Convenor: Michael Glickman (US) Vice-Convenor: Michio Kimura (JP) Secretary: open, worldwide search

underway Architecture Lead Gary Dickenson (US) Methodology Lead George “Woody” Beeler

(US)

21 February 2011WG2 Report to DICOM WG-10 2

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 WG2 Coordination with DICOMDICOM

21 February 2011WG2 Report to DICOM WG-103

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 2011WG2 Report to DICOM WG-10 4

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 2011WG2 Report to DICOM WG-10 5

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

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21 February 2011WG2 Report to DICOM WG-10 7

Lead: Charles Parisot (FR)◦ IHE Liaison

Purpose: Leverage IHE Implementation Process and Experience into ISO

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IHE Approach◦ Interconnect Multiple Applications◦ Incorporate Relevant Industry Standards◦ Establish Integration Profiles◦ Engage Connectathons, Demonstrations◦ Resulting in Actual Implementations

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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

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 2011WG2 Report to DICOM WG-10 10

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 2011WG2 Report to DICOM WG-10 11

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 2011WG2 Report to DICOM WG-10 12

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 2011WG2 Report to DICOM WG-10 13

21 February 2011ISO TC215 WG2/Architecture 14

Submissions

Analysis Data

SDTM / SEND

Glossary

ODM

LAB

ADaM

CDASH

Data Collection

Protocol

Healthcare

HL7 RIM

BRIDGB

RIDG

NWIP ScopeNWIP Scope

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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.

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 PurposeNWIP Purpose

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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

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21 February 2011WG2 Report to DICOM WG-10 18

IS 21090: Harmonized Data IS 21090: Harmonized Data types for Information types for Information InterchangeInterchangeLead 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.

21 February 2011WG2 Report to DICOM WG-10 19

IS 12974:IS 12974: Web access to DICOM Web access to DICOM persistent objects by means of web persistent objects by means of web servicesservices

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.

21 February 2011WG2 Report to DICOM WG-10 20

TR 13128:TR 13128: Clinical Document Clinical Document Registry FederationRegistry FederationLead => 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 February 2011WG2 Report to DICOM WG-10 21

Clinical Trial Registration and ResultsClinical 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

21 February 2011WG2 Report to DICOM WG-10 22

Clinical Trial Registration and ResultsClinical 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.

ISO Reference Information ISO Reference Information ModelModel 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

Reference Model Reference Model ResolutionResolution 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.

Reference Model Reference Model ResolutionResolution 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).

““Foundation” Foundation” Specifications (1)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

““Foundation” Foundation” Specifications (2)Specifications (2) Terminology Binding Rules

◦ Defines 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/coreprinciples/v3modelcoreprinciples.htm#coreP_Coded

◦ Sub-group believes this should be further explored to develop a NWIP between WG 2 and WG3

“ “Foundation” Foundation” Specifications (3)Specifications (3) Methodology

◦ Sub-group is uncertain of the value or requirement for further “methodology” specifications within the ISO TC 215 sphere

The next meetings will be held as follows:

◦ 2011-5-23/27– Finland

21 February 2011WG2 Report to DICOM WG-10 29

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 ProjectsCompleted Projects

21 February 2011WG2 Report to DICOM WG-10 30

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 10159IS 10159 - - Web Access Resource Manifest Web Access Resource Manifest (WARM)(WARM)

Completed Projects Completed Projects (continued)(continued)

21 February 2011WG2 Report to DICOM WG-10 31

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 Completed Projects (continued)(continued)

21 February 2011WG2 Report to DICOM WG-10 32

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 Completed Projects (continued)(continued)

21 February 2011WG2 Report to DICOM WG-10 33