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The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
The Eurorec repository of Functional EHR Requirements - Gerard Freriks
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The Eurorec repository of Functional EHR Requirements - Gerard Freriks

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  • 1. EHR-Qᵀᴺ Polska 2012 The Eurorec repository of Functional EHR Requirements (Lodz, 29 November 2012) Gerard Freriks EuroRec2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 2. EHR-Qᵀᴺ Polska 2012 Gerard Freriks • Trained as General Practitioner • Health IT since 1971 • ProRec-NL board meber • former convener of CEN/tc251 WG1 • former EuroRec Board Member • EN13606 Association Board Member • ERS B.V. Director2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 3. EHR-Qᵀᴺ Polska 2012 Topics – EHR and ISO RM/ODP Viewpoints – EuroRec Association – EHR Functional Requirements • Repository • Tooling – Implementations – Conclusions2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 4. EHR-Qᵀᴺ Polska 2012 Topics – EHR and ISO RM/ODP Viewpoints – EuroRec Association – EHR Functional Requirements • Repository • Tooling – Implementations – Conclusions2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 5. EHR-Qᵀᴺ Polska 20122012 - Gerard Freriks, EuroRec, ProRec.nl
  • 6. EHR-Qᵀᴺ Polska 2012 MIE2012 - Village of the Future M. Rigby/J. Hofdijk2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 7. EHR-Qᵀᴺ Polska 2012 Electronic Health Records (EHR) All stakeholders across the EU have recognized that the Electronic Health Record is: -a key tool for the documentation of the provision of safe, high quality and effective care; -and a critical factor for clinical research.2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 8. EHR and standards HISA 13606 Continua ... PMAC ... ContSys ... SNOMED WHO LOINC ... SemanticHealthNet Dipak Kalra 8© EN13606 Association
  • 9. EHR - Privacy ACL Trust ACL ACL Flexibility ACL ACL ACL 9© EN13606 Association
  • 10. EHR-Qᵀᴺ Polska 2012 Common Trusted Facilities2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 11. EHR-Qᵀᴺ Polska 2012 Trust FUNCTIONAL Requirements Payload Semantic Stack Web Services C++, Java, ... Windows, Linux Hardware Platforms2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 12. EHR-Qᵀᴺ Polska 2012 Topics – EHR and ISO RM/ODP Viewpoints – EuroRec Association – EHR Functional Requirements • Repository • Tooling – Implementations – Conclusions2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 13. EHR-Qᵀᴺ Polska 2012 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)2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 14. EHR-Qᵀᴺ Polska 2012 Austria Established ProRec Centers Belgium Bulgaria Denmark France Cyprus Italy Czech Republic Germany Greece Ireland Hungary Romania Norway Slovenia Poland Spain Slovakia Serbia The Netherlands United Kingdom “ Differences in languages, cultures and HC-delivery/funding systems ”2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 15. EHR-Qᵀᴺ Polska 2012 eHealth StakeholdersClinicians: 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: research, marketing, promotion…Third Party Payers: billing, reimbursement…Academics: education…IT-vendors: software developmentRegulators: legislationPatients: their role in the future…?2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 16. EHR-Qᵀᴺ Polska 2012 Secondary use of (medical) data Patient TRUST Clinician PHR EHR (EMR, EPR…) Privacy Enhancing Techniques Clinical Trials Billing & Research Safety and Marketing Adverse Knowledge Event Decision Healthcare Mgmt Support Management Registers Platforms Systems2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 17. EHR-Qᵀᴺ Polska 2012 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 aspectswhen implementing national EHRs systems- QREC (2006-08), Quality Labeling and Certification of EHRs in Europe- EHR-Q-TN (2009-2011), Thematic Network- Antilope (to start 2012- 2014)-...2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 18. EHR-Qᵀᴺ Polska 2012 Topics – EHR and ISO RM/ODP Viewpoints – EuroRec Association – EuroRec EHR Functional Requirements • Repository • Tooling – Implementations – Conclusions2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 19. EHR-Qᵀᴺ Polska 2012 Rationale (Why Certification is Essential) – Assure compliance to national rules and standards. – Increase quality of the products through coherent and pre-tested functionality. – Leverage exchange of health (care) related data and interoperability of systems. – Improve patient safety in care. – Have a reliable data source for secondary use.2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 20. EHR-Qᵀᴺ Polska 2012 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 systems2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 21. EHR-Qᵀᴺ Polska 2012 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 