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From August 1 to 2, 2026, the "AI-Assisted Surgical Techniques Training Course and Intelligent Orthopaedics Advances Seminar," hosted by the National Orthopaedic Medical Center and Beijing Jishuitan Hospital and organized by Shenzhen Pingle Orthopaedic Hospital, was held in Pingshan, Shenzhen. This marked the first time that national-level orthopaedic surgical robot technology was extended to a district-level medical institution. A total of 74 orthopaedic surgeons from across the country received systematic training in robot-assisted surgery, encompassing both theoretical instruction and hands-on practice. This event signifies the accelerated dissemination of intelligent orthopaedic technology to grassroots medical institutions, but it also brings forth a series of new legal issues: How should surgical robots, as medical devices, be approved for market entry and used in compliance with regulations? How can patients' right to informed consent be safeguarded? In the event of medical harm, how should liability be allocated? This article will examine, from a lawyer's perspective, the legal risks and response strategies associated with the clinical application of orthopaedic surgical robots, in light of the "Regulations on the Supervision and Administration of Medical Devices," the "Civil Code," and other relevant provisions.

Compliance and market access requirements for medical devices of surgical robots

Orthopedic surgical robots are classified as Class III medical devices. According to the Regulations on the Supervision and Administration of Medical Devices, they must undergo registration and approval by the National Medical Products Administration before being marketed, and obtain a medical device registration certificate. When introducing and using such equipment, medical institutions must verify the registration certificate and product qualification documentation, and establish a full-process management system covering procurement, acceptance, use, maintenance, and disposal.

In this training, the engineer explained the basic principles of surgical robots and the key points of image acquisition planning, but from a legal perspective, the greater focus is on: Is the equipment being used within the scope of application and functional specifications approved for its registration? Does the operating physician possess the corresponding qualifications? Does the training meet the requirements for clinical application of restricted technologies as stipulated by the National Health Commission?

According to the "Measures for the Clinical Application Management of Medical Technologies," AI-assisted treatment technology is classified as a restricted technology. Medical institutions carrying out such technology must meet conditions regarding personnel, equipment, facilities, etc., and file with the health administration department. Shenzhen Pingle Orthopedic Hospital, as the organizer, must ensure that its technical capabilities, personnel training, and equipment maintenance all comply with regulations if it subsequently conducts robotic surgery independently; otherwise, it may face administrative penalties or even the risk of suspension for rectification.

Patient informed consent and duty to inform of risks

Robot-assisted surgery is a relatively unfamiliar technology for patients, and the medical side must fully fulfill the duty to inform before the operation. Article 1219 of the Civil Code stipulates that medical personnel shall explain the patient's condition and medical measures to the patient during diagnosis and treatment activities; where surgery, special examinations, or special treatments need to be performed, they shall promptly explain the medical risks, alternative medical plans, and other circumstances to the patient, and obtain the patient's explicit consent.

Specifically for robotic surgery, doctors should not only inform patients of the risks associated with traditional surgery, but should also provide additional explanations: potential mechanical failures of the robotic system, the possibility of conversion to open surgery, the experience level of the operating surgeon, and comparisons of success rates between robot-assisted and purely manual surgery. In practice, some hospitals only have patients sign a generic "surgical consent form" without mentioning the technical details of robotics, which can easily lead to disputes.

Lawyers suggest that medical institutions should develop informed consent templates specifically for robotic surgery, listing clauses such as technical principles, risks, alternatives, and data privacy handling, and have the lead surgeon explain them in person to ensure patients truly understand. Otherwise, if harm occurs, the medical provider may bear liability for fault due to inadequate disclosure.

Determination of Liability for Medical Damage: Product Defect or Medical Malpractice?

Once robotic surgery fails, patient harm may arise from three causes: first, defects in the robotic product itself; second, errors in the doctor's operation; third, improper postoperative care. Different causes correspond to different responsible parties and legal bases.

If damage is caused by product defects such as errors in robot software algorithms or malfunctions of mechanical components, patients may assert product liability against the manufacturer or seller in accordance with Article 1202 of the Civil Code, and may also simultaneously bring an action against the medical institution. If damage is caused by medical negligence such as the doctor's failure to operate in accordance with operating procedures or improper preoperative planning, the medical damage liability under Article 1218 of the Civil Code shall apply, and the medical institution shall bear liability for compensation.

In practice, determining liability is often complex because robotic surgery records contain vast amounts of data, such as preoperative planning images and real-time intraoperative parameters, and these electronic data may become key evidence. Medical institutions must fully preserve surgical logs and data; otherwise, they may bear adverse consequences for failing to provide evidence. Lawyers remind that hospitals should establish encrypted storage and retrieval mechanisms for robotic surgery data to ensure the data is authentic, complete, and traceable.

Data security and patient privacy protection

During operation, surgical robots collect a large amount of patient imaging data and physiological parameters. Such sensitive personal information is protected by the Personal Information Protection Law and the Data Security Law. Medical institutions, as data processors, must adhere to the principle of minimal necessity, clearly inform patients of the purpose of data use, and obtain authorization.

During the training session, the expert showcased real-time images and cases of robot-assisted surgery, and such instructional demonstrations must anonymize patient information. If patient imaging data is used without consent for teaching or research purposes, it may constitute infringement. Additionally, surgical robots typically operate on networked systems, posing data leakage risks. Hospitals should establish network security protection frameworks and conduct regular risk assessments to prevent patient privacy breaches.

Practical advice for medical institutions and patients

For hospitals planning to introduce robotic surgery, lawyers advise: First, comprehensively assess your own technical capabilities and personnel qualifications, and do not blindly follow trends; second, improve internal management systems, including equipment procurement, operating standards, data management, and adverse event reporting; third, strengthen doctor-patient communication to ensure informed consent is truly implemented; finally, purchase medical liability insurance to spread risks.

For patients, before undergoing robotic surgery, they should proactively ask the doctor about relevant experience, success rates, risks, and alternative options, and keep all medical records. If harm occurs, they should promptly seal the medical records and surgical data, consult a professional lawyer, and clarify the path for rights protection.

Guangdong Zhiming Law Firm has long focused on legal affairs in the medical and health sector, offering professional services such as compliance review, risk prevention and control, and dispute resolution for medical institutions, as well as representing patients in medical injury litigation. Intelligent orthopedic technology is rapidly emerging, and legal norms and practical experience will safeguard its steady and long-term development.