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Difference between revisions of "Patient Generated Document Informative Document"

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*Agenda for 04052013:  [[File:PGD_Meeting_Agenda_for_20130405.docx]]
 
*Agenda for 04052013:  [[File:PGD_Meeting_Agenda_for_20130405.docx]]
 
*Agenda for 04122013:  [[File:PGD_Meeting_Agenda_for_20130412.docx]]
 
*Agenda for 04122013:  [[File:PGD_Meeting_Agenda_for_20130412.docx]]
 +
*Agenda for 04192013:  [[File:PGD_Meeting_Agenda_for_20130419.docx]]
 +
*Agenda for 04262013:  [[File:PGD_Meeting_Agenda_for_20130426.docx]]
 +
*Agenda for 05172013:  [[File:PGD_Meeting_Agenda_for_20130517.docx]]
 +
*Agenda for 06202013:  [[File:PGD_Meeting_Agenda_for_20130620.docx]]
 +
*Agenda for 08022013:  [[File:PGD_Meeting_Agenda_for_20130802.docx]]
  
 
=== Meeting Minutes ===
 
=== Meeting Minutes ===
 
*Minutes for 07272012:  [[File:PGHDMinutes0727.docx]]
 
*Minutes for 07272012:  [[File:PGHDMinutes0727.docx]]
 
+
<br>
 
*Minutes for 08032012:  [[File:PGHDMeetingMinutes08032012.docx]]
 
*Minutes for 08032012:  [[File:PGHDMeetingMinutes08032012.docx]]
 
*Minutes for 08102012:  [[File:PGHDMeetingMinutes08102012.docx]]
 
*Minutes for 08102012:  [[File:PGHDMeetingMinutes08102012.docx]]
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*Minutes for 08242012:  [[File:PGHD_Meeting_Minutes_for_20120824.docx‎]]
 
*Minutes for 08242012:  [[File:PGHD_Meeting_Minutes_for_20120824.docx‎]]
 
*Minutes for 08312012:  [[File:PGHD_Meeting_Minutes_for_20120831.docx‎]]
 
*Minutes for 08312012:  [[File:PGHD_Meeting_Minutes_for_20120831.docx‎]]
 
+
<br>
 
*Minutes for 09072012:  [[File:PGHD_Meeting_Minutes_for_20120907.docx‎]]
 
*Minutes for 09072012:  [[File:PGHD_Meeting_Minutes_for_20120907.docx‎]]
 
*Minutes for 09102012:  [[File:PGHD_Meeting_Minutes_for_20120910_HL7_F2F_discussions.docx‎]]
 
*Minutes for 09102012:  [[File:PGHD_Meeting_Minutes_for_20120910_HL7_F2F_discussions.docx‎]]
 
*Minutes for 09212012:  [[File:PGHD_Meeting_Minutes_for_20120921.docx‎]]
 
*Minutes for 09212012:  [[File:PGHD_Meeting_Minutes_for_20120921.docx‎]]
 
+
<br>
 
*Minutes for 10052012:  [[File:PGHD_Meeting_Minutes_for_20121005.docx]]
 
*Minutes for 10052012:  [[File:PGHD_Meeting_Minutes_for_20121005.docx]]
 
*Minutes for 10122012:  [[File:PGHD_Meeting_Minutes_for_20121012.docx]]
 
*Minutes for 10122012:  [[File:PGHD_Meeting_Minutes_for_20121012.docx]]
 
*Minutes for 10192012:  [[File:PGHD_Meeting_Minutes_for_20121019.docx‎]]
 
*Minutes for 10192012:  [[File:PGHD_Meeting_Minutes_for_20121019.docx‎]]
 
*Minutes for 10262012:  [[File:PGHD_Meeting_Minutes_for_20121026.docx‎]]
 
*Minutes for 10262012:  [[File:PGHD_Meeting_Minutes_for_20121026.docx‎]]
 
+
<br>
 
*Minutes for 11092012:  [[File:PGHD_Meeting_Minutes_for_20121109.docx‎]]
 
*Minutes for 11092012:  [[File:PGHD_Meeting_Minutes_for_20121109.docx‎]]
 
*Minutes for 11162012:  [[File:PGHD_Meeting_Minutes_for_20121116.docx‎]]
 
*Minutes for 11162012:  [[File:PGHD_Meeting_Minutes_for_20121116.docx‎]]
 
