What's next after epsos has entered into operational mode? From records to new Horizons Sofia, 13/02/2014

ehealth for Smart and InclusiveGrowth 2020 What's next after epsos has entered into operational mode? From records to new Horizons Sofia, 13/02/2014 Marcello Melgara Lispa / Regione Lombardia DG Health

epsos in Pils epsos Consortium is composed by 48 beneficiaries from 26 States: Austria, Belgium, Croatia, Czech rep., Denmark, Estonia, Finland, France, Greece, Hungary, Germany, Italy, Latvia, Luxembourg, Malta, Netherland, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, Turkey + Industry Team (~45) 15 Observers: Bulgaria, Iceland, Lithuania, Serbia,, + USA e Canada = Total 40 Nations Coordinator: SALAR (Swedish Association of Local Authorities and Regions) From 01.07.2008 to 30.06.2014 2

Goals & Challenges In preparation and application of: EU Directive on Patient Cross-border Mobility (April 2011) Goal for the epsos ehealth Project: to develop a practical ehealth framework and ICT infrastructure [based on existing national infrastructures] that will enable secure access to patient health information, particularly with respect to a basic patient summary and eprescription, between European health care systems Challenges to get there: harmonize 26 Health Care systems Legal Interoperability Organisational Interoperability Semantic Interoperability Technical Interoperability Basic Use Cases: Patient Summary interoperability epresciption / edispensation interoperability Patient Access 3

From a Portuguese Patient Summary 4

to an Italian Patient Summary 5

epsos Infrastructure PoC NCP PoC NCP epsos INTEROPERABILITY NCP NCP PoC PoC PoC PoC PoC PoC PoC The interoperability Infrastructure is based on peer-to-peer network of National Contact Point 6

epsos Service Model 7

Pilot Setting Sails Athens, 08/11/2011: IT- ep dispensed in a Greek pharmacy April 2012: AT, CZ, ES, FR, IT and GR During 2013: PT, CH, DK, SE, EE, FI, MT, SI, HR, HU Passed Projectathon: DE, SK, TR

Pilot Setting Sails Desenzano, 20/12/2013: 1 full loop: Estonian citizen in Desenzano forgot Medication @home. He gave the consent from remote via mobile phone The HP looked into the PS, found the medicinal And made a prescription

Pillars to Interoperability Hardest... Legal Interoperability: Trust / Privacy / Consent management Security: different adoption of EU directive Organisational: Health Care systems / Health Professional roles Document meaning and minimum/maximum information Terminologies: Transcoding among International Coding Systems Syntax: Common document based on CDA -2 L3 / L1: Messages / data exchange: IHE X* profiles Identification of Patients, Authentication of Health Professional... Easiest 10

From Record to Endurance Make things easier and natural as crossing borders in Europe Support creation of ehealth Eco-system across Europe and beyond Generalised / uniform adoption of EU Directives Creation of ehealth Services at National level Creation of market opportunities for Vendors Build sustainability Convergence of Technical specs to International Standards Liaising with Standardisation Bodies for Specs maintenance Simplify process to extend trust to new (Member) States Deliver Open Source platform / foster creation of OS Community Build semantic interoperability through centralised / distributed liability Adopt identification process that does not require centrally managed configuration 11

epsos Circle of Trust A structure of Contracts mutually recognised to control the application of common rules and procedures for security, primacy Robust definition of roles of Data Controller / Data Processor related to the purpose of data processing Continuous relation with National DPAs and WG Article 29 Careful analysis and application of rules for Consent Management Security, privacy and organisational Audits EU level- federating countries epsos Practice Standards National level- federating organisations National level Framework Agreements - To establish the NCP - To establish NCP-pilot partners relation 12

end-2-end Security Assure the required level of Security, Integrity, non-repudiation: VPN based on SHA-2 Certificates, issued by TLS EU fully compliant CA Encripted and signed messages No data stored in NCP Audit trail for every transactions Trust Zone III Trust Zone I Trust Zone IV Trust Zone I Trust Zone III National Infrastructure epsos Services NCP Gate way Trust Zone II DMZ Web Service Proxy epsos Central Service Public Network (e.g. Internet) Web Service Proxy Trust Zone II DMZ NCP Gate way epsos Services National Infrastructure PoC Packet Filter Packet Filter Packet Filter Packet Filter end-to-end (node/country level) end-to-end (NCP-2-NCP message exchange level) end-to-end (business transaction and object lifecycle level) 13

