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To request an out-of-cycle ballot of a candidate standard/document, please complete this form.  Once completed by a sponsoring Work Group co-chair this form should be emailed to the Director of Technical Publications ( ballotmanager@hl7.org ).  Please fill in the information requested in the red-bordered areas.  For those unable to use the preferred method, a PDF version of this document can be printed and filled out by hand; please fax the completed form to headquarters (734-677-6622).  Incomplete and incorrectly completed forms will be returned to the submitter.  Questions should be directed to the Director of Technical Publications ( ballotmanager@hl7.org ).

Official Candidate Standard/ Document Name

HL7 CDA® R2 IG: C-CDA Templates for Clinical Notes R1 Companion Guide, Release 2 (STU)

Name Change

Check here to indicate a name change and include the original document name below.

HL7 CDA® R2 IG: C-CDA Templates for Clinical Notes R1 Companion Guide, Release 1 (Informative)

Standard Classification

Version 2

Version 3

CDA® and Related

EHR

 

Other

 

 

(please specify)

The classification of standard to which your ballotable content belongs.  When possible, actual document names should also reflect this information.  This is most commonly needed for Version 2 and Version 3 standards development so please use "Other" for any other classification of standard and specify that standard.

Rationale Supporting Request

ONC published a new proposed rule in 2019, which necessitates updates to the companion guide.  

Please provide rationale to support this Out-of-Cycle Ballot Request. This rationale will be evaluated by the TSC when considering approval of the request.

Balloting Level [1]

This is a new document.

Please check here to indicate that this is a new, previously un-balloted document.

January 2017

For previously balloted documents, enter the last ballot cycle during which this document was balloted.  Example: May 2007.

Universal

Other: US Realm
(Please indicate)

Realm

Normative

Informative

For Comment Only

Standard for Trial Use

The level you expect this document to be balloted at in the requested ballot.  You will be contacted if this does not agree with our records.

Iteration:

0

The number of times the document has balloted at this level.
NOTE: This document was previously balloted as Informative

Examples: Normative 1 would be the first iteration of a Normative ballot; STU 3 would follow a STU 2 ballot; For Comment Only 2 would follow a For Comment Only 1 ballot.

Yes, Backwards Compatible

No
Not Applicable

Backwards Compatibility Status

Internally Developed

Externally Developed

Internally/Externally Developed

Requested Open Date

Open Date

July

Please provide a general time frame for the ballot, recognizing the need for TSC approval and a 30-day announcement preceding the ballot opening. Ballots are expected to run 30 days.

Responsible Work Groups

The co-chairs of the committees you identify will receive email copies of the ballots submitted.

Structured Documents Working Group

Please list all WGs that retain or share ultimate responsibility for this document

https://confluence.hl7.org/display/SD/2019-03-29+Agenda+and+Minutes

Link to WG Meeting Minutes where this information was discussed and approved. It is important that the inclusion of this ballot document in a ballot cycle and the submission of this information has been approved by your committee.

Project Scope Statement

Yes, a Project Scope Statement for this project exists in Project Insight.  PI ID:   1526__________

Has a project scope statement for this item been uploaded to Project Insight?  It is only required once per release for any given ballot document. 

Document Description / Changes

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.

Please provide a description of the proposed document or the major changes to it since its last ballot.  This description will be used in both the Announcement of Ballot Pools document and other formal notices of this intent to ballot.

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.

 

Provide a summary of changes of material interest (including all substantive changes) in the document since the last ballot.

Previously Balloted Information

If this document has been previously balloted, please identify the following

Yes, I have posted a Reconciliation Package to the Ballot Desktop for all previous Normative ballots of this document.

Did you post your reconciliation package for negative comment dispositions on the Ballot Desktop?  These packages are due two (2) weeks prior to the expected out-of-cycle ballot cycle opening.

Yes, I have advised negative voters of the disposition of their negative comments for each previous Normative ballot of this document.

Have you used the website or provided documentation (email correspondence for example) informing negative voters of the dispositions of their negative comments?

Yes, I have submitted negative voter Withdrawal or Retract Requests for each previous Normative ballot of this document.

Have you used the website or supplied all the proper documentation (email correspondence for example) to request withdrawal or retraction of negative votes from negative?

 

If there has been a name change for this document from its previous ballot, what was the previous name?

Additional Vote Recipients

Matthew.rahn@hhs.gov

In addition to the co-chairs receiving votes via email as they are submitted, supply any additional email addresses of stakeholders who should receive this information.  Please list the email addresses.

 


ANSI Information

The information below is required by ANSI.

Project Need

ONC published a new proposed rule in 2019, which necessitates updates to the companion guide.  

The previously published Companion Guide is an HL7 'Informative' document limiting the ability of Structured Documents to update expeditiously. This new ballot will update the Companion Guide to an HL7 ‘STU’, which supports more efficient subsequent updates.  

 

Briefly state the reason behind the need for this project.  This is required for all ballots.

Other Referenced standards

 

Does this document include text from an ISO or IEC standard?  If so, please cite those standards here

Unit of Measure

U.S.

Metric

Both U.S. and Metric

Not Applicable

As required by ANSI, if measurements are introduced in this standards document, what is the measurement type from the choices available?

Consumer Product

Yes

No

Is this a consumer product?

Stakeholders

Regulatory Agency, Health Care IT, EHR, PHR, Healthcare Institutions, Payors

Please identify the stakeholders.  For example, pharmaceutical, healthcare, etc.

 

 

 

 

For Office Use Only

 

Ballot Cycle Code

 

Document Code

 

ANSI/HL7 Designation

 

Comments

 

 


[1] If this is a domain with content being balloted at different levels, each level is its own ballot and should be defined by the content being balloted.