The EHR Standards an Overview: Paradigm shifts. Gerard Freriks v

The EHR Standards an Overview: Paradigm shifts Gerard Freriks v1 10-10-2006

The EHR Standards Gerard.Freriks@TNO.nl

TNO-ICT Dutch Institute for Applied Sciences Established by law ±5000 employees TNO-ICT is one of 5 institutes Gerard Freriks, MD Active in IT for 30 years 20 years experience as GP Convenor of CEN/tc251 wg1 for 7 years Participant in NEN, CEN, ISO, HL7 Active in: Quality of IT in Healthcare, Information security, Semantic Interoperability, ehealth strategy GF 3

Topics Introduction Role of European standards Semantic Interoperability (Extended ISO OSI stack) The EHR related standards - Exchange formats: CEN, ISO, HL7, Dicom - Coding systems: ICD, ICPC, SNOMED, LOINC,... Roadmap for the EHR: paradigm shifts Conclusions 4

-1- Introduction ehealth Bring data, information and knowledge to the point of care This is what ehealth is about. Data: e.g. lab result, x-ray picture, ECG, address Information: e.g. this person has diabetes, this picture shows a fracture, this ECG shows a cardiac arrest Knowledge: treatment protocol for diabetics 5

-1b- Standard ISO - Standards are - documented agreements - containing technical specifications or other precise criteria - to be used consistently as rules, guidelines, or definitions of characteristics, - to ensure that materials, products, processes and services are fit for their purpose. 6

ISO/IEC Guide 2:1996 defines a standard as - a document, - established by consensus and - approved by a recognized body, that - provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, - aimed at the achievement of the optimum degree of order in a given context. 7

-Ic- Introduction Semantic Interoperability Semantic Co-operability [ISO/IEC TR 10000-1:1998] The ability of two or more IT systems to exchange information and to make mutual use of the information that has been exchanged. 8

-1d- IT Developments Infrastructure advanced standards for representation of clinical concepts Some communication using messages Monolyt Islands PaleoHITic MesoHITic NeoHITic 9 Prototaxic period First a wider look at the history and where we are going. In the past the big monolytes, followed by the mini computers and PC s. Using messaging (edfact) islands still but capable of exchanging some data with difficulties. The end goal (Nirwana) is a system of system each having services that, all that are allowed, have access to. A real plug-and-play world. Nirwana with ubiquitous computing and semantic interoperability. Systems that understand the world.

-1ee-Health Internet Network Time Internet Network Database Database Internet Network Trust Space User Context, Community, Culture User Interoperability means transport of information over: Time: Meaning that information stored now must be usable in 25, 50 100 years or longer. This is called real persistance, or archiving. Space: Over large geographical area s crossing institutional boundaries. and Context, Communities, and Cultures: a thing where Europa has developed a lot of expertise and forgotten by the Angol-Saxon worlds

-1fe-Health Internet Network Time Internet Network Database Database Internet Network User Space Context, Community, Culture User Without standards and standards organisations there are no shared points of reference plus Quality Assurance In order to have many Shared Points of Reference within and across contexts, communities and cultures we need a lot of trust. AND Quality Assurance 11

-2- Role of European Standards 25 European Member States (plus EFTA countries) form one economic market European rules and regulations (Directives) organise this economic market This system of harmonised rules and regulations is called: the New Approach 13 The NEW Approach and European standards shape one European open market. I wonder how many are aware of this. http://www.newapproach.org

European standards play a special role: Only National standards derived from European standards can be used in legislation -2- Role of European Standards National and European standards play a role in procurement One European open market 14

-2- Role of European Standards European standards play a special role: CEN, ETSI and CENELEC are designated European Standardisation Organisations via a series of European Directives Formal relationships with: European National Standardisation Bodies and ISO 15 Only three European Standardisation Organisations are recognised

-2- Role of European Standards Strengths of the European system!2005 CEN all rights reserved! 2005 CEN/CENELEC/ETSI all rights reserved 13/12/2005 A picture telling it all. European standards play a role in legislation

