Who Is Liable When the Algorithm Operates? A Legal Analysis of AI Accountability in Robotic Surgery

DOI: https://doie.org/10.10399/ES.2026290381

Dr. Vivek Saurav, Dr. Richa Kashyap

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N.A

Abstract:

The integration of artificial intelligence (AI) into robotic surgical systems marks a transformative shift in modern healthcare. What began as surgeon-controlled robotic assistance has evolved into increasingly autonomous systems capable of real-time decision-making, tissue recognition, and predictive risk assessment. While these developments promise enhanced precision and improved patient outcomes, they also generate profound legal uncertainty. When harm occurs during an AI-assisted procedure, traditional liability frameworks struggle to identify a clear defendant. Is the surgeon liable for relying on algorithmic outputs? Does responsibility lie with the hospital that adopted the technology, or with the manufacturer and software developer who designed the system?

This article examines the doctrinal gaps in medical negligence and product liability law in the context of AI-driven robotic surgery. It analyses how adaptive algorithms challenge classical notions of breach, causation, and defect, particularly in light of algorithmic opacity and probabilistic decision-making. Through a comparative perspective drawing from regulatory developments in the United States and the European Union, the article highlights the absence of a coherent accountability framework in India. It argues that fault-based models alone are insufficient for high-risk autonomous medical technologies and proposes a layered and risk-based liability regime combining strict liability, institutional responsibility, and mandatory insurance mechanisms. The article concludes that proactive regulatory reform is essential to preserve patient trust while fostering responsible innovation in surgical AI systems.

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