What's next after epSOS has entered into …idg.bg/idgevents/idgevents/2014/0217174317-Melgara_2014...What's next after epSOS has entered into operational mode? From records to new

eHealth for Smart and InclusiveGrowth 2020

Marcello Melgara

Lispa / Regione Lombardia – DG Health

What's next after epSOS has entered into

operational mode?

From records to new Horizons

Sofia, 13/02/2014

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

• 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

Goals & Challenges

3

From a Portuguese Patient Summary…

4

… to an Italian Patient Summary

5

epSOS Infrastructure

PoC

PoC

PoC

NCP

PoC PoC

NCP

NCP

PoC

PoC

PoC

PoC NCP

epSOS

INTEROPERABILITY

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

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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 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

Public Network

(e.g. Internet)

epSOS

Services DMZ

Packet

Filter

Packet

Filter

Web

Service

Proxy

Trust Zone I

Trust Zone II

Trust Zone

III

National

InfrastructureNCP

Gate

way

PoC

epSOS

ServicesDMZ

Packet

Filter

Packet

Filter

Web

Service

Proxy

Trust Zone I

Trust Zone II

Trust Zone

III

National

InfrastructureNCP

Gate

way

end-to-end (node/country level)

end-to-end (NCP-2-NCP message exchange level)

end-to-end (business transaction and object lifecycle level)

epSOS

Central

Service

Trust Zone IV

13

Adoption of IHE / HL7 profiles

NCP-A

(country of affiliation)

NCP-B

(country of care)

Demographics Query

Cross-Gateway Query

with Returned Documents

Provide and Register Document Set

epSOS Identification Service

consumerXCPD

Initiating Gateway

epSOS Identification Service provider

XCPD

Responding Gateway

epSOS Patient Service consumer

epSOS Order Service consumer

XCA

Initiating Gateway

epSOS Patient Service provider

epSOS Order Service provider

XCA

Responding Gateway

epSOS Dispensation Service

consumer

epSOS Consent Service consumer

epSOS Dispensation Service

provider

epSOS Consent Service provider

XDR

Document Source

XDR

Document Recipient

Cross-Gateway Fetch

with Returned Documents

epSOS Patient Service consumer

epSOS Order Service consumer

XCF

Initiating Gateway

epSOS Business Document Provider

XCF

Responding Gateway

ATNA, XUA, BPPC, etc.

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epSOS

Domain

15

Semantic Interoperability

16

Document transformation

The document is trasformed into Pivot HL7 CDA L3, trascoded and translated

Document ACountry

A

Lo

ca

l

Te

rmin

olo

gy

se

rve

r A

Pivot

DocumentDocument B

NCP A NCP B

Lo

ca

l

Te

rmin

olo

gy

se

rve

r B

Country

B

CDA

Language A

ICD-10 4-digits codes

Or ICD-9

CDA

English


CDA

Language B


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*

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]

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

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• 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…

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 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

Major Issue Encountered:

Semantic Sustainability / Liability (2)

19

EC DG CONECT: Infrastructure/infostructure/Guidelines eHealth / Interoperability

EU eHealth initiatives Interaction Model D

irec

tive

Cro

ss B

ord

er 2

01

1/2

4

Art

. 14

eH

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Art

.11

Pre

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Euro

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Faci

lity

(CEF

) In

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f in

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For

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lth

epSOS: eHealth Cross Border

Interoperability

Stork 1 / 2: eID

Peppol: eProcu-rement

eLex- eCodex

EC DG SANCO: Guidelines on Directive adoption

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Dir

ecti

ve C

ross

Bo

rder

20

11

/24

A

rt. 1

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Interoperability

Stork 1 / 2: eID


eLex- eCodex


eHealth Governance Initiative: MoH+Stakeholders

eHealth Network: Ministries of Health

Guidelines eP

Guidelines Cross border PS / eP

EU eHealth initiatives Interaction Model

EMA MoH Roadmap EU Pharmacopea

21

Co

nn

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ng

Euro

pe

Faci

lity

(CEF

) In

fras

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EC Guidelines PS

Dir

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Interoperability

Stork 1 / 2: eID


eLex- eCodex



Guidelines eP (Empirica)

EC+Ministeri EC+Ministeri

EC+Ministeri EC+MoH


22


eSENS: eGov / eHealth Building blocks for CEF

Co

nn

ecti

ng

Euro

pe

Faci

lity

(CEF

) In

fras

tru

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f in

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Dir

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Interoperability

Stork 1 / 2: eID


eLex- eCodex






EC+Ministeri EC+MoH


Trillium PS EU-US)

23


EXPAND: sustenibility / Semantic Asset reuse

Co

nn

ecti

ng

Euro

pe

Faci

lity

(CEF

) In

fras

tru

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Co

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(CEF

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EC DG CONECT: Infrastrutture/infostrutture/Guidelines eHealth / Interoperabilità

eHealth Governance Initiative: Ministeri Salute


Interoperability

Stork 1 / 2: eID


eLex- eCodex

eSENS: definizione specifiche infrastruttura teconogica eGov/eHeath: riuso building block

EC DG SANCO: orientamenti per recepimento Direttiva

eHealth Network: Ministeri Salute




Toward new “Horizons”

Trillium PS EU-US (100%) (Ugenti)

EXPAND: sostenibilità e riuso asset semantici (100%)

PHC 34 - 2014) eHealth interoperability

(i) Convergence in the use of eHealth Standards in Europe and in the world. Contribution to the eHealth Interoperability Framework and to large scale deployment of eHealth Services (including cross border) in Europe. Contribution to the EU-US roadmap

(ii) The proposal should provide practical solutions to solve the specific challenge and enable large scale deployments of cross border ePrescription services in the EU. It is also expected to contribute to the EU-US roadmap and MoU.

(iii) Contribute to better semantic interoperability of eHealth services in Europe, to building a European eHealth Interoperability Framework and to prepare the deployments of eHealth Services in the frame of the Connecting Europe Facility.

(iv) The proposal will contribute to the planning and road-mapping of the CEF for what concerns the deployment of cross border eHealth services. It will also contribute to help the member states and the eHealth Network to prioritise use cases to be deployed at national level and better plan their own national deployments.

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Co

nn

ecti

ng

Euro

pe

Faci

lity

(CEF

) In

fras

tru

ctu

re/i

nfo

stru

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re o

f in

tero

per

abili

ty

For

eGo

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eHea

lth

New Calls in eHealth Interaction Model D

irec

tive

Cro

ss B

ord

er 2

01

1/2

4

Art

. 14

eH

ealt

h

Art

.11

Pre

scri

pt.

EC DG CONNECT: Infrastructure/infostructure/Guidelines eHealth / Interoperability


Interoperability

Stork 1 / 2: eID


eLex- eCodex

Trillium PS EU-US)

EXPAND: sustenibility / Semantic Asset reuse




EC+Ministeri EC+Ministeri EC+Ministeri EC+MoH

Semantic Health Net Strategies on Semantic Virtual Organisation

Horizon2020: PHC 34 - 2014) eHealth

interoperability

Horizon2020: HCO 3 – 201x) Support for the European Reference Networks: Efficient network

modelling and validation

ANTILOPE Interoperability Testing



epSOS Setting Sails

in Lombardy

www.epsos.eu

[email protected]

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

http://www.epsos.eu/





mailto:[email protected]





