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Informed Consent In Ai Systems: Legal Requirement Or Ethical Choice




Ms. Shweta, Research Scholar, Department of Laws, Panjab University, Chandigarh.

Prof. (Dr.) Ajay Ranga, Professor, UILS, Panjab University, Chandigarh


ABSTRACT


The integration of artificial intelligence (AI) into healthcare has triggered profound debates in bioethics and medical law. Traditionally, informed consent has operated as a protective doctrine designed to safeguard patient autonomy and dignity. It ensures that individuals exercise agency over their bodies and treatment by requiring disclosure, comprehension, and voluntary decision-making. Yet the rapid adoption of AI has disrupted this doctrine by introducing algorithmic opacity, data stewardship challenges, and uncertainties around accountability.


This paper investigates whether informed consent in AI-driven healthcare should be treated merely as a legal requirement, imposed through statutes such as the EU’s AI Act or India’s Digital Personal Data Protection Act (2023), or as an ethical choice that clinicians and developers must actively embrace to preserve trust and fairness. Through historical, comparative, and practical analysis, the study argues that law provides the baseline for informed consent, but ethics demands more. Informed consent in AI should not be reduced to a bureaucratic exercise but must evolve into a continuous dialogue that balances innovation with patient rights.


Keywords: Artificial Intelligence, Healthcare, Informed Consent, Bioethics, AI Act, GDPR, DPDP Act 2023, Medical Law, Autonomy, Accountability.



Indian Journal of Law and Legal Research

Abbreviation: IJLLR

ISSN: 2582-8878

Website: www.ijllr.com

Accessibility: Open Access

License: Creative Commons 4.0

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All research articles published in The Indian Journal of Law and Legal Research are fully open access. i.e. immediately freely available to read, download and share. Articles are published under the terms of a Creative Commons license which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

 

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The opinions expressed in this publication are those of the authors. They do not purport to reflect the opinions or views of the IJLLR or its members. The designations employed in this publication and the presentation of material therein do not imply the expression of any opinion whatsoever on the part of the IJLLR.

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