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Standards and the VCDE Community

Harold Solbrig

Mayo Clinic

solbrig.harold@mayo.edu

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Goals and Purpose

Make VCDE WS aware of standards and standards influencing organizations that have a potential to have a significant impact on or could be positively influenced by the caBIG/VCDE WS.

Make preliminary recommendations about how VCDE could approach:

1. being aware of potential impact on VCDE

2. influencing and assisting standards progress

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Disclaimer

The primary purpose of this presentation is to serve as a basis for further investigation and discussion. It is highly likely that important standards have been omitted that need to be added. It is almost a certainty that not everyone will agree with the recommendations – they intended to be a first approximation only.

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Healthcare Related Standards(from Jean Stanford – MITRE)

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Drilling down...

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Drilling further down...

CDISC

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We have to focus.

Scope: VCDEIn Scope:• Standards that impact vocabulary structure,

registration and dissemination• Data and message models• Data element / service registration

Out of Scope:• Terminology content - these arrive through

established mechanisms• Healthcare specific messages, data structures – this is

our business

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The standards participation matrix(adapted from Ed Hammond)

Right DirectionWrong Direction

Eff

ectiv

eIn

effe

ctiv

e

Going the wrong way,but not making muchprogress

Going the right way and doing a good jobat it.

Going the right way,but not making muchprogress.

Going the wrong way,and doing a good jobat it.

Focushere...

... andhere.

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General Assessment Criteria

Applicability to VCDE

1 (not applicable) to 5 (vital)

Currency (not mutually exclusive)

Past: Standards exist, are in use

Current: Standards are emerging and being deployed today

Future: Standards will coalesce at a future time

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General Assessment Criteria(continued)

Participation Cost

TimeLow ( < 40 total hours / year)

Medium (40 to 160)

High (160+)

MoneyLow (free / no travel)

Medium (some fees and/or travel required)

High (high fees or much travel)

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General Assessment Criteria(continued)

Relative Development Speed

Slow: > 2 years from inception to deployment

Medium: 1-2 years

High: 6-12 months

Web: If you sleep, it happens without you

Recommended Level Participation

Know that it exists

Track what is happening (mailers, etc.)

Attend and observe

Participate and contribute

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Participation Commitment

Know that it exists - post information about it on a public site and assigning someone to periodically check in on the organization and update the site.

Track what is happening - all of the above, plus assign someone to monitor web pages, e-mail lists, etc., looking for events that may impact (or be impacted by) VCDE and, when this occurs, reporting this information to the VCDE community.

Attend and Observe - all of the above, plus one or more people are responsible for attending conferences and meetings, summarizing discussion and decisions and reporting back to the VCDE community

Participate and Contribute – all of the above, plus the attendees are also expected to actively critique, contribute and represent the VCDE needs and inputs within the standards body

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Other Approaches

Cross Community PollenizationIt may be in VCDE’s interest to have different standards bodies

communicate, where no communication exists today.

Example: ISO TC 215 and ISO JTC1 / SC 32 / WG 2

Evaluation and PrototypesSometimes test beds and usability studies are as valuable as direct

input

Adoption and PromotionGood standards need evangelists

InnovationBeing on the leading edge often exposes new needs for standardization

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In General

VCDE already has community participants in most of the standards bodies discussed below. The incremental cost, in part, is

(a) enabling them to participate at the level most desirable to VCDE

Maybe they observe, but can’t afford to actively contribute

(b) making them responsible for, and providing the time to provide the necessary review, follow-up and reporting desired by the VCDE community.

Folks often don’t have the time to actively contribute to efforts when those efforts don’t directly effect their “day job” – yet they are often the very experts critical for the standard’s ultimate success.

