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 SHIELD project seeks to revolutionise early detection of pancreatic cancer, focusing on individuals with high heritable genetic risk. Pancreatic ductal adenocarcinoma (PDAC) has a 5-year survival rate of less than 10%, primarily due to late-stage diagnosis. Consequently, 85% of PDAC cases are identified too late for curative treatment. However, early detection can significantly improve outcomes, increasing the survival rate to 42% with surgical intervention. There is a pressing need for better early detection methods, especially for those with familial or genetic predispositions. The only FDA-approved biomarker, CA19-9, is limited to monitoring treatment response due to its lack of sensitivity and specificity, while imaging methods ofter fail to detect early-stage cancers and cause a strain to the healthcare system due to their cost and limited availability. SHIELD aims to validate a new blood-based diagnostic test designed for early PDAC detection in high-risk individuals and pilot an early detection programme in Greece, Slovenia and Lithuania. Developed by partner Reccan, this test uses a 5-plex multiple immunoassay to analyze protein readouts and provides a probability score for pancreatic cancer. Initial studies with over 450 samples showed excellent performance with >91% sensitivity and >96% specificity. The project will validate the test's clinical performance in a prospective multi-center study across seven EU countries, targeting individuals with familial or genetic predispositions. It will also identify new protein biomarkers for other high-risk indications, such as new-onset diabetes (NOD). Collaboration with national screening authorities will help integrate this test into existing programs, and partnerships with patient organizations will enhance recruitment. SHIELD envisions transforming pancreatic cancer diagnostics by increasing the 5-year survival rate to 30% by 2035 in Europe. This action is part of the Cancer Mission cluster of projects on “Prevention & early detection (early detection heritable cancers)

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.

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.

The goal of BPR4GDPR is to provide a holistic framework able to support end-to-end GDPR-compliant intra- and inter-organisational ICT-enabled processes at various scales, while also being generic enough, fulfilling operational requirements covering diverse application domains. To this end, proposed solutions will have a strong semantic foundation and cover the full process lifecycle addressing major challenges and priorities posed by the regulation, including requirements interpretation, broad territorial scope, accountability, security means enforcement, data subject’s rights and consent, unified data view and processing actions inventory, privacy by design, etc. The starting point will be process models, either automatically discovered through organisation logs or manually specified, formally expressed through a Compliance Metamodel, a comprehensive process modelling technology able to capture advanced privacy provisions. Thereupon, a highly expressive policy framework will guide the automatic verification of these models regarding GDPR requirements, and their subsequent transformation, so that they are rendered inherently privacy-aware before being deployed for execution. Subsequently, the consistent execution of GDPR-compliant processes will be ensured by a comprehensive set of tools able to support all diverging requirements that may arise from GDPR, related to data handling, data subjects’ involvement, various PETs, etc., so that even organisations with currently no such infrastructure in place can readily have such mechanisms. Finally, process mining will be extensively used for the ex post analysis of processes, in order to ensure that specified policies are indeed enforced. However, apart from verifying compliance, such techniques will offer the added value of automatically improving process models over time towards optimised fulfillment of both legal and business requirements. Deployed on the Cloud, BPR4GDPR will provide for Compliance-as-a-Service (CaaS)