Informed consent in the age of artificial intelligence: Ethical challenges and the patient’s right to information
DOI:
https://doi.org/10.51660/riftp61392Keywords:
informed consent, artificial intelligence, right to information, patient autonomy, bioethicsAbstract
Background: The integration of artificial intelligence systems in the healthcare sector is transforming clinical decision-making processes, generating new challenges for patients’ fundamental rights. Informed consent, as a safeguard of patient autonomy, is being strained by technical complexity, algorithmic opacity, and automated decision-making, raising concerns about the effectiveness of the right to information in this new context. Methods: This study is conducted through a qualitative legal-doctrinal approach, based on a critical analysis of the current regulatory framework, particularly the General Data Protection Regulation and the European Union Artificial Intelligence Act, as well as a review of relevant academic literature and institutional reports on artificial intelligence and healthcare. The analysis focuses on the relationship between informed consent, the right to information, and automated decision-making systems. Results: The study highlights the limitations of the traditional model of informed consent in the context of the integration of artificial intelligence systems. It identifies phenomena such as algorithmic opacity, increased informational asymmetry, and difficulties in ensuring patients’ effective understanding. Furthermore, a mismatch is observed between current regulatory requirements and technological reality, which leads to the emergence of a merely formal or apparent form of consent. Conclusions: The findings demonstrate the need to reinterpret the patient’s right to information by incorporating criteria of effective understanding, operational explainability, and adaptation to contexts of high technological complexity. Informed consent must evolve toward a reinforced model capable of ensuring genuine patient autonomy in digitally mediated clinical environments.
Downloads
References
Barrio Cantalejo, I. M., Simón Lorda, P., Melguizo, M., & Escalona, I. (2008). Validación de la escala INFLESZ para evaluar la legibilidad de los textos dirigidos a pacientes. Anales del Sistema Sanitario de Navarra, 31(2), 135–152. https://scielo.isciii.es/scielo.php?script=sci_arttext&pid=S1137-66272008000300004 DOI: https://doi.org/10.4321/S1137-66272008000300004
Beauchamp, T. L., & Childress, J. F. (2019). Principles of biomedical ethics (8th ed.). Oxford University Press.
Centers for Disease Control and Prevention. (2024). Addressing bias in artificial intelligence in healthcare. https://www.cdc.gov/pcd/issues/2024/24_0245.htm
Cohen, I. G., & Slottje, P. (2023). Artificial intelligence and the law of informed consent. En StatPearls. StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK613199/ DOI: https://doi.org/10.4337/9781802205657.ch10
Council of Europe. (1997). Convention on Human Rights and Biomedicine (Oviedo Convention). https://www.coe.int/en/web/conventions/full-list?module=treaty-detail&treatynum=164
Council of Europe. (s. f.). Artificial intelligence and human rights. https://www.coe.int/en/web/artificial-intelligence
European Commission. (2022). Proposal for a regulation on the European Health Data Space. https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en
European Parliament and Council of the European Union. (2016). Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 (General Data Protection Regulation). https://eur-lex.europa.eu/eli/reg/2016/679/oj
European Parliament and Council of the European Union. (2024). Regulation (EU) 2024/1689 laying down harmonised rules on artificial intelligence (Artificial Intelligence Act). https://eur-lex.europa.eu/legal-content/ES/TXT/?uri=CELEX:32024R1689
Faden, R. R., & Beauchamp, T. L. (1986). A history and theory of informed consent. Oxford University Press.
Floridi, L., Cowls, J., Beltrametti, M., Chatila, R., Chazerand, P., Dignum, V., Luetge, C., Madelin, R., Pagallo, U., Rossi, F., Schafer, B., Valcke, P., & Vayena, E. (2018). AI4People—An ethical framework for a good AI society: Opportunities, risks, principles, and recommendations. Minds and Machines, 28(4), 689–707. https://doi.org/10.1007/s11023-018-9482-5 DOI: https://doi.org/10.1007/s11023-018-9482-5
Goodman, B., & Flaxman, S. (2017). European Union regulations on algorithmic decision-making and a “right to explanation”. AI Magazine, 38(3), 50–57. DOI: https://doi.org/10.1609/aimag.v38i3.2741
Hernández Herrero, M. (2026). Información clínica y consentimiento informado (a propósito de la STEDH de 26 de junio de 2025). Diario La Ley, (10907).
Katz, J. (2002). The silent world of doctor and patient. Johns Hopkins University Press. DOI: https://doi.org/10.56021/9780801857805
Ley 41/2002, de 14 de noviembre, básica reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica. (2002). https://www.boe.es/buscar/act.php?id=BOE-A-2002-22188
López-Almansa Beaus, L. (2015). Finalidad, alcance y legibilidad de la información en el consentimiento informado (Tesis doctoral, Universidad Católica de Valencia).
López-Almansa Beaus, L. (2024). El impacto de la inteligencia artificial en la mejora del consentimiento informado: análisis de la evolución de la legibilidad y la comprensión del paciente. Derecho y Salud, 34(1), 71–92. DOI: https://doi.org/10.62659/CF2403202
Mittelstadt, B. D., Allo, P., Taddeo, M., Wachter, S., & Floridi, L. (2016). The ethics of algorithms: Mapping the debate. Big Data & Society, 3(2). https://doi.org/10.1177/2053951716679679 DOI: https://doi.org/10.1177/2053951716679679
O’Neill, O. (2002). Autonomy and trust in bioethics. Cambridge University Press. DOI: https://doi.org/10.1017/CBO9780511606250
Simón Lorda, P. (2000). El consentimiento informado: historia, teoría y práctica. Triacastela.
Wachter, S., Mittelstadt, B., & Floridi, L. (2017). Why a right to explanation of automated decision-making does not exist in the General Data Protection Regulation. International Data Privacy Law, 7(2), 76–99. https://doi.org/10.1093/idpl/ipx005 DOI: https://doi.org/10.1093/idpl/ipx005
World Health Organization. (2021). Ethics and governance of artificial intelligence for health. https://www.who.int/publications/i/item/9789240029200
Downloads
Published
Issue
Section
License
Copyright (c) 2026 Revista Internacional de Filosofía Teórica y Práctica
This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.
Articles are published under the terms of a licence that permits use, distribution and reproduction in any medium, provided that the original work is properly cited. Ed&TIC retains the proprietary rights to the published works and actively promotes the reuse of these works under the terms of the aforementioned licence, which encourages the dissemination of knowledge and collaboration in the academic community.
