X-eHealth’s project stands herein for a project of strategic relevance for tomorrow’s European eHealth Union. Assembling at the time of this proposal submission a shared commitment of 47 health actors, the underlying idea of this project is to develop the basis for a workable, interoperable, secure and cross border Electronic Health Record exchange Format in order to lay the foundation for the advance of eHealth sector while using the 3 pillars put forward by the EC as reference. Aimed at promoting a faster and sustainable EU digital transformation, this Cooperative and Support Action is made up of 8 Work Package in which 4 exclusively focus on technical-functional activities (WP4 to WP7). From Generic Aspects to System Architecture and Integration, passing by Functional and Technical Specifications, X-eHealth objective is to move towards a uniform interoperable data-sharing format framework. In addition, to enhance EU’s public health state of play, WP1 and WP8 are responsible for implementation studies, practicality and continuity of eHealth interoperability development. On this basis and building upon the already in place Patient Summary, X-eHealth purpose is to develop the foundations for a common framework for medical imaging, discharge letters, laboratory results and rare diseases to flow both alongside citizens care pathway and across health entities between EU Member States and Neighbour Countries. Focus on cross-border services, this consortium aims to advance an interoperable Common European Health Data Space for citizens and health providers engagement in accordance with privacy and cybersecurity regulations. To achieve this end, X-eHealth gathers 36 consortium partners plus 5 collaborative partners and 6 eHealth skilled experts, eager to develop the abovementioned 4 domains, and distinguished by policy and political actors mixed with national competent authorities to indeed concretely plan, implement and maintain national eHealth infrastructures.

This innovation action will give a powerful impulse to implementation of ISO IDMP (ID of Medicinal Products) standards in EU Member States drug databases, supporting safe cross-border ePrescription/eDispensation and effective pharmacovigilance. Once EU-interoperable data on medicines taken by patients become available, further benefits will accrue through better health data for improved clinical decision support, patient empowerment, public health and clinical research. New opportunities will arise for pharma industry, software developers, SMEs providing smart apps and others, thereby fostering their innovation capacity and competitiveness. The many challenges still to be faced on this road will be tackled by a powerful consortium assembling all relevant actors, with critical mass for impact throughout the EU. After 10 years of development, the IDMP suite of standards is ready for implementation. Though some isolated implementation work has started, the time is now ripe for a more concerted effort towards large-scale implementation, contributing to this global interoperability endeavour and delivering benefits to EU citizens. Project ambition centres on conversion of key regulatory and clinical processes to use IDMP. These information value chains must be converted over their full length from data input to data repositories to data usage. Project work spans all three areas, focussing on the most challenging, the implementation of EU and national SPOR (substances, products, organisations, referentials) data bases, including establishing an EU Substance Reference System (EU-SRS). Such information is fundamental to cross-border ePrescription where safe dispensation may require reliable identification of substances in available products. 19 countries are represented, including 26 national Drug and eHealth Agencies. Stakeholders are involved through their associations. Duration is 4 years, budget € 21 m, with requested funding € 19 m.

EURO-CAS, European eHealth Interoperability Conformity Assessment Scheme aims at maintaining and developing the adoption and take-up of testing the interoperability of ICT solutions against identified eHealth standards and profiles defined in the eHealth European Interoperability Framework (eEIF). The key deliverable is a sustainable Conformity Assessment Scheme (CAS) for Europe. Based on recommendations of the Antilope project and the state-of-art in interoperability testing in eHealth, EURO-CAS is committed to putting in place an operational CAS based on ISO/IEC 17025 that will meet the interoperability requirements of European eHealth projects as well as national and regional eHealth programs. This will allow testing the interoperability capabilities of products and services for a single digital market in eHealth in Europe in line with the Digital Agenda for Europe and based on international profiles and standards. The project will gather a multi-disciplinary consortium of high-level expertise, including organizations focused on implementing international standards as well as industry stakeholders and healthcare providers that will 1) review the state of the art of existing interoperability CAS, 2) collect the requirements and needs from cross border, national/regional levels, 3) establish the CAS for Europe with implementation guidelines and governance, 4) propose business models for the CAS for Europe, 5) validate results and foresee national/regional adoption, 6) inform and educate eHealth stakeholders and motivate industry and projects to participate in a European accreditation process. The CAS for Europe will provide a comprehensive framework completing the eEIF and aligned with the international CAS. Its flexibility will allow better sustainability and harmonization at European, national and regional levels.

ASSESS CT will contribute to better semantic interoperability of eHealth services in Europe, in order to optimise care and to minimise harm in delivery of care. In a joint one-year effort, the ASSESS CT consortium will investigate the fitness of the clinical terminology SNOMED CT as a potential standard for EU-wide eHealth deployments, scrutinising clinical, technical, financial, and organisational aspects. Unbiased towards SNOMED CT adoption, the ASSESS CT project will employ established evaluation approaches from social science. It will scrutinise adoption against two alternative scenarios: to abstain from actions at the EU level, or to devise an EU-wide semantic interoperability framework without SNOMED CT. ASSESS CT will review the current state of SNOMED CT through survey and focus group, regarding its use by IHTSDO members and the fulfilment of semantic interoperability use cases, the relationship with EU-wide recommendations, known technical and organisational drawbacks, and maintenance of the terminology. A series of studies using sampled clinical data will provide new evidence about conceptual and term coverage for selected languages, as well as technical fitness in manual and automated semantic annotation scenarios. The consortium will also analyse the impact of SNOMED CT adoption from a socio-economic viewpoint, encompassing management, business, organisational, and governance aspects. Validation of all working tasks, both political and domain-specific, will be secured through four large workshops with a list of distinguished experts assembled in an Expert Panel, Committee of MS Representatives, and national focus groups. Sufficient budget is reserved, also for coordination across the parallel H2020 Call PHC34 projects. Concrete strategy recommendations will be delivered to both MS, the EC, and SDOs about how SNOMED CT can scale up successful adoption and contribute to building a EU eHealth Interoperability Framework.