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Recommendations

Three sections:

1)Healthcare Standards Setting Bodies

2)Healthcare Standards Influencing Bodies

3)Non-healthcare Standards Bodies

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Healthcare Standards Setting Bodies

• HL7 - http://www.hl7.org/

• ISO TC 215 - http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=54960

• IHTSDO - http://www.ihtsdo.org/

• CDISC - http://www.cdisc.org/

• DICOM - http://dicom.nema.org/

• LOINC - http://loinc.org/

• WHO - http://www.who.int/en/

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Health Level Seven (HL7)

One of the major healthcare standards organizations within and now outside of the United States

Version 2 – emerged circa 1987, widely used for healthcare messaging today

Version 3 - began in 1995, beginning to find adoption

To date, version 3 is primarily achieving adoption in new applications and new areas... the incentive to upgrade from V2 isn’t huge.

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Health Level Seven (HL7)(continued)

Core Infrastructure• DataTypes – core data types for healthcare (R2 adopted as ISO

Standard ISO 21090.• RIM – Reference Information Model (A “meta-model” with a strong

healthcare focus)• CCOW – Standard for maintaining desktop context• CTS – Common Terminology Services• Templates – RIM based “profiles” for particular healthcare contexts• MIF & HDF – Model Interchange Format and Healthcare

Development Framework (model and process)• CDA – Clinical Document Architecture• Messaging specifications – RIM based specifications for

exchanging healthcare information in a myriad of contexts and settings – V2 and V3

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Health Level Seven (HL7)(continued)

Emerging Projects• Collaboration with Object Management Group on SOA

• HL7 provides requirements• OMG provides implementation

• SAEAF – Services Aware Enterprise Architecture Framework

• New project – refactoring HL7 for SOA vs. messaging• Three paradigms:

• Messaging

• Document

• Service

• Using Reference Model for Open Distributed Processing (RM-ODP) as framework

• IHTSDO – SNOMED-CT Integration

• Tooling, “terminfo”, others tbd

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Health Level Seven (HL7)(continued)

• Dozens of committees, projects, tasks, etc.• We have to be selective...

• VCDE is interested in:• Vocabulary – content, format, dissemination• Data Models and how they align with vocabulary• Tooling – editing, modeling, ...• Architecture – SOA, Grid, ...

• Specific committees... • ... need input from HL7 community

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Health Level Seven (HL7)Recommendations

• Applicability to VCDE – 5• Currency – Past, Current, and Future• Participation Cost

• Time - Medium• Money - Medium

• Relative Speed - Medium• Participation Level

• Participate and Contribute (Selectively)• Other aspects to consider

• RIM as core of caGRID/caDSR Model• VCDE ad Test bed for architectures and deployment

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ISO TC 215 – Health Informatics

Eight Working Groups• Data structure• Messaging and communications• Health Concept Representation• Security• Health Cards• Pharmacy and Medication• Devices• Business Requirements for EHR

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ISO TC 215 – Health Informatics(continued)

• Works closely with HL7 community• Selected Standards

• ISO 17115:2007 – Vocabulary for Terminology Systems (VoTe)

• ISO DIS 27961 – Common Terminology Services

• ISO TS 25237:2008 - Pseudonymization

• ISO DIS 21090 - Harmonized data types for information interchange (Approved)

• JIC balloted

• OID Registry - NWI

• BRIDG as JI-SDO (will impact Europe, etc.)• JI-SDO – Joint Initiative on SDO Global Health Informatics Standardization

• ISO TC 215 / HL7 / CEN TC 251 / CDISC

• http://www.global-e-health-standards.org/

From: http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=54960

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ISO TC 215 – Health Informatics(Recommendations)

Applicability to VCDE – 4 (largely because of the mandatory nature of ISO standards)

Currency –Current, and Future

Participation Cost

Time - Medium

Money - Medium

Relative Speed - Medium

Participation Level

Observe – could be “track” except that a better liaison effort is really important, especially when it comes to potentially generic standards (21090, OID Registry, ...)