*Minutes for 11302012:  [[File:PGHD_Meeting_Minutes_for_20121130.docx‎]]
 
*Minutes for 11302012:  [[File:PGHD_Meeting_Minutes_for_20121130.docx‎]]
 
+
<br>
 
*Minutes for 12072012:  [[File:PGHD_Meeting_Minutes_for_20121207.docx‎]]
 
*Minutes for 12072012:  [[File:PGHD_Meeting_Minutes_for_20121207.docx‎]]
 
+
<br>
 +
*Minutes for 01112013:  [[File:PGHD_Meeting_Minutes_for_20130111.docx‎]]
 
*Minutes for 01112013:  [[File:PGHD_Meeting_Minutes_for_20130111.docx‎]]
 
*Minutes for 01112013:  [[File:PGHD_Meeting_Minutes_for_20130111.docx‎]]
 
+
<br>
*Minutes for 01252013  [[File:PGD_Meeting_Minutes_for_20130125.docx‎]]
+
*Minutes for 02082013:  [[File:PGD_Meeting_Minutes_for_20130208.docx‎]]
 
+
*Minutes for 02152013: [[File:PGD_Meeting_Minutes_for_20130215.docx‎]]
*Minutes for 02082013 [[File:PGD_Meeting_Minutes_for_20130208.docx‎]]
+
*Minutes for 02222013: [[File:PGD_Meeting_Minutes_for_20130222.docx‎]]
*Minutes for 02152013  [[File:PGD_Meeting_Minutes_for_20130215.docx‎]]
+
<br>
*Minutes for 02222013  [[File:PGD_Meeting_Minutes_for_20130222.docx‎]]
+
*Minutes for 03012013: [[File:PGD_Meeting_Minutes_for_20130301.docx‎]]
 
+
*Minutes for 03152013: [[File:PGD_Meeting_Minutes_for_20130315.docx‎]]
*Minutes for 03012013  [[File:PGD_Meeting_Minutes_for_20130301.docx‎]]
+
*Minutes for 03292013: [[File:PGD_Meeting_Minutes_for_20130329.docx‎]]
*Minutes for 03152013  [[File:PGD_Meeting_Minutes_for_20130315.docx‎]]
+
<br>
*Minutes for 03292013  [[File:PGD_Meeting_Minutes_for_20130329.docx‎]]
+
*Minutes for 04052013: [[File:PGD_Meeting_Minutes_for_20130405.docx‎]]
 
+
*Minutes for 04122013: [[File:PGD_Meeting_Minutes_for_20130412.docx‎]]
*Minutes for 04052013  [[File:PGD_Meeting_Minutes_for_20130405.docx‎]]
+
*Minutes for 04192013:  [[File:PGD_Meeting_Minutes_for_20130419.docx‎]]
*Minutes for 04122013  [[File:PGD_Meeting_Minutes_for_20130412.docx‎]]
+
<br>
  
 
== Deliverable Timelines ==
 
== Deliverable Timelines ==
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<br>
 
<br>
 
**Ballot comment reconciliation 20130419: [[File: PGD_Consolidatedballots_20130419A.xlsx‎]] BEFORE committee MEETING 20130419
 
