The EU legal framework for using artificial intelligence and imaging databases and imaging biobanks for research purposes: applying the notion of Fairness
PDF
XML

Keywords

Artificial intelligence
Right to health
Legislation as topic

DOI:

https://doi.org/10.17566/ciads.v13i4.1288

How to Cite

1.
The EU legal framework for using artificial intelligence and imaging databases and imaging biobanks for research purposes: applying the notion of Fairness. Cad. Ibero Am. Direito Sanit. [Internet]. 2024 Nov. 20 [cited 2025 Apr. 30];13(4):124-40. Available from: https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/1288

Abstract

Objective: To analyze the issue of justice and discrimination in artificial intelligence systems based on medical image databases. Methodology: Analysis of documents that constitute the regulatory framework of the European Union for the use of artificial intelligence, compared with the report FUTURE-AI: Guiding Principles and Consensus Recommendations for Trustworthy Artificial Intelligence in Medical Imaging. Results: The study indicates that artificial intelligence trained with unbalanced data tends to generate biased predictions, which can exacerbate health inequalities and affect justice. Discrimination in artificial intelligence systems appears abstract, subtle, and difficult to detect compared to traditional forms of discrimination. Final Considerations: Robust regulation is necessary to ensure justice in artificial intelligence systems, considering the need for interdisciplinary collaboration to prepare this new generation of legal professionals with an enhanced perspective on the topic and its various dimensions.

Submission: 10/01/24| Review: 10/04/24| Approval: 10/04/24

PDF
XML

References

European Union. Regulation (EU) 2024/1689 of the European Parliament and of the Council of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act). European Union [Internet]. Jun. 12, 20124 [cited 2024 Sep 30]. Available from: https://eur-lex.europa.eu/eli/reg/2024/1689/oj

Klamert, Marcus, and Alexandre-Xavier-Pierre Lewis. Article 28 TFEU. In: Kellerbauer M, Klamert M, Tomkin J (eds). The EU Treaties and the Charter of Fundamental Rights: A Commentary. New York: Oxford Academic [Internet], 2019. [cited 2024 Sep 30]. Available from: https://doi.org/10.1093/oso/9780198759393.003.104

OECD. Best Practice Guidelines for Biological Resource Centers. Paris: OECD Publications, 2007. Available from: https://www.oecd-ilibrary.org/science-and-technology/oecd-best-practice-guidelines-for-biological-resource-centres_9789264128767-en

European Strategy Forum for Research Infrastructures. ROADMAP 2011. Strategy Report on Research Infrastructure. Milano: ESFRI, Dipartimento di Fisica – Università degli Studi di Milano, 2021, 243 p. Available from: https://roadmap2021.esfri.eu/media/1295/esfri-roadmap-2021.pdf

Perry M. Accessing accessions, biobanks and benefit‐sharing. In: Pascuzzi G, Izzo U, Macilotti M. Biobanks. Springer: 2013, p. 267.

European Society of Radiology (ESR). ESR Position Paper on Imaging Biobanks. Insights Imaging [Internet]. 2015 Aug. [cited 2024 Sep 30]; 6(4):403-10. DOI: 10.1007/s13244-015-0409-x

Borgheresi R, Barucci A, Colantonio S, Aghakhanyan G, Assante M, Bertelli E, et al. NAVIGATOR: an Italian regional imaging biobank to promote precision medicine for oncologic patients. Eur Radiol Exp [Internet]. 2022 Nov. [cited 2024 Sep 30]; 8;6(1):53. DOI:10.1186/s41747-022-00306-9.

Gaskell G, Allum N, Bauer M, Durant J, Allansdottir A, Bonfadelli H et al. Biotechnology and the European public. Nat Biotechnol [Internet]. 2000 [cited 2024 Sep 30]; 18(9):935-8. DOI: 10.1038/79403

Slokenberga S, Tzortzatou O, Reichel J. GDPR and Biobanking: Individual Rights, Public Interest and Research Regulation across Europe. Cham Springer. 2021, p. 1.

