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

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.