**Ballot comment reconciliation 20130419: [[File: PGD_Consolidatedballots_20130419A.xlsx‎]] BEFORE committee MEETING 20130419
 +
**Ballot comment reconciliation 20130419: [[File: PGD_Consolidatedballots_20130419B.xlsx‎]] BEFORE SDWG MEETING 20130425
 +
**Ballot comment reconciliation 20130419: [[File: PGD_Consolidatedballots_20130419C.xlsx‎]] AFTER SDWG MEETING 20130425
 +
<br>
 +
*** Feedback to CDA R3 development regarding use of ResponsibleParty: [[File: Use_of_ResponsibleParty.docx‎]] sent to Austin on 20130427
 +
 +
<br>
 +
**Ballot comment reconciliation 20130619: [[File: PGD_Consolidatedballots_20130619A.xlsx‎]] BEFORE SDWG MEETING 20130620
 +
**Ballot comment reconciliation 20130620: [[File: PGD_Consolidatedballots_20130619B.xlsx‎]] AFTER SDWG MEETING 20130620 - clean-up on processing of 8 comments:1,2,39,63,79,83,93,94
 +
 +
<br>
 +
**Ballot comment reconciliation 20130725: [[File: PGD_Consolidatedballots_20130621C.xlsx‎‎]] AFTER SDWG MEETING 20130725 - Resolved need to loosen the constraints on DocumentationOf/Service even and align with C-CDa General Header.
 +
*** Copy approved for use: [[File: Alternate_DocumentationOf-ServiceEvent_20130715.docx‎]]
 +
<br>
 +
**Ballot comment reconciliation 20130801: [[File: PGD_Consolidatedballots_20130621D.xlsx‎‎]] AFTER SDWG MEETING 20130725 - Resolved need to loosen the constraints on DocumentationOf/Service even and align with C-CDa General Header.
 +
*** Updated PGD Header Template IG to include all ballot reconciliations: [[File: PGHD_Document_Header_IG_qa_20130801_v2.docx]] All ballot reconciliations implemented - needs new sample snippets.
 +
<br>
 +
**Ballot comment reconciliation 20130814: [[File: PGD_Consolidatedballots_20130621E.xlsx‎‎]] BEFORE SDWG MEETING 20130815 - Need to resolve 4 missed ballot comments.
 +
**Ballot comment reconciliation 20130815: [[File: PGD_Consolidatedballots_20130621F.xlsx‎‎]] AFTER SDWG MEETING 20130815 - Unanimously accepted the proposed dispositions for the 4 missed ballot comments.
 +
 +
== Revised PGD Header IG to incorporate Ballot Comment Resolutions ==
 +
* Processing session 20130528
 +
** Edits made on  20130528 : [[File:PGHD_Document_Header_IG_br_20130528_v1.docx]]
 +
<br>
 +
* Processing session 20130531
 +
** Edits made on 20130531: [[File:PGHD_Document_Header_IG_br_20130531_v1.docx]]
 +
** Tracking of Implemented Comments: [[File:PGD_Consolidatedballots_20130531.xlsx]]
 +
** Edits accepted : [[File:PGHD_Document_Header_IG_br_20130531_v2.docx]]
 +
<br>
 +
* Processing session 20130607
 +
** Edits made on 20130607: [[File:PGHD_Document_Header_IG_br_20130607_v1.docx]]
 +
** Tracking of Implemented Comments: [[File:PGD_Consolidatedballots_20130607.xlsx]]
 +
** Edits accepted : [[File:PGHD_Document_Header_IG_br_20130607_v2.docx]]
 +
<br>
 +
* Processing session 20130612
 +
** Edits made on 20130612: [[File:PGHD_Document_Header_IG_br_20130612_v1.docx]]
 +
** Tracking of Implemented Comments: [[File:PGD_Consolidatedballots_20130612.xlsx]]
 +
** Edits accepted : [[File:PGHD_Document_Header_IG_br_20130612_v2.docx]]
 +
<br>
 +
* Processing session 20130614
 +
** Edits made on 20130614: [[File:PGHD_Document_Header_IG_br_20130614_v1.docx]]
 +
** Tracking of Implemented Comments: [[File:PGD_Consolidatedballots_20130614.xlsx]]
 +
** Edits accepted : [[File:PGHD_Document_Header_IG_br_20130614_v2.docx]]
 +
<br>
 +
* Processing session 20130615
 +
** Edits made on 20130615: [[File:PGHD_Document_Header_IG_br_20130615_v1.docx]]
 +
** Tracking of Implemented Comments: [[File:PGD_Consolidatedballots_20130615.xlsx]]
 +
** Edits accepted : [[File:PGHD_Document_Header_IG_br_20130615_v2.docx]]
 +
<br>
 +
* Processing session 20130621 - versions to guide QA Review of comment processing
 +
** Comments added to prior version 20130621: [[File:PGHD_Document_Header_IG_br_20130615_v3.docx]]
 +
** Tracking of Implemented Comments: [[File:PGD_Consolidatedballots_20130621.xlsx]] Includes ballot clean-up done on 6/20
 +
<br>
 +
* Processing session 20130703 - versions to show completed QA Review of comment processing
 +
** Comments included from the QA team: [[File:PGHD_Document_Header_IG_qa.docx]]
 +
** Tracking of Implemented Comments - with QA assessment: [[File:PGD_Consolidatedballots_20130621_-_1st_QA_Review.xlsx]]
 +
<br>
 +
* Processing session 20130708 - versions to show incorporating of the QA issues that needed work
 +
** Comments included from the QA team: [[File:PGHD_Document_Header_IG_qa.docx]]
 +
** Tracking of Implemented Comments - with QA assessment: [[File:<br>
 +
* Processing session 20130703 - versions to show completed QA Review of comment processing
 +
** Comments included from the QA team: [[File:PGHD_Document_Header_IG_qa.docx]]
 +
** Tracking of Implemented Comments - with QA assessment: [[File:PGHD_Document_Header_IG_qa_20130708_v1.docx]]
 +
<br>
 +
Processing session 20130730 - versions to show incorporating of the revision to DocumentationOf/ServiceEvent
 +
** Changes to US Realm PGH Template to incorporate approved copy for DocumentationOf/ServiceEvent [[File:PGHD_Document_Header_IG_qa_20130730_v1.docx]]
 +
** Track changes accepted for US Realm PGH to incorporate approved copy[[File:PGHD_Document_Header_IG_qa_20130730_v2.docx]]
 +
** Changes to UV Realm PGH Template to incorporate generalized version of the approved copy for DocumentationOf/ServiceEvent[[File:PGHD_Document_Header_IG_qa_20130730_v3.docx]]
 +
** Track changes accepted for UV Realm PGH to incorporate approved copy[[File:PGHD_Document_Header_IG_qa_20130730_v4.docx]]
 +
 +
== Revised PGD Header Sample Documents ==
 +
<br>
 +
* Sample #1A - US Realm -  Patient for Self
 +
** Finished on 20130702: [[File:PAN_sample1_20130702.zip‎]]
 +
** Finished on 20130802: [[File:PGD_sample1_us_20130802.zip]]
 +
<br>
 +
* Sample #2A - US Realm - Patient Relation for the Patient
 +
 +
<br>
 +
<br>
 +
* Sample #1B - UV Realm - Patient for Self
 +
 +
** Finished on 20130802: [[File:PGD_sample1_univ_20130802.zip]]
 +
 +
* Sample #2B - UV Realm - Patient Relation for the Patient
  