-2- Role of European Standards Trading within the European Union! Four basic freedoms: " Free movement of goods " Free movement of persons " Free movement of capital " Freedom of establishment and free movement of services! Barriers to trade: " Traditional barriers such as tariffs or quotas " Technical barriers such as differences in standards and conformity assessment!2005 CEN all rights reserved 17! 2005 CEN/CENELEC/ETSI all rights reserved 13/12/2005 Freedom of movement of: citizens, goods, services and capital

-2- Role of European Standards Directive 98/34/EC Aids functioning of the Single Market through:! Establishing transparency in technical regulations and standards! Information exchange procedure on national activities! Recognition of 3 European Standardization Bodies: CEN, CENELEC and ETSI! Legal basis for addressing standardization requests (mandates) to CEN, CENELEC and ETSI! Standstill obligation!2005 CEN all rights reserved 18! 2005 CEN/CENELEC/ETSI all rights reserved 13/12/2005 By setting Directives based minimal quality levels. Levels of quality defined by European standards produced by the market players. Standards produced by one of the three recognised SDO s.

-2- Role of European Standards Benefits of the New Approach! Essential requirements " Specify the desired outcome to be achieved without specifying how it should be achieved! References to standards " European Standards which meet the essential requirements are developed by experts through the European Standards Organizations " Standards are voluntary! Conformity assessment policy " Manufacturers following ENs have presumption of conformity (CE marking)!2005 CEN all rights reserved! 2005 CEN/CENELEC/ETSI all rights reserved 13/12/2005 The process: essential requitements, standards and a quality assurance process. 19

-2- Role of European Standards Creating a single market! European Directives under the New Approach contribute to some of the most important industrial sectors! Industry production in the European Union countries benefits from the New Approach " Machinery " Lifts " Construction products " Low voltage equipment " Pressure equipment " Packaging and packaging waste " Information and communication technology!2005 CEN all rights reserved 20! 2005 CEN/CENELEC/ETSI all rights reserved 13/12/2005 Many successful examples, including medical devices.

Security Politics driven Government Rules and regulations Laws Healthcare driven CEN Archetypes Healthcare Logistics Clinical Pathways protocols Healthcare driven Cen ContSys Terminology Healthcare specific Healthcare Industry driven Industry driven CEN Archetypes CEN EHR system CEN EHR document CEN EHR messages Objects Documents Messages ISO/OSI Stack Application layer HL7 Templates HL7 documents HL7 messages HL7 RIM HL7 IST XML Sector specific standards generic business driven models ICT/ technology standards Industry driven ISO/OSI Stack 1-6 Basic ICT/ technology standards Standards community driven Standards for standards makers Standards to produce standards Types of standards (right) and their drivers (Left) Plus the placement of HL7 and CEN/tc251 components

ISO Vienna agreement CEN ISO/TC215 CEN/TC251 NSO NSO Member States ANSI HL7 HL7 National Affiliates Memorandum Of Understanding Others IEEE DICOM UNCEFACT? DIN NEN 25 Member States NSAI NSAI NSAI BSI UNI AFNOR... National Standardisation Organisations (NSO s) in Europe form the members of CEN. NSO s can become a member of ISO. ANSI is a NSO in the USA and member of ISO. HL7 is an ANSI accredited standards organisation, that has a special agreement with ISO. CEN and ISO have the Vienna agreement for co-operation and avoidance of duplicate work. CEN/TC251 and HL7 inc have a Memorandum of Understanding. On the level of HL7 International affiliates and European SDO s there is not always any co-operation.

-3- Semantic Interoperability Infrastructure advanced standards for representation of clinical concepts Some communication using messages Monolyt Islands PaleoHITic MesoHITic NeoHITic 24 Prototaxic period First a wider look at the history and where we are going. In the past the big monolytes, followed by the mini computers and PC s. Using messaging (edifact) islands still but capable of exchanging some data with difficulties. The end goal (Nirvana) is a system of system each having services that, all that are allowed, have access to. A real plug-and-play world. Nirvana with ubiquitous computing and semantic interoperability. Systems that understand the world.

