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eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Extending “Certification of Electronic Health Records” at a Pan-European Level (Prague, 19 February 2009) Georges De Moor, MD, PhD Gent University, Gent, Belgium EuroRec President Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Electronic Health Records (EHR) All stakeholders across the EU have recognized that the Electronic Health Record is: -a key tool in the provision of safe, high quality and effective care ; -and a critical factor for clinical research . Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY EuroRec (http://www.eurorec.org ) • The « European Institute for Health Records » • A European not-for-profit organisation (April 16, 2003) • Mission: the promotion of high quality Electronic Health Record systems (EHRs) in Europe • Federation of National ProRec Centres (incl. all types of stakeholders) Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Established ProRec Centers Austria Belgium Bulgaria Denmark France Italy Germany Ireland Romania Slovenia Spain Slovakia Serbia The Netherlands United Kingdom New applicants: Cyprus Greece Hungary Norway Poland Portugal Sweden “ Differences in languages, cultures and HC-delivery/funding systems ” Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Contacts and Liaison DG INFSO BT and TC 251 TC 215 IHTSDO Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Trends in Health Systems The Old World The New World Provider-focused Patient and family-focused Illness Wellness Site-of-care Continuum of care Episode Management Disease Management Supply Management Demand Management Solitary Decision Making Collaborative, evidence-based decisions Efficiency General care Effectiveness Specialized care (from UHN, Toronto) Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Trends in eHealth systems • Patient-centered (gatekeeper?) and longitudinal (life-long) records • Multi-disciplinary / multi-professional • Transmural and virtual • Structured and coded (cf. semantic interoperability) • Intelligent (cf. decision support) • More sensitive content (e.g. genetic data) Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY The eHealth Contexts In Health and eHealth, the data are delivered from multiple sources using many different communication channels. The data may be used by different types of users for different purposes (e.g.: care, research, management…). Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY EHR systems « The boundaries between EHR systems are fading away… » Settings: primary care, acute hospital care, tertiary care, … Content: summary records, emergency records, discharge records, … Approach: problem-oriented, care pathway-, clinical pathway-oriented, … Context: prevention, diagnostic, therapeutic (care & cure), monitoring, palliation (or combination), research, … Author: medical record (EMR), nursing record, administrative record, patient personal health record (PHR) Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY eHealth Stakeholders Clinicians: care… (access to medical records, e-prescription, care pathways… administrative simplifications !…) Researchers: clinical trials, disease management studies, post-marketing surveillance, health economics… Health Authorities: pharmacovigilance, healthcare management, quality assessment, utilisation review… Data-brokers & industry: Third Party Payers: research, marketing, promotion… billing, reimbursement… Academics: education… IT-vendors: software development Regulators: legislation Patients: their role in the future…? Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Secondary use of (medical) data Patient Clinician TRUST EHR (EMR, EPR…) PHR Privacy Enhancing Techniques Clinical Trials & Research Billing Safety and Adverse Event Registers Prof. Dr. Georges De Moor, MD, PhD Knowledge Mgmt Platforms Marketing Decision Support Systems Healthcare Management Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY EuroRec: History of EC Projects - MediRec (1994-95), Medical Records and Quality - ProRec (1996-98), Promotion Strategy for EHRs in Europe - Widenet (2000-03), Establishing EuroRec’s Network - RIDE (2008-10), Semantic Interoperability (partner) - EHR-Implement (2008-10), Political, Social and Economical aspects when implementing national EHRs systems - QREC (2006-08), Quality Labeling and Certification of EHRs in Europe - EHR-Q-TN (2009-2011), Thematic Network Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY The QREC project: Main Objective To develop formal methods and to create a mechanism for the quality labelling and certification of EHR systems in Europe (in primary- and in acute hospital-care settings) EuroRec Institute was coordinating partner QREC had 12 partners and 2 subcontractors Project duration was 30 months (1/1/2006-30/6/2008) Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Q-REC Rationale (Why Certification is Essential) - To assure the quality of EHR systems: patient safety - Sharing of information requires a quality assessment of EHR products with a view to ensuring interoperability with other systems - Certification of EHRs is essential for both the buyers and the suppliers to ensure that EHR systems are robust enough to deliver the anticipated benefits. (EHR systems and related product quality - data portability and interoperabilityare difficult to judge!) Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY QREC: ORIGIN Several EU-member states (Belgium, Denmark, UK, Ireland,France …) have already proceeded since many years with (EHRs-) quality labelling and/or certification (more often in primary care) but these differ in scope, in legal framework under which they operate, in policies and organisation, and perhaps most importantly in the quality and conformance criteria used for benchmarking … These differences represent a richness but also a risk: harmonisation efforts should help to avoid further market fragmentation in Europe Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY EuroRec’s Central Repository and Tools EuroRec has installed a central repository of « validated » quality criteria and other relevant materials and has developed tools that can be used to harmonise quality labelling, product documentation and procurement specification of EHR systems. EuroRec will not impose particular certification models or specific criteria on any member country but wishes to foster, via authorized channels, the progressive adoption of consistent and comparable approaches to EHR system quality labelling. EuroRec should be considered as a service provider. Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY EHRs Quality Criteria: just a few Business Cases • An e-Health programme wishing to implement quality labelling or certification as to ensure consistent EHR system functionality regionally or nationally • A purchaser wishing to procure an EHR system module • A vendor/developer wishing to document his system or to (re-) develop an EHR system module or wishing to interface a given module of his system across multi-vendor systems Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Benefits for the Stakeholders Industry Market ( R.O.I.) EHRs - Quality Labelling / Certification Quality and Safety Efficiency of HC Delivery Systems Health Services Management Patients, Clinicians Public Health Prof. Dr. Georges De Moor, MD, PhD Health Authorities Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY A growing number of strategic eHealth projects Are or become certification dependent, e.g.: • • • • • • • • Administrative simplification Electronic billing Care pathways and disease management projects Electronic prescription Interaction with validated databases Secure medical data exchange (summary records!) Interoperability, operability and portability ... Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Certification: a powerful weapon… New instruments Authority 4 New functions 3 Physicians 1 € Vendors 2 Pressure Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY How to Manage Certification? EuroRec has Multiple Options: 1. Authority: Government (or mandated subcontr.) vs. Non Gov. 2. Self-certification by Industry (also an option!) 3. National based vs. Pan European (or joint, cf. specific/generic) 4. Mandatory vs. voluntary (with or without incentives) 5. Formal audit/testing vs. self-assessment (or pre-test assessment) 6. Scoring/rating scheme: pass/fail or more graded approach 7. Scheme review rate (1,2,…n year cycles) 8. Quality Assurance vs. Quality Improvement focus Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY EuroRec’s Workflow Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Typology of EHR System Statements • Source Statements/ Referenced Statements (RS) – faithfully extracted from existing original EHR system specifications and test plans – translated if necessary • Fine Grained Statements (FGS) (at present: n>1500) – usually derived from source statements – made more generic, decomposed, reworded, corrected • Good Practice Requirements (GPR) (n~150) – recomposed from FGS into the more common useful building blocks – may enhance or extend the scope of FGS: “push the boat out a bit” • Generic Test Criteria – derived from FGS and/or GPR – formally worded as testable functions Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Methodology for the Repository Design 1. 2. 3. 4. 5. Typology of EHR system statements (the quality criteria) Generic information model for the repository Design of indices (indexing system, ontology) Planning of the repository management workflow Design of web-based user interface requirements • Review of other relevant work of this kind – e.g. HL7, CCHIT, ISO TC/215, academic work Learning from early iterations of statement classification Testing of the pilot repository • • Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Typology of Indexes Multiple indexing of each statement to maximise the likelihood of finding all relevant statements when searching via the indices Business Functions (50 in 8 subcategories) Care Settings (18 in 3 subcategories) Component Types (18 in 4 subcategories) •A0 EHR data (record) management •A2 Administrative services •A00 EHR data entry •A20 Appointments and scheduling •A01 EHR data analysis •A21 