---
kind: "section"
citation: "45 C.F.R. § 170.205"
title: "45"
number: "170.205"
heading: "Content exchange standards and implementation specifications for exchanging electronic health information."
url: "https://uscodex.org/cfr/45/170.205"
---

# §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](/cfr/45/170.299.md)). 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](/cfr/45/170.299.md)).
  - (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](/cfr/45/170.299.md)). 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](/cfr/45/170.299.md)).
- (b) **Electronic prescribing—**
  - (1) **Standard.** National Council for Prescription Drug Programs (NCPDP): SCRIPT Standard Implementation Guide; Version 2017071 (incorporated by reference in [§ 170.299](/cfr/45/170.299.md)). 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](/cfr/45/170.299.md)).
- (c) **Real-time prescription benefit—**
  - (1) **Standard.** NCPDP Real-Time Prescription Benefit Standard, Implementation Guide, Version 13 (incorporated by reference in [§ 170.299](/cfr/45/170.299.md)).
  - (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](/cfr/45/170.299.md)).
  - (3) [Reserved]
  - (4) **Standard.** HL7 2.5.1 (incorporated by reference in [§ 170.299](/cfr/45/170.299.md)). 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](/cfr/45/170.299.md)) 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](/cfr/45/170.299.md)).
- (e) **Electronic submission to immunization registries.**
  - (1) [Reserved]
  - (2) -(3) [Reserved]
  - (4) **Standard.** HL7 2.5.1 (incorporated by reference in [§ 170.299](/cfr/45/170.299.md)). Implementation specifications. HL7 2.5.1 Implementation Guide for Immunization Messaging, Release 1.5 (incorporated by reference in [§ 170.299](/cfr/45/170.299.md)) and HL7 Version 2.5.1 Implementation Guide for Immunization Messaging (Release 1.5)—Addendum, July 2015 (incorporated by reference in [§ 170.299](/cfr/45/170.299.md)).
- (f) [Reserved]
- (g) **Electronic transmission of lab results to public health agencies. Standard.** HL7 2.5.1 (incorporated by reference in [§ 170.299](/cfr/45/170.299.md)). 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](/cfr/45/170.299.md)) with Errata and Clarifications, (incorporated by reference in [§ 170.299](/cfr/45/170.299.md)) and ELR 2.5.1 Clarification Document for EHR Technology Certification, (incorporated by reference in [§ 170.299](/cfr/45/170.299.md)).
- (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](/cfr/45/170.299.md)).
  - (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](/cfr/45/170.299.md)).
    - (i) **Cancer information.**
  - (1) [Reserved]
  - (2) **Standard.** HL7 Clinical Document Architecture (CDA), Release 2.0, Normative Edition (incorporated by reference in [§ 170.299](/cfr/45/170.299.md)). 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](/cfr/45/170.299.md)).
- (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](/cfr/45/170.299.md)).
  - (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](/cfr/45/170.299.md)).
  - (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](/cfr/45/170.299.md)).
- (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](/cfr/45/170.299.md)).
  - (2) [Reserved]
- (p) **XDM package processing—**
  - (1) **Standard.** IHE IT Infrastructure Technical Framework Volume 2b (ITI TF-2b) (incorporated by reference in [§ 170.299](/cfr/45/170.299.md)).
  - (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](/cfr/45/170.299.md)). 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](/cfr/45/2.1.2.1.md) (pages 69-72);
    - (ii) Antimicrobial Resistance Option (ARO) Summary Report (Denominator) specific document template in [Section 2.1.1.1](/cfr/45/2.1.1.1.md) (pages 54-56); and
    - (iii) Antimicrobial Use (AUP) Summary Report (Numerator and Denominator) specific document template in [Section 2.1.1.2](/cfr/45/2.1.1.2.md) (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](/cfr/45/170.299.md)).
  - (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](/cfr/45/170.299.md)).
  - (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](/cfr/45/170.299.md)).
  - (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](/cfr/45/170.299.md)).
  - (4) **Standard.** Reportable Conditions Trigger Codes Value Set for Electronic Case Reporting. (incorporated by reference, see [§ 170.299](/cfr/45/170.299.md)).
- (u) **Formulary and benefit—**
  - (1) **Standard.** NCPDP Formulary and Benefit Standard Version 60 (incorporated by reference in [§ 170.299](/cfr/45/170.299.md)).
  - (2) [Reserved]

## Notes

### Amendments

[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]

### Source

Source: 75 FR 44649, July 28, 2010, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 300jj-11; 42 U.S.C 300jj-14; 5 U.S.C. 552.

### Source

Source: 75 FR 2042, Jan. 13, 2010, unless otherwise noted.

### Amendments

[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]