ONC has established the voluntary Standards Version Advancement Process (SVAP)1 to enable health IT developers’ ability to incorporate newer versions of Secretary-adopted standards and implementation specifications, 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 more advanced version of the standard(s) and implementation specification(s) approved by the National Coordinator than is adopted in the ONC 2015 Edition Certification Criteria. Currently, this flexibility is limited to standards and implementation specifications that are adopted in the certification criteria required to meet “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).
Health IT developers taking advantage of the SVAP flexibility must ensure that their real-world testing plans and results of the certified health modules use these updated standards and implementation specifications. Additionally, certified health IT developers are required to provide advance notice to their clients and their ONC-Authorized Certification Body (ONC-ACB) before adopting the new standards.
Working with industry stakeholders and providing ample notice, ONC will follow a collaborative process to identify a more advanced version of the standards or implementation specifications, for approval by the National Coordinator.
The table below lists the standards and implementation specifications (and their versions) that will be considered for advancement and those that have received National Coordinator approval via the Standards Version Advancement Process. It does not include any minimum vocabulary standards as health IT can continue to be certified or upgraded to newer version(s) of identified minimum standard code sets, unless newer version(s) are explicitly prohibited by the Secretary. The table can be sorted by either "Current Standard/Implementation Specification" or "Regulatory Text Citation" by clicking on the column name.
The table below will be updated throughout the year to include standards with newer versions under consideration for the current SVAP cycle. However, if there is a newer version of a standard and it’s not listed below it can still be considered for inclusion in the current SVAP cycle. As with the 2022 SVAP cycle, future public comment periods will align with important standards development activities, such as the yearly release of new United States Core Data for Interoperability (USCDI) versions and HL7® standards related to C-CDA® and FHIR® US Core, thereby establishing a consistent cadence of SVAP comment periods and releases. Beginning with the recently completed 2022 SVAP cycle, the yearly SVAP comment cycle will be open from January to May with a final release of SVAP for that year to occur in June.
For the latest information on the approved standards for use, see the ONC Health IT Certification Program SVAP page.
View / Comment | Current Standard / Implementation Specification listing in IBR (170.299) | Regulatory Text Citation for Standard / Implementation Specification Adopted Sort descending | Certification Criteria(on) References Standard / Implementation Specification | National Coordinator Approved Advanced Version(s) | View / Comment |
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§ 170.202(a)(2) |
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§ 170.202(b) |
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§ 170.202(d) |
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§ 170.202(e)(1) |
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§ 170.204(a)(1) |
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§ 170.204(a)(2) |
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§ 170.205(a)(3) |
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§ 170.205(a)(4) |
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§ 170.205(a)(4) |
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§ 170.205(a)(5) |
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§ 170.205(b)(1) |
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§ 170.205(d)(4) |
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§ 170.205(d)(4) |
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§ 170.205(e)(4) |
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§ 170.205(e)(4) |
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§ 170.205(g) |
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§ 170.205(g) |
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§ 170.205(h)(2) |
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§ 170.205(h)(3) |
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§ 170.205(i)(2) |
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§ 170.205(i)(2) |
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§ 170.205(k)(3) |
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§ 170.205(o)(1) |
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§ 170.205(p)(1) |
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§ 170.205(r)(1) |
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§ 170.205(s)(1) |
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§ 170.205(s)(1) |
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§ 170.213 |
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§ 170.215(a)(1) |
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§ 170.215(a)(2) |
HL7 FHIR® US Core Implementation Guide STU 6.1.0, June 30, 2023 (Available 9/11/2023)
HL7 FHIR® US Core Implementation Guide STU 5.0.1, June 13, 2022 (Available 8/29/2022)
