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.

The public-private partnership, READI, seeks to help clinical studies (CS) to finally serve the complete general population, and therefore more patients. To date CS have struggled to recruit and retain participants from diverse backgrounds and communities, such as marginalized or disadvantaged groups (e.g., sexual, gender, age, cultural, and socioeconomic cohorts). The resulting knowledge gaps entrench or increase health disparities. The READI consortium strives to tackle these challenges by fostering a more cohesive and integrated CS ecosystem for underserved (US) and underrepresented (UR) communities. It will actively connect all key stakeholders who can facilitate access to a wide range of patient populations. It will provide these stakeholders with the necessary tools, training programs, and approaches essential for the recruitment and retention of US/UR patients in CS. In addition, it will design, build and implement a digital platform which is patient-centred, sustainable, open and innovative. This will foster improved access to CS information and READI tools, while also supporting patient connections with the created communities. Finally, at least 4 CS will be used for testing the effectiveness of the developed tools and approaches. READI has a three-fold objective: to help US/UR communities overcome CS participation barriers (e.g., lack of information/awareness, mistrust, poor communication, geographic limitations, prejudice), which in turn will improve research of many diseases and conditions, preventative care and treatment effectiveness in different demographic groups, and better serve society. READI’s success will draw from its interdisciplinary, multi-stakeholder, consortium composition of 73 organizations from 18 countries, with key expertise in drug development and CS (design and operations), engagement strategies for US/UR populations, digital platform development, training and capability building initiatives, effective communication and dissemination, long-term sustainability, ethics and regulatory affairs.

Healthcare is the fasted growing EU27 expenditure. Personalised medicine, comprising tailored approaches for prevention, diagnosis, monitoring and treatment is essential to reduce the burden of disease and improve the quality of life. Integration of multiple data types (multimodal data) into artificial intelligence models is required for the development of accurate and personalised interventions. This is particularly true for the inclusion of genomic data, which is information-rich and individual-specific, and more routinely available as the cost of sequencing continues to fall. Multimodal data integration is complex due to privacy & governance requirements, the presence of multiple standards, distinct data formats, and underlying data complexity and volume. NextGen tools will remove barriers in data integration several cardiovascular use cases. NextGen deliverables will include tooling for multimodal data integration and research portability, extension of secure federated analytics to genomic computation, more effective federated learning over distributed infrastructures, more effective and accessible tools for genomic data analysis; improved clinical efficiency of variant prioritisation; scalable genomic data curation; and improved data discoverability and data management. A comprehensive gap analysis of the existing landscape, factoring ongoing initiatives will ensure NextGen deliverables are forward-looking and complementary. NextGen embedded governance framework and robust regulatory processes will ensure secure multi-jurisdictional multiomic multimodal data access aligned with initiatives including “1+ Million Genomes” and the European Health Data Space. Several real-world pilots will demonstrate the effectiveness of NextGen tools and will be integrated in the NextGen Pathfinder network of five collaborating clinical sites as a self-contained data ecosystem and comprehensive proof of concept.

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.

The FLUTE project will advance and scale up data-driven healthcare by developing novel methods for privacy-preserving cross-border utilization of data hubs. Advanced research will be performed to push the performance envelope of secure multi-party computation in Federated Learning, including the associated AI models and secure execution environments. The technical innovations will be integrated in a privacy-enforcing platform that will provide innovators with a provenly secure environment for federated healthcare AI solution development, testing and deployment, including the integration of real world health data from the data hubs and the generation and utilization of synthetic data. To maximize the impact, adoption and replicability of the results, the project will contribute to the global HL7 FHIR standard development, and create novel guidelines for GDPR-compliant cross-border Federated Learning in healthcare. To demonstrate the practical use and impact of the results, the project will integrate the FLUTE platform with health data hubs located in three different countries, use their data to develop a novel federated AI toolset for diagnosis of clinically significant prostate cancer and perform a multi-national clinical validation of its efficacy, which will help to improve predictions of aggressive prostate cancer while avoiding unnecessary biopsies, thus improving the welfare of patients and significantly reducing the associated costs. Team. The 11-strong consortium will include three clinical / data partners from three different countries, three technology SMEs, three technology research partners, a legal/ethics partner and a standards organization. Collaboration. In accordance with the priorities set by the European Commission, the project will target collaboration, cross-fertilization and synergies with related national and international European projects.