (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; 89 FR 1426, Jan. 9, 2024; 89 FR 51265, June 17, 2024]