Convergence and the eHealth Interoperability Framework Benoit Abeloos DG Communications Networks, Content and Technology European Commission Unit, Health and Well-being Brussels, 20 March, 2013

Interoperability in the EC policy agenda Action 77: Foster EU-wide standards, interoperability testing and certification of eHealth systems by 2015 through stakeholder dialogue Digital Agenda for Europe Formal, voluntary network of MS under Directive on patients’ rights in cross-border healthcare Advisory body on eHealth issues including interoperability and standardisation eHealth Network eHealth Action Plan 2012-2020 eHealth Action Plan Connecting Europe Facility Large scale deployment of Digital Services Part of the Multi Annual Financial Framework proposal CEF Regulation in co-decision

Towards a single digital market in 2020 The need for an eHealth Interoperability Framework CEF Source: Digital Agenda for Europe (http://ec.europa.eu/information_society/digital-agenda/ )

Phase II of eHealth Interoperability Framework study eHealth EIF Phase I eHealth EIF Phase II Jan June July Dec 2013 Workshop Study report including the methodological approach 1 The vision on the eHealth European Interoperability Framework (EIF) (including the legal, semantic, organisational and technical levels) 2 An assessment framework to assess profile development organisations and individual profiles 3 A first proposal for the population of the technical level of the eHealth EIF 4 4

Vision on eHealth EIF structure Governance Interoperability Levels High-Level Use Cases Legal Interoperability Organisational Interoperability Use case 1 Principles Interoperability Agreements Use case 2 Semantic Interoperability Technical Interoperability ...

Vision on technical interoperability eHealth European Interoperability Framework International base standards and profile development Use Case A Profile 1 Profile 2 Profile 4 Profile 1 Use Case B Profile 1 Profile 3 Profile 4 Base Standard 1 Profile 2 EU Cross-Border deployment under the CEF Base Standard 2 (Extensions) Use Case A1 Profile 1 Profile 2 Profile 4 Specific Profile Base Standard 3 Profile 3 Base Standard 4 National/Regional eHealth Interoperability Project (Extensions) Use Case A2 Profile 1 Profile 2 Profile 4 Specific Profile Base Standard 5 Profile 4 Local (e.g. Hospital) eHealth Interoperability Project (Extensions) Use Case B1 Profile 1 Profile 2 Profile 4 Specific Profile

The PDOs in scope for this study were IHE and Continua IHE and Continua are international organizations developing and testing (technical) interoperability specifications in eHealth. They represent organizations which have a good market penetration. IHE and Continua IHE has developed a use case based methodology which is being endorsed by the ISO: ISO TR28380 IHE Global Standards Adoption Process. History: M403 was already going to work on epSOS, hospital and telehealth use cases. IHE and Continua profiles used in some national frameworks Note A profile combines and refines the use of a set of base standards to address a specific technical use case A technical use case is a description of sequences of technical events that, taken together, lead to a system doing something useful Note: PDO = Profile Development Organisation

The selected list of ten use cases covers a relevant excerpt of medical care provision Cross-border Level Medical care provision National / Regional Level UC 1 - Pharmacy Citizens at home & on the move Inpatient medical care provision Medical care provision UC 2a/ 2b - Primary care physician - PC-based Care Mgt. - Pharmacy - Hospital IIIa RIS LIS UC 8 UC 5a - Medical Specialist - Primary care physician UC 6 UC 7 - Mobile-based Care Mgt. UC 5b - Hospital I UC 9 - Medical Specialist RIS LIS - Hospital IIIb - Sensor-based Care Mgt. - Rehabilitation - Hospital II UC 3 + UC 4 UC 10 (2 hospital locations affiliated to same hospital mgt. organization) - Rehabilitation

Organisational criteria The assessment framework is based on Annex II of the Regulation on European Standardisation Annex II of Regulation of European Standardisation Organisational criteria Technical Specification criteria Category ‘Type of organisation’ Category ‘Market Acceptance’ Category ‘Openness’ Category ‘Coherence ’ Category ‘Consensus’ Category ‘Availability’ Category ‘Relevance and Effectiveness’ Category ‘Transparency’ Category ‘Neutrality and Stability’ Category ‘Maintenance’ Category ‘Quality’ Category ‘Intellectual property rights ’

Conclusions of the study IHE No major non compliance Rooms for improvements Continua: Original non compliances on transparency, openness and consensus Continua Board approved changes in their process in Dec 2012 This will affect future specifications only

Governance of eHealth EIF eHealth Network (MS, EC) CEF Governance (MS, EC, industry) eHealth Stakeholders Group From 2012, permanent From 2014, permanent eHealth Governance Initiative ICT standards multi-stakeholders platform (MS, EC, others) Until 2014, project based From 2013, permanent eHealth standards eGov standards Internet standards Other ICT standards eHealth EIF project 7 IHE profiles were submitted to the ICT MSP in Feb 2013

The eHealth EIF study is only the start of a process to populate the eHealth EIF Receiving feedback Review by Commission, MS and stakeholders New insights Identification of specs by ICT MSP Update of eHealth EIF

The next step is to populate the semantic level Convergence between EU initiatives is needed…

Thank you! Benoit Abeloos: benoit.abeloos@ec.europa.eu

Backup slides

Use cases list Nr Level Use case 1 Cross-border epSOS project : e-Prescription and e-Dispensation for cross-border information sharing for citizens travelling in Europe   2a epSOS project : patient summaries for cross-border information sharing for citizens travelling in Europe 2b epSOS project - patient having access to his or her patient summary. 3 National/Regional Request and results (imaging results, diagnostic examinations) sharing workflow for radiology in inter-hospital setting on national/regional scale 4 Request and results (laboratory reports, test results) sharing workflow for laboratory in inter-hospital setting on national/regional scale 5a Cross-Enterprise Sharing of Medical Summaries IHE Integration Profile: Ambulatory Specialist Referral 5b Cross-Enterprise Sharing of Medical Summaries IHE Integration Profile: Acute Care Discharge to Ambulatory Care Environment 6 Intra-Hospital Request and results (imaging diagnostics tests) distribution workflow for radiology in intra-hospital setting 7 Request and results (clinical laboratory tests) sharing workflow for laboratory in intra-hospital setting 8 Citizens at home and on the move. Involvement of patient in documentation of his/her specific chronic disease and making it available via PC or web based applications to healthcare provider (e.g., diabetes, CVD, COPD, hypertension) 9 Involvement of patient in documentation of his/her specific chronic disease and making it available via mobile monitoring devices and mobile phones to healthcare provider (e.g., diabetes, CVD, COPD,…) 10 For ever-present care outside conventional care facilities, involving the interoperability necessary from sensor devices to monitor activity, e.g. of elderly people