Building federated infrastructure of PROTECT-CHILD WP2!
The focus of Work Package 2 (WP2), Codesign and Multi-Stakeholder Requirements, is to ensure that the voices of all stakeholders from PROTECT-child are listened to shape the digital ecosystem considering its ethical and legal frameworks. Below you can find some key insights about our progress after 12 months of activities!
Why this matters: The challenge of data integration
The potential of genomic data to revolutionize transplant medicine is enormous, but so are the challenges. Fragmented data systems, strict privacy regulations, and the technical complexity of integrating data across different hospitals and countries present real barriers. To address these challenges, PROTECT-CHILD aims to build a digital ecosystem where sensitive clinical and genomic data can be securely managed, shared, and analyzed across institutions, all while complying with European regulatory standards such as the General data protection regulation (GDPR) and the upcoming European Health Data Space (EHDS).
But building such a system requires more than just software, it demands understanding what users need, what is technically feasible, and what is legally permissible. That’s where WP2 comes in.
Multi-stakeholder co-design
To ensure the PROTECT-CHILD platform will be both effective and usable, WP2 is employing a multi-step process centered on stakeholder involvement and evidence-based design. The process included:
- Systematic literature review: A PRISMA-based review of 53 articles provided the basis for identifying the functional and non-functional requirements essential to building a federated infrastructure for managing health and genomic data. The review highlighted three key functional requirrements such as data mangment, data pre-processing and analysis and data visuakization and reporting. Additionally, non-functional equirements such as communication and support, security and compliance, ux/ui characteristics, and technical infrastructure.
- Stakeholder survey: Fifty-two experts from clinical, technical, and legal domains assessed the importance and feasibility of 70+ requirements. The survey revealed consensus around several priorities, such as privacy-preserving techniques, automated data quality checks, and federated learning.
- Co-design workshop: Thirty-six stakeholders joined forces in a hands-on workshop to validate existing findings and propose practical solutions to data integration and governance challenges.
- User stories and prototypes: Insights were compiled and use to generate visual user stories using a Figma prototype. These will be used in future validation sessions to ensure continues alignment with stakeholder expectations.
- Definition of contractual frameworks: Based on stakeholder input, UDGA has identify three necessary contractual frameworks that are now under development: (1) Internal Data and Material Sharing Agreement: For use by pilot project teams (led by La Paz/SERMAS). (2) Project-wide Data Governance and Sharing Agreement: Establishing clear guidelines for data use across the whole consortium. (3) Exploitation Agreement: Clarifying how the PROTECT-CHILD DataSpace will be maintained and used after project funding ends. This will be developed before project closure.
- Definition of data model: By engaging in discussions with healthcare and clinical stakeholders through WP2 and WP8 meetings, the data model has been defined. DEUSTO is now initiating the design of an Entity–Relationship (ER) model to represent key entities and relationships.
What we learned: key findings
Through this multi-step, stakeholder-driven process, we learned that meaningful involvement from clinical, technical, legal, and patient communities is essential to ensuring that the PROTECT-CHILD infrastructure is both effective and usable. The combination of a systematic literature review and hands-on stakeholder engagement allowed us to identify and refine different functional and non-functional requirements. Across these activities, a clear consensus emerged around priorities such as privacy-preserving techniques, automated data quality checks, and federated learning, highlighting strong alignment between technical possibilities and stakeholder needs. Furthermore, early efforts to define contractual frameworks has emphasized the importance of legal clarity and governance in building trust and ensuring compliance across the partners in the project. Moreover, the development of the data model, guided by continuous engagement with clinical experts, ensured that the platform’s architecture supports real-world data capture and analysis needs. Collectively, these efforts show the value of combining evidence-based design with multi-stakeholder collaboration in building a robust, future-proof infrastructure.
What’s next: toward a usable, compliant platform
In the coming months, WP2 will focus on several activities to ensure continued progress and alignment. These include:
- Validate user stories and the prototype with clinical and non-clinical stakeholders, also involving patients, through follow-up workshops and interviews.
- Refine requirements in collaboration with technical teams and data holders to ensure feasibility and technical accuracy.
- Strengthen the alignment between tasks within the work package by translating high-level requirements into architectural and technical designs.
- Ensure alignment of requirements with legal and ethical regulations, as well as with the data model of the future system architecture.
- Continue mapping clinical observations to the OHDSI OMOP Common Data Model (CDM) and develop metadata elements in line with FAIR principles, adhering to the HEALTH-DCAT-AP specification to maximize dataset findability and interoperability.
The PROTECT-CHILD platform isn’t just a technical system, it’s a collaborative infrastructure built to support better, more ethical, and more effective care for some of Europe’s most vulnerable patients. WP2’s progress highlights the value of co-design, interdisciplinary input, and continuous iteration. As we move into the next phase, our focus remains clear: to develop a federated ecosystem that respects data privacy, empowers users, and accelerates innovation in pediatric transplant care.
Author: Valeria Resendez, University of Twente (UTW)