 
== Other Documents ==
 
== Other Documents ==
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*Sample Forms
 
*Sample Forms
 
**Sample Hospital PreVisit/Registration Form : [[File:AdultAdmissionRegistrationForm.pdf]]
 
**Sample Hospital PreVisit/Registration Form : [[File:AdultAdmissionRegistrationForm.pdf]]
 +
<br>
 +
*Ballot Comments provided on Form Specification and Questionnaire Response IGs
 +
**Submitted by Brian Scheller : [[File:Ballotcomments_CDAR2_IG_QRDOC_R1_D1_2013MAY.xls]] Questionnaire Response comments
 +
**Submitted by Lisa Nelson : [[File:Ballotcomments_CDAR2_IG_QRDOC_R1_D1_2013MAYlrn.xls]] Questionnaire Response comments
 +
**Submitted by Lisa Nelson : [[File:Ballotcomments_CDAR2_IG_SFDEFDOC_R1_D1_2013MAY.xls]] Form Specification comments
 +
<br>
 +
== FINAL PACKAGE SUBMITTED TO SDWG ==
 +
 +
* Project Scope Statement: [[File:HL7_Project_Scope_Statement_v2012_Patient_authored_notes-2.docx]]
 +
* Publication Request: [[File:HL7_Publication_Request_Template_2013Jul.docx]]
 +
* Final Reconciled Ballot Comment Sheet: [[File:PGD_Consolidatedballots_20130621F.xlsx]]
 +
** Final Reconciled Ballot Comment Sheet: [[File:PGD_Consolidatedballots_20130621D.xlsx]] REPLACED
 +
* Implementation Guide with processed reconciliations: [[File:PGD_Header_Template_IG_20130802v2.docx‎ ]]
 +
* Sample PGD US Realm: [[File:PGD_sample1_us_20130802.zip]]
 +
* Sample PGD UV Realm: [[File:PGD_sample1_univ_20130802.zip]]
  
 
== Open Issues & Tasks ==
 
== Open Issues & Tasks ==
*When will the Patient Authored CDA documents be created; What are the trigger points;
+
*Confirm associated Errata get addressed in C-CDA v2 (DSTU #227, #228)
**These will be application workflow dependent
+
==Comments and Errata ==
**The CDA document will define the content, NOT the workflow or the application business logic
+
NOTE:  US Realm PGDH template is maintained in C-CDA. Only UV Realm errata issues are recorded here.
*Looking thru the errata of the C-CDA document & reconciling with changes in the draft IG
+
 
