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2013-06-18 RCRIM Call Minutes

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Return to RCRIM Teleconference Minutes and Agendas

Meeting Information

HL7 RCRIM Agenda

Location: Dial: 770-657-9270 Passcode: 7485962#

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Date: 2013-06-18
Time: 10:00-11:00 am Eastern Time
Facilitator Ed Tripp Note taker(s) Ed Tripp
Attendee Name Affiliation
x Crystal Allard FDA
x Barry Brown Mortara Instrument, Inc.
x Joel Finkle Image Solutions, Inc.
x Myron Finseth Medtronic
x Mark Gray FDA
x Ed Helton NCI
x Don Jaccard FDA
x Jared Lantzy FDA
x Behnaz Minaei FDA
x Armando Oliva FDA
x Jason Rock Global Submit
x Karin Sailor Medtronic
x Lise Stevens FDA
x Ed Tripp Edward S. Tripp and Associates
x Marti Velezis Sonrisa Consulting
x Mead Walker colspan="2"|
Quorum Requirements Met: YES
quorum for RCRIM is 4 plus a co-chair


Agenda Topics

  1. Agenda review and approval
  2. Approve Minutes from 2013-06-04
  3. Review RPS DSTU Results
  4. Review and approve RPS harmonization Proposal
  5. Review and approve RPS ballot plans
  6. Request for WGM Agenda change
  7. Other Items

Supporting Documents
RPS Harmonization Proposal for Status Code


Minutes/Conclusions Reached:

  1. Agenda review and approval
    No additions or changes to agenda
  2. Review and Approve Minutes from 2013-06-04 Teleconference
    Standing Motion to approve minutes
    Affirmative - 15, Opposed - 0, Abstain - 0
    Motion carries
  3. Review RPS DSTU Results
    Mark Gray provided the following overview
    After the DSTU ballot, ICH created a number of test cases to determine if the RPS model will meet the defined ICH requirements and RPS storyboards. Based on the testing, ICH requested a couple of minor tweaks to the model and also had a new requirement that resulted in adding confidentiality code to the model. In addition, the IMDRF group reviewed the model and requested some model changes. A summary of the model changes are provided below.
    • SubmissionUnit.componetOf.Sequence number is now optional
    • ContextOfUse: Link was removed: Note the removal was link was an agreement we made in the last ballot. Removal of link removes threaded communication.
    • ContextOfUse: setid is now optional
    • subjecOf.negationInd set default value = true. There was a ballot comment that the datatype and cardinality did not show. None of the Boolean values show the datatype.
    • Document: confidentiality code was added
    • ServiceDeliveryLocation was removed from Review
  4. Review and approve RPS harmonization Proposal
    RCRIM has not had an active vocabulary facilitator for several years. Margaret Haber (the current Vocabulary Facilitator has not participated at HL7 recently). Julie James has volunteered to accepted the position. No objections in the meeting. Ed Tripp will notify Julie and HL7.
  5. RPS Plans
    There is a special teleconference scheduled for June 11, 2013 to approve the harmonization proposal from RPS, and approve plans to ballot in September. Additionally the RPS will review plans for an Implementation Guide.
  6. Patient Safey
    The Patient Safety Work Group is processing paperwork to formally dissolve. Projects related to regulated safety reporting will be passed to RCRIM.
  7. Other Items
  • Adjourned 10:30 a.m. Eastern.

Meeting Outcomes

Action Item Owner Due Date
Contact Julie James and HL7 HQ on Vocabulary Facilitator E. Tripp 6/10/2013

Next Meeting Preliminary Agenda Items

  1. Agenda review and approval
  2. Review RPS DSTU Results
  3. Review and approve RPS harmonization Proposal
  4. Review and approve RPS ballot plans
  5. Other Items

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