Other Modes – Interface needed between JTC1/SC32, OMG and TC37

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IHTSDO

International Health Terminology Standards Development Organization

“IHTSDO is a not-for-profit association that develops and promotes use of SNOMED CT to support safe and effective health information exchange. SNOMED CT is a clinical terminology and is considered to be the most

comprehensive, multilingual healthcare terminology in the world.”• Developing SNOMED-CT Content• Developing authoring, curation and classification tooling (in

conjunction with OHT)• Has a lot to say about how terminology and information models

go together (in conjunction with HL7)• Mappings underway involving LOINC, ICD-9 / ICD-10 & others

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IHTSDORecommendations

Applicability to VCDE – 5

Currency –Current, and Future

Participation Cost

Time - Medium

Money – Medium (travel)

Relative Speed - Medium

Participation Level

Participate – IHSDO is currently involved in a whole series of tasks involving terminology / data integration, registration, publication, etc.

Other Modes – Use of SNOMED in caBIG, test benches, co-development

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CDISC

Clinical Data Interchange Standards Consortium“The CDISC mission is to develop and support global, platform-

independent data standards that enable information system interoperability to improve medical research and related areas of healthcare.”

• CDISC Study Data Tabulation Model (SDTM) is standard used widely in clinical trials.

• CDISC Biomedical Research Integrated Domain Group (BRIDG) – domain analysis model for protocol-driven biomedical and clinical research

• CDISC is the standards epicenter for anything that has to do with protocol driven research

• Already working closely with NCI and VCDE

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CDISCRecommendations

Applicability to VCDE – 5

Currency – Past, Current, and Future

Participation Cost

Time - Medium

Money – Low to Medium

Relative Speed – Medium to Fast

Participation Level

Participate – Make sure that VCDE is represented, and feed VCDE (and other caBIG) input in

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DICOMRecommendations

Digital Imaging and Communications in Medicine• Works with HL7, IHE and ISO TC 215

• Utilizes LOINC, SNOMED

• RadLex (RSNA) Dicom and RSNA collaborate

Applicability to VCDE – 2

Currency – Past, Current, and Future

Relative Speed - Slow

Participation Level

Track – Monitor appropriate mailers and keep an eye out for modeling or terminology changes that impact VCDE

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LOINC®

Logical Observation Identifiers Names and Codes• Originally developed to create standardized names for laboratory tests

• Now addressing many other clinical areas:

• Closely collaborates with HL7

• Beginning collaboration with IHTSDO

Applicability to VCDE – 2 (VCDE uses LOINC content, but what LOINC decides has little impact on what VCDE does or visa-versa)

Currency – Past, Current, and Future

Relative Speed - Slow

Participation Level

Track (or Be Aware?)

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WHO – World Health OrganizationICD-11

WHO International Classification of Disease version 11• Targeted for release in 2015• Using Web 2.0 Principles• Developing an model of ontology, classification and

“linearization” (meaning, categories and publication)• Referencing SNOMED-CT for ontology component

Applicability to VCDE – 3

Currency –Future

Participation Level

Track

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CONSORThttp://www.consort-statement.org/

CTCAEhttp://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm

IHEhttp://www.himss.org/ASP/topics_ihe.asp

OHT & OHFhttp://www.openhealthtools.org/

http://www.eclipse.org/ohf/

OpenEHRhttp://www.openehr.org/home.html

OMG Healthcare DTF http://healthcare.omg.org/

NCBOhttp://bioontology.org/

OBO Foundryhttp://www.obofoundry.org/

W3C HCLShttp://www.w3.org/2001/sw/hcls/

Healthcare Standards Influencing Bodies

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CONSORT

Consolidated Standards of Reporting Trials• The CONSORT “Statement” – improvement for the

reporting on randomized clinical trials• Checklist, Flow Diagram, Explanation and Elaboration,

Translations• May be a natural synergy between VCDE and

CONSORT for electronic reporting standards

Applicability to VCDE – 2 (now) 4 (future?)

