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

TL;DR

This paper proposes an informed consent form for robot-assisted medical procedures to clarify legal responsibilities and ensure patient understanding.

Contribution

The paper introduces a proposed informed consent form tailored for robotic systems in interventional radiology.

Findings

Physicians remain ultimately responsible for robot-assisted procedures, sharing liability with manufacturers.

A dedicated informed consent process is necessary to maintain patient-centered care and clarify risks.

Robotic systems could reshape workflows and doctor-patient relationships in interventional radiology.

Abstract

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.

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.

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.

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.

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