Patient Safety and the Deployment of Artificial Intelligence in Healthcare

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This book examines how patient safety can be protected in the age of artificial intelligence, drawing on lessons from the EU AI Act, international healthcare regulations, and research conducted in India and the European Union. It explores how AI can be governed responsibly while enabling innovation and improving healthcare outcomes. As AI, and particularly generative AI, becomes increasingly integrated into healthcare, new challenges arise at the intersection of technology, law, ethics, and patient care. Different stakeholders often have competing priorities, while legal frameworks struggle to keep pace with rapid technological change. The book argues that alongside formal regulation, flexible governance approaches are needed to balance innovation with accountability and patient protection. AI offers significant opportunities to improve access to care, increase efficiency, and enhance healthcare quality. However, issues such as algorithmic bias, data quality, transparency, informed consent, and privacy can undermine trust and compromise patient safety. These concerns are particularly relevant in resource-constrained settings, where healthcare systems must address local needs while meeting ethical and legal standards. Drawing on frameworks such as the WHO Global Patient Safety Action Plan, the EU AI Act, GDPR, and OECD guidance, the book presents a comparative analysis of emerging approaches to AI governance. Case studies from Europe and India illustrate both the benefits and challenges of AI-enabled healthcare, from diagnostics and hospital administration to training and clinical decision-making. These examples highlight the need for clear, harmonized standards that protect patients and support responsible innovation. Combining legal, ethical, and policy perspectives, the book provides practical insights for policymakers, healthcare professionals, researchers, and academics. It offers tools and recommendations that help translate principles into practice and promotes an inclusive, transparent, and human-centered approach to AI adoption. Its central message is that technological progress in healthcare must always be guided by patient safety, human dignity, and equitable access to care.

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