Joint Initiative on SDO Global Health Informatics Standardization by malj


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

JWG Meeting #5
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

• •

SDO Work Program Harmonization

Apologies Confirmation of the agenda Confirmation of minutes from JWG Meeting 4 – May 2008, Gothenburg Actions from previous meetings Report from JIC (Ed Hammond / Audrey Dickerson) 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

Joint Work Program – Status, Review and Discussion

Next steps for analysis

13606 and HL7 V3 implementation guide project Data types Pharmacovigilance and identification of medicinal products Glossary Entity Name Harmonization Units of Measure
Individual Case Safety Report (ICSR) (Balloting Challenges)


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



Other Business / Next meetings

Processes for communication on joint projects Processes for feedback on Joint Initiative outcomes Joint Working Group website www. 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
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

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
1. 2.


JIC Processes for Beginning and Maintaining a Joint Initiative Task Group (JITG): Joint Project Proposals, (based on a template) are proposed by any Joint Initiative SDO or the Joint Working Group (JWG). 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. The JIC makes a determination on the new Joint Project Proposal to do one of the following:
1. 2.
3. 4.


An appropriate project lead, identified from the host SDO with other SDO’s, as required, also

One SDO develops and all / multiple SDO’s agree to adopt 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 It is not accepted into the Joint Work Program Joint Project Proposal is returned for more information

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.

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.

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

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 (
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)

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