Health systems today generate and collect vast amounts of health-related data. Simultaneously, research networks compile patient and/or population-level health data for various diseases in research cohorts. European research infrastructures like BBMRI and ECRIN work on harmonizing the collection of biological samples and promoting clinical trial development for broader researcher reuse. However, challenges such as dispersed data generation, ethical/legal constraints, unstructured clinical data, limited interoperability, and a lack of specific computing resources hamper health data's use in research.
Data sharing for secondary use, using data generated in healthcare systems not for care activities but for research, will be key driver of the digital revolution in health research. The convergence of health data availability and Big Data techniques is expected to revolutionize healthcare by facilitating unprecedented studies. This includes benefits for drug development, utilizing real-life effectiveness data of known drugs. Moreover, artificial intelligence models derived from high-quality FAIR (Findable, Accessible, Interoperable, and Reusable) data may enable novel decision support systems. The FAIRification of high-quality health data and its integration for secondary use could usher in a new era of personalized medicine, focusing on individual genetic profiles and their interactions with lifestyle and environmental factors. Crucially, FAIR data has the potential to enhance data-driven decision-making across the healthcare value chain, providing better-informed insights for researchers, healthcare professionals, regulators, HTA bodies, and policymakers, ultimately positively impacting healthcare organisation and management.
HealthyCloud aims to drive this convergence of health data availability and Big Data techniques and align health data expertise shared between European and international actors to lay the foundations for the future European Health Research and Innovation Cloud (HRIC). The HRIC will enable health data sharing, secondary use of health data and data analytics capabilities to push the boundaries of health research, within an ethically sound and legally compliant framework that fosters patient and citizen trust. To this end, HealthyCloud produced a Strategic Agenda based proposing the following services:
- A monitoring service for health-related research to periodically survey the landscape of data-driven health research activities in Europe, capturing developments and gathering feedback from research communities.
- A legal/regulatory guidance service to provide guidance, compliance support, and advocacy for collective interests for the use and re-use of health-related data for research, innovation and policy-making purposes.
- A metadata standards and data interoperability guidance service to Provision of information, training, and guidance for consistently using data and metadata standards, aiming to improve the findability and interoperability for data use and re-use.
- A health research community interface service, with the EOSC to set a reference point to foster the interaction between EOSC service providers and health researchers.
- and, a health research community interface service, with EHDS to establish a direct communication channel to facilitate the integration and adoption of European Health Data Space (EHDS) capabilities into health-related research communities.
