Technical outcome – The Health IT Module can create a summary record (formatted to Consolidated Clinical Document Architecture (C-CDA) Release 2.1) that is tagged at the document, section, and entry level as restricted and subject to re-disclosure restrictions using the HL7® Implementation Guide: Data Segmentation for Privacy (DS4P), Release 1.
Clarifications:
- This certification criterion in § 170.315(b)(7) focuses on a Health IT Module’s ability to tag a C-CDA document as restricted and subject to re-disclosure restrictions using the HL7® DS4P standard, not on the content of the C-CDA document. As such, this certification criterion is not subject to the Consolidated CDA creation performance certification criterion (§ 170.315(g)(6)) because testing for § 170.315(g)(6) focuses on the content of the C-CDA document. We established a certification criterion for Consolidated CDA creation performance to promote the interoperability of C-CDA documents during exchange by testing conformance of the C-CDA’s content to the variation permitted by the HL7® standard. [see also 80 FR 16859]
- In order to mitigate potential interoperability errors and inconsistent implementation of the HL7® Implementation Guide for CDA® Release 2: Consolidated CDA Templates for Clinical Notes, Draft Standard for Trial Use, Release 2.1, ONC assesses, approves, and incorporates corrections as part of required testing and certification to this criterion. [see the Health IT Certification Program Overview] Certified health IT adoption and compliance with the following corrections are necessary because they implement updates to vocabularies, update rules for cardinality and conformance statements, and promote proper exchange of C-CDA documents. There is a 90-day delay from the time the CCG has been updated with the ONC-approved corrections to when compliance with the corrections will be required to pass testing (i.e., Edge Testing Tool: Message Validators). Similarly, there will be an 18-month delay before a finding of a correction’s absence in certified health IT during surveillance would constitute a non-conformity under the Certification Program.
- Through the C-CDA Patch Process, the HL7® Structured Documents Work Group (SDWG) approves C-CDA “patches”, which are corrections for issues with the C-CDA implementation guide (C-CDA IG) and companion guides. C-CDA “patches” include corrections for issues such as ambiguous requirements and requirements incompatible with real world deployment. Similar to C-CDA “patches” are C-CDA “additional guidance”. C-CDA “additional guidance” approved by the SDWG indicates guidance included in a newer version of the C-CDA IG or companion guide as being relevant to a previous version of the C-CDA IG or companion guide. A C-CDA “patch” may require a code change to correct errors or ambiguities in the guide, while “additional guidance” is purely clarifying and does not require any code changes. Though C-CDA “patches” and “additional guidance” are not required for certification purposes (unless indicated in the Certification Companion Guide), health IT developers may optionally implement C-CDA “additional guidance” in their Health IT Module and still be conformant with § 170.315(b)(7) criterion requirements.
- More information regarding the C-CDA Patch Process and C-CDA “patches” and “additional guidance” approved by the SDWG is available on the HL7® Confluence pages of C-CDA 'Patch' Process and Approved Patches and Additional Guidance.
