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


Veröffentlicht: Μαρ 30, 2026
Karl-Philippe Bretel
https://orcid.org/0009-0003-6525-6584
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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Annaratone L, Arcella P, Barberis M, Berrino E, Bonizzi G, Botti G, Canzonieri V, Daidone MG, De Palma G, Di Martino S, Mannelli C, Marchio C, Paradiso AV, Parodi B, Sapino A, Steffan A. Biobanking for precision medicine in oncology. SpringerLink, 13.7.2021: https://www.researchgate.net/figure/Biobanking-for-precision-medicine-in-oncology-Practical-example-of-the-potential-of_fig2_353222206#:~:text=Biobanking%20involves%20collecting%2C%20storing%2C%20and,personalised%20treatment%20decisions%20%5B57%5D%20
Arrighi N, Messaoudi Z, Soltani N. Bioéthique: l’existence des contraintes légales et réglementaires des biobanks / Legal and ethical considerations for the use of biobanks. Med Sci (Paris), 2020, 36: https://www.medecinesciences.org/en/articles/medsci/full_html/2020/03/msc200050/msc200050.html#:~:text=Le%20cadre%20juridique%20des%20biobanques,-%C3%80%20ce%20jour&text=R%C3%A9form%C3%A9e%20avec%20la%20loi%20n,souches%20embryonnaires%20%C2%BB%20%5B3%5D.
Arrighi N, Messaoudi Z, Soltani N, Arrighi N. Bioéthique: l’existence des contraintes légales et réglementaires des biobanques. Med Sci (Paris), 3.2020: https://www.medecinesciences.org/fr/articles/medsci/pdf/2020/03/msc200050.pdf
BBMRI-ERIC. Member States National Nodes Contact forLocal Biobanks. BBMRI-ERIC, 2024: https://www.bbmrieric.eu/national-nodes/
Bercy Infos.Le règlement général sur la protectiondes données (RGPD), mode d’emploi. economie.gouv,11.4.2023:https://www.economie.gouv.fr/entreprises/reglement-general-protection-donnees-rgpd#
Biobanking.org.10 Largest Biobanks in the World. Biobanking.org,17.9.2021: https://www.biobanking.com/10-largest-biobanks-in-the-world/
Biobank Sweden. About Biobank Sweden. Biobank Sweden, 26.2.2024: https://biobanksverige.se/en/about-biobank-sweden/
Biobank Sweden. Document, change of consent. Biobank Sweden, 2024: https://biobanksverige.se/en/documents/
Bruxant M.12 milliards économisés dans le domaine de la santé grâce à l’intelligence artificielle ? Mathieu Michely croit. RTL Info, 6.2.2024: https://www.rtl.be/actu/belgique/politique/12-milliards-economises-dans-le-domaine-de-la-sante-grace-lintelligence/2024-02-06/article/634841
Cadigan RJ, Conlon I, Davis AM, Edwards TP, Evans JP, Henderson GE, Nelson AG, Weiner BJ, Zimmer C. Characterizing biobank organizations in the U.S.: results from a national survey. Genet Med, 1.2013: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3706795/
Centre Hospitalier Universitaire de Clermont-Ferrand. Consentement libre et éclairé. Centre Hospitalier Universitaire de Clermont-Ferrand, 2024: https://www.chu-clermontferrand.fr/consentement-libre-et-eclaire
Cohorte Constance.BIOBANQUE. Cohorte Constance, 2024: https://www.constances.fr/espace-scientifique/biobanque/
CORDIS.Final Report Summary – PERMED (Personalised Medicine 2020 and Beyond – Preparing Europe for Leading the Global Way). European Commission, 2024: https://cordis.europa.eu/project/id/602139/reporting/fr
Council for International Organisations of Medical Sciences, World Health Organisation. International Ethical Guidelines for Health-related Research Involving Humans. CIOMS, 2016: https://cioms.ch/wp-content/uploads/2017/01/WEB-CIOMS-EthicalGuidelines.pdf
Dagher G. Biobanking and bioresources ISO TC 276/WG2. INSERM, 7.2017: https://regepe.cirad.fr/content/download/4204/31537/version/1/file/170905_presentation+norme+ISO+20387+b.pdf
Delmont-Koropoulis A. Proposition de loi relative à l’innovation en santé. Sénat, 16.2.2022: https://www.senat.fr/rap/l21-498/l21-4985.html
European Commission. Artificial Intelligence Act. European Commission, 13.3.2024: https://www.europarl.europa.eu/doceo/document/TA-9-2024-0138_EN.pdf
Global Market Insights. Artificial Intelligence in Healthcare Market Size. Global Market Insight, 6.2024.: https://www.gminsights.com/industry-analysis/healthcare-artificialintelligence-market
Global Market Insights. Artificial Intelligence in Precision Medicine Market Size. Global Market Insights, 6.2023: https://www.gminsights.com/industry-analysis/artificialintelligence-in-precision-medicine-market
Global Market Insights. Taille du marché de la médecine de précision. Global Market Insights, 4.2024: https://www.gminsights.com/fr/industry-analysis/biobanking-market
Harrell HL, Rothstein MA. Biobanking Research and Privacy Laws in the United States. J Law Med Ethics, 3.2016: https://pubmed.ncbi.nlm.nih.gov/27256128/
Haunschild R, Kays J, Rõgo L, Kays M., Bibliometric analysis of publications that cited the CIOMS 2016 “International ethical guidelines for health-related research involving humans”.Heliyon 2024, 10(17): e36833, 15.9.2024: https://www.sciencedirect.com/science/article/pii/S2405844024128642#:~:text=The%20Council%20for%20International%20Organizations,attention%20to%20low%2Dresource%20settings.