HL7 FHIR® US Core Implementation Guide STU 4.0.0, June 28, 2021 (Available 8/29/2022) |
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§ 170.215(a)(3) |
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§ 170.215(a)(4) |
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§ 170.215(b) |
1SVAP is permitted in ONC’s 21st Century Cures Act Final Rule in the Real World Testing CoC/MoC: § 170.405(b)(7) and (8) and ONC-ACB PoPC §170.523(t)
Comment
Submitted by hantran on 2023-05-22
CAP Comments on 2023 SVAP
The ONC is considering including version 3 of the United States Core Data for Interoperability (USCDI) in the 2023 SVAP. The College of American Pathologists (CAP) supports the inclusion of USCDI v3 in the 2023 SVAP to support the use, promotion, and advancement of the USCDI in the health information technology ecosystem. In its participation in the USCDI development process, the CAP has advocated for the USCDI to align with CLIA Test Report requirements in the Clinical Laboratory Improvement Amendments (CLIA) of 1988. CLIA’s test report requirements (42 CFR § 493.1291(c)) are as follows: (1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (2) The name and address of the laboratory location where the test was performed. (3) The test report date. (4) The test performed. (5) Specimen source, when appropriate. (6) The test result and, if applicable, the units of measurement or interpretation, or both. (7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. Although USCDI v3 does not align with CLIA, it is an improvement over USCDI v1 and is a step in the right direction. If the draft version of USCDI v4 is finalized as is, it would be preferable to USCDI v3 for the SVAP, as USCDI v4 is more closely aligned with CLIA. The CAP is aware that in the ONC’s proposed rule Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1), the ONC proposes to replace USCDI v1 with USCDI v3 as the new baseline for certification.Submitted by nssp@cdc.gov on 2023-05-22
CDC NSSP Syndromic Surveillance Comments
This is the current implementation standard and specifications in use PHIN Messaging Guide for Syndromic Surveillance: Emergency Department, Urgent, Care, Inpatient and Ambulatory Care, and Inpatient Settings, Release 2.0, April 21, 2015 and Erratum to the CDC PHIN 2.0 Implementation Guide, August 2015 and the National Syndromic Surveillance Program does not have any recommended changes at this time.Submitted by gregthole on 2023-05-12
Oracle Health Comments on 2023 SVAP
Please find attached Oracle Health's 2023 SVAP comment letter. We appreciate the opportunity to share our insights and recommendations on this important topic.Submitted by Toni Wilken on 2023-05-11
MEDITECH Comments on 2023 SVAP
On behalf of Medical Information Technology, Inc. (MEDITECH), I am pleased to comment on the 2023 Standards Version Advancement Process (SVAP). Please see the attached comment letter.Submitted by nachcinformatics on 2022-09-26
Updating SVAP to include USCDIv3
The National Association of Community Health Centers (NACHC) recommends that SVAP references to USCDIv2 be replaced with references to USCDIv3.Submitted by lamartw3 on 2022-05-02
SVAP Comments Submission on behalf of FEHRM Program Office
1) On this page: https://www.healthit.gov/isa/node/2151 Comment: If it is published before the next SVAP update is published, then please consider the HL7 CDA® R2 IG: C-CDA Templates for Clinical Notes STU Companion Guide, Release 3 - US Realm as a new version of this standard. This updated version of the standard includes modelling and guidance to support implementation of USCDI v2 data classes and elements. Submitter: Russell Ott, russell.t.ott3.ctr@mail.mil 2) On this page: https://www.healthit.gov/isa/svap-standard/170215a2 Comment: If it is published before the next SVAP update is published, then please consider the HL7 FHIR® US Core Implementation Guide STU 5.0.0 as a new version of this standard. This updated version of the standard includes modelling and guidance to support implementation of USCDI v2 data classes and elements. Submitter: Russell Ott, russell.t.ott3.ctr@mail.milSubmitted by KatelynFontaine on 2022-05-02
MEDITECH 2022 SVAP Comments
On behalf of Medical Information Technology, Inc. (MEDITECH), I am pleased to comment on the 2022 Standards Version Advancement Process (SVAP).Medical Information Technology Inc. (MEDITECH) 2022 SVAP Comments.pdf
Submitted by EHRAcomms on 2022-05-02
EHR Association additional comments to ONC on the SVAP
As the review period of the Standards Version Advancement Process (SVAP) is coming to a close on May 2, 2022, the EHR Association would like to refresh our comments submitted on October 11, 2021. In that letter we expressed support for delaying the SVAP review and publication to aim for a summer 2022 SVAP publication, so the necessary HL7® FHIR® US Core and HL7® CDA® C-CDA Companion Guide guidance could be updated to reflect the additions made to USCDI V2. We also expressed a desire to proceed with all other proposed standards, as they were ready to move forward. Our comments are attached in full.Submitted by chris.baumgart… on 2022-04-29
Submitted by knicholoff@ehra.org on 2023-05-23
EHR Association Comments on 2023 SVAP
On behalf of our nearly 30 member companies, the HIMSS Electronic Health Record (EHR) Association appreciates the opportunity to provide feedback to the ONC on the 2023 Standards Version Advancement Process (SVAP). Our comments are attached in full.EHR Association Comments to ONC on 2023 SVAP.pdf