Wright J, Ploem C, Śliwkac M, Geversb S. Regulating Tissue Research: Do We Need Additional Rules to Protect research Perticipants? European Journal of Healt Law [Internet]. 2010 [cited 2024 Sep 30]; 17(5):455-469. Available from: https://doi.org/10.1163/157180910X525295

European Commission. Communication From The Commission To The European Parliament, The European Council, The Council, The European Economic And Social Committee And The Committee. Of The Regions Artificial Intelligence for Europe COM(2018) 237 final. European Union [Internet]. 2018 [cited 2024 Sep 30]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=COM%3A2018%3A237%3AFIN

European Commission. Communication From The Commission To The European Parliament, The Council, The European Economic And Social Committee And The Committee Of The Regions Empty Building Trust In Human-Centric Artificial Intelligence. Com (2019) 168 Final. European Union [Internet]. 2019 [cited 2024 Sep 30]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A52019DC0168

European Commission. WHITE PAPER On Artificial Intelligence - A European approach to excellence and trust. Com (2020) 65 final. European Union [Internet]. 2020 [cited 2024 Sep 30]. Available from: https://commission.europa.eu/document/download/d2ec4039-c5be-423a-81ef-b9e44e79825b_en?filename=commission-white-paper-artificial-intelligence-feb2020_en.pdf

European Commission. Regulation of the European Parliament and of the council. Laying down Harmonised Rules on Artificial Intelligence (artificial intelligence act) and Amending Certain Union Legislative Acts. Com (2021) 206 final. European Union [Internet]. Apr. 21, 2021 [cited 2024 Sep 30]. Available from: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52021PC0206

European Commission. ALTAI portal. Futurium [Internet]. 2024 [cited 2024 Sep 30]. Available from: https://futurium.ec.europa.eu/en/european-ai-alliance/pages/altai-assessment-list-trustworthy-artificial-intelligence

European Commission. Ethics guidelines for trustworthy AI. Publications Office [Internet]. 2019 [cited 2024 Sep 30]. Available from: https://data.europa.eu/doi/10.2759/346720

Permanent Representatives Committee. 5808/19 COMPET 75 MI 70 IND 22 DIGIT 15 JUSTCIV 26 RECH 56 EDUC 33. Artificial intelligence: b) Conclusions on the coordinated plan on artificial intelligence-Adoption. Council of the European Union. 2019 [cited 2024 Sep 30]. Available from: https://data.consilium.europa.eu/doc/document/ST-6177-2019-INIT/en/pdf

Sandra Wachter, Brent Mittelstadt, Chris Russell, Why fairness cannot be automated: Bridging the gap between EU non-discrimination law and AI. Computer Law & Security Review [Internet]. 2021 [cited 2024 Sep 30]; 41: 1-72 Available from: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3547922

Lekadir K, Osuala R, Gallin C, Lazkrak N, Kushibar K, Tsakou G, et al. FUTURE-AI: Guiding Principles and Consensus Recommendations for Trustworthy Artificial Intelligence in Medical Imaging. Arxiv [Internet]. 2024 [cited 2024 Sep 30]; 1: 1-54. Available from: https://arxiv.org/abs/2309.12325

Larrazabal AJ, Nicolás Nieto, Peterson V, Milone DH, Ferrante E. Gender imbalance in medical imaging datasets produces biased classifiers for computer-aided diagnosis. Proceedings of the National Academy of Sciences [Internet]. 2020 [cited 2024 Sep 30]; 117(23):12592–12594. DOI: 10.1073/pnas.1919012117

Puyol-Antón E, Ruijsink B, Piechnik SK, Neubauer S, Petersen SE, Razavi R, et al. Fairness in cardiac mr image analysis: An investigation of bias due to data imbalance in deep learning-based segmentation. In: de Bruijne M, Cattin PC, Cotin S, Padoy N, Speidel S, Zheng Y, et al. Medical Image Computing and Computer Assisted Intervention – MICCAI 2021. MICCAI 2021. Lecture Notes in Computer Science [Internet]: Springer. 2021 [cited 2024 Sep 30]. Available from: https://doi.org/10.1007/978-3-030-87199-4_39

L Burzagli, User. In the context of biobanks who are the users and which factors relate to the human component to consider? (in printing). Arnold R, Cippitani R, Colcelli V, Brochhausen C (eds.). Paper accepted for the publication in GDPR Requirements for Biobanking Activities Across Europe Handbook. Cham: Springer International Publishing, 2022.

Geis JR, Brady AP, Wu CC, Spencer J, Ranschaert E, Jaremko JL, et al. Ethics of Artificial Intelligence in Radiology: Summary of the Joint European and North American Multisociety Statement. Canadian Association of Radiologists Journal [Internet]. 2019 [cited 2024 Sep 30]; 70(4), 329-334. Available from: https://doi.org/10.1016/j.carj.2019.08.010, p.3-4

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Copyright (c) 2024 Valentina Colcelli (Autor)