What's next after epsos has entered into operational mode? From record to endurance. Marcello Melgara Lispa / Regione Lombardia DG Salute

Transcription

1 What's next after epsos has entered into operational mode? From record to endurance Marcello Melgara Lispa / Regione Lombardia DG Salute

2 epsos in Pils Page 2 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 Page 3 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 23 Health Care systems Legal Interoperability Organisational Interoperability Semantic Interoperability Technical Interoperability Basic Use Cases: Patient Summary interoperability epresciption / edispensation interoperability Patient Access

4 This is an extract from a Turkish Patient Summary, taken during the last Project a thon in Bern May 24 th 2012

5 This is an extract from a Patient Summary display device, taken during the last Project a thon in Bern May 24 th 2012

6 epsos Infrastructure Page 6 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

7 epsos Service Model Page 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 May 2013: PT, CH Approved for Operation in Sept.2012: DK, SE, SK, EE, FI Passed Projectathon May 2013: MT, CR, SI, HR, TR

9 Pillars to Interoperability Page 9 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 epsos Circle of Trust Page 10 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

11 end-2-end Security Page 11 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

12 Adoption of IHE profiles Page 12

13 Semantic Interoperability Page 13 13

14 Document transformation Page 14 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 CDA English ICD-10 3-digits codes 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

15 From Record to Endurance Page 15 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

16 Sustainable Architecture Page 16 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

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

19 Modello interazioni iniziative ehealth EU Direttiva Cross Border 2011/24 Art. 14 ehealth Art.11 Prescript. Connecting Europe Facility (CEF) Infrastruttura/infostruttura di interoperabilità per egov e ehealth Gare per 1 G dal 2014 EC DG SANCO: orientamenti per recepimento Direttiva EC DG CONECT: Infrastrutture/infostrutture/Guidelines ehealth / Interoperabilità epsos: ehealth Cross Border Interoperability Stork 1 / 2: eid Peppol: eprocurement elexecodex

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 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 2014

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 epsos: ehealth Cross Border Interoperability ehealth Network: Ministeri Salute EC+Ministeri EC+Ministeri EC+Ministeri EC+Ministeri esens: definizione specifiche infrastruttura teconogica egov/eheath: riuso building block Stork 1 / 2: eid Peppol: eprocurement elexecodex Connecting Europe Facility (CEF) Infrastruttura/infostruttura di interoperabilità per egov e ehealth Gare per 1 G dal 2014

22 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 EC+Ministeri EC+Ministeri EC+Ministeri EC+Ministeri EXPAND: sostenibilità e riuso asset semantici (100%) (???) esens: definizione specifiche infrastruttura teconogica egov/eheath: riuso building block Stork 1 / 2: eid Peppol: eprocurement elexecodex Connecting Europe Facility (CEF) Infrastruttura/infostruttura di interoperabilità per egov e ehealth Gare per 1 G dal 2014

23 epsos Setting Sails in Lombardy Page 23