Patient consents, authorisations, directives •A02 EHR data content •A22 Patient demographic services •A03 EHR data structure •A23 Certificates and related reporting services •A04 EHR data display •A24 Patient financial and insurance services •A05 EHR data export/import •A3 Care Supportive services •A09 EHR generic data attributes •A30 Supportive care service requests (orders) •A1 Clinical functions Business Functions service reporting (results) Health care enterprises •B0 Generic or ubiquitous •A31 Supportive care•B1 •C3 Directory services •C0 EHRS functional component •A10 Clinical: medication management •A32 Laboratory services •B10 Long-term care (institution) •B01 Regional healthcare network •C30 Directory: patients •C1 EHRS distribution) infrastructure component (specific •A11 Clinical: long-term illness management •A33 Imaging services•B11 General practice •C31 Directory: personnel •C10 EHRS Interoperability component •B02 Virtual or telehealth •A12 Clinical: health needs assessment •A34 Diagnostic and therapeutic services (other): •B12 Secondary care •C32(hospital) Directory: equipment ECG/EEG etc. •C11 Security management component Personal health •A13 Clinical: care planning and care•B03 pathways •B13 Tertiary care centre (specialist hospital) •C33 Directory: health service directories •A35 Pharmacy services •A14 shared care •B04 Community •C2 and Knowledge home care resources •B14 Domain specific •C34 Directory: service resources •A4 Analysis and reporting •C20 Knowledge: terminology •A15 Clinical: alerts, reminders and •B05 decision support Health, wellness and prevention •B15 Profession specific •C35 Third parties •A40 Screening •C21 Knowledge: ontology and preventive health •A16 Clinical: workflow and task management •B06 Occupational health •B2 Secondary uses •C4 Profiling or authoring tool •A41 Care setting reports •C22 Knowledge: archetype •A17 Clinical: patient screening and •B07 preventive services Publiccare health •B20 Research and knowledge discovery •C5 Documentation, support etc. •C23 Knowledge: template Care Settings Component Types Prof. Dr. Georges De Moor, MD, PhD •C24 Knowledge: data set •C25 Knowledge: guideline •B21 Education •C6 EHR system functional component •B22 Health service and planning •C26 Knowledge: algorithm Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Good Practice Requirements - Links Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY EuroRec Languages (non-exhaustive list) • English (default language) • Bulgarian • Danish • Dutch • French • German • Italian • Romanian • Slovakian • Slovenian • Serbian Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY EuroRec Use Tools The EuroRec Composer ™ To compose user defined, re-usable and exchangeable baskets of Fine Grained Statements. The EuroRec Certifier ™ To format a EuroRec Basket content to obtain the basic layer for the certification of EHR systems. This is done by adding structure and attributes to the selected Fine Grained Statements (e.g. mandatory, optional...) The EuroRec Documenter ™ To document EHR systems and their functions, enhancing their understanding and comparability by using the EuroRec statements. The EuroRec Procurer ™ To list and describe, for purchase purposes, required functionalities and product characteristics using EuroRec statements. The EuroRec Scripter ™ To produce and link Test Scenarios to EuroRec Baskets for Certification, Documentation and/or Procurement purposes. Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY EuroRec stakeholders (Users of the EuroRec tools) • National or Regional Healthcare Authorities (quality labelling) • EHR System providers (self assessment/ product documentation) • Health IT purchasers (procurement) • Health IT professional users • Health IT research and education Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY EuroRec Baskets Certifier Composer Procurer Documenter Certification Documentation EuroRec Repository of Statements Procurement Test Criteria Sets Scripter Test Scenarios Test Procedures EuroRec Use Tools Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY EuroRec at your Service ! 1. Developing & maintaining a central repository with quality criteria 2. Developing tools: certification, procurement and product doc. 3. Providing guidance and assistance to all stakeholders 4. Assisting Authorities in introducing / adopting certification 5. Training and accreditation of surveyors (European level) 6. Set-up of certification session (incl. scenario scripting/operations) 7. Validation of clinical archetypes (clinical models) 8. Continous & total Q.A. of processes and procedures Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Certification – Step 1 • Agree - as authority - with the users and suppliers what should be certified. • Select appropriate criteria to be validated during a particular certification session: – initial certification might be comprehensive; – but is later often limited to specific (new/changed) functions. • Use the Indexes and Good Practice Requirements as filters. • If needed, complete the set with new statements (and send to the EuroRec repository). • Result => Basket of