-3- Semantic Interoperability Internet Network Time Internet Network Database Database Internet Network Trust Space User Context, Community, Culture User Interoperability means transport of information over: Time: Meaning that information stored now must be usable in 25, 50 100 years or longer. This is called real persistence, or archiving. Space: Over large geographical area s crossing institutional boundaries. and Context, Communities, and Cultures: a thing where Europe has developed a lot of expertise and forgotten by the Anglo-Saxon worlds

Example of problems with Semantic Interoperability Words Date: 10 January 2006 Date: January 10 2006 Many variations but humans solve it Simple code Date: 10-01-2006 Date: 01-10-2006 Date: 2006-01-10 Date: 2006/01/10 Date:2006:01:10, etc Concept Date: Year=2006, Month=01, Day=10 Many variations IHE processes are needed to implement it because the message standard doesn t specify all implementation possibilities One interoperable definition that is plug-and-play A simple example of Semantic Interoperability. 26

Interoperability -1- Document Terms codes concepts Citizen C Document Sender A Document Secure transport and Accountability Receiver B Sender A Culture 1 Language 2 Legal jurisdiction 3 Context A Security Quality Assurance Can I trust the other person or system? Receiver B Culture n Language m Legal jurisdiction o Context B Sender and receiver exchange information Via a document/message information is exchanged Each participant to the exchange operates from its own context: culture, language and legal jurisdiction The transport must be secured to respect the privacy. Therefore Quality Assurance at both sides is necessary.

Interoperability -2- Document Terms codes concepts Document content Citizen C Medium, time, language etc about a Citizen Document Sender A Culture 1 Language 2 Legal jurisdiction 3 Documents/messages are about a person Security Quality Assurance Receiver B Culture n Language m Legal jurisdiction o Documents/messages can be sent using different media: paper, telephone, fax, USB stick, smart cart, CD-ROM, Internet using various languages, coding systems The document/massage contains: Term: Words like Diagnosis is Diabetes Code: words can be coded. e.g. When Diagnosis=D and Diabetes=123.456 this results in the message D,123.456 Concept: can consist of terms and codes. e.g. Concept=Diagnosis. D=123.456, Date of onset: 01.12.2005,...

Interoperability -3- Document Terms codes concepts Citizen C Uniquely identify, code and publish all items Document Sender A Culture 1 Language 2 Legal jurisdiction 3 Security Quality Assurance Receiver B Culture n Language m Legal jurisdiction o All items in this slide have to be coded uniquely. We need services to register and publish these codes. Unique identification (unique codes) of all persons and entities are needed, including codes for language, jurisdiction, etc, etc Then all these unique codes have to be registered and published.

Interoperability -4- Processes/services are needed to produce, maintain and publish: identify persons and entities, unique codes Document Terms codes concepts Citizen C Processes/services are needed to produce, maintain and publish: identify persons and entities, unique codes Document Sender A Culture 1 Language 2 Legal jurisdiction 3 Security Quality Assurance Receiver B Culture n Language m Legal jurisdiction o Each jurisdiction has to define, produce, maintain and publish: the codes and policies in order to achieve interoperability in that jurisdiction. Processes and services realise this.

Interoperability -5- Processes/services are needed to produce, maintain and publish: identify persons and entities, unique codes Document Terms codes concepts Citizen C Processes/services are needed to produce, maintain and publish: identify persons and entities, unique codes Document Sender A Culture 1 Language 2 Legal jurisdiction 3 Security Quality Assurance Translate and Map Bridge policies Receiver B Culture n Language m Legal jurisdiction o In order to gap differences between contexts (jurisdictions) processes and services are needed that translate, map and bridge policies. Translate: e.g. terms from one language to an other: Dutch: Suikerziekte to English: Diabetes Map: e.g. ICPC code used by GPs to the ICD code used by specialists. 12 -> 8.3.a Bridge Policies: E.g. Recognise privacy methods used in one country in an other. Or recognise the credentials of an healthcare provider in one country in the other. Or recognise certification process in an other country.

