45 CFR § 170.205
Federal
Content exchange standards and implementation specifications for exchanging electronic health information.
45 CFR § 170.205
Source text
51 segments
45 CFR § 170.205
45 CFR § 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).
(1)
[Reserved]
(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]
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