Sharing sensitive research data in the practice of personalised medicine

Abstract

Fragmentation of health data and biomedical research data is a major obstacle for precision medicine based on data-driven decisions. The development of personalized medicine requires the efficient exploitation of health data resources that are extraordinary in size and complexity, but highly fragmented, as well as technologies that enable data sharing across institutions and even borders. Biobanks are both sample archives and data integration centers. The analysis of large biobank data warehouses in federated datasets promises to yield conclusions with higher statistical power. A prerequisite for data sharing is harmonization, i.e., the mapping of the unique clinical and molecular characteristics of samples into a unified data model and standard codes. These databases, which are aligned to a common schema, then make healthcare information available for privacy-preserving federated data sharing and learning. The re-evaluation of sensitive health data is inconceivable without the protection of privacy, the legal and conceptual framework for which is set out in the GDPR (General Data Protection Regulation) and the FAIR (findable, accessible, interoperable, reusable) principles. For biobanks in Europe, the BBMRI-ERIC (Biobanking and Biomolecular Research Infrastructure - European Research Infrastructure Consortium) research infrastructure develops common guidelines, which the Hungarian BBMRI Node joined in 2021. As the first step, a federation of biobanks can connect fragmented datasets, providing high-quality data sets motivated by multiple research goals. Extending the approach to real-word data could also allow for higher level evaluation of data generated in the real world of patient care, and thus take the evidence generated in clinical trials within a rigorous framework to a new level. In this publication, we present the potential of federated data sharing in the context of the Semmelweis University Biobanks joint project. Orv Hetil. 2023; 164(21): 811-819.