1. EU E H EALTH INTEROPERABILITY, STANDARDIZATION AND DEPLOYMENT STRATEGY Benoit Abeloos, Standardization and Interoperability DG CNECT, Health and Wellbeing Unit Workshop on Sensor Communications & Technologies, BAN, e-Health Services and Standardization 4 April 2014

2. Directive on the application of patients’ rights in cross-border healthcare Regulation on European Standardization Digital Agenda for Europe: Action 75: Give Europeans secure online access to their medical health data and achieve widespread telemedicine deployment Action 76: Propose a recommendation to define a minimum common set of patient data Action 77: Foster EU-wide standards, interoperability testing and certification of eHealth eHealth Action Plan Achieving wider interoperability of eHealth Services Facilitating uptake and ensuring wider deployment of eHealth European Innovation Partnership in Active and Healthy Ageing Medical Devices Directive, being revised Policy drivers

3. Towards a single digital market in 2020 Source: Digital Agenda for Europe (http://ec.europa.eu/information_society/digital-agenda/ )http://ec.europa.eu/information_society/digital-agenda/

4. eHealth Governance The eHealth Network: Article 14 of Directive on the application of patients’ rights in cross-border healthcare Voluntary network of national authorities in charge of eHealth to Cooperate on sustainable economic and social benefits of European eHealth systems (interoperability, trust and security, quality & continuity of care, patient safety) Draw up guidelines on Patient Summary (adopted Nov 2014) and ePrescription Develop eID and authentication measures eHealth Governance initiative Prepares the work for the eHealth Network Experts, multi stakeholders, focused on MS eHealth Stakeholders' Group SDOs, patients, health care providers, SMEs, industry,…

5. European Innovation Partnership on Active & Healthy Ageing The first attempt to bring together interested parties from public and private sectors to deliver innovative solutions for an ageing society What?

6. 6 EIP-AHA: Public Consultation Standards uptake is key...

7. Standardization regulation and MSP Establishes the ICT standards multi-stakeholders platform composed of Member states – min in charge of standards ESO – CEN, CENELEC, ETSI International SDOs: ISO, IEC, ITU De facto SDOs: OASIS, IEEE, IETF, W3C, GS1, ECMA, OMG… Consortia: Digital Europe, OpenForumEurope,… Advises on identification of ICT technical specifications Based on criteria in annex II of the regulation: Openness, Transparency, Consensus, Maintenance, availability, IPR, relevance, neutrality and stability, quality

8. 8 Interoperability Levels Principles Interoperability Agreements Governance Legal Interoperability Organisational Interoperability Semantic Interoperability Technical Interoperability Achieving wider interoperability of eHealth services The eHealth Interoperability Framework was defined in a study ( http://ec.europa.eu/digital-agenda/en/news/ehealth-interoperability-framework-study-0 )

9. Instruments Standardization Mandates with EU SDOs H2020 Work Program–eHealth Interoperability-PHC34 Connecting Europe Facility Large scale deployment of interoperable cross border services eHealth in 2015 Identification of technical specifications eHEIF study Submission of IHE specifications – ongoing

10. EU Cross-Border eHealth Interoperability Project Profile 1 Profile 2 Profile 4 Vision of eHealth EIF 10 International base standards and profile development Base Standard 1 Base Standard 2 Base Standard 3 Base Standard 4 Base Standard 5 Profile 1 Profile 2 Profile 4 Profile 3 eHealth European Interoperability Framework: EU Recognised profiles B-Use Case A B-Use Case B Profile 1 Profile 2 Profile 4 Profile 1 Profile 3 Profile 4 Profile 1 Profile 2 Profile 4 B-Use Case A1 Specifi c Profile (Extensions) National/Regional eHealth Interoperability Project Profile 1 Profile 2 Profile 4 Profile 1 Profile 2 Profile 4 B-Use Case A1 B-Use Case A2 Specifi c Profile (Extensions) Local (e.g. Hospital) eHealth Interoperability Project Profile 1 Profi le 2 Profile 4 Profile 1 Profile 2 Profile 4 B-Use Case A1 B-Use Case B1 Specifi c Profile (Extensions) (Note: B-Use Case = Business Use Case)

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

12. The EIF is a process 12 Review by eHealth Governance Initiative Review & decision by eHealth Network Update of eHealth EIF Acerta’s Data Governance Framework New insights Receiving feedback eHealth EIF project

13. Ongoing initiatives epSOS Large scale pilot – 13 nations piloting Ends in June 2014 Interoperability Framework based on international standards and IHE profiles Extensions for cross border exchange of health data (IHE) Published open source components EXPAND eHealth Governance Initiative eHR4CR – IMI – Conference on April 9 SemanticHelathNet – NoE Discussions with IHTSDO for the use of SNOMED

14. The Antilope project Refining the eHealth Interoperability Framework Further defining the high level use cases Adoption and take up of standards and profiles for eHealth Interoperability (DAE action 77) Main target dissemination target: procurers and (consequently) vendors Defining a quality assurance model for interoperability testing Identifying and addressing gaps in testing tools Defining an IOp Label and certification process Validating scalability to EIP and adoption

15. A MoU (signed in Dec 2010 by EC VP N. Kroes and US Secretary of Health K. Sebelius) aims to foster a mutual understanding of the common challenges The Trans-Atlantic Economic Council (TEC) of Nov. 2011 reinforced commitment to the MoU Two issues identified of having immediate importance: Development of international interoperability standards and specifications for eHR Strategies for development of skilled health IT workforces A commonly agreed roadmap was published on 20 June 2013 – it needs to be updated eHealth Forum 2014, Athens, May 12-14: EU-US workshop The Trillium Bridge (www.trilliumbridge.eu) project is supporting this effort End result could be a standardization project The EU-US roadmap and the Trillium Bridge project

16. Thank you! ec.europa.eu/digital-agenda/ehealth @EU_ehealth @EU_ehealthweek EU.ehealth Ehealthweek.eu Benoit Abeloos: benoit.abeloos@ec.europa.eu