Lessons Learned From European Health Data Projects With Cancer Use Cases: Implementation of Health Standards and...

Area of Science:

• Health Informatics
• Artificial Intelligence in Healthcare
• Data Standardization and Interoperability

Background:

• The European Health Data Space (EHDS) regulation mandates health data integration for primary and secondary uses, including AI model training for cancer prevention and personalized treatment.
• EU-funded cancer projects face significant challenges due to fragmented data, lack of standardized metadata, storage, access, and processing protocols.
• Existing initiatives aim to harmonize heterogeneous health data analysis in alignment with EHDS implementation, particularly for secondary data use (EHDS2).

Purpose of the Study:

• To examine interoperability standards adopted by six EU-funded cancer projects (IDERHA, EUCAIM, ASCAPE, iHelp, BigPicture, HealthData@EU pilot) in relation to EHDS2.
• To assess the adoption of health standards and Internet of Things (IoT) semantic interoperability within these projects.
• To develop a template for the EHDS2 interoperability framework, aligning with the European Interoperability Framework (EIF) and EHDS governance.

Main Methods:

• Conducted meetings and workshops with six EU-funded cancer projects from October 2023 to July 2024 to discuss health standards and IoT semantic interoperability.
• Focused discussions on health data interoperability standards, knowledge graphs, data quality frameworks, patient-generated health data, AI reasoning, federated approaches, security, and privacy.
• Developed a template mapping EHDS2-recommended standards to the EIF model and ISO standards, and analyzed its application across the studied projects.

Main Results:

• Identified challenges and innovative approaches to interoperability among EU cancer projects.
• Developed a template for the EHDS2 interoperability framework, aligning with EIF and EHDS governance standards, and linking data quality frameworks to ISO standards.
• Facilitated knowledge exchange on standards, legal implementation, sustainability, and EHDS2 harmonization through HSbooster.eu support.

Conclusions:

• The developed template and lessons learned will form an interactive toolkit to guide projects in aligning with EHDS2 technical and legal requirements.
• Standardization efforts, including contributions to ISO/IEC 21823-3 and ISO/PWI 24051-2 for digital pathology and AI, are crucial for global adoption.
• This work provides a foundation for a common EHDS2 interoperability framework, enhancing data integration and AI development in cancer research and care.