e-health Registration process functions ISO Layers: Sufficient? Application Presentation Session Transport Network Data Link Physical Platform 2003 U.S. Department of Veterans Affairs Page 3 The seven ISO/OSI layers are NOT sufficient 32 The ISO layered model has provided significant utility and insight into the separation of concerns and evolution of standards. Though extremely pragmatic in many venues, this model does not provide extreme depth of insight into areas of middleware its impact on application development. It is clear that additional dimensions that are particularly relevant to applications and their development do not fit naturally into the ISO model. The areas introduced here (which are representative and not a complete set) show that the application space must be teased apart using some reference model to better depict the issues inhibiting or enabling interoperability.

e-health Registration process functions ISO Layers: Insufficient! Dynamic (Extensible) Stds-based Semantics Dynamic (Extensible) Semantics Static (closed community) Semantics Middleware, Dynamic-Discovery, Stds Based Middleware, Static-binding, Stds Based Custom/Proprietary Interfaces Application Presentation Session Transport Network Data Link Physical Platform 2003 U.S. Department of Veterans Affairs Page 4 The seven ISO/OSI layers are NOT sufficient 33 The ISO layered model has provided significant utility and insight into the separation of concerns and evolution of standards. Though extremely pragmatic in many venues, this model does not provide extreme depth of insight into areas of middle-ware its impact on application development. It is clear that additional dimensions that are particularly relevant to applications and their development do not fit naturally into the ISO model. The areas introduced here (which are representative and not a complete set) show that the application space must be teased apart using some reference model to better depict the issues inhibiting or enabling interoperability.

e-health Registration process functions Pyramid of Interoperability High Ability to Interoperate Low The seven ISO/OSI layers are NOT sufficient 34 The pyramid demonstrates several interacting components that influence interoperability. The color-temperature scale on the right shows that the peak of the pyramid represents highest interoperability, with minimal interoperability at the base. The left side of the pyramid shows factors influencing information and its ability to carry meaning across systems and organizations. The right side addresses the mechanism of interaction. Note that neither side of the pyramid alone produces interoperability. Though we can improve the mechanisms of interoperability to state of the art technology using standards-based middle-ware and mechanisms such as dynamic discovery, interoperability cannot be achieved unless the corresponding information has semantic meaning. Interoperability is achieved as one scales the pyramid, improving the semantic integrity and understanding of the knowledge, as well as improving the access mechanisms by which that knowledge can be attained. At the peak (but not actually part of the pyramid) is the software application itself. These applications, built upon many or all of the components depicted below it, provide the integrating mechanism by which the component technologies and knowledge come together to provide business value.

e-health Registration process functions Shared Points of Reference Extended ISO/OSI 10- Classifications/Terminologies 9- Documents/Objects,Messages 8- Middleware/Workflow 7- Application 6- Presentation 5- Session 4- Transport 3- Network 2- Data Link 1- Physical 35 Patient Safe communication between communicating parties need common shared points of reference in the complete ISO/OSI stack. Plus three more layers: 8- Workflow, (behaviour of communicating parties) 9- Document structure, Clinical concepts, Archetypes/templates, Clinical protocols,units of Measurement, Data types, etc, etc 10-Classifications, (reference) Terminology's, Vocabularies

e-health Registration process functions Internet Network Internet Network Database Database Internet Network User Trust Trust must be provided by a third party: when communicating parties don t know each other when legal accountability is needed 36 User

e-health Registration process functions Internet Network Internet Network Database Secondary Database Secondary Internet Network Primary Primary User User Primary Services and applications (e.g. sending/receiving system) Secondary (Supporting) services (e.g. Network, PKI, Terminology server, MPI server, Notary services) Primary ICT services consist of several applications owned by an organisation in the sender or receiving system. Secondary (third party) ICT services support the primary services. (e.g. PKI, Master Patient Index File server, Terminology server, Internet, electronic Clearing house) 37