Adoption of IHE / HL7 profiles NCP-B (country of care) epsos Identification Service consumer XCPD Initiating Gateway ATNA, XUA, BPPC, etc. Demographics Query NCP-A (country of affiliation) epsos Identification Service provider XCPD Responding Gateway epsos Patient Service consumer XCA Initiating Gateway epsos Order Service consumer Cross-Gateway Query with Returned Documents epsos Patient Service provider XCA Responding Gateway epsos Order Service provider epsos Patient Service consumer XCF Initiating Gateway epsos Order Service consumer Cross-Gateway Fetch with Returned Documents epsos Business Document Provider XCF Responding Gateway epsos Dispensation Service consumer XDR Document Source epsos Consent Service consumer Provide and Register Document Set epsos Dispensation Service provider XDR Document Recipient epsos Consent Service provider 14

Semantic Interoperability epsos Domain 15

Document transformation The document is trasformed into Pivot HL7 CDA L3, trascoded and translated Local document A is coded with ICD-10 4-digit codes and sent to NCP A Transformation ICD-10 4-digit to 3-digits codes Accession to epsos Terminology Server A Translation of displayname A to displayname E Creation of pivot Document E* Accession to epsos Terminology Server B Translation of displayname E to displayname B Creation of local Document B* Country A Document A NCP A Pivot Document NCP B Document B Country B CDA Language A ICD-10 4-digits codes Or ICD-9 Local Terminology server A CDA English ICD-10 3-digits codes Local Terminology server B CDA Language B ICD-10 3-digits codes epsos Central Reference Terminology Service: Master Value Set Catalogue: [MVC,] Subset of International Coding Systems (WHO ICD10, ATC; SNOMED-CT, EDQM, UCUM, HL7, IHE, ISCO)+ Master Translation/Transcoding Catalogue [MTC] 16

Sustainable Architecture A full Open Source version of NCP components recognised as common to all Participating Nations will be provided under either ASL v2 or GPL v3 licenses. OpenNCP components will be made available through JoinUp Open Source community Join Connectathon: international test event 17

Major Issue Encountered: Semantic Sustainability / Liability (1) epsos transforms / translates / exchanges documents with clinical and legal validity for real patients Each Country has its own Coding Systems and (specific) agreements with SDOs In order to interoperate a mechanism of transforming documents (HL7 CDA 2 L3), transcoding and translating from Country of Affiliation to Country of Treatment was established The Master Value Set Catalogue (MVC), gathering all ValueSets from standard coding systems, was established, together with the controlled procedure to generate the Master Value Set Translation/Transcoding Catalogue (MTC) for each Country For Patient Summary and eprescription services, liabilities were identified and safeguards were introduced However 18

Major Issue Encountered: Semantic Sustainability / Liability (2) Maintaining MVC / MTC is potentially hardly sustainable Translation / transcoding procedures may introduce legal issues with SDOs and patient safety risks Maintaining a Central Terminology Server is not the task for a Project New epsos services, like Patient Access (Country of Affiliation allows the patient to display his PS/eP in any EU language) has demonstrated new issues: Possibility to share translations among the Countries Liability on the shared / used translations Proposal: Move back to SDOs the task of maintaining, translating and provide certified transcoding Foresee the creation of a HL7 CTS2 compliant EU Central Terminology Service to allow appropriate access to the selected Coding Systems in EU languages 19

Directive Cross Border 2011/24 Art. 14 ehealth Art.11 Prescript. Connecting Europe Facility (CEF) Infrastructure/infostructure of interoperability For egov e ehealth EU ehealth initiatives Interaction Model EC DG SANCO: Guidelines on Directive adoption EC DG CONECT: Infrastructure/infostructure/Guidelines ehealth / Interoperability epsos: ehealth Cross Border Interoperability Stork 1 / 2: eid Peppol: eprocurement elexecodex 20

Directive Cross Border 2011/24 Art. 14 ehealth Art.11 Prescript. Connecting Europe Facility (CEF) Infrastructure/infostructure of interoperability For egov e ehealth EU ehealth initiatives Interaction Model EC DG SANCO: Guidelines on Directive adoption ehealth Network: Ministries of Health Guidelines ep EMA MoH Roadmap EU Pharmacopea EC Guidelines PS EC DG CONECT: Infrastructure/infostructure/Guidelines ehealth / Interoperability ehealth Governance Initiative: MoH+Stakeholders Guidelines Cross border PS / ep epsos: ehealth Cross Border Interoperability Stork 1 / 2: eid Peppol: eprocurement elexecodex 21