IBM. What Is Artificial Intelligence (AI)?. IBM, 2024.: https://www.ibm.com/think/topics/artificial-intelligence
ISBER.ISBER – Annual Report 2023. ISBER, 2023.
ISO.ISO 20387:2018 Biotechnology — Biobanking — General requirements for biobanking. Online Browsing Platform (OBP), 2018: https://www.iso.org/obp/ui/en/#iso:std:iso:20387:ed-1:v1:en
Jordan B.Cancer : les trois époques de la médecine personnalisée / Chroniques génomiques – Cancer: trois époques de la médecine personnalisée.Med Sci (Paris) 2017, 33(10): https://www.medecinesciences.org/en/articles/medsci/full_html/2017/08/medsci20173310p905/medsci20173310p905.html
Lyle L. Revived USA Health Biobank offers comprehensive services for researchers. University of South Alabama, 19.1.2021.: https://www.usahealthsystem.com/news/revived-usa-health-biobank
Market and Market. Precision Medicine Market. Market and Market, 9.2023.: https://www.marketsandmarkets.com/Market-Reports/precision-medicine-market-215185595.html
Ministry of Health and Social Affairs of Sweden. A New Biobank Act. Biobank SVERIGE, 16.2.2023: https://biobanksverige.se/en/research/a-new-biobank-act/
Ministry of Health and Social Services. 45 FR § 164.506 –Uses and disclosures to carry out treatment, payment, or health care operations. Cornell Law School Legal Information Institute, 1.25: https://www.law.cornell.edu/cfr/text/45/164.506
Musso M. Former les « biobankers » de demain. Université Côte d’Azur, 2024: https://newsroom.univ-cotedazur.fr/actualites-evenements/former-les-biobankers-de-demain
OneTrust. Sweden. OneTrust Data Guidance 2024: https://www.dataguidance.com/jurisdiction/sweden
Precedence Research. Biobanking Market Size, Share, and Trends 2024 to 2034. Precedence Research, 2023.: https://www.precedenceresearch.com/biobanking-market
Reichel J, Slokengerga S, Tzortzatou O. Sweden, GDPR and Biobanking: Individual Rights, Public Interest and Research Regulation across Europe. Springer, 1.2021.
Sprumont D, Talanova V. La réglementation des biobanques et des banques de données de santé en Europe: Étude de droit comparé. Online Federal Public Health Platform (OFSP), 14.6.2018.
University of British Columbia Office of Biobank Education Research, Canadian Tissue Repository Network.BIOBANK RESSOURCE CENTER biobanking.org, 2024.: https://biobanking.org/locator#:~:text=There%20are%20currently%20374%20registered,list%20of%20other%20online%20resources
U.S. Government.45 CFR 46. Office for Human Research Protections, 2018.: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
World Medical Association. Members: Who Can Be a WMA Member? World Medical Association, 2026: https://www.wma.net/who-we-are/members/?letter=S
World Medical Association.WMA Declaration of Taipei on Ethical Considerations regarding Health Databases and Biobanks.World Medical Association, 10.2016: https://www.wma.net/policies-post/wma-declaration-of-taipeion-ethical-considerations-regarding-health-databasesand-biobanks/