Health Authorities Public Health2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 22. EHR-Qᵀᴺ Polska 2012 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 • ...2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 23. EHR-Qᵀᴺ Polska 2012 Certification: a powerful weapon… New instruments New functions 4 3 1 € 2 Pressure2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 24. EHR-Qᵀᴺ Polska 2012 How to Manage Certification? EuroRec has Multiple Options: 1. Authority: Government (or mandated subcontr.) vs. Non Gov. 5. Self-certification by Industry (also an option!) • National based vs. Pan European (or joint, cf. specific/generic) • Mandatory vs. voluntary (with or without incentives) • Formal audit/testing vs. self-assessment (or pre-test assessment) • Scoring/rating scheme: pass/fail or more graded approach • Scheme review rate (1,2,…n year cycles) • Quality Assurance vs. Quality Improvement focus2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 25. EHR-Qᵀᴺ Polska 2012 “National” Certification in Europeure compliance to national rules and standards.rease quality“national”products through coherent and pre-tested functiona •Existing of the certificationerage exchange of health (care) related data and interoperability of syst • Foreseen within 1-2 yearsprove patient safety in care. • Consideredve a reliable data source for secondary use. 2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 26. EHR-Qᵀᴺ Polska 2012 Applicable standards Stakeholder Applicable ISO/IEC Standard Accreditation Body ISO/IEC 17011:2004 ISO 9000:2000 ISO/IEC 17000:2004 VIM:1993 Certification Body ISO/IEC Guide 65 Conformity Assessment Body ISO/IEC 17025:20052012 - Gerard Freriks, EuroRec, ProRec.nl
  • 27. EHR-Qᵀᴺ Polska 2012 Recommendations by the EHR-QTN Consortium2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 28. EHR-Qᵀᴺ Polska 2012 Belgrade Recommendations by the EHR-QTN Consortium “ If quality labelling and certification of EHR systems is to become generalised, then it needs endorsement at the highest competent levels e.g. by the EU Commission, the responsible Member States Ministries, the Healthcare Providers Organisations and the specialised industry.” See the Belgrade Declaration on www.eurorec.org2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 29. EHR-Qᵀᴺ Polska 2012 Belgrade Recommendations by the EHR-QTN Consortium (summary) 1. Create and harmonise the legal and regulatory framework stimulating national and regional authorities to enforce the use of quality labelled and certified applications. 2. Certification bodies should be accredited and compliant to international standards, more precisely ISO 17020. • Strengthen the European scale pioneering initiatives (EuroRec / I.H.E.) in order to keep certification on the agenda and invest in maintenance and expansion of the actual descriptive statement and profiles. • Address the issue of personnel shortage in health informatics in general and more specifically in health informatics quality assessment.2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 30. EHR-Qᵀᴺ Polska 2012 Belgrade Recommendations by the EHR-QTN Consortium (summary) 5. Third party assessment is the most suitable procedure for quality labelling and certification in the still immature market of the EHR systems. 6. The incentivised model seems the most promising, surely for self- employed healthcare professionals. • Promote equivalence of certificates across Europe by validating at European level both the functional descriptive statements of EuroRec and the IHE profiles. • Consider the possibility to create a cross-border “Register of Quality Labelled or Certified Clinical Software”, offering information about the products and documentation about the certification process.2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 31. EHR-Qᵀᴺ Polska 2012 Topics – EHR and ISO RM/ODP Viewpoints – EuroRec Association – EuroRec: EHR Functional Requirements • Repository • Tooling – Implementations – Conclusions2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 32. EHR-Qᵀᴺ Polska 2012 EuroRec’s Workflow2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 33. EHR-Qᵀᴺ Polska 2012 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>1700) – 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 functions2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 34. EHR-Qᵀᴺ Polska 20122012 - Gerard Freriks, EuroRec, ProRec.nl
