Italy

Fondazione Monasterio is a public research organization and healthcare provider of the Tuscany Regional Healthcare Service, Italy, established by the National Research Council (CNR) and the Tuscany Region. It operates across two hospitals (Pisa and Massa) and is a tertiary centre focused on the research, diagnosis, treatment, and prevention of cardiovascular and pulmonary diseases in both adults and children. Monasterio Foundation integrates advanced clinical care with cutting-edge biomedical and clinical research, emphasizing innovation, technology developments and transfers. Its core mission revolves around patient-centre fd care, combining clinical excellence with advancements in areas like medical informatics, bioengineering, advanced imaging (e.g., cardiovascular imaging), and the development of new diagnostic and therapeutic methods, including managing rare diseases within its specialty areas. Monasterio’s Hospitals are following a population of 462.000 patients form all the Italian regions and from all the EU and Mediterranean countries.
As an adoption site for the X-Share project, Fondazione Monasterio aims to leverage its expertise in managing complex clinical data and its advanced IT infrastructure to contribute to the development and implementation of the European Health Data Space (EHDS). Monasterio’s vision aligns with X-Share’s goal of empowering individuals through better access and control over their health data, facilitating research, and improving healthcare quality. By participating, Monasterio seeks to enhance its capabilities for secure and interoperable data sharing directly controlled by patients, contributing clinical use cases from its specialized domains (cardiopulmonary medicine, cardiac surgery, rare diseases, etc.) to test and validate the X-Share framework, particularly in the usage of the European Electronic Health Record Exchange Format (EEHRxF) and the “Yellow Button” concept.
Monasterio’s objectives within X-Share include piloting the secure sharing of specific health data categories using the EEHRxF, testing the Yellow Button functionalities for patient-mediated data sharing, and ensuring the practical applicability of the X-Share architecture within a complex hospital and research environment. This involvement supports Monasterio’s commitment to scientific leadership, innovation in healthcare, and contributing to a more connected and efficient European health data ecosystem.
Personas - use cases
Priority categories
Hospital Discharge Reports
Cardiovascular Imaging Reports
ePrescription
Laboratory reports
Yellow Button basic functionalities
Download Button added in FTGM Patient Portal /App related for each report to download:
- Reports in PDF format with embedded FHIR report and QRCODE
- EEHRxF Json structured format
Architecture
In yellow are reported components used from the general xShare architecture:

The yellow blocks referenced in the general architecture is implemented in the following diagram:

By connecting our architecture with YellowButton, we enhance the overall functionality and reach of our system, allowing for efficient communication and data sharing across a broader network.
Timeline
- BUC Definition - May 2024
- First Architecture for developments – October 2024
- Early tests for download functionality – November 2024
- First release for experimental testing (HL7 FHIR Document Builder for HDR Download) on FTGM Patient Portal/App – June 2025
- Second release for pilot testing for single Hospital on FTGM Patient Portal/App (HDR)– January 2026
- User Acceptance Testing (UAT) with Pilot Users – May 2026
- Third release for scaling-up testing and IHE validation on FTGM Patient Portal/App (HDR, Imaging)– June 2026
Kick-off & Requirements Finalisation – June 2025
Detailed Architecture Design & Alignment – July 2025
Development: HL7 FHIR Document Builder (Discharge Reports) – September 2025
Development: HL7 FHIR Document Builder (Other Reports) – September 2025
Development: PDF Generator & FHIR Embedding Logic – October 2025
Integration: EHR System to Report Generators – November 2025
Development: FTGM App Yellow Button Integration – December 2025
Internal System & Integration Testing – January 2026
User Acceptance Testing (UAT) with Pilot Users – February 2026
Pilot Go-Live (Discharge & Imaging Reports) – March 2026
Initial Monitoring & Feedback Phase – April 2026
Demonstrations / interviews
Challenges and Remarks
Fondazione Monasterio is committed to actively contributing to the X-Share project as an adoption site.
Moving forward, the primary focus for post-project activities will centre on formalizing the transition from pilot demonstrators to full-scale, sustainable production environments. This necessitates continuous alignment with the evolving European Health Data Space (EHDS) regulation, ensuring that all implemented systems strictly adhere to established EEHRxF standards. Future work will prioritize the hardening of existing architectures to guarantee long-term interoperability, data security, and compliance, while simultaneously fostering the adoption of these standards across the broader healthcare ecosystem to maximize cross-border utility and patient empowerment.
Challenges and Remarks for Post-Project Alignment:
- EHDS & EEHRxF Integration: Transitioning pilot-phase demonstrators into production environments that are fully compliant with the evolving EHDS regulation.
- Technical Scalability: Evolving from current interim, pragmatic architectures to robust, high-performance systems capable of near real-time ingestion and interoperability.
- Sustainability of Standards: Ensuring continuous mapping to EEHRxF/FHIR standards to avoid technical debt and maintain persistent cross-border data usability.
- Governance & AI Integration: Implementing long-term, GDPR-compliant data governance models that support the integration of advanced AI-based analytics and secondary data use.
- Organizational Collaboration: Sustaining the multi-disciplinary collaboration between clinical, IT, and research departments to ensure the long-term operational success of the ‘Yellow Button’ and patient-controlled data sharing functionalities.
Contact information
Paolo Marcheschi [email protected]
Stefano Dalmiani [email protected]