What's next after epsos has entered into operational mode? From record to new Horizons

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1 Progetto Mattone Internazionale Innovazione sanitaria: quale futura dimensione strategica, passi immediati What's next after epsos has entered into operational mode? From record to new Horizons Marcello Melgara Lispa / Regione Lombardia DG Salute

2 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 to

3 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

4 Allergies Blood Group Active Problems This is an extract from a Turkish Patient Summary, taken during the last Project-a-thon in Bern May 24 th

5 Allergies Blood Group Active Problems This is an extract from a Patient Summary display device, taken during the last Project-a-thon in Bern May 24 th

6 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

7 epsos Service Model 7

8 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

9 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 9

10 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 10

11 Adoption of IHE 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 12

12 Semantic Interoperability epsos Domain 13

13 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] 14

14 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 interoprability through centralised / distributed liability Adopt identification process that does not require centrally managed configuration 15

15 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 avaialble through JoinUp Open Source community Join Connectathon: international test event 16

16 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 17

17 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 CTS-2 compliant EU CentralTerminology Service to allow appropriate access to the selected Coding Systems in EU languages 18

18 Modello interazioni iniziative ehealth EU EC DG SANCO: orientamenti per recepimento Direttiva Direttiva Cross Border 2011/24 Art. 14 ehealth Art.11 Prescript. EC DG CONECT: Infrastrutture/infostrutture/Guidelines ehealth / Interoperabilità epsos: ehealth Cross Border Interoperability Stork 1 / 2: eid Peppol: eprocurement elexecodex Connecting Europe Facility (CEF) Infrastruttura/infostruttura di interoperabilità per egov e ehealth Gare per 1 G dal

19 Modello interazioni iniziative ehealth EU EC DG SANCO: orientamenti per recepimento Direttiva Direttiva Cross Border 2011/24 Art. 14 ehealth Art.11 Prescript. Guidelines ep (Empirica) EC DG CONECT: Infrastrutture/infostrutture/Guidelines ehealth / Interoperabilità ehealth Governance Initiative: Ministeri Salute epsos: ehealth Cross Border Interoperability ehealth Network: Ministeri Salute Guidelines Cross border PS / ep Stork 1 / 2: eid EMA MoH Roadmap EU Pharmacopea Peppol: eprocurement elexecodex Connecting Europe Facility (CEF) Infrastruttura/infostruttura di interoperabilità per egov e ehealth Gare per 1 G dal

20 Modello interazioni iniziative ehealth EU EC DG SANCO: orientamenti per recepimento Direttiva Direttiva Cross Border 2011/24 Art. 14 ehealth Art.11 Prescript. Guidelines ep (Empirica) EC DG CONECT: Infrastrutture/infostrutture/Guidelines ehealth / Interoperabilità ehealth Governance Initiative: Ministeri Salute epsos: ehealth Cross Border Interoperability ehealth Network: Ministeri Salute esens: definizione specifiche infrastruttura teconogica egov/eheath: riuso building block Stork 1 / 2: eid EC+Ministeri EC+Ministeri EC+Ministeri EC+Ministeri Peppol: eprocurement elexecodex Connecting Europe Facility (CEF) Infrastruttura/infostruttura di interoperabilità per egov e ehealth Gare per 1 G dal

21 Modello interazioni iniziative ehealth EU EC DG SANCO: orientamenti per recepimento Direttiva Direttiva Cross Border 2011/24 Art. 14 ehealth Art.11 Prescript. Guidelines ep (Empirica) EC DG CONECT: Infrastrutture/infostrutture/Guidelines ehealth / Interoperabilità ehealth Governance Initiative: Ministeri Salute Trillium PS EU-US (100%) (Ugenti) epsos: ehealth Cross Border Interoperability ehealth Network: Ministeri Salute esens: definizione specifiche infrastruttura teconogica egov/eheath: riuso building block Stork 1 / 2: eid EC+Ministeri EC+Ministeri EC+Ministeri EC+Ministeri EXPAND: sostenibilità e riuso asset semantici (100%) Peppol: eprocurement elexecodex Connecting Europe Facility (CEF) Infrastruttura/infostruttura di interoperabilità per egov e ehealth Gare per 1 G dal

22 Verso nuovi Horizon Direttiva Cross Border 2011/24 Art. 14 ehealth Art.11 Prescript. 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. Connecting Europe Facility (CEF) Infrastruttura/infostruttura di interoperabilità per egov e ehealth Gare per 1 G dal

23 epsos Setting Sails in Lombardy 24 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

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