Digital Agenda for Europe
A Europe 2020 Initiative

Action 77: Foster EU-wide standards, interoperability testing and certification of eHealth

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Foster EU-wide standards, interoperability testing and certification of eHealth systems by 2015 through stakeholder dialogue.
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The action aims at fostering EU-wide standards, interoperability testing and certification of eHealth systems by 2015 through stakeholder dialogue.

In 2014, the Commission will guide the development of the European eHealth Interoperability Framework at semantic and technical level for its endorsement by the eHealth Network, and propose specifications for their identification by the ICT standards multistakeholders platform for their endorsement by the eHealth Network and inclusion in the Interoperability Framework (recurring activity).

What is the problem? Lack of a common EU interoperability, testing and certification framework contributes to market fragmentation

The eHealth market in the EU is highly fragmented, reflecting the different national, regional, local  or event project based interoperability frameworks that are defined by competent authorities (if defined at all). As a result, the ICT (Information and Communication Technology) solutions provided are tailored only for one specific location or service provider and thus risk being more expensive, closed, non-reliable and non-interoperable elsewhere. Interoperability testing is done on a project or on a local level and there is no certification scheme making the life of purchasers of eHealth systems easier.

Why is EU action required? The development of an EU eHealth Interoperability, testing and certification framework is essential to reduce market fragmentation

EU action will support the creation and seek the endorsement by major stakeholders (starting with the eHealth Network) of an EU eHealth Interoperability Framework composed of 4 levels or dimensions: technical, semantic, organisational and legal. Those levels will then be populated with standards, specifications, use cases, workflows, subset of terminologies, interoperability agreements, guidelines developed by standards development organisations, fora, consortia or EU funded projects after they have been identified or endorsed by the relevant EU governance bodies (eHealth Network, ICT Standards Multistakeholders platform and later the CEF governance).

In a second stage, an EU Interoperability testing and certification framework will be developed and proposed to the stakeholders (starting with the eHealth Network) for their endorsement.

DAE action 77 is also contributing to the delivery of the European Innovation Partnership in the field of active and healthy ageing, proposed under the Innovation Union flagship.

The eHealth Interoperability Framework should be developed by the eHealth Network.

What has the Commission done so far?

  • Guided and ensured coordination and convergence between existing EU projects and launched relevant projects according to interoperability needs (recurring activity).  Two convergence workshops have been organised and the EXPAND project has been negotiated and launched.
  • Strengthened cooperation with International organisations such as IHTSDO and WHO in matters related to interoperability and standardization (recurring activity).  The Commission (DG SANCO and CNECT) have met IHTSDO twice and  a specific objective to study SNOMED CT has been included in H2020 work plan 2014-2015.
  • Leveraged the results, assets and recommendations developed by the epSOS project to contribute to the eHealth Interoperability Framework. This will start with a set of patients' summary data for cross-border exchange which will be proposed for endorsement by the eHealth Network.  The patient summary guidelines, which have been largely inspired by the patient summary and the interoperability framework develped by epSOS has been adopted by the eHealth Network.
  • EU-US MoU:  Agreed and published a roadmap supporting the objectives of the EU-US Memorandum of Understanding on eHealth interoperability standards and specifications (recurring activity).  The roadmap needs to be adapted now.
  • Partly established the governance of the Connecting Europe Facility related to eHealth Interoperability - to be pursued.

Developed a common approach for testing and certification of eHealth solutions and services in Europe by the Antilope project (CIP).

What will the Commission do next?

In 2014:

  • Establish the governance of the Connecting Europe Facility related to eHealth Interoperability for its endorsement by the eHealth Network.
  • Guide the development of the European eHealth Interoperability Framework at semantic and technical level (including through the development of eID and ePrescription guidelines) for its endorsement by the eHealth Network.
  • Guide the development of a business plan for the CEF for its endorsement by the eHealth Network.
  • Study the legal requirements (national and international) for the safe cross border exchange of health data in the EU.
  • Develop the appropriate legal framework for an eHealth Interoperability Framework in view of the deployment of cross border eHealth services under the CEF.
  • Leverage the results, assets and recommendations developed by the epSOS, eSense and other EC projects to contribute to the eHealth Interoperability Framework and to the launch of the CEF.
  • Propose interoperability specifications for their identification by the ICT standards multistakeholders platform for their endorsement by the eHealth Network and inclusion in the Interoperability Framework (recurring activity).
  • EU-US MoU: develop and implement the agreed roadmap (recurring activity).
  • Develop a common interoperability framework for eID in eHealth in a cross sectorial and mutual recognition perspective.

In 2015:

  • Study the legal and operational requirements for the deployment of an eHealth testing and certification system in Europe.
  • Launch the deployment of interoperable eHealth cross border services on large scale under the CEF (recurring activity).
  • Develop new cross border eHealth services to be deployed (H2020).
  • Propose an EU eHealth Interoperability testing and certification framework to the eHealth Network for its endorsement.
  • Populate the different levels (technical, semantic, organisational, legal) of the eHealth Interoperability Framework.

In 2016:

  • Develop a legal framework for the deployment of an eHealth testing and certification system at European level.
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Progress Report
Status: On track Benoit Abeloos Contact
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