Original Project Scope (from 2019 Confluence PSS):

The Office of the National Coordinator (ONC) releases periodic proposed rules, and final rules, which reference the use of Consolidated CDA (C-CDA). The Companion Guide to Consolidated Clinical Document Architecture (C-CDA) provides supplemental guidance to the Health Level Seven (HL7) CDA® R2 IG: C-CDA Templates for Clinical Notes STU. The prior version of the companion guide is specific to a rule, the 2015 ONC Certification rule.

This project will update the companion guide to support C-CDA implementations in the US.

Updates may include new C-CDA templates and other revisions to meet industry requirements, for example changes in government requirements. The set of updates for any release SHALL require approval by the Structured Documents Work Group and the US Realm Steering Committee.

Current Scope:

The Office of the National Coordinator (ONC) published Version 2 of The United States Core Data for Interoperability (USCDI) in July of 2021.

This 2021-2022 C-CDA Companion Guide update will be strictly limited to the CDA representation of these new Data Classes and Elements.

Where USCDI V2 data elements or classes map to already existing C-CDA templates, attributes or elements, a mapping table from USCDI V2 Data Elements and classes to C-CDA templates, attributes or elements will be created that includes explanatory text to support the new USCDI V2 Data elements and classes to guide C-CDA implementations to prepare for the exchange of USCDI V2 Data Elements. 

Where new design is needed, new C-CDA conformant templates with examples will be created. While the 2021-2022 C-CDA Companion Guide update will contain new templates and/or guidance, the USCDI V1 templates will be removed and moved to the C-CDA main Implementation Guide during the January ballot/update.

This current (2021-2022) scope represents a transitional Companion Guide format containing new design. In future, new template design and balloting for C-CDA will be housed in C-CDA Implementation Guide updates. The C-CDA Companion Guide will become a true guidance document.

The  ONC Health IT Standards Bulletin, Issue 2021-3 July 2021 contains a table that highlights the new Data Classes and Elements in USCDI V2.

Some new domains to be examined are the representation or guidance on sending Assessments, Goals, Problems/Health Concerns and Interventions that are associated with Social Determinants of Health (SDOH) and the CDA representation of Gender Identity and Sexual Orientation as described in USCDI V2.

The purpose of the new Companion Guide is to:

• Supplement the C-CDA Implementation Guide to provide design and guidance to implementers that will represent new Data Classes and Elements from USCDI V2 in C-CDA
• Map the new Data Classes and Elements to the appropriate C-CDA locations
• Provide clinically valid examples of C-CDA components necessary to meet USCDI V2
• Recommend an approach to implementations using the C-CDA IG and this companion guide to meet the needs of implementers and clinicians, particularly with respect to the  SDOH Data Elements

Ongoing and Future Scope:

The present intent for ongoing C-CDA Companion Guide Versions, is to transition to purely implementation guidance with respect to C-CDA Implementation Guide templates and NOT to include new template design.

This PSS covers all future Companion Guide updates, supporting the concept of C-CDA becoming a maintained and supported standard, occasionally requiring clarification and guidance as needed by stakeholders. The exact scope of these updates will be discussed with the SDWG and documented on SDWG Confluence project pages.