The Regulatory Vacuum of Research Biobanks: Between Grey Areas and Future Developments in Health Data

Abstract

Research biobanks, fundamental engines for scientific progress, managing vast quantities of biological samples and associated data. Despite their importance, they suffer from a significant regulatory vacuum, lacking a specific and organic discipline. Currently, their regulation is fragmented between national healthcare standards and the complex technicalities of personal data protection. This paper analyzes the existing legal framework and the current gaps, focusing on recent regulatory evolutions. If correctly interpreted, these innovations could disruptively influence the operations of biobanks, offering crucial perspectives to fill existing legal uncertainties while enhancing modern scientific research.