2.  Convenor: Michael Glickman (US)  Vice-Convenor: Michio Kimura (JP)  Secretary: open, worldwide search underway  Architecture LeadGary Dickenson (US)  Methodology LeadGeorge “Woody” Beeler (US) 21 February 2011 WG2 Report to DICOM WG-10 2

3.  Six (6) of the Eleven (11) WG2 Work Items are of interest to DICOM  Three (3) of these Six (6) require direct coordination between our organizations  This deck provides background materials for all items ◦ I will be brief for the purposes of this session  Continued Participation and Coordination are both encouraged and appreciated WG2 Coordination with DICOM 21 February 2011 WG2 Report to DICOM WG-10 3

4.  IHE Integration Profiles  Quality Measures for Telehealth  CDISC BRIDG Model  Clinical Genomics- Pedigree Topic  Clinical Trials Registry and Results (CTR&R)  Provisions for Health Applications on Mobile/Smart Devices 21 February 2011 WG2 Report to DICOM WG-10 4

5.  Harmonized Data Types for Information Interchange  Web access to DICOM persistent objects by means of web services WADO-WS  Clinical Document Registry Federation  HL7 V3 Reference Information Model - Maintenance Release Process  Terminology Binding Rules 21 February 2011 WG2 Report to DICOM WG-10 5

6.  Lead: Jill Kaufman (US), Amnon Shabo  Promotion of HL7 Standard to ISO DIS (13449)  Focus: Representation and Exchange of Family Health History, Family Tree  At This Meeting ◦ Joint DIS Ballot with HL7 Comments Incorporated and Dispositions recorded confirmed  Next Step ◦ Submitted for Publication as DIS 21 February 2011 WG2 Report to DICOM WG-10 6

7. 21 February 2011 WG2 Report to DICOM WG-10 7  Lead: Charles Parisot (FR) ◦ IHE Liaison  Purpose: Leverage IHE Implementation Process and Experience into ISO

8. 21 February 2011 WG2 Report to DICOM WG-10 8  IHE Approach ◦ Interconnect Multiple Applications ◦ Incorporate Relevant Industry Standards ◦ Establish Integration Profiles ◦ Engage Connectathons, Demonstrations ◦ Resulting in Actual Implementations

9. 21 February 2011 WG2 Report to DICOM WG-10 9  Phase I ◦ TR 28380-1 - IHE Global Standards Adoption Process ◦ TR 28380-2 - IHE Integration and Content Profiles  With Annual Updates  Phase II ◦ Use Cases and Integration Profiles (now)  Initial Focus – Regional/National Health Information Networks  Phase III ◦ Conformance Testing for Interoperability (Future)  Methodology, Process and Test Tools

10.  New Title: Quality Criteria for Services and Systems In Telehealth  Lead: Jan Talmon (Netherlands)  Target: Technical Specification  Focus ◦ Care Provision ◦ Information Provision ◦ Business Processes 21 February 2011 WG2 Report to DICOM WG-10 10

11.  At This Meeting ◦ CD reviewed and Questions pondered  Extraordinary Interest  Develop appropriate scope to manage effort and support needs of NMBs ◦ Developed Liaison Relationships  ISO TC215 WG7  Continua Alliance  DICOM  IHE  International Society of Telemedicine  ITU  Others identified at this meeting ◦Next Step  Update CD Document for Ballot 21 February 2011 WG2 Report to DICOM WG-10 11

12.  CDISC = Clinical Data Interchange Standards Consortium  BRIDG = Biomedical Research Integrated Domain Group  At This Meeting ◦ CD Passed ◦ Completing Resolution of 257 Comments ◦ Continued ongoing coordination between WG1/2 21 February 2011 WG2 Report to DICOM WG-10 12

13.  Progressed BRIDG with HL7/ISO CD comments resolved and disposed via a consolidated document which will then be coordinated with ISO, HL7 experts and submitting NMB/individual authors.  Next ◦ CD Ballot Resolution and release resulting version 3.0.2 for ballot as a DIS 21 February 2011 WG2 Report to DICOM WG-10 13

14. 21 February 2011 ISO TC215 WG2/Architecture 14 Submissions Analysis Data SDTM / SEND Glossary ODM LAB ADaM CDASH Data Collection Protocol Healthcare HL7 RIM BRIDGBRIDG BRIDGBRIDG

15. NWIP Scope 21 February 2011 WG2 Report to DICOM WG-10 15  Scope  The scope of this standard is a domain analysis model that provides a shared view of the dynamic and static semantics for the protocol-driven biomedical research domain.

