Health Data-Driven Research - Time for a Stronger Human Rights Governance Structure?

Abstract

This article is inspired by Herman Nys's tireless academic insistence on the importance of human rights and fundamental ethical principles in biomedicine. It examines the evolving landscape of data-driven health research in Europe, using a recent Danish case involving large-scale access to electronic health records as a point of departure. The article explores whether existing European regulatory frameworks adequately safeguard the rights and freedoms of data subjects in contemporary research contexts. The article argues that while data-driven research is often justified by public interest, this concept remains underdefined and insufficiently aligned with patients' and citizens' expectations. It concludes that current legal instruments may not fully reflect the broader catalogue of human rights at stake, including dignity, integrity, and protection against discrimination. The article calls for a recalibration of safeguards and governance mechanisms, including stronger ethical review and participatory structures, to ensure that health data research respects both individual rights and collective imaginaries of technological development.