Recommended Participation

? – Need further discussion w/ Steve Harris

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CTCAE

Common Terminology for Adverse Events• Part of NCI CTEP• Of importance to caBIG, but (arguably) not impacting

of impacting VCDE....• Format and structure could impact repository

Recommended Participation

Track - (Again, strictly from a VCDE perspective)

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IHE

Integrating the Healthcare Enterprise• Coupled with HIMSS

• Focus arriving at standards based implementation profiles

• Heavy standards modifiers

Applicability to VCDE – 3

Currency – Future

Participation Cost

Time – Medium

Money – Low

Relative Speed - Medium

Participation Recommendations

Observe (or track?)

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OHT & OHF

OHT – Open Health Tools

A community of health and IT professionals focused on creating a common health interoperability framework. Open source, free.

Modeled on Eclipse Foundation (and, in some ways, Eclipse)“Open Health Tools has based its governance, legal and intellectual

property policies, development processes, marketing, and business models on Eclipse.  Many of those working to create Open Health Tools were intimately involved with creating Eclipse.  And we will be using the Eclipse Open Health Framework (OHF) and other Eclipse software as a base for Open Health Tools’ technology.  While Eclipse is a member of Open Health Tools, the two organizations are not affiliated in a corporate sense.” - http://www.openhealthtools.org/faq.htm

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OHT & OHF(Continued)

Emerging collaboration with IHTSDO, but SNOMED CT itself is not included in model

• Open Health Forge – software repository for additional software.http://www.openhealthtools.org/OHTForge.htm

Applicability to VCDE – 2

Currency – Future

Participation Cost

Time – Low

Money – Potentially High

Relative Speed - Unknown

Participation Recommendations - Track (for now)

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ONC

The Office of the National Coordinator for Health Information Technology

• Supersedes AHIC as part of the HR1 Stimulus package

• Created as a permanent organization

• Policy committee – replacement to AHIC

• Standards committee – replacement for NCVHS

• First standards committee meeting in 2 weeks (~May 15, 2008)

• VCDE should care about standard committee

• NHIN – National Health Information Network

• Pharma focus, enabling “grid level” communication among providers.

• Internet messaging with CCD (Continuity of Care Document)

• Of interest to Architecture group

http://www.nhin.com/

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ONC(continued)

• CCHIT – Certification Commission for Healthcare Information Technology• Certification of IT systems• May be of strategic interest at some point to caBIG, but

nothing for VCDE• http://www.cchit.org/

• Privacy and Security of Health Information Technology – of interest to architecture group, but not VCDE

• http://healthit.hhs.gov/portal/server.pt?open=512&objID=1147&parentname=CommunityPage&parentid=1&mode=2&in_hi_userid=10741&cached=true

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ONC(continued)

• HITSP - Healthcare Information Standards Panel• Turning out mandated interoperability profiles based on

CDA• Makes recommendations to DHHS, who then mandates

it for any federal communications• Currently in 90 day reorganization period

• Architecture, terminology, value set infrastructure• Currently using USHIK (a 11179 based DR)• CDC PHINVADS for terminology point

• http://www.hitsp.org/

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ONCRecommendations

Applicability to VCDE – 5 (HITSP)

Currency – Future

Participation Cost

Time - Medium

Money – Low

Relative Speed – Medium to Fast

Participation Level

Participate – VCDE, caDSR and other approaches may be a good fit. Will have to interchange w/ HITSP work, fed mandates

Additional note – needs to begin to happen quickly – all of this is underway as we speak!

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OMG Healthcare DTF

Responsible for implementations of HL7 standards – does not initiate standards on its own.

• Work includes • Entity Identification Service – through DSTU• Retrieval Update Service (Health information locator service)• DSS Decision Support Services• CTS-2 (Maybe...)

Applicability to VCDE – 2 (but may change as HL7 / SAEAF evolves)

Currency – Present and Future

Participation Cost

Time – Medium

Money – High

Relative Speed - Medium

Participation Recommendations

Track (But see OMG in general as well)

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OpenEHR

Focus is on archetypes for healthcare ICT• Specifications• Software• Tools

• Creating reusable clinical models of content and process, w/ “formal interfaces to terminology”

• ISO 13606 Standard derived from OpenEHR• Part 2 part of the Microsoft CHF architecture

• ISO DTR 20514 – EHR Definition, Scope and Context drawn from this as well

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OpenEHR

• Relationship w/ HL7 is still uncertain

Applicability to VCDE – 2

Currency – Present and Future

Participation Recommendations

Track (or Be Aware?)

