what's next after epsos has entered into operational mode? · epsos circle of trust a...
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What's next after epSOS has entered into operational mode?
From record to enduranceMarcello Melgara
Lispa / Regione Lombardia – DG Salute
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 Associationof Local Authorities and Regions)
– From 01.07.2008 to 31.12.2013
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• 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
Goals & Challenges Page 329/05/2013
This is an extract from a Turkish Patient Summary,taken during the last Project‐a‐thon in Bern May 24th 2012
This is an extract from a Patient Summary display device,taken during the last Project‐a‐thon in Bern May 24th 2012
epSOS Infrastructure
PoC
PoC
PoC
NCP
PoC PoC
NCP
NCPPoC
PoC
PoCPoC NCP
epSOSINTEROPERABILITY
The interoperability Infrastructure is based on peer-to-peer network of National Contact Point
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epSOS Service Model Page 729/05/2013
Pilot Setting SailsAthens, 08/11/2011: IT‐ eP dispensed in a Greek pharmacy
April 2012: AT, CZ, ES, FR, IT and GRMay 2013: PT, CH
Approved for Operation in Sept.2012:DK, SE, SK, EE, FI
Passed Projectathon May 2013:MT, CR, SI, HR, TR
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
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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
National level- federating organisations
epSOS Practice Standards
National level Framework Agreements- To establish the NCP- To establish NCP-pilot partners relation
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end-2-end SecurityAssure 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
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Adoption of IHE profilesPage 12
29/05/2013
13
Semantic InteroperabilityPage 13
29/05/2013
14
Document transformation
The document is trasformed into Pivot HL7 CDA L3, trascoded and translated
Document ACountry A
Pivot Document Document BNCP A NCP B Country
B
CDALanguage A
ICD-10 4-digits codesOr ICD-9
CDAEnglish
ICD-10 3-digits codes
CDALanguage B
ICD-10 3-digits codes
Transformation ICD-10 4-digit to 3-digits codesAccession to epSOS Terminology Server A
Translation of displayName A to displayName ECreation of pivot Document E*
Accession to epSOS Terminology Server BTranslation of displayName E to displayName B
Creation of local Document B*Local document A is coded with ICD-10
4-digit codes and sent to NCP A
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]
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From Record to EnduranceMake 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
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Sustainable ArchitectureA 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 componentswill be made avaialblethrough JoinUp OpenSource community
Join Connectathon:international test event
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• epSOS transforms / translates / exchanges documents with clinical andlegal 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/TranscodingCatalogue (MTC) for each Country
• For Patient Summary and ePrescription services, liabilities were identified and safeguards were introduced
• However…
Major Issue Encountered: Semantic Sustainability / Liability (1)
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• 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 transcodingForesee the creation of a CTS-2 compliant EU CentralTerminologyService to allow appropriate access to the selected Coding Systems in EU languages
Major Issue Encountered: Semantic Sustainability / Liability (2)
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Modello interazioni iniziative eHealth EUDirettiv
aCross Bo
rder 201
1/24
Art. 14 eH
ealth
Art.11 Prescript.
Conn
ectin
gEu
rope
Facility(CEF)
Infrastruttura/infostruttura
di interope
rabilità
per eG
ove eH
ealth
Gare pe
r 1 G€dal 2014
EC DG CONECT: Infrastrutture/infostrutture/GuidelineseHealth / Interoperabilità
epSOS: eHealthCross Border
Interoperability
Stork 1 / 2: eID
Peppol: eProcu‐rement
eLex‐eCodex
EC DG SANCO: orientamenti per recepimento Direttiva
Direttiv
aCross Bo
rder 201
1/24
Art. 14 eH
ealth
Art.11 Prescript.
Conn
ectin
gEu
rope
Facility(CEF)
Infrastruttura/infostruttura
di interope
rabilità
per eG
ove eH
ealth
Gare pe
r 1 G€dal 2014
EC DG CONECT: Infrastrutture/infostrutture/GuidelineseHealth / Interoperabilità
epSOS: eHealthCross Border
Interoperability
Stork 1 / 2: eID
Peppol: eProcu‐rement
eLex‐eCodex
EC DG SANCO: orientamenti per recepimento Direttiva
eHealth Governance Initiative: Ministeri Salute
eHealth Network: Ministeri Salute
Guidelines eP(Empirica)
GuidelinesCross border PS /
eP
Modello interazioni iniziative eHealth EU
EMA MoH Roadmap EU Pharmacopea
Direttiv
aCross Bo
rder 201
1/24
Art. 14 eH
ealth
Art.11 Prescript.
Conn
ectin
gEu
rope
Facility(CEF)
Infrastruttura/infostruttura
di interope
rabilità
per eG
ove eH
ealth
Gare pe
r 1 G€dal 2014
EC DG CONECT: Infrastrutture/infostrutture/GuidelineseHealth / Interoperabilità
eHealth Governance Initiative: Ministeri Salute
epSOS: eHealthCross Border
Interoperability
Stork 1 / 2: eID
Peppol: eProcu‐rement
eLex‐eCodex
eSENS: definizione specifiche infrastruttura teconogica eGov/eHeath: riuso building block
EC DG SANCO: orientamenti per recepimento Direttiva
eHealth Network: Ministeri Salute
Guidelines eP(Empirica)
EC+MinisteriEC+MinisteriEC+MinisteriEC+Ministeri
Modello interazioni iniziative eHealth EU
Direttiv
aCross Bo
rder 201
1/24
Art. 14 eH
ealth
Art.11 Prescript.
Conn
ectin
gEu
rope
Facility(CEF)
Infrastruttura/infostruttura
di interope
rabilità
per eG
ove eH
ealth
Gare pe
r 1 G€dal 2014
EC DG CONECT: Infrastrutture/infostrutture/GuidelineseHealth / Interoperabilità
eHealth Governance Initiative: Ministeri Salute
epSOS: eHealthCross Border
Interoperability
Stork 1 / 2: eID
Peppol: eProcu‐rement
eLex‐eCodex
eSENS: definizione specifiche infrastruttura teconogica eGov/eHeath: riuso building block
EC DG SANCO: orientamenti per recepimento Direttiva
eHealth Network: Ministeri Salute
Guidelines eP(Empirica)
EC+MinisteriEC+MinisteriEC+MinisteriEC+Ministeri
Modello interazioni iniziative eHealth EU
TrilliumPS EU‐US (100%) (Ugenti)
EXPAND: sostenibilità e riuso asset semantici (100%) (???)
epSOS Setting Sails in Lombardy
www.epsos.eu
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