what's next after epsos has entered into operational mode? · epsos circle of trust a...

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)

Page 1829/05/2013

Modello interazioni iniziative eHealth EUDirettiv

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Art. 14 eH

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Art.11 Prescript. 

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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

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1/24

Art. 14 eH

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Art.11 Prescript. 

Conn

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Facility(CEF)

Infrastruttura/infostruttura

di interope

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per eG

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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

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Art. 14 eH

ealth

Art.11 Prescript. 

Conn

ectin

gEu

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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

marcello.melgara@cnt.lispa.it

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