16.  The primary purpose is to provide a global domain analysis model for anyone involved in protocol-driven biomedical research or for anyone in healthcare informatics, who provides data for research and related purposes, such as post- marketing surveillance. Such a model is designed to bring consistency to the global medical research community by helping standards developers create coherent messages based upon a common model; the resulting standards should therefore be harmonized. This common model can also be used to provide context for applications developers, thus resulting in interoperable products in this domain.  The BRIDG domain analysis model will streamline information flow from protocol through analysis and reporting within organizations and will facilitate data sharing across partnering organizations, including healthcare and clinical research entities. As such the BRIDG is an important initial step toward achieving integration between the worlds of healthcare and medical research.  The time between the availability of medical research results and their use to inform healthcare decisions must be shortened in order to detect patient safety issues and important research findings in a more timely manner. In addition, the quality of care can be improved through better processes and research findings. Building a bridge between these two communities is the foundation for faster development of therapies, improved healthcare and patient safety globally. NWIP Purpose 21 February 2011 WG2 Report to DICOM WG-10 16

17.  What is special and unique about mobile devices and healthcare applications  Is there a Reference Architecture that can be utilized or modified, or is something new required  Bringing forward a NWIP for a TR to investigate, analyze and report findings 21 February 2011 WG2 Report to DICOM WG-10 17

18. 21 February 2011 WG2 Report to DICOM WG-10 18 IS 21090: Harmonized Data types for Information Interchange Lead Grahame Grieve – Australia  Comments were reviewed at Kyoto in May. Final document and disposition was sent to Central Secretariat.  Editorial issues, resolved.  The document will be released for ballot.

19. 21 February 2011 WG2 Report to DICOM WG-10 19 IS 12974: Web access to DICOM persistent objects by means of web services Lead => Nick Brown - UK  Work to be carried out by joint ISO TC215 WG2/DICOM task group led by NB  Completion of this document is awaiting a document from DICOM that will be completed in June 2010.  DICOM, ISO and Public Comments completed 8Oct2010 and at this meeting. It is expected that final document will be available for the WG2 meeting in Finland.

20. 21 February 2011 WG2 Report to DICOM WG-10 20 TR 13128: Clinical Document Registry Federation Lead => Byoung-Kee Yi, (Korea). ◦ Byoung-Kee Yi presented a revised draft of this document that addressed questions raised in prior reviews. ◦ The group suggested modest changes (agreed-to during the discussion.) ◦ DTR ballot of ISO 13128

21. 21 February 2011 WG2 Report to DICOM WG-10 21 Clinical Trial Registration and Results Lead => Bron Kisler, (US). ◦ Scope and Purpose ◦ Global data exchange standard to meet the current global requirements for clinical trial registration and basic results reporting  Extend the initial standard to meet the requirements of expanded results reporting  Align data elements with notable registries  ClinicalTrials.gov (US), EudraCT v8 (EU), and WHO Clinical Trial Registry

22. 21 February 2011 WG2 Report to DICOM WG-10 22 Clinical Trial Registration and Results ◦ Approved JIC project with initial version of standard already being balloted in HL7 and CDISC ◦ Participating Organizations: CDISC, HL7, EMA, WHO, US FDA, NCI & NLM, Clinical Translational Science Center ◦ At this meeting- NWIP prepared and forwarded as a Resolution 2.

