The iRobo-Surgeon conundrum: comparative reflections on the legal treatment of intraoperative errors committed by autonomous surgical robots
This article examines whether existing US product liability rules under the Restatement (Third) of Torts and the European Commission's proposed revised Product Liability Directive provide adequate redress for patients injured by fully autonomous surgical robots. It explores key legal concepts such as product definition, defectiveness, and information disclosure, concluding that both regimes are not entirely inadequate for protecting patient rights. The comparative analysis focuses on navigating the complexities of AI-related medical harm and manufacturer liability.
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Who issued it
Who it governs
Legal scholars, policymakers, and medical device manufacturers studying liability frameworks for artificial intelligence in healthcare.
What the document contains
The article covers a comparative legal analysis of US and European product liability regimes as applied to fully autonomous surgical robots, focusing on definitions of products, defectiveness, risk-utility balancing, and evidentiary burdens.
It does not provide binding legislative text or administrative regulations, focusing instead on academic legal commentary and comparative jurisprudence.
- Autonomous surgical robots present unique challenges for assigning legal responsibility in cases of patient injury or death.
- The Restatement (Third) of Torts in the US can generally encompass software and AI-driven medical devices as products.
- The European Commission's proposed revised Product Liability Directive introduces updated mechanisms to address digital technologies and complex AI systems.
- Opacity and the black-box nature of machine learning complicate the ability of plaintiffs to prove causation and defectiveness.
- Existing product liability frameworks in the US and Europe are not entirely inadequate for addressing harms caused by autonomous robotic surgery.
· Abstract · Introduction · Product Liability Frameworks in US and EU · Defining Product and Defectiveness in AI Surgery · Evidentiary Burdens and Information Disclosure · Conclusion
How it scores
Each score is backed by a quote verified against the document text. Editorial review has not yet confirmed them.
Accountability
5/5Clear responsibility for AI outcomes
The bridge towards fully autonomous, context-aware surgical robots is fraught with challenges, not least of which is ascribing legal responsibility in the event of inadvertent patient injury or death.
ABSTRACT
screening score · 2026-10-24
Fairness
0/5Non-discrimination and equitable treatment
screening score · 2026-10-24
Human Dignity
1/5Respect for the inherent worth of persons
protecting the fundamental rights of patients in the context of autonomous robotic surgery.
ABSTRACT
screening score · 2026-10-24
Human Oversight
3/5Humans remain in control of consequential decisions
The ‘human-out-of-the-loop’ scenario draws the focus of the present analysis onto the manufacturer of the robotic surgical system.
41
screening score · 2026-10-24
Privacy
1/5Protection of personal data and private life
Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data
108
screening score · 2026-10-24
Transparency
3/5Openness about how AI systems work and are used
On the ‘black box’ problem and the call for ‘Explainable AI’, see Charles Kerrigan and Oliver Vercoe
Note 80
screening score · 2026-10-24
Enforcement
4/5Consequences and compliance mechanisms with real force
Effective liability rules also provide an economic incentive to comply with safety rules and therefore contribute to preventing the occurrence of damage
Note 18
screening score · 2026-10-24