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.

A structured European mechanism for COVID-19 exchange to organize and share information between countries is urgently needed, especially in the area of population health. Information on the broader impacts of COVID-19 on the health of populations is needed to facilitate multidisciplinary European research and underpin decision making. PHIRI aims to facilitate and support open, interconnected, and data-driven research through the sharing of cross-country COVID-19 population health information and exchange of best practices related to data collection, curation, processing, use and reuse following ELSI and FAIR principles. It has the objective: to provide a Health Information portal for COVID-19 with FAIR catalogues on health and health care data, to provide structured exchange between countries on COVID-19 best practices and expertise, and to promote interoperability and tackle health information inequalities. To this end, it builds with national nodes a Health Information portal (WP4) on data sources, population health studies, training material and courses, considering ethical and legal aspects. The portal is supported by WP7 that provides the technological substrate for the development of a federated research infrastructure. WP5 develops a consolidated framework to assess the direct and indirect impacts of COVID-19 on population wellbeing, morbidity and mortality. WP6 will look at COVID-19 impacts in specific subgroups by conducting research through use cases of immediate relevance and facilitates research by making scalable, reproducible methods available within PHIRI. WP8, the Rapid Exchange Forum, provides swift responses to research and policy questions that are raised in countries to handle the COVID-19 pandemic. WP9 gains insights in possible future health impacts of the coronavirus outbreak by modelling scenarios for national situations. This will be carried out in close collaboration with different types of actors and initiatives across Europe (WP3).

xShare envisions everyone sharing their health data in EEHRxF with a click-of-a-button. The xShare button to be featured across health portals and patient apps and allow people to exercise their data portability rights under GDPR. Hence, the European EHRxF will be the driver for research and innovation in EHDS. xShare will establish the European EHRxF Standards and Policy Hub, the “Hub” partnership of six standards developing organizations (CEN/TC251, HL7 Europe, IHE Europe, SNOMED, CDISC, IEEE) market actors (DIGITAL Europe, MedTech-Europe and EUCROF), supported by competence centers, nationals and regional authorities and European SMEs. xShare will develop: 1) Harmonized common specifications, create and maintain xBundles i.e., collection of common data specifications including FHIR implementation guides, tools and data sets, and educational support for key EHRxF health information domains as noted in the EHDS draft regulation Annex 1. 2) A set of common elements across EHRxF health information domains applicable across EHDS-1 (JA-9), public/population health (EHDS-2), and clinical research. 3) Extended harmonized IPS specification to include care plans and making it fit for the purpose of clinical research use cases i.e. clinical trial eligibility, real world data, patient reported outcomes, and returning clinical research data to patients. 4) xShare feature the xShare Button in 8 adoption settings in Hospital network (Italy), National portal (Greece, Ireland, Cyprus), regional network with emphasis in medical tourism and the connection of the public to the private sector (Catalunya and Madeira), entry of digital health applications to the myHealthSpace ecosystem in France. Care plans will be demonstrated in Denmark. xShare investigate the feasibility and value of the EU xShare Industry label as a vehicle towards implementing the draft EHDS regulation. Lastly open calls at the last year of the project aim to onboard with EHRxF almost 100 settings across Europe.

This proposal for a European Cancer Patient Digital Centre (ECPDC) Information Portal, EU-CIP, addresses the information needs of cancer patients, survivors, relatives, and caregivers. EU-CIP aims to create a patient-centric cancer information portal that improves health literacy, empowers patients, and reduces inequalities in access to cancer care information across Europe. The EU-CIP primary goal is to improve quality of life and enhance cancer patient care by improving access to general and personalized knowledge, delivering comprehensive information on cancer prevention, early detection, diagnosis, and treatment options including risks, side effects and late effects as well as information on rehabilitation and management of recurrence and palliative care. EU-CIP will prioritise high-incidence cancers, those with poor prognosis, and paediatric cancers. A Common Library of Contents available to all Member States will be created and EU-CIP nodes will be deployed in 10 Member States. The Library of Contents will use information from evidence-based sources such as the Knowledge Centre on Cancer and the European Cancer Information Service, existing Cancer Information Portals, and European guidelines. A governance framework for scalable content creation and review processes supported by AI tooling will be established. The consortium partners, including several patient organisations, will ensure that the patients’ view is reflected in the content review and technology usability aspects. The EU-CIP Central and local nodes will be built in a modular fashion to allow integration with existing electronic health infrastructures. To align with the EU Cancer Mission goal to improve lives through prevention, EU-CIP will raise awareness about the Mission and Europe’s Beating Cancer Plan. Alignment with the Mission’s overall plans will be realized through collaboration with the EU funded projects of the related 01-01/01-02 calls.