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Minutes from SDWG Call

4/3/2019 11:00 AM Eastern


Gay Dolin RN MSN -

Calvin - Host

Celia Bowen -

Didi Davis -

Thomson -




  1. Review and approval of the comments on the ONC NPRM for the PAC.



Motion to approve revisions made to the document shared on the ONC NPRM and submit to the HL7 PAC from SDWG. Made by: Gay, Second by John Vote Against: 0 Abstain: 0 For: 6 motion passes.



Comments to ONC NPRM from SDWG  

 iv. Clinical Notes

With respect to the note types “… we propose to include the following clinical note types for both inpatient and outpatient (primary care, emergency department, etc.) settings in USCDI v1 as a minimum standard: (1) Discharge Summary note; (2) History & Physical; (3) Progress Note; (4) Consultation Note; (5) Imaging Narrative; (6) Laboratory Report Narrative; (7) Pathology Report Narrative; and (8) Procedures Note. “

SDWG agrees that the clinical note types identified are useful to providers when providing clinical care and believe they represent a good starter set for the USCDI.

We do seek a clarification; with the inclusion of these new clinical notes in the USCDI, is the intent to only include these clinical notes within summary documents; CCD, Hospital Summaries, etc. as indicated in the C–CDA Companion Guide or can they also be shared as separate C-CDA document types when using Direct or Exchange transport, analogous to the capabilities proposed for FHIR using the DocumentReference resource?

v. Provenance

In response to the question “We request comment on the inclusion of these three data elements and whether any other provenance data elements, such as the identity of the individual or entity the data was obtained from or sent by (sometimes discussed in standards working groups as the provenance of the data’s ‘‘last hop’’), would be essential to include as part of the USCDI v1 standard.”

SDWG believes the three elements that ONC has identified are appropriate as the starter set in USCDI. As there are no industry best practices currently defined around use of or compelling justifications to support the “last hop” data items in provenance, we would suggest that these be deferred at this time.

One issue that has been identified relates to a current practice in the industry with reconciliation of data extracted from C-CDA CCDs. It’s been noted that the fields identified for provenance will get updated when discrete content is incorporated into the receiving EMR. The CCD documents are stored intact preserving original provenance, but the entries extracted typically identify the clinical user exercising clinical judgement when performing the reconciliation as the author, etc. It is not uncommon that during reconciliation that content received will need to be validated with the patient and revisions / edits may need to be performed to ensure the correctness of the data.

As this seems to be a current practice for reconciliation, should not an allowance be made for this data to be changed when performing reconciliation?

d. Clinical Notes C–CDA Implementation Specification

Structured Documents WG (SDWG) agrees with the proposed recommendation: “We propose to adopt this C–CDA Companion Guide to support best practice implementation of USCDI v1 data classes and 2015 Edition certification criteria that reference C– CDA Release 2.1. “

SDWG agrees that best practices / guidance should be separate and not intended to be used for certification criteria moving forward. In addition, the SDWG would encourage the ONC to reference the latest version available of the C-CDA and C-CDA companion guide.

D. Updates to Standards 

"As described in the ONC 21st Century Cures Act proposed rule, under the proposed ONC Standards Version Advancement Process, ONC would allow health IT developers participating in the ONC Health IT certification program to voluntarily use updated versions of adopted standards in their certified Health IT Modules, so long as certain conditions are met..."

SDWG endorses the versioning process outlined in the NPRM for standards and vocabularies.

ii. Proposed Adoption of Associated FHIR Release 2 Implementation Specifications

With respect to the following requirement, “We also clarify that the clinical note text included in this FHIR resource would need to be represented in its ‘‘raw’’ text form. In other words, it would be unacceptable for the note text to be converted to another file or format (e.g., .docx, PDF) when it is provided as part of an API response.”

SDWG requests that clarifications or potentially an alternative statement inclusive of the goal or capability desired. A number of questions have been raised:

  • What if the source document was only available on paper and a scanned tiff image was generated?
  • What about source device, say a specialized lab system producing only natively in PDF format?
  • What if the raw format is RTF, would this format still be acceptable?
  • What if the information was dictated and recorded in audio files originally?

Is the intent to preserve the original formatting and presentation of the clinical note?

Is the intent to ensure the clinical note may be processed via NLP or by other means?

It’s difficult to respond to the requirement, without better understanding of the intended benefit or goal desired.

7. Data Segmentation for Privacy and Consent Management Criteria

 Given the extensive coding enabled via the privacy and consent management criteria, and the limited real world implementation experience in the healthcare industry, what are the best practices or regulatory guide lines to be followed when coming across specific tags?

SDWG would recommend that a companion guide be developed to assist implementers, if this proposal is to be enacted.

Example: What are we to do when we receive a document with redacted content?

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