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Joint Initiative on SDO Global Health Informatics Standardization

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					Joint Initiative on SDO Global
      Health Informatics
        Standardization
    Joint Working Group
          Meeting #5
      (SDO Harmonization)
JWG Meeting #5

    Welcome

    Vancouver (w/HL7 Plenary)

    Follows meetings in:
      Brisbane (w/ISO TC215, Aug/07)
      Dublin (w/CEN TC251, Oct/07)
      Orlando (Open, Feb/07)
      Goteborg (w/ISO TC215 and CEN TC251,
      Jun/08)
         Opening of the meeting
                Apologies
                Confirmation of the agenda

Agenda          Confirmation of minutes from JWG Meeting 4 – May 2008, Gothenburg
                Actions from previous meetings
                Report from JIC (Ed Hammond / Audrey Dickerson)
         SDO Work Program Harmonization
                Review of Joint SDO work program inventory version 2.1
                Feedback from members on SDO Work program harmonization issues
            •        European Union ESO Mandate project update (Gaps / Overlaps)
            •        Standards map / identification of required standards / Standards Knowledge Management
                     Tool use
                Next steps for analysis
         Joint Work Program – Status, Review and Discussion
                13606 and HL7 V3 implementation guide project
                Data types
                Pharmacovigilance and identification of medicinal products
            •        Individual Case Safety Report (ICSR) (Balloting Challenges)
                Glossary
                Entity Name Harmonization
                Units of Measure
         Harmonization Needs and Issues – Open Discussion
                Potential joint work items
                Issues / Tasks to be addressed
            •        EHR-S Functional Model Release 2
            •        Common Terminology Services (R2/R1)
         Standardization processes
                JIC / Task Group Process
                Current joint initiative processes update
                Issues to be addressed
            •        Balloting of differing versions of same standard in different SDO’s
         Communications
                Processes for communication on joint projects
                Processes for feedback on Joint Initiative outcomes
                Joint Working Group website www. global-e-health-standards.org
         Other Business / Next meetings
                ISO TC 215 / CEN TC 251 meeting (Istanbul) – 12 October 12 2008, 8-11am
Joint Initiative Council Update

   Getting organized
   Additional participating SDO’s
     CDISC
     Nomination
     Criteria
   JIC Processes (details in agenda item 6)
   Other
SDO Work Program Harmonization
  Joint SDO Work Program Inventory (V2.1)
    Active Items (not preliminary)
     • 67 ISO and CEN active work items (Spring08)
     • 143 HL7 active work items (Summer08)
    How to “review for harmonization”
     • A classification approach
     • A use case approach
    EU ESO Mandate Project Update (Melvin)
    Standards Map / SKMT Tool available to use
    Next Steps (who, how, help (task group))
Joint Work Program

  Data Types
    Grahame Grieve
  Pharmacovigilance and identification of
  medicinal products
    Individual Case Safety Report (first full standard)
    Balloting requirements
Joint Work Program

  13606 and HL7 V3 Implementation Guide
    Dipak Kalra
    Overall 13606 / HL7 harmonization to date
    Submitted Task Group Proposal
     • Implementation Guide Steps (11 person months)
        – Interoperability use cases f/4 countries (identifying transformation
          requirements)
        – Model transformations
        – Transformation test (per use case w/test-data examples, tool,
          examples)
        – Documented outcome (the guide !!)
    Project team (Dipak Kalra(lead), Mark Shafarman,
    William Goossen, Charlie McCay, Beatriz Leao)
Joint Work Program

   Glossary
     Heather Grain
     Joint ISO WG3 and CEN WG1 are supportive, as is the
     HL7 Vocabulary group
    •   As a mechanism to reduce the task work required if done
        individually and to improve the outcome
     Two phases
    1. Entry of existing terms and “clean-up” to establish consistent
       agreed term use (and terms to be retired)
    2. Ongoing management and maintenance of glossary
     10 specific steps -Phase 1 and 5 steps -Phase 2
     Phase 1 time – unfunded 15-18 months, funded 3-4
     months
     Lead identified ISO/TC215 – WG3
Joint Work Program (other new)

   Preliminary - Template / Proposal needed
       Entity Name Harmonization (between data types
       and Identification of Subjects of Care and
       Providers)
       Units of Measure


