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eHealth interoperability

Specific Challenge: There are a number of challenges to effective eHealth service deployment in Europe, each of which is to be addressed by an individual Co-ordination and Support Action as below.

(i) There is little stakeholder consensus on a common reference information model for eHealth deployment in Europe, and it seems unlikely that international consensus can be reached for common (clinical) reference standards in a reasonable timeframe and budget. It is therefore reasonable to ask whether competing / overlapping standards can co-exist in a common eHealth European interoperability framework; this is of relevance to the MoU on eHealth between the EC and the US department of Health and Human services.

(ii) The Directive on patients' rights in cross-border healthcare (Directive 2011/24/EU) pursues the objective to enhance safety and continuity of cross-border treatment through interoperable access to patients' summary data and interoperable ePrescriptions. The challenge in ePrescription is how medicines can be communicated in the cross border setting. There is neither a common data model nor a common vocabulary for medicinal or pharmaceutical products throughout Europe.

(iii) The clinical domain is probably among the most complex from a semantic point of view. Vocabularies, terminologies, classification and coding systems, and ontologies have been developed by different stakeholders to address different needs in different subdomains. The semantic health report had already demonstrated the central role that SNOMED CT[1] could play as a core terminology to solve semantic interoperability issues, provided that ""evidence-based results of SNOMED CT’s fitness for purpose are assessed"". The epSOS pilot project has retained SNOMED CT as one of the constituents of its master value sets catalogue which ensures semantic interoperability across the borders in the frame of the pilot. More recently, the eHealth Network called on the Commission to play a more active role in assessing the value of SNOMED CT for eHealth deployments in Europe. A detailed analysis on the advantages and disadvantages, as well as the impact of using SNOMED CT as the core terminology at the EU level is needed.

(iv) The Connecting Europe Facility will provide the funding and the governance framework to deploy cross border eHealth Services, among other digital services, until 2020. The intention is to migrate progressively the Connecting Europe facility from a publicly funded initiative to a self-financed operation. There is a need to identify the right business model and plan which would identify sustainable sources of revenue and all the costs which the operations of such services would generate. Gathering evidence that interoperability contributes to lowering the cost of health systems is an important element for decision makers when they have to envisage eHealth investments.

Scope: (i) The proposal should at minimum build on existing CEN, ISO, and HL7 standards. The need for a formal standardization activity in the area should be demonstrated, as well as a realistic roadmap with concrete deliverables. Alternative scenarios should be envisaged. Proposals should build on existing initiatives and EU projects in the area. Proposals should ensure sufficient involvement of stakeholders (including at least Member States, Industry and international standards development organisations (SDOs)), consensus building and endorsement of the work carried out and of the submitted deliverables. Contribution to the EU eHealth Interoperability Framework should be demonstrated. The successful proposal should support large scale deployments of eHealth services (including cross border) in Europe and contribute to the implementation of the EU-US MoU and roadmap.

(ii) Proposals should investigate the possibility of combining existing or developing a new European or international standard which address the following issues:

         Unambiguous definition and description of medicinal and pharmaceutical products, including unique identification.

         Handling of substitution

Proposals should be submitted by a consortium composed of relevant international standards development organisations, member states' public authorities and fora and consortia which have a demonstrated expertise to perform the work.

Proposals should build on existing standard vocabularies, terminologies and ontologies and demonstrate a likely contribution to the adoption of existing, or the development of new international standards

(iii) Proposals should investigate the use of SNOMED CT as a core terminology to solve semantic interoperability issues for cross border but also national and regional eHealth deployments in the EU. Proposals should cover aspects such as costs (license or membership, but also operational, translations, mapping to local terminologies, maintenance, training,…), fitness to clinical requirements, legal, technical and operational, benefits, governance, impact on the different stakeholders including patients and healthcare providers, for the cross border as well as for the national and regional scenarios. Proposals should compare the SNOMED scenario with at least two scenarios: a) do nothing at the EU level and b) define a semantic interoperability framework without SNOMED CT. Proposals should assess whether SNOMED CT satisfies the criteria listed in the annex II of the EU standardization regulation. Proposals should take into account advice and guidelines from the eHealth Network but also developments related to the EU-US roadmap.

Proposals for section (iii) should have a duration of no longer than one year.

(iv) The proposal should build on existing work done by projects such as epSOS[2] and SemanticHealthNet[3] which will have developed key building blocks which will help to address the challenge. The epSOS pilot project has been piloting two basic use cases (ePrescription and Patient Summary) and successful proposals should identify and agree on a roadmap of use cases that should be deployed on large scale in the future after the epSOS use cases. Proposals should demonstrate the value proposition of healthcare providers with regard to interoperability and assess sustainable incitement schemes that would encourage healthcare providers to encode health data and provide it in an interoperable way and to invest in interoperable eHealth systems.

Proposals should gather a large multidisciplinary group of stakeholders from the Member States, Regions, SDO, sectoral fora and consortia, industry, health insurance companies, key interoperability experts, patients associations, health care providers associations, and any other stakeholders which will be deemed necessary. Proposals should deliver a full business plan going beyond 2020 including all revenue streams and cost items.

The Commission considers that proposals requesting a contribution from the EU of up to EUR 1 million would allow this specific challenge to be addressed appropriately. Nonetheless, this does not preclude submission and selection of proposals requesting other amounts.

Expected impact:  

(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. In line with the Union’s strategy for international cooperation in research and innovation[4], proposals will contribute to the implementation of the EU-US roadmap

(ii) Practical solutions to solve the specific challenge and enable large scale deployments of cross border ePrescription services in the EU. Contribution 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) Contribution to the planning and road-mapping of the CEF for that which concerns the deployment of cross border eHealth services. Contribution to help the EU Member States and the eHealth Network to prioritise use cases to be deployed at national level and to better plan their own national deployments.

Type of action: Coordination and support actions





[4] COM(2012)497