The Standards Version Advancement Process (SVAP) permits health IT developers to voluntarily update health IT products certified under the ONC Health IT Certification Program (Certification Program) to newer versions of adopted standards as part of the “Real World Testing” Condition and Maintenance of Certification requirement (§ 170.405) of the 21st Century Cures Act.
Using SVAP, Certified Health IT developers are permitted to voluntarily use a newer approved version of a standard than is adopted in regulation. Currently, this flexibility is limited to standards that are adopted in the certification criteria required to meet the “Real World Testing” Condition of Certification, which include § 170.315(b), (c)(1) through (c)(3), (e)(1), (f), (g)(7) through (g)(10), and (h).
Certified Health IT developers taking advantage of the SVAP flexibility must ensure that their Real World Testing plans and results of the Certified Health IT Modules address these updated standards. Additionally, developers updating their already Certified Health IT Modules are required to provide advance notice to their clients and ONC-Authorized Certification Body (ONC-ACB) before adopting a newer approved version of a standard.
Working with industry stakeholders, ONC has developed a collaborative public comment process to identify newer versions of standards that are ready for use in the Certification Program. For additional information on the annual process, including the list of standards and versions eligible for consideration, please visit the SVAP Process Page.
Learn more about the recent 2023 updates to SVAP via the following resources:
- SVAP Fact Sheet
- Approved Standards for 2023
- Blog Post Announcing Approved Standards for 2023
- Approved Standards for 2022 and Approved Standards for 2020
- ONC Standards Bulletin: Sign up for and also view previous alerts for healthcare stakeholders that include updates about ONC health IT standards initiatives such as the SVAP.
Approved SVAP Versions
All the standards in the table below are currently available for voluntary certification under the Certification Program. The 2023 approved SVAP versions were announced July 11, 2023 and went into effect on September 11, 2023. Once effective, any newer versions of approved standards replace existing approved standards from previous years.
Several standards that were included as 2023 Approved SVAP Versions have been incorporated by reference in regulation as of March 11, 2024, the effective date of the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule. These standards, listed below the Approved SVAP Version table, are no longer available for certification through the SVAP process. Health IT Modules that have already updated to these standards via SVAP will not need to update their standard versions again as part of HTI-1 Final Rule requirements, but may have other required updates for their certified criteria. Please contact your ONC Authorized Certification Body (ONC-ACB) for information on the update requirements related to HTI-1 Final Rule.
Additionally, the SVAP approved standard of HL7® FHIR® US Core Implementation Guide STU 4.0.0, June 2021, will continue to remain available for certification via SVAP while the United States Core Data for Interoperability (USCDI), Version 1, July 2020 Errata remains available for use in the Certification Program as a standard adopted in regulation until it expires on January 1, 2026, as outlined in the HTI-1 Final Rule.
Certification Criteria | Current Standard Version(s) | SVAP Version(s) Approved | Regulatory Text Citation |
---|---|---|---|
Applicability Statement for Secure Health Transport, Version 1.2, August 2015 (Direct) | Applicability Statement for Secure Health Transport Version 1.3, May 2021 (Direct) (2022 SVAP Approved) | § 170.202(a)(2) | |
§ 170.315(c)(1) - Clinical quality measures (CQMs) — record and export | HL7® CDA® R2 Implementation Guide: Quality Reporting Document Architecture - Category I (QRDA I); Release 1, DSTU Release 3 (US Realm), Volume 1 - Introductory Material, June 2015 | HL7® CDA® R2 Implementation Guide: Quality Reporting Document Architecture - Category I (QRDA I); Release 1, STU Release 5.3 with errata - US Realm, December 2022 New 2023 SVAP Approved! | § 170.205(h)(2) |
§ 170.315(c)(2) - Clinical quality measures (CQMs) — import and calculate | HL7® CDA® R2 Implementation Guide: Quality Reporting Document Architecture - Category I (QRDA I); Release 1, DSTU Release 3 (US Realm), Volume 1 - Introductory Material, June 2015 | HL7® CDA® R2 Implementation Guide: Quality Reporting Document Architecture - Category I (QRDA I); Release 1, STU Release 5.3 with errata - US Realm, December 2022 New 2023 SVAP Approved! | § 170.205(h)(2) |
CMS Implementation Guide for Quality Reporting Document Architecture: Category I; Hospital Quality Reporting; Implementation Guide for 2020 | § 170.205(h)(3) | ||
