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

Ensuring data protection is a major challenge in clinical research involving sensitive patient information. However, secure processing environments (SPEs) enable the ethical and compliant secondary use of real-world data (RWD) for evidence generation. This study presents a collaborative infrastructure integrating a comprehensive Health Population Database (BPS) with a legal and computational framework to facilitate secure, large-scale clinical studies. The Andalusian Platform for Medical Evidence Generation is an SPE embedded within the Andalusian healthcare network, leveraging RWD from over 15 million patients from the BPS. It supports diverse studies, including treatment efficacy, survival analyses, and predictive modeling, while ensuring alignment with the General Data Protection Regulation (GDPR) and proactively designed to meet forthcoming European Health Data Space (EHDS) requirements. Data are processed within a secure ecosystem, preventing unauthorized access and enabling legally compliant research collaborations. By combining clinical RWD with a robust ethical and legal framework, we present a scalable model for secure, data-driven region-level healthcare innovation. The platform supports cost-effective predictive models, particularly relevant for aging populations, and establishes a blueprint for regional and international adaptation. This approach strengthens the role of healthcare systems in both knowledge generation and sustainable economic growth, ensuring that patient data is leveraged for scientific and societal benefit.