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.

Shashikala Gurpur is the Senior Professor, Director of Symbiosis Law School, Pune, and Dean Faculty of Law, SIU, India since 2007. She is the Principal Investigator, of the SPARC Project P2595 “Legal and Ethical Framework for the Use of Artificial Intelligence in Healthcare sector with special reference to Patient Safety” funded by Ministry of Education, Government of India. She is also the Jean Monnet Chair Professor, Fulbright Scholar, AHRB Fellow UK and National Merit Scholar. She has experience in corporate, academic and non-governmental sectors. She holds PhD in International Law and was a member of Law commission of India. She is the Head of Symbiosis Centre for Advanced Legal Studies and Research (SCALSAR), and the pioneer of EU Legal Studies in India.
Claes Granmar is Associate Professor (Docent) at Faculty of Law, Stockholm University, Sweden. He is the International Principal Investigator, of the SPARC Project P2595. He has held prestigious academic positions as a Visiting Fellow at Oxford University, an Honorary Fellow at Melbourne Law School, and a Fellow at New York University and the Max Planck Institute. He completed his doctoral research at the European University Institute and Stockholm University. His research focuses on EU internal market law, constitutional pluralism, digital globalization, and fundamental rights.
Angelica Bonfanti (PhD) is an Associate Professor of International Law at the University of Milan, where she teaches the courses ‘International Law’, ‘EU Law on Business and Human Rights’, and ‘Cultural Diversity and Human Rights Law’. She is the co-principal investigator in SPARC project P2595. Angelica is also co-director of the Business and Human Rights Summer School, former Head of Studies of the Master program in Sustainable Development at the University of Milan, and member of the Committee on Business and Human Rights of the International Law Association. Her research focuses primarily on public and private international law, business and human rights, AI and cyber law, cultural diversity.
Chiara Ragni is a Full Professor of International Law at the University of Milan, Italy, where she also serves as the Head of Studies of the joint-degree master’s program in Migration Studies and New Societies and as a member of the Ethical Committee. She is the co-principal investigator in the SPARC Project P2595. She actively participates in several international research projects and has previously served as a researcher in international law at the University of Milan. She is a member of the Scientific and Editorial Board of three journals – QIL, Review of Private International Law and GenIUS. Her research focuses primarily on public international law, human rights and transnational families.
Harko Verhagen is a Full Professor of Intelligent Systems at the Department of Computer and Systems Sciences, Stockholm University, Sweden and serves as the Head of the Interaction Design and Learning Unit. He is the co-principal investigator in the SPARC Project P2595. His has published extensively in the fields of computer games and gaming, computational social simulation, agent-based theories and models, social ontology, multi-agent systems, and ethics in AI design and development. He is the President of the European Social Simulation Association (ESSA) and represents his university in the Swedish national infrastructure for digital and experimental research in the humanities (HumInfra) as leader of the Digital Human Science unit at Stockholm University.
Rupal Rautdesai is a Visiting Professor and Research Advisor at Symbiosis Law School, Pune, SIU. She also is an independent consultant in the field of Intellectual Property Rights. She practiced as a lawyer for 2 years and has been an academician for the last 19 years. She has published several research papers especially in the field of Intellectual Property Rights, Data Protection Law, Big Data, Artificial Intelligence, and Taxation Law. She has guided several LL.M. and 8 Ph.D. Students. She has contributed as a faculty team member in 4 Erasmus projects. She is serving as a legal expert on two Institutional Ethics Committees (IEC).
Atmaram F. Shelke is working as a Professor at Symbiosis Law School, Pune (a constituent of Symbiosis International (Deemed University)). He is the recipient of Two Gold Medals for standing first in LL.M. at Symbiosis International University, Pune, India. His Ph.D. research focused on Intellectual Property Rights Violation in Cyberspace. Dr. Shelke specialises in IPR Violation in Cyberspace, Constitutional Law, Administrative Law and Research Methodology. The fields of his research interest are IPR Violation in Cyberspace, Constitutional Law, Administrative Law and Criminal Law. He has more than 40 publications on his account. He has more than 17 years of teaching experience.
Raj A. Varma is an Assistant Professor of Law at Symbiosis Law School, Pune, and has over a decade in legal academia, specializing in Information Technology, Artificial Intelligence, Media, Cyber, and Health Law. A recognized Ph.D. supervisor, he was a core member to write and execute competitively funded international (Erasmus+ CBHE, Shastri Indo-Canadian) and national (SPARC, SIU) research projects. He has developed courses across EU, AI, TMT Laws and trains government, defence, and police institutions on emerging technology law. He leads a criteria in national academic compliances and is a part of academic administration at his institute.