CMS Implementation Guide for Quality Reporting Document Architecture: Category III; Eligible Clinicians and Eligible Professionals Programs; Implementation Guide for 2020 | § 170.205(k)(3) | ||
Web Content Accessibility Guidelines (WCAG) 2.0, December 11, 2008 | Web Content Accessibility Guidelines (WCAG) 2.1, June 05, 2018 (Available 3/12/2021) (2020 SVAP Approved) | § 170.204(a)(1) | |
Web Content Accessibility Guidelines (WCAG) 2.0, December 11, 2008 | Web Content Accessibility Guidelines (WCAG) 2.1, June 05, 2018 (Available 3/12/2021) (2020 SVAP Approved) | § 170.204(a)(2) | |
§ 170.315(f)(6) Transmission to public health agencies – antimicrobial use and resistance reporting | HL7® Implementation Guide for CDA® Release 2 – Level 3: Healthcare Associated Infection (HAI) Reports, Release 1, U.S. Realm, August 2013 | HL7® CDA® R2 Implementation Guide: Healthcare Associated Infection (HAI) Reports, Release 3 - US Realm, December 2020 (2022 SVAP Approved) | § 170.205(r)(1) |
§ 170.315(f)(7) - Transmission to public health agencies — health care surveys | 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, December 2014 | HL7® CDA® R2 Implementation Guide: National Health Care Surveys (NHCS), R1 STU Release 3 - US Realm (Available 3/12/2021) (2020 SVAP Approved) | § 170.205(s)(1) |
HL7® FHIR® US Core Implementation Guide STU 3.1.1, August 8, 2020 | HL7® FHIR® US Core Implementation Guide STU 4.0.0, June 2021 (2022 SVAP Approved) | § 170.215(b)(1)(i) | |
HL7® FHIR® Bulk Data Access (Flat FHIR®) (v1.0.0: STU 1), August 22, 2019 | HL7® FHIR® Bulk Data Access (Flat FHIR®) (v2.0.0: STU 2), November 26, 2021 (2022 SVAP Approved) | § 170.215(d)(1) | |
Applicability Statement for Secure Health Transport, Version 1.2, August 2015 (Direct) | Applicability Statement for Secure Health Transport Version 1.3, May 2021 (Direct) (2022 SVAP Approved) | § 170.202(a)(2) | |
Applicability Statement for Secure Health Transport, Version 1.2, August 2015 (Direct) | Applicability Statement for Secure Health Transport Version 1.3, May 2021 (Direct) (2022 SVAP Approved) | § 170.202(a)(2) |
Previously Approved SVAP Versions Incorporated by Reference in the Certification Program
Certification Criteria | Current Standard Version(s) | Previous SVAP Version(s) Approved | Regulatory Text Citation |
---|---|---|---|
HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2-US Realm, October 2019 | HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1 - US Realm, June 2023 (2023 SVAP Approved) | § 170.205(a)(6) | |
United States Core Data for Interoperability (USCDI), Version 1, July 2020 Errata | United States Core Data for Interoperability (USCDI), Version 3, October 2022 Errata (2023 SVAP Approved) | § 170.213 | |
HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2-US Realm, October 2019 | HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1 - US Realm, June 2023 (2023 SVAP Approved) | § 170.205(a)(6) | |
United States Core Data for Interoperability (USCDI), Version 1, July 2020 Errata | United States Core Data for Interoperability (USCDI), Version 3, October 2022 Errata (2023 SVAP Approved) | § 170.213 | |
HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2-US Realm, October 2019 | HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1 - US Realm, June 2023 (2023 SVAP Approved) | § 170.205(a)(6) | |
HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2-US Realm, October 2019 | HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1 - US Realm, June 2023 (2023 SVAP Approved) | § 170.205(a)(6) | |
United States Core Data for Interoperability (USCDI), Version 1, July 2020 Errata | United States Core Data for Interoperability (USCDI), Version 3, October 2022 Errata (2023 SVAP Approved) | § 170.213 | |
United States Core Data for Interoperability (USCDI), Version 1, July 2020 Errata | United States Core Data for Interoperability (USCDI), Version 3, October 2022 Errata (2023 SVAP Approved) | § 170.213 | |
HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 2-US Realm, October 2019 | HL7® CDA® R2 Implementation Guide: C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 4.1 - US Realm, June 2023 (2023 SVAP Approved) | § 170.205(a)(6) | |
United States Core Data for Interoperability (USCDI), Version 1, July 2020 Errata | United States Core Data for Interoperability (USCDI), Version 3, October 2022 Errata (2023 SVAP Approved) | § 170.213 | |
United States Core Data for Interoperability (USCDI), Version 1, July 2020 Errata | United States Core Data for Interoperability (USCDI), Version 3, October 2022 Errata (2023 SVAP Approved) | § 170.213 | |
HL7® FHIR® US Core Implementation Guide STU 3.1.1, August 8, 2020 | HL7® FHIR® US Core Implementation Guide STU 6.1.0, June 30, 2023 (2023 SVAP Approved) | § 170.215(b)(1)(ii) | |
HL7® FHIR® SMART Application Launch Framework Implementation Guide Release 1.0.0, November 13, 2018 | HL7® FHIR® SMART Application Launch Framework Implementation Guide Release 2.0.0, November 26, 2021 (2022 SVAP Approved) | § 170.215(c)(2) |