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NCBO

National Center for Biomedical Ontology• “... develop innovative technology and methods allowing scientists to

create, disseminate, and manage biomedical information and knowledge in machine-processable form.”

• BioPortal - emerging toolkit for annotating and integrating ontological (and terminological...) resources

• Also involved in ontology metadata and annotation.

• Directly impacts and (should be) impacted by VCDE

• Tools – BioPortal and related software could (and probably should) be integrated w/ VCDE

• Content and Annotations – may be a secondary (or even primary?) resource for content

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NCBORecommendations

Applicability to VCDE – 5

Currency – Present and Future

Participation Cost

Time – Low

Money – Low

Relative Speed - High

Participation Recommendations

Observe (or Participate?)

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OBO Foundry

Open Biomedical Ontologies• Principles for ontology development (BFO based)• Developing orthogonal ontologies in biomedical domain• Registry of content, requests for changes• Content, software and process for VCDE

Applicability to VCDE – 5

Currency – Present and Future

Participation Cost

Time – Low

Money – Low

Relative Speed - High

Participation Recommendations

Observe

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W3C HCLS

Semantic Web Health Care and Life Sciences Interest Group

• Very active community, with a (current) focus on pharma and neurology

• Six workgroups• BioRDF

• COI – Clinical Observations Interoperability

• LODD – Linking of Open Drug Data

• Pharma Ontology – Ontology of Pharma

• Terminology

• A showcase for W3C (Semantic Web) and healthcare

• Community for information exchange, generic tooling, web integration

• Shared Names Group – possibility of resolution for naming issues

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W3C HCLS

Applicability to VCDE – 4

Currency – Future

Participation Cost

Time – Medium

Money – Low

Relative Speed - Web

Participation Recommendations

Observe (but consider directed participation)

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Non-Healthcare Standards Bodies

W3C SWDWG - W3C Semantic Web Deployment Working Grouphttp://www.w3.org/2006/07/SWD/

ISO/IETF JTC1/SC32 WG2 – Metadata Standardshttp://metadata-stds.org/

ISO TC37 – Terminology and Other Language and Content Resourceshttp://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/

iso_technical_committee.htm?commid=48104

OMG – Object Management Grouphttp://www.omg.org/

WS-I – Web Services Interoperability Organizationhttp://www.ws-i.org/

OASIShttp://www.oasis-open.org/home/index.php

UDEFhttp://www.opengroup.org/udef/

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W3C SWDWG

W3C Semantic Web Deployment Working Group• Standards for many of the things that are in IT’s future

today and tomorrow• OWL 2.0• SKOS revision• RDFa

• Contact point for what is available, what is happening, etc.

• Networking

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W3C SWDWGRecommendations

Applicability to VCDE – 3

Currency – Future

Participation Cost

Time – High

Money – High

Relative Speed - Web

Participation Recommendations

Observe – (we need reports, understanding of issues, etc.)

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ISO/IETF JTC1/SC32 WG2

Metadata Standards• Evolved from and includes SQL standards• ISO 11179 Edition 2 – basis for caDSR• ISO 11179 Edition 3 part 3 – currently in CD-2, being

refined and voted on• Advised by caDSR experience• Working with members of W3C community• Still needs much work on part 6 and other components• Definitive description of terminology/information model

IF

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ISO/IETF JTC1/SC32 WG2(continued)

• ISO 19763 series of standards – Metadata Interoperability, including...• Metamodel for ontology registration• Metamodel for model mapping• Metamodel for process model registration• Metamodel for service registration

• Common Logic specification• Study groups on forms, others...