   Tracking
       Document Registry (ISO/IHE) (defer to ISO lWG 2
       discussion)
       Clinical Knowledge Management / Clinical
       Decision Support (out of WG1 of ISO)
Harmonization Needs and Issues

     Open discussion
     Other potential work items
     Issues / Tasks
       EHR-S Functional Model (R2
        • R1 being balloted at ISO/TC215, R1 needing
          to be commented, dispositioned, updated
          and published
       Common Terminology Services (R1, R2)
Standardization Processes

     Joint Initiative Council
       New Process Just Approved (Next 3
       slides)


     Outstanding issues
       Balloting of different versions of same
       standard in different SDO’s (timings)
       Maintenance of same standard in
       different SDO’s
Processes for Joint Initiative Task
Groups

      General Procedures for Joint Initiative Task Group
      (JITG)
      The JIC determines the need for any JITG through
      assessment of received proposals and through unanimous
      agreement to proceed with an SDO hosted JITG. JIC can
      also determine to use present in-place agreements for
      proposed work.
      The target deliverable for any joint initiative work is, at
      minimum, an ISO standard and can also be a standard of
      any other Joint Initiative SDO.
      The standard and its intellectual property (IP) will be
      owned, marketed and maintained by each SDO that ballots
      the standard successfully.
      The JIC will dissolve the JITG upon the unanimous
      agreement of the Joint Initiative SDO’s.
Processes for Joint Initiative Task
Groups
         JIC Processes for Beginning and Maintaining a
         Joint Initiative Task Group (JITG):
    1.   Joint Project Proposals, (based on a template) are
         proposed by any Joint Initiative SDO or the Joint Working
         Group (JWG).
    2.   The JIC applies due diligence in assessing the Joint
         Project Proposal including, as necessary, decision tree
         information, resourcing and funding availability, lead SDO
         identification, SDO working group or technical committee
         identification and other information as may be useful.
    3.   The JIC makes a determination on the new Joint Project
         Proposal to do one of the following:
           1.   One SDO develops and all / multiple SDO’s agree to adopt
           2.   Joint Proposal accepted into Joint Work Program and a JITG is
                formed and a host SDO is identified to undertake joint
                development and ongoing maintenance
           3.   It is not accepted into the Joint Work Program
           4.   Joint Project Proposal is returned for more information
    4.   An appropriate project lead, identified from the host SDO
         with other SDO’s, as required, also
Processes for Joint Initiative Task
GroupsJIC Processes for Beginning and Maintaining a Joint
          Initiative Task Group (Continued):
          An appropriate project lead, identified from the host SDO with
          other SDO’s, as required, also providing co-leads.
             Establishes time lines, meeting schedules
             Coordinates meetings for the joint project in conjunction with SDO
             meetings or by electronic means
             Provides timely agendas and meeting documentation (agendas at least 60
             days in advance)
             Uses balloted versions of standards as starting points if available
             Appropriately uses current versions of any referenced standards
             Makes available, through the host SDO, working draft and other standard
             documentation for all joint project participants
             Manages the standard development and drafting work, in conjunction with
             the Host SDO, right up to publication
             Provides progress reports through the host SDO or a normal JWG meeting
          The Joint Initiative SDO’s take responsibility for identifying
          participants, either by individual or committee, for joint project
          work.
          Joint Project standards are balloted across all Joint Initiative
          SDO’s, as required, following each SDO’s rules for balloting and
          respecting each balloting SDO’s rules for IP, ownership,
          marketing.
Communications

    On joint projects / work items
      How / by SDO / through ISO, ??
      w/ content from Project Leads ??
      To whom (through SDO Secretariats)


    For Joint Initiative overall
      New SDO’s participating
      How to participate (criteria / nomination)
      Joint Work Program list, SDO Active Item
      Inventory, …
Communications / Next Meetings

     Open Web site (www.global-e-health-
     standards.org)
       Charter, inventory (v2.1) processes,
       meeting information


     Next Meetings
       October 12-15, ISO / CEN Meeting
Joint Initiative on SDO Global
      Health Informatics
        Standardization
    Joint Working Group
         Meeting #5
      (SDO Harmonization)

         THANK YOU

				
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Lingjuan Ma Lingjuan Ma MS
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