Topics Paradigm shifts Introduction Role of European standards Semantic Interoperability (Extended ISO OSI stack) The EHR related standards - Exchange formats: CEN, ISO, HL7, Dicom - Coding systems: ICD, ICPC, SNOMED, LOINC,... Roadmap for the EHR: Paradigm shifts Conclusions 38

-4- EHR related standards EuroRec Repositories Ontology : Contsys,... Coding System : SNOMED, ICD, ICPC Exchange structure : EN13606, HL7, ISO, Dicom other: - Framework / architecture : CEN: HISA, OMG, IHE-XDS - Security/Safety : ISO: 9000, PKI, PMAC - Devices :CEN/ISO/IEEE 39 Many Shared Points of Reference mean that there must be a way where users and vendors can find the standards, XML schema s and coding systems that play a role around the EHR. As part of the Q-Rec project EuroRec will produce and maintain repositories. A few examples ate given. EN13606 the CEN EHR standards, HL7, ISO and Dicom as exchange structure. I placed CEN System of Concepts for continuity of Care at the level of ontologies. CEN Health Information Services Architecture is a standards on the level of Frameworks and architecures. As are OMG and IHE-XDS. Examples of safety and security related developments are: ISO: Quality Management standards, Public Key Management in Healthcare and Privilege Management and Access Control CEN/ISO/IEEE work on many standards related to medical devices including those related to devices used at the point of care.

-5- Roadmap Internet Network Time Internet Network Database Database Internet Network Trust Space User Context, Community, Culture User Interoperability means transport of information over: Time: Meaning that information stored now must be usable in 25, 50 100 years or longer. This is called real persistance, or archiving. Space: Over large geographical area s crossing institutional boundaries. and Context, Communities, and Cultures: a thing where Europa has developed a lot of expertise and forgotten by the Angol-Saxon worlds

-5- Roadmap Infrastructure advanced standards for representation of clinical concepts Some communication using messages Monolyt Islands PaleoHITic MesoHITic NeoHITic Prototaxic period Over time ICT systems developed from: - Monolytic to - Islands to - Islands with some communication to (Only a few Interoperability problems had to be solved) - Infrastructure. (In this fase a lot of complex Interoperability problems have to be solved)

IT spending 8 % 6 % global impact Utopian era 4 % ad hoc integration regional integration neohitic period Modern era 2 % co-operation between applications mesohitic period Prototaxic era stand alone applications paleohitic period 0 1985 1990 2000 2010 2015 Each era has its distinctive features and costs involved.

-5- Roadmap old fragmented context new structuring context Technical awareness Political awareness Isolated decisions Global direction local drivers - local needs - local vision - local decisions - local solutions - local deployment global drivers - Collective needs - Consultation on the vision - Consensus on the roadmap - Concertation on the solutions - Cooperation on deployment There are differences between the early and utopian eras.

-5- Roadmap Healthcare Community Healthcare process Healthcare support process Quality Organisation Finances People Knowledge/Education Registration Interoperability/standards Control (ICT) Infrastructure European Local Regional National The Utopian era needs agreements and active processes executed by organisations on: - several levels (Healthcare, Supporting processes, Infrastructure), - many topics, - various scales.

-5- Roadmap Transition Management Transition Management Governments EU Commission Public: Rules and Regulations Government Finances Security Healthcare providers Scientific societies (logistics) Public/private: INFO-structure Applications Terminology Actors: Minimal Datasets Archetype the Market GP plus Hospital systems systems Governments Pharmacy systems Protocols... Implementation Standards Norms Public/ private: agreements standards laws implementation specifications CEN National Standardsation Organisation ISO (HL7, DICOM,.. IHE) INFRA-structure Regional National Supra- National Quality Assurance Quality Assurance EU Directives Legislation Q-REC Actors of any roadmap. Government: producing laws and regulations. Setting quality levels for patient/citizen safety. The market actors: - Health care providers - Actors providing INFOstructure services - Application providers - INFRAstructure (service) providers - Standardisation organisations (and implementation producing organisations) - Organisations to assists in Quality Assurance / certification. - And in order to make all behave in an organised way doing the correct things at the correct time: we need a Transition Manager. All actors can play the game following the New Approach Rules.

