Standards in Medical Informatics Dr Jeremy Rogers MD

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

Why Standardise ? How Standards are built Standards Bodies HL 7

Why Standardise ? Standards Bodies How Standards are built HL 7

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

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

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. 50 Hz AC, HTML, POP 3 Proprietary E. g. Sony Memory Stick, VHS/Betamax

About Standards… Benefits 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

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

Why Standardise ? Standards Bodies How Standards are built HL 7

Standards Bodies ISO CEN HL 7 See also IEEE, ANSI, DICOM, W 3 C, NCPDP, NCCLS, Corba etc

ISO International Organisation for Standardisation ISO is acronym for…? Est 1947 TC 215 – medical informatics WG 1 Health Records and Modelling WG 2 Messaging and Communication WG 3 Health Concept Representation WG 4 Security WG 5 Health Cards

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. 5 m)

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

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

HL 7 Health Level Seven Independent, but ANSI accredited activity, entirely devoted to health HL 7 = level 7 of ISO model for OSI = Open Systems Interconnection 1. The physical layer deals with data at a bit level 2. The data link layer breaks input data into data frames and the receiver returns acknowledgement frames 3. The network layer controls the transmission of packets of data, including routing and control of traffic congestion 4. The transport layer manages data from the session layer, if necessary splitting it into smaller sections 5. The session layer allows machines to communicate, this includes synchronisation of activity 6. The presentation layer manages the syntax and semantics of information, this may also include data compression and encryption 7. The application layer defines file structure and transfer, and manages compatibility between different systems

HL 7 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 HL 7 version 2, the whole thing was such a mess that it could easily cost more than a million dollars and take forever. With HL 7 version 2 it is estimated that it still costs several hundred thousand dollars and takes months. HL 7 version 2 is, therefore, better than nothing but far from ideal. We need to do better (because there a lot of US healthcare organisations merging right now). Dan Russler The hope is that connecting two HL 7 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. ’

HL 7 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

HL 7 Organisation 3 plenary meetings per year Special Interest Groups RIM Harmonisation Committee Iterative process, final ballot Technical Committees email discussions 27 HL 7 SIGs 28 HL 7 Technical Committees Arden Syntax Laboratory Attachments Patient Safety Cardiology Pediatric Data Standards Clinical Guidelines Pharmacy Clinical Genomics Public Health and Emergency Response Community Based Health Services Conformance Template XML Emergency Care Ballot Task Force Generation of Anesthesia Standards Clinical Statements Government Project Common Message Element Types Health Care Devices Dynamic Model Imaging Integration Java Harmonization HL 7 Terminfo Services BOF Technical Steering Committee Architectural Review Board CCOW Orders/Observations Organization Review Committee Outreach Committee for Clinical Research Clinical Decision Support Education Patient Care Electronic Health Record Electronic Services Personnel Management Process Improvement Financial Management Implementation Patient Administration Publishing Regulated Clinical Research Information Mgmt. Infrastructure and Messaging International Affiliates Marketing Medical Records/Information Management Modeling and Methodology Scheduling and Logistics Security Structured Documents Tooling Committee Vocabulary

Why Standardise ? Standards Bodies How Standards are built HL 7

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

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

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

Building Standards The Economic Cost $400 Individual Annual Subscription $11000 for company with >$50 M 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

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

DISCUSSION EXERCISE Standards: friend or foe ? Standards and Procurement Problems with monolithic Mega. Corp Problems with Tiny. Corp 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 are emergent standards used in marketing e. g. 811 g?

Why Standardise ? Standards Bodies How Standards are built HL 7

HL 7 Standard Versions 2. 0 (1988) Prototype 2. 1 (1990) First standard 2. 2 (1994) Widely Adopted 2. 3 (1997) In operation 2. 3. 1 (1999) Approved ANSI standard 2. 4 (2000) Approved ANSI standard 2. 5 (2003) Current ANSI standard 3. 0 In development

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

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

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

HL 7 Version 3 Clinical Messaging Clinical Documentation Leg Lower Limb Femur (Vocabulary)

HL 7 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

HL 7 Overview of Components Reference Information Model Domain Information Model Use Case Model Interaction Model Message Information Model Domain Specification Database Hierarchical Message Description Common Message Element Types

HL 7 RIM Ultra High Level View PARTICIPATION ENTITY ROLE MESSAGE CONTROL 6 classes: ACT STRUCTURED DOCUMENTS 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)

HL 7 Reference Information Model (RIM) v 0. 99 (Sep 2000)

HL 7 Reference Information Model (RIM) v 2. 11 (Jul 2005) ENTITY HL 7 v 3 RIM version 2. 11 14 TH July 2005 ROLE PARTICIPATION MESSAGE CONTROL ACT STRUCTURED DOCUMENTS

HL 7 RIM e. g. ACTS

HL 7 RIM e. g. Message Control

EXERCISE Compare RIM v 0. 99 with v 2. 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 v 0. 99?

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

Pharmacy DMIM 2003 Pharmacy DMIM v 11. 1 (20. 3. 2003)

Route. Code Ontology of routes? CMET for encounter Detail from Pharmacy DMIM v 11. 1 (2003)

HL 7 RMIM e. g. Parent Prescribing RMIM v 3. 1. 06 (2004)

Detail from Parent Prescribing RMIM v 3. 1. 06 (2004)

HL 7 Clinical Documentation Clinical Document Architecture (CDA) Exchange model for clinical documents Leverages XML, HL 7 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

HL 7 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 Open. EHR archetypes)

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? HL 7 Predominant body at the moment