23. ISO Reference Information Model  The group discussed the current status of ISO/HL7 21731 – Reference Information Model.  Background The HL7 RIM Release 1 completed ANSI ballot in 2004 (?). Previously, CEN TC251 had opted to use the RIM as a basis for its work. It was offered for adoption by ISO under the HL7-ISO Agreement and became "ISO/HL7 21731:2006” in 2006. Its attributes are bound to HL7 Abstract Data Types Release 1. In 2009, HL7 determined to maintain the RIM under the ANSI “Continuous Maintenance” process, and adopted a procedure, using both face-to-face harmonization and formal balloting, to provide a formal RIM release each year. RIM Release 2 was approved in September 2009 and is bound to the ISO Data Types (HL7 Abstract Data Types Release 2)  Discussion centered around how to bring subsequent releases of the RIM into ISO given that the HL7 maintenance process for the RIM produces an annual release. WG2 Report to DICOM WG-10

24. Reference Model Resolution  This working group supports the objective of having a unified ISO Reference Information Model that is consistent with ISO/HL7 21731 and the continued evolution of the HL7 RIM.  Choices for achieving this might include – ◦ Open the HL7 Maintenance process to ISO participation and continue to use a joint "fast-track” process for ISO adoption ◦ Use the HL7-ISO agreement as the basis to adopt HL7 RIMs on a periodic basis (at least every other release) ◦ Define a JIC process that “delegates” maintenance of the ISO Reference Model to “open” HL7 process that accepts ISO participation ◦ Follow the DICOM/ISO method which would leave the maintenance and update of the RIM to the HL7 process, which allows for the introduction of items from ISO.

25. Reference Model Resolution  At this meeting - Bringing forward a proposal for “HL7 V3 Reference Information Model - Maintenance Release Process”.  This will also support what needs to be completed for the BRIDG model (ISO 14199).

26. “Foundation” Specifications (1) Further discussion of the need for “foundation” or “infrastructure” specifications in ISO TC 215. Included consideration of:  Reference Model - Discussed previously and will proceed  Data Types - Near completion

27. “Foundation” Specifications (2)  Terminology Binding Rules ◦ D efines the means of defining “bindings” between data elements and Terminologies. ◦ Alternatively, establish the data requirements and relationships needed to provide terminology constraints for coded information in a data element (“attibute”, “slot”, “data field”, etc.) within a message, document or other artifact. ◦ Example can be found at: http://www.hl7.org/v3ballot/html/infrastructure/coreprinci ples/v3modelcoreprinciples.htm#coreP_Coded http://www.hl7.org/v3ballot/html/infrastructure/coreprinci ples/v3modelcoreprinciples.htm#coreP_Coded ◦ Sub-group believes this should be further explored to develop a NWIP between WG 2 and WG3

28. “Foundation” Specifications (3) “Foundation” Specifications (3)  Methodology ◦ Sub-group is uncertain of the value or requirement for further “methodology” specifications within the ISO TC 215 sphere

29.  The next meetings will be held as follows: ◦ 2011-5-23/27– Finland 21 February 2011 WG2 Report to DICOM WG-10 29

30.  ISO 18307-2001 – Interoperability and Compatibility in Messaging and Communications Standards  ISO 21089-2004 – Trusted End-to-End Information Flows  ISO 16056-2004 – Telehealth Interoperability  ISO 16058-2004 – Telehealth Interoperability – Telelearning Example Completed Projects 21 February 2011 WG2 Report to DICOM WG-10 30

31.  IS 27932 - Clinical Document Architecture (Release 2)  IS 27931 - HL7 Version 2.5 messaging standard  IS 17432 - Web access to DICOM Persistent Objects (WADO)  IS 10159 - Web Access Resource Manifest (WARM) Completed Projects (continued) 21 February 2011 WG2 Report to DICOM WG-10 31

32.  IS 21090 - Harmonized Data Types for Information Interchange (name change 2007) (@ CS)  TR 28380-1 - IHE Global Standards Adoption Part 1 - Process (@ CS)  TR 28380-2 - IHE Global Standards Adoption Part 2 - Integration and Content Profiles (@ CS) Completed Projects (continued) 21 February 2011 WG2 Report to DICOM WG-10 32

33.  ISO 12052 – DICOM  ISO 25720 – Genomic Sequence Variation Markup Language (GSVML)  ISO 10159 - Web Access Resource Manifest (WARM)  IS 21731 - HL7 version 3 - Reference information model, release 1  IS 18232 - Format of length limited globally unique string identifiers Completed Projects (continued) 21 February 2011 WG2 Report to DICOM WG-10 33