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Standards in Medical Informatics

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Presentation on theme: "Standards in Medical Informatics"— Presentation transcript:

1 Standards in Medical Informatics
Dr Jeremy Rogers MD MRCGP Senior Clinical Fellow in Health Informatics Northwest Institute of Bio-Health Informatics

2 Why Standardise ? How Standards are built Standards Bodies HL7

3 Why Standardise ? Standards Bodies How Standards are built HL7

4 Why Standardise? Joseph Whitworth 1803-1887
British Standard Whitworth (BSW) BS 84:1956 : 55º Pitch Joseph Whitworth Whitworth Hospital Darley Dale (1887) Whitworth Institute Darley Dale (1890) Stanley Grove Care Home (1892)

5 About Standards… Definitions
Minimum acceptable manufacturing specification, issued by a body that creates such specifications Concrete example of an item or a specification against which all others may be measured Common technical specification for competing entities in a market that brings benefits without hurting competition Conspicuous object used as a rallying point in battle

6 About Standards… Types
De jure – followed because you have to De facto – followed because they’re worth it Open – publicly available though not necessarily royalty free E.g. 50Hz AC, HTML, POP3 Proprietary E.g. Sony Memory Stick, VHS/Betamax

7 About Standards… Benefits Pitfalls
Increased interoperability of components (in theory) Reduce duplication of effort Enable competitive supplier market Pitfalls Proprietary ~ supplier lock-in Open ~ “Embrace, extend and extinguish” Aka “Copy, corrupt, copyright, circulate, control” Extinguish = turn and open standard into a proprietary one

8 'The main reason standards are so wonderful is that there are so many to choose from'

9 Why Standardise ? Standards Bodies How Standards are built HL7

10 ISO CEN HL7 Standards Bodies
See also IEEE, ANSI, DICOM, W3C, NCPDP, NCCLS, Corba etc

11 ISO International Organisation for Standardisation
ISO is acronym for…? Est 1947 TC 215 – medical informatics WG1 Health Records and Modelling WG2 Messaging and Communication WG3 Health Concept Representation WG4 Security WG5 Health Cards

12 CEN Comité Européen de Normalisation
MISSION: to promote voluntary technical harmonization in Europe in conjunction with worldwide bodies and its partners in Europe. Harmonization: Diminishes trade barriers Promotes safety Allows interoperability of products, systems and services Promotes common technical understanding 2005 Budget: 11,202,000 Euro (~$13.5m)

13 CEN Who is in it? Austria Belgium Cyprus Czech Republic Denmark
Estonia Finland France Germany Greece Hungary Iceland Ireland Italy Latvia Lithuania Luxembourg Malta The Netherlands Norway Poland Portugal Slovakia Slovenia Spain Sweden Switzerland United Kingdom ALL procurements by government or other public bodies from these CEN members MUST comply with all relevant CEN standards

14 CEN TC 251 Health Informatics
Website: Working Groups Information models (WG I) Terminology and knowledge representation (WG II) Security, Safety and Quality (WG III) Technology for Interoperability (WG IV)

15 HL7 Health Level Seven Independent, but ANSI accredited activity, entirely devoted to health HL7 = level 7 of ISO model for OSI OSI = Open Systems Interconnection The physical layer deals with data at a bit level The data link layer breaks input data into data frames and the receiver returns acknowledgement frames The network layer controls the transmission of packets of data, including routing and control of traffic congestion The transport layer manages data from the session layer, if necessary splitting it into smaller sections The session layer allows machines to communicate, this includes synchronisation of activity The presentation layer manages the syntax and semantics of information, this may also include data compression and encryption The application layer defines file structure and transfer, and manages compatibility between different systems

16 HL7 Raison d’être ‘When two healthcare providers in the USA merge (one buys the other) they often have different computer systems. To make one business IT system, you need to get the two systems working as one system, if possible. Before HL7 version 2, the whole thing was such a mess that it could easily cost more than a million dollars and take forever. With HL7 version 2 it is estimated that it still costs several hundred thousand dollars and takes months. HL7 version 2 is, therefore, better than nothing but far from ideal. We need to do better (because there are a lot of US healthcare organisations merging right now). The hope is that connecting two HL7 version 3 systems together might only cost a few tens of thousands of dollars and take a few weeks, because trying to work out how to make the data flow will require even fewer experts and less time. This is because a lot more things that were previously variable or optional in version 2 will now be fixed or compulsory in version 3.’ Dan Russler

