Legal Implication in Utilizing Automated Robots: A Written Informed Consent Form Proposal

Legal Implication in Utilizing Automated Robots: A Written Informed Consent Form Proposal
Maria Teresa Contaldo, Sonia Triggiani, Giacomo Vignati, Daniele Bracchi, Gianpaolo Carrafiello
International Journal of Medical Robotics and Computer Assisted Surgery, 22 April 2025
Abstract
Background
Robotic systems enhance physicians’ capabilities by replicating hand movements in real‐time, ensuring precise control and a quick return to conventional procedures if patient safety is compromised. Physicians performing robot‐assisted procedures bear ultimate responsibility, sharing potential liability with manufacturers for malfunctions.
Methods
This study, conducted by a transdisciplinary team of interventional radiologists and a legal expert, evaluates the integration of robotic systems in interventional radiology through a comprehensive literature review, addressing potential legal contingencies.
Results
This paper aims to define liability in this context and examines how workflows and doctor‐patient relationships might be reshaped: patients must be informed about treatment options, including details about robot‐assisted procedures and associated risks.
Conclusions
These systems could significantly impact interventional radiology practice. A dedicated informed consent process is necessary to ensure clear communication and protect the decision‐making process and patient‐centred care; thereby, an informed consent is proposed to comprehensively address these needs.