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ISO/IETF JTC1/SC32 WG2Recommendations

Applicability to VCDE – 5 Currency – Past, Present, Future

Participation Cost

Time – Medium

Money – Medium

Relative Speed - Slow

Participation Recommendations

Participate

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ISO TC37

Source or key documents for terminology management• ISO 704: 2000 – Terminology Work, Principles and

Methods• ISO 108701:2000 – Vocabulary – Part 1: Theory and

Application• ISO 12200:1999 – MARTIF• ISO 12620: 1999 – Data Categories (DCR)• ISO 16642: 2003 – Terminology Mark-up Framework

(TMF)

Very active in translation and library communities

Foundation for SKOS

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ISO TC 37Recommendations

Applicability to VCDE – 2 Currency – Past, Present, Future

Participation Cost

Time – Low

Money – Low

Relative Speed - Slow

Participation Recommendations

Track

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OMG – Object Management Group

• Not-for-profit industry consortium that creates industry standards

• Responsible for UML, CORBA• Focus of BPM (Business Process Modeling) and MDA

(Model Driven Architecture)• ODM – Ontology Definition Metamodel• CWM – Common Warehouse Metamodel• Many others• The key is a lot of the reason that Eclipse, Enterprise

Architect, oXygen, XML Spy, ... work together is due to work done at the OMG

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OMG(Continued)

Of particular interest is the “Common Terminology Services 2” (CTS-2) process – the “Service Functional Model” (SFM) is being voted on in the HL7 Kyoto meeting.

If passed, may go to the Ontology Platform Group...

... which might mean that CTS-2 could be available “out of the box” with standard tools (!)

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OMGRecommendations

Applicability to VCDE – 3 (if CTS-2 adopted, 5) Currency – Past, Present, Future

Participation Cost

Time – Medium

Money – High

Relative Speed - Medium

Participation Recommendations

General: Track (OMG is in the upper right hand quadrant of the Hammond matrix)

Ontology PSIG: Participate (w/ CTS-2)

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Others

WS-I - Best Practices for Web Services Standards

A whole series of profiles, sample applications, testing tools, etc. for web services.

OASIS – Organization for the Advancement of Structured Information Standards

A de-facto “standards” body web related standards. Many of the standard tools we use today are OASIS standards

ebXML – ElectronicBusiness using XML

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Others

UDEF - Universal Data Element Framework• From the Open Group• Method of categorizing data

Participation Recommendations for WS-I, OASIS, UDEF:Be Aware - know that they are there and check in periodically.

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Summary

25 potential points of participation

• Applicability

• 9 High (5)

• 6 Medium (3-4)

• 10 Limited (1-2)

• Recommendations

• Actively Participate• HL7• IHTSDO• CDISC• ONC HITSP• ISO/IETF JTC1/SC32 WG2• OMG CTS-2

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Summary(continued)

25 potential points of participation• Recommendations (continued)

• 6 Observe – become a member, listen in• IHE• ISO TC 215• W3C HCLS• NCBO• OBO Foundry• W3C SWDWG

• 9 Track• 4 Be aware

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Summary(continued)

Existing participation• All but one of the participate recommendations

already have VCDE community members involved...• CDISC 10, HL7 9, HITSP 3, SC32 3 and IHTSDO 2• OMG CTS-2 not engaged yet, but may require

incentive• All of the observe recommendations have one or two

community members except IHE...• About half of the track recommendations have

members already involved

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Resources

Bruce Bargmeyer – LBNL

Calvin Beebe – Mayo Clinic

Christopher Chute, M.D., Dr. P.H – Mayo Clinic

Anthony Julian – Mayo Clinic

Eric Prud'hommeaux – W3C

Sarah Ryan

Ken Rubin – EDS

Jean Stanford – MITRE

Denise Warzel – NCI

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Questions

What did we miss?• Remember – focus is on VCDE... tooling, infrastructure, content

only to the extent that it impacts model or architecture

Were the assessments correct?• Were there organizations who could be tracked or simply

documented that were in the observe or participate category?• Are there organizations that need more active participation?

Are there other roles besides participation that the VCDE

community should be playing?• Think about the RIM core recommendation from HL7...