*Work with the Vocabulary group on the new / changed value sets
+
<!-- Copy the following template to the end of the table to add a new comment
* While making updates to 20121116-d1, we need to revise the open issues and remove issues that are resolved, and add an open issue about the need to resolve the concept domain binding and subsequent US realm binding of a specific value set to the concept domain. We'll need Rob Hausam's help to figure out how that gets done. We can ask for guide to come from ballot comments, too.
+
    Replace each <> with your comment (remove the <>'s)
 +
    COPY BELOW THIS LINE
 +
|-
 +
|<CONF #>
 +
|<Full Name #>
 +
|<Summary of issue>
 +
|<Existing wording>
 +
|<Proposed wording>
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|<Comments>
 +
STOP HERE - DO NOT COPY THIS LINE -->
 +
 
 +
 
 +
{| class="wikitable sortable" style="font-size:90%; width:99%;"
 +
|-
 +
! style="font-size:110%; background: #B0C4DE" | DATE
 +
! style="font-size:110%; background: #B0C4DE" | CONF#
 +
! style="font-size:110%; width:140px; background: #B0C4DE" | Name
 +
! style="font-size:110%; background: #B0C4DE" | Summary of Issue
 +
! style="font-size:110%; background: #B0C4DE" | Existing Wording
 +
! style="font-size:110%; background: #B0C4DE" | Proposed Wording
 +
! style="font-size:110%; background: #B0C4DE" | Comments
 +
 
 +
|-
 +
|Date reported
 +
|9045
 +
|Example Person
 +
|Short problem statement
 +
|This text is how the issue is currently documented in the IG
 +
|This text is the proposal for how the issue could be documented differently in the IG
 +
|This is why the issue is important or tells why the proposed wording is beneficial
 +
 
 +
|-
 +
|10/25/2015
 +
|n/a
 +
|Brian Reinhold
 +
|Author Issue
 +
|As discussed in today’s meeting here is a reminder about the issue of trying to move the following constraint from the ‘printed’ document to Trifolia.
 +
The printed document has<br/>
 +
 
 +
1. When the author is a person, this assignedAuthor SHALL contain one [1..1] code (NEWCONF:xxxxx).<br/>
 +
a. The code, SHALL contain exactly one [1..1] @code, which SHOULD be selected from the Personal And Legal Relationship Role Type 2.16.840.1.113883.11.20.12.1  (NEWCONF:xxxxx) <br/>
 +
|The item is a conditional and the only way it could be entered in Trifolia was to place the code requirement as a primitive of the assignedAuthor element, and the code@code requirement as a primitive of the primitive. To use the code element in Trifolia would require setting the code to either MAY, SHOULD, or SHALL. The closest match in content using the Trifolia code element would be the MAY.<br/>
 +
|The downside of using the primitive is that is occurs last in the hierarchy when printed and not in the sequence order as required by the schema.
 +
 
 +
|}

Latest revision as of 14:53, 17 November 2015

Project Details

Overview

In the “era of patient empowerment”, we want to define a specification for patient-authored clinical documents. Medical practices are looking for ways to allow patients to electronically complete certain tasks online such as filling out registration forms, health history forms, consenting to certain practice policies, and other types of clinical documents yet to be defined. As electronic document interchange increases, we see a growing need to communicate documents created by patients (including those needed by providers and/or those document types defined by patients). Often, this is done through a secure web interface controlled by the patient such as a patient portal or a personal health record. As more and more practices incorporate EMR technology into their practice workflow, they want to be able to import patient provided structured information into their EMR’s. This is being driven by the need to meet Meaning Use 2 requirements for patient engagement as well as other needs to reduce manual processes managing patient-provided data.

The HL7 CDA Consolidation Documents types only address provider-initiated documents and do not incorporate guidance for patient-generated documents. It is necessary to create a new implementation guide describing how to incorporate patient-generated input. In many cases, existing templates within the current Consolidation Template Library can be re-used with minimal modification.

The scope of this project is to create an implementation guide, which will guide the users on using the elements of the C-CDA consolidation header for patient authored documents. New CDA document types for patient authored documents is NOT in scope for this project. The document described by this guide could be characterized as a parallel to Consolidated CDA, that would ultimately cover specific patient-authored document types. We anticipate that Consolidated CDA templates will be heavily reused. If required, we may extend the project scope or introduce another project for defining an implementation guide for a set of patient authored document types.

