El consentimiento informado en la era de la inteligencia artificial: retos éticos y derecho a la información del paciente

Abstract

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.

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