What Are the Liability Issues in AI-Assisted Surgery?

By Rasit Dinc

Introduction

Artificial intelligence (AI) is rapidly transforming the landscape of medicine, with surgery being one of the most promising frontiers. AI-assisted surgical systems offer the potential to enhance precision, improve patient outcomes, and reduce the workload of healthcare professionals. However, the increasing integration of these sophisticated technologies into the operating room brings with it a host of complex ethical and legal questions, paramount among them being the issue of liability when something goes wrong [1]. As AI's role evolves from a simple tool to an active participant in surgical procedures, the traditional lines of responsibility become blurred, creating a challenging new legal frontier for surgeons, hospitals, and technology developers alike [2].

The Complex Web of Liability

In the event of an adverse outcome in an AI-assisted surgery, pinpointing accountability is a formidable task. The liability chain is intricate, with several parties potentially bearing responsibility:

• The Surgeon: Traditionally, the surgeon is the captain of the ship in the operating room and holds ultimate responsibility for the patient's care. This responsibility extends to the use of AI tools. Surgeons are tasked with interpreting the AI's outputs, making the final clinical decisions, and intervening if the technology falters. A surgeon could be found negligent if they misuse the AI system, fail to recognize an obvious error in its recommendation, or blindly follow its guidance without exercising their own professional judgment [3].

• The Hospital or Healthcare Institution: Healthcare institutions have a duty to provide a safe environment for patients. This includes ensuring that the AI technologies they procure and implement are safe, effective, and fit for purpose. A hospital could be held liable if it fails to properly validate and maintain the AI system, provide adequate training for its staff, or establish clear protocols for the use of AI in surgery [1].

• The AI Developer and Manufacturer: The creators of AI surgical systems have a significant responsibility to ensure their products are designed and manufactured to the highest safety standards. If a patient is harmed due to a flaw in the AI's algorithm, a software bug, or a hardware malfunction, the developer and manufacturer could be held liable under product liability laws [2]. The “black box” nature of some AI systems, where the decision-making process is opaque even to its creators, presents a particular challenge in proving a defect [1].

Navigating the Legal Landscape

Several established legal doctrines are being adapted to address the unique challenges of AI-assisted surgery:

• Medical Malpractice: This is the most common legal claim in cases of medical error. A malpractice claim in the context of AI-assisted surgery might allege that the surgeon's use of the AI system fell below the accepted standard of care. As AI becomes more integrated into surgical practice, the standard of care itself will evolve. A crucial question will be whether a reasonably prudent surgeon would have used the AI system in a similar situation and how they would have interpreted its outputs [2].

• Product Liability: This area of law holds manufacturers and sellers responsible for injuries caused by defective products. In the context of AI, a product liability claim could be based on a design defect (the AI algorithm is inherently flawed), a manufacturing defect (an error in the production of the specific unit), or a failure to warn (the manufacturer did not provide adequate instructions or warnings about the system's risks and limitations) [2].

The Surgeon's Perspective and the Importance of Informed Consent

Surgeons themselves are grappling with the implications of AI in their practice. A recent study of surgeons' perspectives revealed an acceptance of their ultimate responsibility, but also a significant concern about the lack of legal clarity and the potential for AI to impact the standard of care [3].

A critical element in mitigating liability risk is the process of informed consent. Patients have the right to be fully informed about the risks and benefits of any medical procedure. When AI is involved, this conversation must be expanded to include the role of the technology, its potential benefits, and its inherent risks, including the possibility of error. As one surgeon noted, the patient should be involved in the decision-making process of whether to accept the machine's decision [3]. This transparent communication is not only an ethical imperative but also a crucial legal safeguard.

The Path Forward

The question of liability in AI-assisted surgery is far from settled. It is a multifaceted issue that requires a collaborative effort from all stakeholders, including surgeons, hospitals, AI developers, legal experts, and regulatory bodies. As AI technology continues to advance, the legal and ethical frameworks governing its use must evolve in parallel. The development of clear guidelines, robust regulatory oversight, and new legal precedents will be essential to ensure that these powerful technologies are deployed safely and responsibly, ultimately benefiting both patients and the healthcare professionals dedicated to their care.

References

[1] Cestonaro, C., Delicati, A., Marcante, B., Caenazzo, L., & Tozzo, P. (2023). Defining medical liability when artificial intelligence is applied on diagnostic algorithms: a systematic review. Frontiers in Medicine, 10, 1305756. https://pmc.ncbi.nlm.nih.gov/articles/PMC10711067/

[2] Eldakak, A., Alremeithi, A., Dahiyat, E., El-Gheriani, M., Mohamed, H., & Abdulrahim Abdulla, M. I. (2024). Civil liability for the actions of autonomous AI in healthcare: an invitation to further contemplation. Humanities and Social Sciences Communications, 11(1), 1-12. https://www.nature.com/articles/s41599-024-02806-y

[3] Duffourc, M., Møllebæk, M., Druedahl, L. C., Minssen, T., & Gerke, S. (2025). Surgeons’ Perspectives on Liability for the Use of Artificial Intelligence Technologies in the United States and European Union: Results From a Focus Group Study. Annals of Surgery Open, 6(1), e542. https://pmc.ncbi.nlm.nih.gov/articles/PMC11932586/