LEGAL AND REGULATORY READINESS FOR ARTIFICIAL INTELLIGENCE IN SAUDI ARABIA’S ORGAN TRANSPLANTATION SYSTEM: CHALLENGES, AND POLICY PATHWAYS

Abstract

The increase in the use of artificial intelligence (AI) in the world of healthcare, has raised serious regulatory and ethical dilemmas particularly in the domain of organ transplantation. In Kingdom of Saudi Arabia (KSA), where both religious and legal and institutional standards control organ donation, AI allocation and decision-making present concerns regarding transparency, accountability and Shariah standards. Although the KSA have introduced programs like Vision 2030 and National Strategy of Data and Artificial Intelligence (NSDAI), but the legal frameworks of AI regulation in KSA is still in infancy. The paper follows a qualitative, desk-based, legal, and policy review based on the Regulatory Governance Theory (RGT) to evaluate the preparation of Saudi Arabia to integrate AI into the field of organ transplantation. It examines the domestic policies, documents, ethical guidelines and the international models of the United States, the United Kingdom, and the European Union. The study found serious gaps in algorithmic regulation, information management, and organizational capability. The results show that there is an immediate necessity of industry regulation, ethical audit frameworks, and inter-agency cooperation. The research suggests a culturally based system of governance, which will be consistent with the Islamic bioethics, social responsibility, and international best practices regarding AI implementation. It provides pragmatic suggestions to reform laws and the policy innovations, which facilitate the shift of KSA to ethical and technologically based organ transplantation systems.