HL7 Project Scope

  • HL7 Project Scope Statement (approved June 07, 2012 by SDWG, pending review/approval by Steering Division and TSC):

http://wiki.hl7.org/images/4/4c/HL7_Project_Scope_Statement_v2012_Patient_authored_notes.docx

Subgroup Members

  • Virinder Batra, Intuit Health
  • Lisa Nelson, Life Over Time Solutions
  • Elaine Ayres, Academy of Nutrition and Dietetics, National Institutes of Health
  • Catherine Welsh, St. Jude Children's Research Hospital
  • Bob Dolin, Lantana Consulting
  • Emma Jones, Allscripts
  • Shawn Meyers, Healthwise
  • Brian Scheller, Healthwise
  • Chris Schultz, Child Health & Development Interactive System (Chadis)
  • Gordon Raup, Datuit
  • Vinayak Kulkarni, Siemens Healthcare
  • Jessi Formoe, Intuit Health
  • Leslie Kelly Hall, Healthwise
  • Kevin Harbauer,Healthwise
  • Allen Traylor, Child Health & Development Interactive System (Chadis)
  • Stephen Chu, National e-health Transition Authority (Nehta), Australia,
  • Vin Sekar, National e-health Transition Authority (Nehta), Australia

Meeting Logistics

Meeting Schedule

Meeting Agendas

Meeting Minutes











Deliverable Timelines

  • Notice of ballot in September 2012
  • Word document (Implementation Guide) by Dec 1, 2012
    • Ballot Package Submitted on December 07
  • Ballot in WG Meeting in Phoenix January, 2013
    • Reconciliation in Structure WG, Q4 in Phoenix

Use Cases

Discussion on Document LOINC Code

Discussion on Header Attributes

Discussion on Value Sets

  • Code System: HL7 ParticipationType 2.16.840.1.113883.5.90
    • ParticipationType Value Set: ParticipationType 2.16.840.1.113883.1.11.10901
  • CodeSystem: NUCC Health Care Provider Taxonomy 2.16.840.1.113883.6.101

Implementation Guide History of Development


Narrative Components Developed and Incorporated into the Implementation Guide

FINAL Implementation Guide and Sample Documents

  • Package Submitted for January 2013 Ballot: File:PAN Document Header IG.zip Includes IG and two (2) Patient Authored Note Document Samples
  • Package Submitted for January 2013 Ballot: File:PGD IGLineNum.zip Includes IG and two (2) Patient Authored Note Document Samples

Ballot Comments and Reconciliation

















Revised PGD Header IG to incorporate Ballot Comment Resolutions










Processing session 20130730 - versions to show incorporating of the revision to DocumentationOf/ServiceEvent

Revised PGD Header Sample Documents



  • Sample #2A - US Realm - Patient Relation for the Patient



  • Sample #1B - UV Realm - Patient for Self
  • Sample #2B - UV Realm - Patient Relation for the Patient

Other Documents



FINAL PACKAGE SUBMITTED TO SDWG

Open Issues & Tasks

  • Confirm associated Errata get addressed in C-CDA v2 (DSTU #227, #228)

Comments and Errata

NOTE: US Realm PGDH template is maintained in C-CDA. Only UV Realm errata issues are recorded here.


DATE CONF# Name Summary of Issue Existing Wording Proposed Wording Comments
Date reported 9045 Example Person Short problem statement This text is how the issue is currently documented in the IG This text is the proposal for how the issue could be documented differently in the IG This is why the issue is important or tells why the proposed wording is beneficial
10/25/2015 n/a Brian Reinhold Author Issue As discussed in today’s meeting here is a reminder about the issue of trying to move the following constraint from the ‘printed’ document to Trifolia.

The printed document has

1. When the author is a person, this assignedAuthor SHALL contain one [1..1] code (NEWCONF:xxxxx).
a. The code, SHALL contain exactly one [1..1] @code, which SHOULD be selected from the Personal And Legal Relationship Role Type 2.16.840.1.113883.11.20.12.1 (NEWCONF:xxxxx)

The item is a conditional and the only way it could be entered in Trifolia was to place the code requirement as a primitive of the assignedAuthor element, and the code@code requirement as a primitive of the primitive. To use the code element in Trifolia would require setting the code to either MAY, SHOULD, or SHALL. The closest match in content using the Trifolia code element would be the MAY.
The downside of using the primitive is that is occurs last in the hierarchy when printed and not in the sequence order as required by the schema.