Striking the Balance: Genomic Data, Consent and Altruism in the European Health Data Space

Striking the Balance: Genomic Data, Consent and Altruism in the European Health Data Space
Book Chapter
Eila El Asry, Juli Mansnérus, Sandra Liede
The European Health Data Space, 2025 [Taylor & Francis]
Abstract
The Data Governance Act (DGA) defines data altruism as sharing of data for purposes of general interest without seeking or receiving reward. The consent of the data subject is required if personal data is shared within the context of data altruism. Simultaneously, the European Health Data Space (EHDS) sets as one of its objectives to ensure a consistent and efficient framework for the secondary use of health data for the purposes of, inter alia, research, innovation and regulatory activities, thus at least partly sharing common goals with the concept of data altruism. The sharing of health data under the EHDS for secondary use is however not in principle based on the individual’s consent, though the final text includes an opt-out mechanism. This chapter discusses the compatibility of and relation between the data subject consent requirements in the DGA, GDPR and EHDS. While there is huge potential in the advanced use of genomic data for innovative biomedical research, advanced analytics and access to digitised and personalised healthcare, genetic data is inherently sensitive. Balancing the data subjects’ self-determination rights with the critical need for access to valuable data that can potentially save lives presents a significant challenge in this context.