Biobanks, personalised medicine, and artificial intelligence: legal and ethical perspectives

Abstract

Biobanks and personalised medicine have become central pillars of contemporary biomedical research, reflecting a broader ambition to move towαrds more precise, preventive, and patient-centred healthcare models. By enabling the large-scale collection and long-term storage of biological samples and associated data, biobanks provide the foundational infrastructure required for advances in genomics, precision therapies, and data-driven medical innovation. The integration of artificial intelligence (AI) into this ecosystem further amplifies their potential, while simultaneously raising complex legal and ethical challenges. This article examines the evolving role of biobanks in personalised medicine through a legal and ethical lens, with particular attention to the regulatory fragmentation that characterises this field at the international level. Despite the existence of accreditation standards and ethical declarations developed by international organisations, biobanks remain primarily governed by national legal frameworks. This lack of harmonisation results in significant differences between jurisdictions regarding consent models, data protection safeguards, international data sharing, and the involvement of private actors. Through a comparative analysis of selected countries, including France, Sweden, and the United States, the article highlights how divergent regulatory approaches shape both research practices and the protection of individual rights. Ultimately, this study argues that the sustainable development of biobanks and AI enabled personalised medicine depends on robust governance mechanisms, transparent consent practices, and strong ethical oversight. Ethics committees, legal safeguards, and international cooperation remain essential to ensuring that innovation in this field benefits society as a whole without undermining individual rights or social equity.

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