When The Surgeon Becomes the System: Legal and Ethical Accountability in Ai-Guided Robotic Surgery

Abstract

As artificial intelligence capabilities advance, robotic surgical systems are rapidly evolving from surgeon-controlled tools to intricate socio-technical environments in which algorithms provide perception, prediction, recommendation and execution. This shift creates an accountability void that neither traditional medical negligence nor product-liability doctrines are entirely fit to fill. This article analyses the legal and ethical dimensions of AI assisted surgery through comparative doctrinal and normative analysis with special focus on India, as well as lessons from the European Union and USA. It examines various laws and regulations, including the National Medical Commission Act 2019, Consumer Protection Act 2019, Bharatiya Nyaya Sanhita (Law of Justice) 2023 in India; Medical Devices Rules (GSR 78(E)) of 2017; Regulation on the European Union's Implementation of and Transitional Provisions for 'Regulation (EU) No. Abstract Algorithms are responsible for performing sophisticated decision-making, yet a myriad of challenges pertaining to the deployment of algorithms can have important ramifications on society. In order to remedy these shortcomings, this article presents a Distributed Accountability Framework (DAF) that disperses accountability based on attributes of effective control, autonomy, foreseeability, causal contribution and access to technical evidence. The framework introduces the accountability-control mismatch, positing that liability should gradually move away from clinicians towards manufacturers, developers and medical institutions as machine autonomy increases. The study recommends adaptive-AI regulation, algorithmic audit trails, monitoring through the lifecycle of an AI application, local validation of AI for data and context applicability, clearer standards on human-oversight, and risk-based compensation mechanisms for India.