Directive Cross Border 2011/24 Art. 14 ehealth Art.11 Prescript. Connecting Europe Facility (CEF) Infrastructure/infostructure of interoperability For egov e ehealth EU ehealth initiatives Interaction Model EC DG SANCO: Guidelines on Directive adoption ehealth Network: Ministries of Health Guidelines ep (Empirica) EC+Ministeri EC+Ministeri EC+Ministeri EC+MoH EC DG CONECT: Infrastructure/infostructure/Guidelines ehealth / Interoperability ehealth Governance Initiative: MoH+Stakeholders esens: egov / ehealth Building blocks for CEF epsos: ehealth Cross Border Interoperability Stork 1 / 2: eid Peppol: eprocurement elexecodex 22

Directive Cross Border 2011/24 Art. 14 ehealth Art.11 Prescript. Connecting Europe Facility (CEF) Infrastructure/infostructure of interoperability For egov e ehealth EU ehealth initiatives Interaction Model EC DG SANCO: Guidelines on Directive adoption ehealth Network: Ministries of Health Guidelines ep (Empirica) EC+Ministeri EC+Ministeri EC+Ministeri EC+MoH EC DG CONECT: Infrastructure/infostructure/Guidelines ehealth / Interoperability ehealth Governance Initiative: MoH+Stakeholders EXPAND: sustenibility / Semantic Asset reuse Trillium PS EU-US) esens: egov / ehealth Building blocks for CEF epsos: ehealth Cross Border Interoperability Stork 1 / 2: eid Peppol: eprocurement elexecodex 23

Directive Cross Border 2011/24 Art. 14 ehealth Art.11 Prescript. Connecting Europe Facility (CEF) Infrastructure/infostructure of interoperability For egov e ehealth Toward new Horizons EC DG PHC SANCO: 34 - orientamenti 2014) ehealth per interoperability recepimento Direttiva (i) Convergence in the ehealth use of Network: ehealth Ministeri Standards Salute in Europe and in the world. Contribution to the ehealth Interoperability Framework and to large Guidelines scale deployment ep of ehealth EC+Ministeri Services (including cross border) in (Empirica) Europe. Contribution to EC+Ministeri the EC+Ministeri EU-US roadmap (ii) The proposal should provide practical EC+Ministeri solutions to solve the specific challenge and enable large scale deployments of cross border eprescription EC DG CONECT: services Infrastrutture/infostrutture/Guidelines in the EU. It is also expected to contribute to the EU-US roadmap and ehealth MoU. / Interoperabilità ehealth Governance Initiative: Ministeri Salute (iii) Contribute to better semantic interoperability of ehealth services in Europe, EXPAND: to building sostenibilità a European e riuso ehealth asset Interoperability semantici (100%) Framework and to prepare the deployments of ehealth Services in the frame Trillium of the Connecting esens: definizione Europe Facility. specifiche infrastruttura PS EU-US (iv) The teconogica egov/eheath: riuso building block (100%) proposal (Ugenti) will contribute to the planning and road-mapping of the CEF for what concerns the deployment of cross border ehealth epsos: ehealth Peppol: services. It will also contribute Stork 1 help the member states elex- and the Cross Border eprocurement ehealth Network to prioritise / 2: use eid cases to be deployed ecodex at national Interoperability level and better plan their own national deployments. 24

Directive Cross Border 2011/24 Art. 14 ehealth Art.11 Prescript. Connecting Europe Facility (CEF) Infrastructure/infostructure of interoperability For egov e ehealth New Calls in ehealth Interaction Model EC DG SANCO: Guidelines on Directive adoption ehealth Network: Ministries of Health Horizon2020: PHC 34-2014) ehealth interoperability EC DG CONNECT: Infrastructure/infostructure/Guidelines ehealth / Interoperability Trillium PS EU-US) Guidelines ep (Empirica) EC+Ministeri EC+Ministeri EC+MoH Horizon2020: HCO 3 201x) Support for the European Reference Networks: Efficient network modelling and validation ehealth Governance Initiative: MoH+Stakeholders ANTILOPE Interoperability Testing EXPAND: sustenibility / Semantic Asset reuse Semantic Health Net Strategies on Semantic Virtual Organisation esens: egov / ehealth Building blocks for CEF epsos: ehealth Cross Border Interoperability Stork 1 / 2: eid Peppol: eprocurement elexecodex

epsos Setting Sails in Lombardy 26 ASL PV: PS/eP-A ASL BS: PS/eP-A, PS-B AO Desenzano: PS-B ASL MI 1: PS/eP-A AO Garbagnate: PS-B AO Niguarda: PS-B AO Sacco: PS-B www.epsos.eu marcello.melgara@cnt.lispa.it