  • 35. EHR-Qᵀᴺ Polska 2012 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 •B0 Generic or ubiquitous •A31 Supportive care •B1 Health care enterprises service reporting (results) •C3 Directory services •C0 EHRS functional component •A10 Clinical: medication management Regional healthcare network •B01 •A32 Laboratory services Long-term care (institution) •B10 •C30 Directory: patients •A11 Clinical: long-term illness management •C1 EHRSdistribution) component (specific infrastructure services •A33 Imaging •B11 General practice Directory: personnel •C31 •B02 Virtual or telehealth •A34 Diagnostic component •A12 Clinical: health needs assessment •C10 EHRS Interoperability and therapeutic services (other): ECG/EEG etc. •B12 Secondary care (hospital) equipment •C32 Directory: •A13 Clinical: care planning and care•B03 Personal health Security management component pathways •C11 •A35 Pharmacy services Tertiary care centre (specialist hospital) directories •B13 •C33 Directory: health service •A14 shared care •B04 Community •C2 Knowledge resources and home care •B14 Domain specific Directory: service resources •A4 Analysis and reporting •C34 •A15 Clinical: alerts, reminders and decision support •C20 Knowledge: terminology •B05 Health, wellness and preventionBusiness •B15 Profession specific •C35 Third parties •A16 Clinical: workflow and task management •C21 Knowledge: ontology and preventive health •B06 Occupational health •A40 Screening •B2 Secondary uses Profiling or authoring tool •C4Functions •C22 Knowledge: archetype reports •A17 Clinical: patient screening and preventive care services •B07 Public health •A41 Care setting •B20 Research and knowledge discovery •C5 Documentation, support etc. •C23 Knowledge: template •B21 Education •C6 EHR system functional component •C24 Knowledge: data set Care Settings •C25 Knowledge: guideline •B22 Health service and planning •C26 Knowledge: algorithm Component Types2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 36. EHR-Qᵀᴺ Polska 2012 Good Practice Requirements - Links2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 37. EHR-Qᵀᴺ Polska 20122012 - Gerard Freriks, EuroRec, ProRec.nl
  • 38. EHR-Qᵀᴺ Polska 2012 EuroRec Languages (non-exhaustive list) • English (default language) • Bulgarian • Danish • Dutch • French • German • Italian • Romanian • Slovakian • Slovenian • Serbian2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 39. EHR-Qᵀᴺ Polska 20122012 - Gerard Freriks, EuroRec, ProRec.nl
  • 40. EHR-Qᵀᴺ Polska 2012 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.2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 41. EHR-Qᵀᴺ Polska 2012 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 education2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 42. EHR-Qᵀᴺ Polska 2012 Composer EuroRec Baskets EuroRec Repository Certifier of Procurer Documenter Statements Certification Documentation Procurement Test Criteria Sets Scripter Test Test Scenarios Procedures EuroRec Use Tools2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 43. EHR-Qᵀᴺ Polska 2012 EuroRec at your Service ! 1. Developing & maintaining a central repository with quality criteria 7. Developing tools: certification, procurement and product doc. • Providing guidance and assistance to all stakeholders • Assisting Authorities in introducing / adopting certification • Training and accreditation of surveyors (European level) • Set-up of certification session (incl. scenario scripting/operations) • Validation of clinical archetypes (clinical models) • Continous & total Q.A. of processes and procedures2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 44. EHR-Qᵀᴺ Polska 20122012 - Gerard Freriks, EuroRec, ProRec.nl 13 mei 2008
  • 45. EHR-Qᵀᴺ Polska 2012 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.2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 46. EHR-Qᵀᴺ Polska 2012 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”.2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 47. EHR-Qᵀᴺ Polska 2012 Content of the Seal • 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.2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 48. EHR-Qᵀᴺ Polska 2012 The GPR with most selected FGS2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 49. EHR-Qᵀᴺ Polska 2012 Topics – EHR and ISO RM/ODP Viewpoints – EuroRec Association – EHR Functional Requirements • Repository • Tooling – Implementations – Conclusions2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 50. EHR-Qᵀᴺ Polska 2012 Seals United Kingdom Austria Belgium Spain Slovenia Bulgaria Croatia Slovakia Cyprus Serbia Czech Republic Romania Portugal 23 EuroRec Denmark EHR-Q TN Poland Quality Seals Estonia 28 Partners Norway France 25 Countries Netherlands Germany Luxembourg Greece Italy Hungary Ireland2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 51. EHR-Qᵀᴺ Polska 20122012 - Gerard Freriks, EuroRec, ProRec.nl
  • 52. EHR-Qᵀᴺ Polska 2012 Topics – Introduction Semantic Interoperability – Introduction EHR – EHR and Quality • Functional quality • EuroRec Quality Labeling – Conclusions2012 - Gerard Freriks, EuroRec, ProRec.nl
  • 53. EHR-Qᵀᴺ Polska 2012 Conclusions - EuroRec provides: • European Functional requirements at the Enterprise level • Tooling support • Quality Labeling • 23 Seals awarded – Adopt the Belgrade Declaration2012 - Gerard Freriks, EuroRec, ProRec.nl

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