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'
Anon

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)
ENTITY
ROLE
PARTICIPATION
ACT
HL7 v3 RIM version TH July 2005
MESSAGE CONTROL
STRUCTURED DOCUMENTS

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