17 HL7 Who is in it? USA origin and primary market National Groups in:
Argentina Australia Canada China Czech Republic Finland Germany India Italy Japan Korea Lithuania The Netherlands New Zealand Southern Africa Switzerland Taiwan Turkey United Kingdom

18 HL7 Organisation 3 plenary meetings per year Special Interest Groups
Technical Committees discussions RIM Harmonisation Committee Iterative process, final ballot Arden Syntax Attachments Cardiology Clinical Guidelines Clinical Genomics Community Based Health Services Conformance Emergency Care Generation of Anesthesia Standards Government Project Health Care Devices Imaging Integration Java Laboratory Patient Safety Pediatric Data Standards Pharmacy Public Health and Emergency Response Template XML Ballot Task Force Clinical Statements Common Message Element Types Dynamic Model Harmonization HL7Terminfo Services BOF 27 HL7 SIGs Technical Steering Committee Architectural Review Board CCOW Clinical Decision Support Education Electronic Health Record Electronic Services Financial Management Implementation Infrastructure and Messaging International Affiliates Marketing Medical Records/Information Management Modeling and Methodology Orders/Observations Organization Review Committee Outreach Committee for Clinical Research Patient Administration Patient Care Personnel Management Process Improvement Publishing Regulated Clinical Research Information Mgmt. Scheduling and Logistics Security Structured Documents Tooling Committee Vocabulary 28 HL7 Technical Committees

19 Why Standardise ? Standards Bodies How Standards are built HL7

20 Building Standards Who builds them?
Manufacturers of products Customers of products Collectors of tax when one person buys something from another Competitors with any of the above Academic experts largely innocent of the above dynamics

21 CEN Development of CEN standards
Influence of members: National standards bodies in each member state e.g. BSI Mirror panels of national experts e.g. NHS IST 35 mirrors CEN TC 251 Nominated expert goes to CEN meetings CEN Working: Options: Adopt a pre-existing standard often but not always from ISO Ask ISO to develop it the Vienna agreement Convene a CEN Technical Committee to draft new standard

22 Building Standards How are they built?
Short Strategic Study Open Tender Document Reject TC 251 Board Reject Project Team TC 251 Member Anyone Working Group Proposal Interim Reports (INR) First Working Draft (FWD) Final Version (FFV) Comments Voting Pre-Standard (ENV) Full Standard (EN) Abandon 3 years 3 months

23 Building Standards The Economic Cost
$400 Individual Annual Subscription $11000 for company with >$50M turnover $16000 ~ 3 Meetings per year 3 x $700 Transatlantic flight 3 x $900 Hotel for a week 3 weeks physically in attendance 3 weeks consultancy time

24 Standards An Observation
Labour intensive process Costly to participants Economic viability: Revenue from process Revenue from result

25 DISCUSSION EXERCISE Standards: friend or foe ?
Standards and Procurement Problems with monolithic MegaCorp Problems with TinyCorp Standards and Sales How do standards create a market? Can a standard create an acceptable customer lock-in? Who funds development of competing ‘open’ standards? Why? Why are emergent standards used in marketing e.g. 811g?

