Ethical Considerations of Using Artificial Intelligence and Associated Legal Frameworks in Tertiary Healthcare Organisations

Abstract

The integration of Artificial Intelligence (AI) in healthcare, particularly in oncology, has transformed clinical decision-making, diagnostics, and patient management. However, its rapid adoption presents significant ethical, legal, and regulatory challenges, including concerns over data privacy, algorithmic bias, patient safety, and accountability. Existing legal frameworks remain inadequate in addressing AI-driven risks, leading to uncertainties in liability, transparency, and compliance. The evolving role of Institutional Review Boards (IRBs) further highlights the need for adaptive oversight in AI-based clinical research. This study aims to identify key risks associated with AI in healthcare, assess their legal and ethical implications, and evaluate the sufficiency of existing regulations in protecting patients and healthcare professionals from potential harm or misconduct. Addressing these gaps requires enhanced regulatory policies, stronger cybersecurity measures, ethical AI design, and interdisciplinary collaboration between policymakers, healthcare providers, and AI developers. Establishing clear accountability frameworks and robust governance structures is essential to ensure AI’s responsible and equitable integration in healthcare, fostering trust, safety, and long-term sustainability.

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