-5- Roadmap Paradigm shifts Quality Architecture / Framework Plug-and-Play Semantic Interoperability 47

-5- Paradigm shift: Quality Old paradigm: the clever salesman and his trusting looking blue eyes Japanese EHR Project Rejected August 17, 2006 A $50.95 million, Japanese Economy, Trade and Industry Ministry electronic health record project has been abandoned in 14 out of 26 selected municipalities, the Daily Yomiuri Online reports. The EHR system was intended to prevent duplicate tests and medications by letting hospitals and clinics access patients' health records through a computer network. The system also could be used to obtain second opinions. The ministry promoted the project from January 2001 through February 2001 and received applications from 169 municipalities. The ministry provided between $389,000 and $2.76 million to develop EHR software and lease computers and servers for the 26 municipalities it selected. However, some medical societies and hospitals stopped using the system after the ministry ended its financial support for the project after the first year, the Daily Yomiuri Online reports. The Internal Affairs and Communications Ministry in an administrative evaluation said the Economy, Trade and Industry Ministry had not first determined if the system would be viable for 48 The OLD paradigm. Many times people think that the EHR is simple. It is the screen and some database and forget that an EHR capable of patient safe commpunication is very complex. Buyers do not know what to ask for. Sellers do not know what they realistically can offer. Joke: What is the difference between a Car Salesman and an EHR system seller? The care sales man knows that he is lying.

-5- Paradigm shift: Quality Old paradigm: the clever salesman and his blue eyes - No quality criteria for IT in healthcare - No Quality Assurance process (except for medical devices and their software) - the Chinese restaurant around the corner is subjected to more rules and regulations than a hospital information system Imposing quality related requirements from the point of view of patient safety and accountability. Safe, trusted communication is possible only when we can trust or communication partners. A system must provide trust. Essential requirements, standards and quality assurance are indispensable. All must be in place. 49

-5- Paradigm shift: Quality New paradigm: the trusted Salesman, show me, Quality criteria, Trust, Validation, Certification European developments: - EU Commission draft working paper for an intended Recommendation on Semantic Interoperability - Q-Rec: 6th Frame work project: Quality Labelling and Certification of EHR-systems - proposal to extend the Medical Device Directive - include all software used in Healthcare - the complete product life cycle Europe is working to establish systems that provide trust around IT systems. Including Quality Assurance: via Q-Rec Joke: About the car salesman and EHR salesman. The car salesman knows that he is lying. Several privacy related EU Directives are in place.

-5- Paradigm shift: Architecture An EHR system is a complex system of systems with many co-operating services 51 The next paradigm shift. This complex slide is shown to demonstrate that an EHR-system is complex and consists of many services. It is not hardware and software only. Services that, when those EHR-systems start to co-operate, need to be accesses and behave in a predicted way. More integration of systems (and services) will be needed. This means that transparent systems, federated systems, need to be based on the same standard for a Health Information Services Architecture.

-5- Paradigm shift: Architecture Old paradigm: IT systems as islands, each its own architecture and messages Infrastructure advanced standards for representation of clinical concepts Some communication using messages Monolyt Islands Present systems do not have a common services architecture. Message standards connect more or less systems. Completely autonomous systems It is technology from the 80 s. Messages are not a perfect solution. Because it makes Plug-and-play difficult or impossible. PaleoHITic MesoHITic NeoHITic Prototaxic period 52

-5- Paradigm shift: Architecture New paradigm: One shared architecture, Interchangeable components Infrastructure advanced standards for representation of clinical concepts CEN/tc251 HISA EN12967 Monolyt Islands PaleoHITic MesoHITic NeoHITic Prototaxic period 53 Some communication using messages Health Information Services Architecture Systems of the future will have to be based in one common Framework. One common Architecture. One common standard for a SERVICES architecture. Systems will be composed of common service definitions or components. Components can be exchanged. best of breed systems become possible. But, more importantly, systems get predictable behaviour. This is needed for IT of the future and plug-and-play exchange of: DATA, INFORMATION and KNOWLEDGE. CEN/tc 251 wg1 has produced an European Norm: Health Information Services Architecture. It is based on more than 15 years European R&D.

-5- Paradigm shift: Architecture CEN/tc251 EN12967 HISA Health Information Services Architecture 3 part standard - part 1: Enterprise viewpoint - part 2: Information viewpoint - part 3: Computation viewpoint Will be accepted in 2007 Under consideration to become an ISO standard CEN/tc 251 wg1 has produced an European Norm: Health Information Services Architecture. It is based on more than 15 years European R&D. And is deployed in Italy and Denmark in large organisations and regions. And might become the basis for an Open Source Reference EHR-system and Open Source Components. 54

-5- Paradigm shift: Semantic Interoperability Old Paradigm: Message - one size fits all exchange of data, - IT Islands, - problematic scaling, IHE implementation process New Paradigm: Two Level Model (Archetype) - flexible, adaptable exchange of data, information, knowledge, protocols, - federated systems, - plug-and-play The last Paradigm Shift I will present. There are more but there is not enough time to discuss those. The Old paradigm enables exchange of data in messages. Experiences in the UK show that scaling is a problem. Implementation needs substantial resources. Plug-and-play interoperability is impossible. Because a lot of semantics are embedded in system software. In the new paradigm plug-and-play semantic interoperability of not only DATA but Information and Knowledge become possible. 55

Old Paradigm One static representation one size fits all complex world constructed -5- Paradigm shift: Semantic Interoperability With the new paradigm and the standardised tooling and components communities can build what ever they need. A. Lipson 2003LEGO is a trademark of The LEGO Group Suppose the software vendor implements in his system the LEGO blocks.

-5- Paradigm shift: Semantic Interoperability A. Lipson 2003LEGO is a trademark of The LEGO Group The new Archetype paradigm enables to build any model. It is not one size fits all. Suppose the Healthcare community designs Concepts using the LEGO bricks.

-5- Paradigm shift: Semantic Interoperability A. Lipson 2003LEGO is a trademark of The LEGO Group Both the old Message paradigm and the new Archetype Paradigm make the construction of complex worlds possible. Vendors know how to use the LEGO-bricks. Because of this they know how to deal with the concepts the healthcare community is using. Including the Information Models they have constructed. The vendors known how to interpret the blue prints the healthcare providers produced.

-5- Paradigm shift: Semantic Interoperability A. Lipson 2003LEGO is a trademark of The LEGO Group The difference between the old Message and the new Archetype paradigm is that it is the healthcare community that does the building. And not the IT vendor. The vendors know how to deal with the LEGO blocks and the CEN EHRcom European standard based Archetypes definitions. Without the interference by the Software vendor, all possible Information Models can be produced by a community. THIS IS WHAT MAKES PLUG-and-PLAY possible.

-5- Paradigm shift: Semantic Interoperability The clinical discours Phenomena Expertise Knowledge output input output input Documenting system World of HL7 Messages CDISC SPL DATA Human Information World of CEN Documents Documented ISO Statements openehr In healthcare the healthcare providers takes in appearances of phenomena as data. With his expertise and knowledge he interprets the data and makes INFORMATIOn out of it. The data and the Information he registers in documents. When seen again by the same person or sent to an other healthcare provider it is read as data. Messages transport data. HL7 (and therfore CDISC) is originally conceived as message standard and never as document or EHR standard. CEN/tc251 with EN13606 the only EHR norm, that is based on a extensive collection of very detailed requirements. ISO/tc215 TR 13803 The EHR norm (EHRcom) is designed to collect clinical statements in a document. Including versioning, and digital signatures. openehr is an open Source community that has produced the implementation specification of the CEN/tc251 EN13606 EHRcom standard. Plus some more.

In addition the EHRcom norm is simpler, less voluminous than the )over) complex HL7v3 message spec. -5- Paradigm shift: Semantic Interoperability Message paradigm Two Model paradigm EHR requirements based Healthcare ICT vendor Ballot package 147 Mb Zipped Archetype editor Ballot package 6 Mb Zipped EHRcom part 2 EHRcom part 1 61 What is the name for the new exciting paradigm thats make splug-and-play interoperability possible? The Two Level Model or Archetype paradigm. In the Message paradigm People from healthcare and IT meet in for example HL7. They define a message specification that all vendors implement. Hopefully in the same way. And then the healthcare providers are capable to communicate what has been agreed. A problem is that healthcare will change all the time. Each time the complete process will have to be followed: specification,publication, implementation. And since healthcare has 50-100 domains and each with 5-20 messages. Vendors will have a hard time to cope. An extra problem is that must of the semantics of the message specifications will end up in software written for this specific unique specification. In the new Paradigm. Vendors implement ONCE one simple specification. This is part one of the CEN/tc251 EHRcom Norm. Healthcare providers in communities define what they have to store, and exchange using an Archetype Editor (tart 2 of the EHrcom norm, Observe that semantics are completely decoupled. Any change in the specs of archetypes will not affect the application.

Not Plug-and-play (No exchange: Information) No exchange: Knowledge Not EHR requirements based Needs IHE implementation process Solves primarily problems of IT vendors Plug-and-play Exchange: Information Exchange: Knowledge EHR requirements based Doesn t need IHE implementation process Solves problems of Healthcare community Message paradigm Two Model paradigm Healthcare ICT vendor 62 In summary. EHRcom CEN/tc251 EN13606 will play a role in IT of the future. The separation of knowledge and IT has many advantages.

-5- Paradigm shift: Semantic Interoperability CEN/tc251 EN13606 EHRcom: - 5 part standard EHRcom has a recognised International future. - part 1: Reference Model for any Document - part 2: Archetype Reference Model - part 3: Supporting terminology - part 4: Patient Mandate (privacy, patient rights, etc) - part 5: Implementation guide, mapping to HL7v2, HL7v3, extended features of openehr, etc, etc 63 HL7 decided to use openehr to define clinical information models the NHS is slowly changing from the messaging to the Archetype paradigm Australia decided not to use HL7v3 in their infrastructure

-5- Paradigm shift: Semantic Interoperability CEN/tc251 EN13606 EHRcom: - Will become an European standard and National standard in all 25 Member States - Part 1 will become a European standard in 2006 Parts 2,3 and 4 are expected to be accepted in 2007 - Is developed together with Standards Australia. It will become an Australian standard - Will become an ISO International standard EHRcom has a recognised International future. 64

-5- Paradigm shift: Semantic Interoperability EHRcom is designed to be used in Healthcare. What is the difference between a Health record for humans, for animals and an insurrance record, a building report, or a business order?

Paradigms not discussed Workflow - Clinical Pathways Workflow in various types will be have to dealt with. it is the expression of many types of business rules in and between systems - case management, diagnostic and treatment procedures, inclusion/exclusion procedures - patient/person/material/processes flow, - document/messages/data, information workflow And all very flexible and plug-and-play.

Paradigms not discussed Human-computer interaction Human-computer interaction New ways must be explored in stead of the common ugly viewing pipes looking at tables in a database.

Conclusions European standards play a special role in legislation and procurement CEN, ISO, DICOM and HL7 play a role in the production of EHR related standards Quality, Architecture and plug-and-play semantic interoperability will be realised with new exciting paradigms CEN/tc251 makes plug-and-play semantic interoperability possible via: - EN13606 EHRcom and - HISA 69

Questions? Remarks! 70