Fine Grained Statements Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Certification – Step 2 • Structure the Basket: – Order – Grouping in subsets • Define: – Essential (mandatory) criteria – Optional criteria – Criteria “for later” • Assign weights to individual criteria and/or subsets • Produce certification documentation (for the suppliers & users) Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Certification – Step 3 • Define test scripts • Link to each script a number of FGS / criteria that will be validated by that script • Combine scripts in a test scenario • Link one or more test scenarios to a certification session • Produce certification forms (to be completed during a certification session…) Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 13 mei 2008 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Unveiling the EuroRec Seal • To have a “base” level set of functions that can be accredited across Europe. • This will greatly appeal to the supplier industry and allow for more early stage accreditation of systems across national boundaries. • Harmonisation of the certification will favour harmonisation of products. • Develop a strong, growing and profitable EHR supplier industry that can be competitive globally. Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Content of the Seal (1) • Not all EHR functions can - at present - be harmonised across the European Community: – Specific regulations (incl. HC reimbursement systems); – Linguistic and cultural issues; – Differences in available services (e.g. drug- and other databases in use); – Even sometimes different options regarding evidence based medicine (EBM) issues ! (cf. decision support modules). • First versions of the EuroRec seal & criteria will therefore mainly focus on what is really essential and thus be related to “generic” aspects, e.g. “the trustworthiness of the content of an EHR”. Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Content of the Seal (2) • The first set of selected criteria will: – not be too specific, e.g not related to very particular functions; – correspond with what is considered essential (e.g. security, medication management, ....) • Fair chance that a large number of existing EHR products will conform to the chosen criteria. Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY The GPR with most selected FGS Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY EHR-Q-TN: EuroRec’s new Project Thematic Network on Quality Labelling and Certification of EHR Systems (2009-2011) Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Beneficiaries United Kingdom Austria Belgium Spain Bulgaria Slovenia Croatia Slovakia Cyprus Serbia Czech Republic Romania Portugal Denmark 28 Partners Poland Estonia 25 Countries Norway France Germany Netherlands Luxembourg Greece Italy Hungary Ireland Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Objectives of the EHR Q Thematic Network 1. 2. 3. 4. 5. 6. 7. Validate and Customise the EuroRec criteria on eprescription and patient summaries in 24 countries Database of stakeholders (incl. EHRs vendors) Inventory of legal issues Local coordination & education Annual EHR-QTN International Conferences Five Regional EHR-QTN Conferences EHR-QTN (Mediteranian, Eastern, Central, Western and Nordic regions) In each country one workshop every year on: • Validation of EuroRec Repository (Y1) • Tools for certification, product documentation & procurement (Y2) • Procedures for EHR Quality Labelling and Certification Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Other EuroRec Activities and Services 1. An Inventory of Certification Criteria for EHR systems 2. An Inventory of Standards relevant for EHR systems 3. EHR Archetype validation 4. Open Source Components and XML Schemas 5. EHR Tutorials 6. Register of Health Coding Systems in use in Europe 7. Events Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY The EuroRec Institute is partnering the openEHR Foundation in developing governance practices for archetype development, and the quality criteria and editorial policies by which certified libraries of archetypes can be recognised. As part of the quality labelling and certification of EHR-systems, it may take joint responsibility for the governance of archetypes and templates alongside the openEHR Foundation. Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY What is a Clinical Archetype A clinical archetype is an agreed, formal and interoperable specification for representing a given clinical entity such as a clinical observation, a finding, a plan or a treatment within an electronic health record • • • • invented and maintained by openEHR ratified by CEN: EN 13606 Part 2 being balloted by ISO to be quality labelled by EuroRec Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Patient safety management and the pursuit of evidence based care require computable information that can be linked to and queried by alerting components, decision support and clinical pathway systems. The efficient management of health services and the support of public health and clinical research through audits and population analyses also require EHRs that can semantically be processed. All these purposes of use ideally require that the clinical findings within EHRs are represented and organised consistently across vendor products and communities of use: semantic interoperability. Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY openEHR Semantic architecture Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY When authoring an archetype, additional details need to be provided about each node such as the number of occurrences that are permitted within instances of EHR data, the terminology values that may be used, numeric ranges and measurement units. Schematic diagram of an archetype for adverse reaction (to medication) Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Messages: “an older way to support semantic interoperability” • Enterprise viewpoint will contain the use case, i.e. the standardised work process; • Information viewpoint contains the Message Information Model; • Computational viewpoint is about the choreography of messages in the interaction schemas; • Engineering viewpoint is the level where the XML schema is defined. Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Archetypes and Templates Archetypes and templates can play a key role in semantic interoperability. Archetypes define what is maximally documented in the world about a specific health record entity. An archetype defines a data structure, including optionality and multiplicity, data value constraints, and relevant bindings to natural language and terminology systems. Templates define what in a specific context at a specific point in time, will be stored, retrieved, presented, exchanged and archived. In part, clinical meaning within an EHR will be expressed through the structure of the archetype/template, and in part the meaning will be expressed through codes from coding systems Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Archetypes and Templates A way to view this metaphorically is: • codes are the words in a dictionary; • the structure of the archetype/template is the grammar; • with both codes and archetypes sentences can be formed that make or do not make sense; • but archetypes define what makes sense; • and templates define what makes sense in a specific context. Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY To support semantic interoperability clinical archetypes need to be shared and used consistently by EHR system vendors and their users, so that the EHR data they create is consistently organised. Archetypes therefore need to be shared and managed as a common knowledge asset, and incorporated into the design of clinical applications, rather like a terminology system. Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Given that many archetypes may be needed to cover a given domain, it is also important for them to be mutually consistent and bind to terminology systems in appropriate and consistent ways. This is necessary in order to minimise the diversity of ways in which a given kind of EHR data might be represented. Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Clinical archetypes need to be quality assured, since they will direct the ways in which clinical data are captured, processed and communicated. It is important that the design of individual archetypes is an accurate and faithful reflection of good practice for the clinical disciplines in which each of them might be used. They need to be optimally designed for their purpose, and considered trustworthy within their intended communities of use. Large and comprehensive sets of archetypes are needed that cover whole clinical domains in a systematic and inclusive way, catering for the inevitable diversity of use cases and users but helping to foster consensus and best practice. For these to be endorsed by health systems, implemented by vendors and trusted by end users, these archetypes need to be quality assured and to be published and maintained by reliable certified sources. Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Some Conclusions • Certification is a powerful weapon: use it! • Continuity of certification should be guaranteed (a credibility issue) • Efficiency: do not (re-)invent the wheel • Take advantage of the growing EuroRec repository and of the broadening certification scope (e.g. EHRs in other settings and other eHealth applications) • Align choices & strategies with European and International ones (cf. standards, clinical models and coding systems ...) • Professionalize the certification procedures • Build a long term, incremental and consistent certification roadmap which is in harmony with your overall healthcare strategy • ...EuroRec is your partner and is at your service ! Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009 eHEALTH FOR INDIVIDUALS, SOCIETY AND ECONOMY Welcome to our next EuroRec Annual Conference Sarajevo (Sept 2, 2009) in conjunction with MIE 2009 (http://www.eurorec.org) The topics of the Conference are: - Quality labeling of EHR systems Secondary use of health data PHR (Patient Health Records) Clinical models and Archetypes www.mie2009.org Prof. Dr. Georges De Moor, MD, PhD Prague, 19.02.2009