26 Why Standardise ? Standards Bodies How Standards are built HL7

27 HL7 Standard Versions 2.5 (2003) Current ANSI standard
2.0 (1988) Prototype 2.1 (1990) First standard 2.2 (1994) Widely Adopted 2.3 (1997) In operation (1999) Approved ANSI standard 2.4 (2000) Approved ANSI standard 2.5 (2003) Current ANSI standard 3.0 In development

28 Limitations of Version 2.x
Implicit information model, not explicit Events not tightly coupled to profiles Uncontrolled vocabularies Limited to a single encoding syntax No explicit support for object technologies No explicit support for security functions Optionality is ubiquitous and troublesome

29 Version 2.x Implementation Issues
Problem Honest misunderstanding of specifications Misleading conformance claims Cause Different implicit information models No vocabulary to describe conformance concepts Complex integration: at least 2-4 months to implement interfaces

30 Other Factors Increasing pace of business change
Migration toward an evidence-based model Transition from managing visit to managing cost Regulatory pressures Increasing complexity of HIT

31 HL7 Version 3 Clinical Messaging Clinical Documentation (Vocabulary)
Leg Lower Limb Femur

32 HL7 version 3 Main Messaging Components
Message Development Framework (MDF) Reference Information Model (RIM) Large, shared object model representing clinical domain Message, and ACT life-cycle focus “An ANSI standard … simple abstract framework which addresses the wildly heterogeneous and interlinked nature of clinical data with only six important classes” RIM-derived information models DMIM, RMIM XML CMET, HMD Approved Vocabularies

33 HL7 Overview of Components
Domain Information Model Use Case Model Reference Information Model Interaction Model Domain Specification Database Message Information Model Hierarchical Message Description Common Message Element Types

34 HL7 RIM Ultra High Level View
PARTICIPATION ACT ENTITY ROLE MESSAGE CONTROL STRUCTURED DOCUMENTS 6 classes: ACT actions that must be documented as healthcare unfolds ACT-RELATIONSHIP mutual binding between acts e.g. order and observation ENTITY physical things of interest or take part in healthcare ROLE role that entities play in different ACTS ROLE LINK relationship between roles PARTICIPATION binds acts to Entities (e.g. who did it, where etc)

35 HL7 Reference Information Model (RIM) v0.99 (Sep 2000)

36 HL7 Reference Information Model (RIM) v2.11 (Jul 2005)

37 HL7 RIM e.g. ACTS

38 HL7 RIM e.g. Message Control

39 EXERCISE Compare RIM v0.99 with v2.11
When was each version released? List the subtypes of [Role] that an [Entity] may play Can all subytpes of [Entity] sensibly play all subtypes of [Role]? What attributes can [Person] take in each version? Which attributes of [Person] have disappeared since v0.99?

40 RIM-derivatives Domain Message Information Model (D-MIM)
Makes the abstract RIM specific Defines the information elements for a specific domain or specialty area e.g. Prescribing Refined Message Information Model (R-MIM) Refines a DMIM to define elements of a family of messages e.g. Parent Prescribing Common Message Element Types (CMET) Reusable DMIM or RMIM components Hierarchical Message Definition (HMD) Tabular ordered representation of RMIM elements ? Similar to an XML DTD

41 Pharmacy DMIM 2003 Pharmacy DMIM v11.1 ( )

42 RouteCode Ontology of routes? CMET for encounter
Detail from Pharmacy DMIM v11.1 (2003)

43 HL7 RMIM e.g. Parent Prescribing
Parent Prescribing RMIM v (2004)

44 Detail from Parent Prescribing RMIM v3.1.06 (2004)

45 HL7 Clinical Documentation
Clinical Document Architecture (CDA) Exchange model for clinical documents Leverages XML, HL7 RIM and coded vocabularies XML Syntax & framework for expressing clinical document semantics Discharge Summary, Imaging Report, Admission & Physical etc Minimum version ~ Dublin Core XML-RIM metadata Header, content not marked up Level 3 CDA implies extensively marked up content also ANSI Standard November 2000

46 HL7 Clinical Documentation
Clinical Context Management Specification (CCOW) Protocol for linking multiple applications Means to identify common clinical ‘context’ across boundaries = identity of patient and previous encounters ANSI Standard September 2000 Templates RIM-compliant CDA data structures Express specific clinical data e.g. BP May be combined to define template for larger datasets Embedded data validation rules (thus,similar to OpenEHR archetypes)

47 About Standards… Summary
Tool for interoperability Extensive and costly activity in health informatics Complex output Chiefly, information models (UML etc) Cautious industrial buy-in: what’s the migration pathway? HL7 Predominant body at the moment

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