What’s New in the 2022 Approved Standards via Standards Version Advancement Process

Rob Anthony and Avinash Shanbhag | June 28, 2022

We are pleased to announce the publication of the Approved Standards for 2022 for our annual Standards Version Advancement Process (SVAP). The SVAP is designed to make ONC’s Certification program responsive to industry needs by allowing for better alignment to industry efforts for standards advancement, removing barriers for standards development and version updates, and improving the ability for health IT developers to provide relevant, timely, and innovative solutions to their clients.

Beginning August 29, 2022, health IT developers participating in ONC’s Health IT Certification Program can voluntarily incorporate new versions of standards approved by the national coordinator into their Certified Health IT Modules. To further support implementation of the approved 2022 standards, ONC will update all the associated test data and tools, including C-CDA validators, Cypress, Edge Testing Tool, and Inferno by the end of August 2022.

If you are interested in detailed information on the added standards and their associated certification criteria, please see the 2022 SVAP Fact Sheet.

Notable Updates and Background on the 2022 Approved SVAP Standards

The Approved Standards for 2022 include the advancement of ten standards. The United States Core Data for Interoperability version 2 (USCDI v2) is among the notable standards we approved for the 2022 SVAP cycle, as are three HL7® standards related to C-CDA and FHIR® US Core. USCDI v2 will continue to advance important health equity work via key patient demographic data and will be included in two of the HL7 standards. SVAP provides an accelerated pathway for health IT developers to adopt the social determinants of health (SDOH) and sexual orientation and gender identity (SOGI) data standards from USCDI v2.

The three HL7 standards we approved include the HL7® Clinical Document Architecture (CDA®) R2 Implementation Guide: C-CDA Templates for Clinical Notes Release 3 and two US Core Implementation Guides, Versions 4.0.0 and 5.0.1. Together, these standards will guide the industry towards consistent implementation of USCDI Version 1, for which Certified Health IT Modules are required to be updated by December 31, 2022. Specifically, US Core Version 4.0.0 will support USCDI version 1, and US Core Version 5.0.1 and C-CDA Templates for Clinical Notes R2.1 Companion Guide, Release 3 will support USCDI Version 2.

Approving two US Core Implementation Guides in the same SVAP cycle is unusual and a reflection of the shift we announced late last year. The HL7® FHIR® US Core Implementation Guide version 4.0.0 supports USCDI v 1. Both the C-CDA Companion Guide Release 3, and the HL7® FHIR® US Core Implementation Guide version 5.0.1, support USCDI v2. It made sense to include both implementation guides because version 4.0.0 addresses certain ambiguities and makes improvements to US Core version 3.1.1. This implementation guide will provide better implementation guidance to Certified Health IT Developers working towards certification for Standardized API for patient and population services. As an example, for Certified Health IT Developers looking to support their clients with new SDOH data elements, US Core Implementation Guide version 5.0.1 and the C-CDA Release 3 provide guidance from HL7® on how to do so consistently.

In addition to the US Core Implementation Guides, there are two additional standards for Standardized API for patient and population services that are advancing this cycle, and they include the SMART Application Launch Framework and Bulk Data Access Implementation Guides. These two standards support authentication and authorization services and bulk export capabilities. With the advancement of these additional standards, health IT developers will have the opportunity to advance all the core standards for the Standardized API for patient and population services criterion. These standards will enable health care providers to obtain data from multiple patients, helping them better manage their patient population. To support this, the Inferno Framework will include a suite of test kits that allow the testing of different combinations of these SVAP standards.

Another notable interoperable standard in this year’s SVAP announcement is the update to the HL7® CDA R2 IG for Healthcare Associated Infection (HAI) Reports, Release 3 – US Realm. This data exchange standard provides updated implementation guidance for Health IT Modules on how to electronically transmit antimicrobial resistance event reports to the National Health Safety Network (NHSN). The Centers for Disease Control and Prevention (CDC) maintains a NHSN CDA Validator that will include updates for this SVAP version. This data exchange standard is included in the Transmission to public health agencies—antimicrobial use and resistance reporting criterion and provides implementation guidance for Health IT Modules on how to electronically create antimicrobial use and resistance reporting information for electronic transmission to public health registries.

We are also excited to note the advancement of the Applicability Statement for Secure Health Transport (Direct) to Version 1.3, May 2021. This standard supports secure transport of health information over the internet and is supported by the Edge Testing Tool (ETT).

Other updates include the Centers for Medicare &Medicaid Services (CMS) Quality Reporting Document Architecture (QRDA) Category I and III Implementation Guides included in the Clinical quality measure (CQM) – report criterion to support CMS’ Hospital Inpatient Quality Reporting (IQR) and the Medicare Promoting Interoperability Programs reporting requirements. Because these standards are updated annually, developers had to update their products outside of the ONC Health IT Certification Program to comply. Now with SVAP’s annual advancement, ONC can better support developer adherence to these standards. Because of different reporting and publishing timelines, the SVAP advancement of new versions of the CMS QRDA Implementation Guides will always lag approximately six months behind CMS publication.

Overall, these new standards give developers the ability to continue to advance their products and display their updated functionality via their product listings in the Certified Health IT Product List (CHPL). Also, as developers prepare their inaugural Real World Testing, these standards can be incorporated into their measures to demonstrate their products’ real-world use.

Please make sure to review the SVAP fact sheet for more information on the Standard Version Advancement Process and how Certified Health IT Developers can voluntarily update to these newer versions of adopted standards.

Approved Standards for 2022: