Ethical and secure evidence generation from regionwide clinical data through a collaborative environment for...

Area of Science:

• Health Informatics
• Clinical Research
• Data Privacy

Background:

• Sensitive patient data in clinical research poses significant data protection challenges.
• Secure Processing Environments (SPEs) are crucial for ethical and compliant secondary use of Real-World Data (RWD).
• Existing infrastructure often lacks integrated legal and computational frameworks for large-scale RWD utilization.

Purpose of the Study:

• To present a collaborative infrastructure, the Andalusian Platform for Medical Evidence Generation, as an SPE.
• To demonstrate the platform's capability for secure, large-scale clinical studies using RWD.
• To ensure compliance with General Data Protection Regulation (GDPR) and prepare for European Health Data Space (EHDS) requirements.

Main Methods:

• Integration of a comprehensive Health Population Database (BPS) with a legal and computational framework.
• Leveraging RWD from over 15 million patients within the Andalusian healthcare network.
• Processing data within a secure ecosystem to prevent unauthorized access and ensure legal compliance.

Main Results:

• The platform supports diverse clinical studies, including treatment efficacy, survival analyses, and predictive modeling.
• Demonstrated alignment with GDPR and proactive design for EHDS.
• Enabled legally compliant research collaborations and secure data processing.

Conclusions:

• The presented SPE offers a scalable model for secure, data-driven healthcare innovation at a regional level.
• The platform supports cost-effective predictive models, particularly for aging populations.
• This approach establishes a blueprint for regional and international adaptation, fostering knowledge generation and economic growth.