The European Health Data Space and biobanking in Europe: synergies, tensions and the future governance of data-driven health research

作者：Laura Grech, Nikolai Paul Pace · 发表于：Frontiers in Genetics · 年份：2026 · DOI：10.3389/fgene.2026.1932078 · 研究领域：Ethics in Clinical Research、Genomics and Rare Diseases、BRCA gene mutations in cancer

The European Health Data Space (EHDS) represents the most ambitious attempt to date to create a common legal, technical and governance framework for the use of health data across the European Union. Its adoption creates a new infrastructure for both primary use, focusing on cross-border access to electronic health records for care, and secondary use, centred on research, innovation, public health, regulatory science and policymaking. In parallel, European biobanking has matured into a core research infrastructure supporting genomic medicine, biomarker discovery, rare disease research and precision public health. The convergence of EHDS-enabled electronic health records, BBMRI-ERIC-associated biobanks, and the 1+ Million Genomes initiative offers a plausible route towards federated, large-scale, molecularly informed health systems in Europe. This article critically examines that opportunities and challenges arising from this convergence. It argues that the EHDS and biobanking are complementary but not automatically interoperable. Biobanks provide depth: biospecimens, molecular assays, longitudinal cohorts and consented research infrastructures. The EHDS provides breadth: population-scale clinical trajectories, regulatory gateways, Health Data Access Bodies and Secure Processing Environments. The 1+ Million Genomes and Genomic Data Infrastructure initiatives provide a genomics-specific federated layer that may connect these ecosystems through standards such as GA4GH, Beacon, Ph...