What is the legal risk of orthopedic surgical robots landing in Pingshan, Shenzhen

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From August 1st to 2nd, 2026, the "Artificial Intelligence Assisted Therapy Technology Training Course and Intelligent Orthopedic New Progress Learning Course" hosted by the National Orthopedic Medical Center and Beijing Jishuitan Hospital, and undertaken by Shenzhen Pingle Orthopedic Hospital, will be held in Pingshan, Shenzhen. This is the first time that national level orthopedic surgical machine and human technology has been integrated into district level medical institutions. 74 orthopedic doctors from across the country received systematic training on robot assisted surgery, covering theoretical lectures and practical exercises. The accelerated popularization of technology at the grassroots level has also brought a series of legal issues: how can surgical robots be used as medical devices in compliance? How to implement patient informed consent? How to allocate responsibility once medical damage occurs? This article combines the provisions of the Regulations on the Supervision and Administration of Medical Devices and the Civil Code to sort out the risk points.

1、 The admission and usage boundaries of surgical robots

Orthopedic surgical robots belong to the third category of medical devices. According to the Regulations on the Supervision and Administration of Medical Devices, registration and approval from the National Medical Products Administration are required before listing, and a medical device registration certificate must be obtained. Medical institutions must verify the registration certificate and product qualification certificate when introducing and using such equipment, and establish a full process management system for procurement, acceptance, use, maintenance, and scrapping.

During the training, the engineer explained the basic principles of robots and the key points of image acquisition planning. The legal aspect is more concerned with three issues: whether the device is used within the scope and functional specifications approved for registration? Do the operating doctors have the corresponding qualifications? Has the training met the requirements for clinical application of restricted technologies?

According to the "Management Measures for Clinical Application of Medical Technology", artificial intelligence assisted therapy technology belongs to the restricted technology category. Medical institutions carrying out such technology must meet the conditions of personnel, equipment, facilities, etc., and register with the health administrative department. Undertaking training is one thing, conducting surgery independently is another. If carried out in the future, technical capabilities, personnel training, and equipment maintenance must meet the regulations, otherwise administrative penalties may be imposed.

2、 Informed consent: Clearly state where the "difference" lies

Robot assisted surgery is an unfamiliar technology for most patients, and the obligation to inform before surgery must be fully implemented. According to the Civil Code, medical personnel should explain the condition and medical measures to patients during diagnosis and treatment activities; If surgery, special examination, or special treatment is required, medical risks, alternative medical plans, etc. should be explained in a timely manner, and explicit consent should be obtained.

Regarding robotic surgery, in addition to the risks associated with traditional surgery, it is also necessary to explain the potential mechanical failures of the system, the possibility of transitioning to open surgery, the actual number of cases in which the lead surgeon uses the system, and the differences in effectiveness and risks between robot assisted and conventional surgery.

A common problem in practice is that hospitals only require patients to sign a vague "surgical consent form" without mentioning a single word about the robot part. This type of document is difficult to prove in disputes that the obligation to inform has been fulfilled. A more prudent approach is to develop a dedicated consent form template that outlines the technical principles, risks, alternative solutions, and data usage methods. The lead surgeon will explain in person and record the communication in the medical record.

3、 After damage occurs: product defect or medical fault

If there are problems with robotic surgery, the damage may come from three directions: defects in the robot itself, doctor's operational errors, and improper postoperative care. Different reasons correspond to different responsible parties.

If damage is caused by product defects such as software algorithm errors or mechanical component failures, patients can claim responsibility from the producer or seller in accordance with the provisions on product liability in the Tort Liability Code of the Civil Code, or sue medical institutions at the same time. If the damage is caused by medical errors such as failure to use according to operating procedures or improper preoperative planning, the provisions of medical damage liability shall apply, and the medical institution shall bear the compensation liability.

The determination of responsibility is often complex, as robot surgical records contain a large amount of data - preoperative planning images, real-time intraoperative parameters, and operation logs. These electronic data are key evidence. Medical institutions must keep them intact, otherwise they may not be able to bear adverse consequences due to the burden of proof. It is recommended that hospitals establish an encrypted storage and retrieval mechanism for surgical data to ensure authenticity, completeness, traceability, and clarify the retention period.

4、 Data Security and Patient Privacy

Surgical robots collect a large amount of imaging data and physiological parameters during operation, which are sensitive personal information and protected by the Personal Information Protection Law and the Data Security Law. As data processors, medical institutions should adhere to the principle of minimum necessity, clearly disclose their intended use, and obtain authorization.

The real-time images and cases displayed in the training activities, which involve patient information, must be desensitized. Using patient images for teaching or scientific research without consent may constitute infringement. In addition, robots usually operate online, which poses a risk of data leakage. Hospitals should establish network security protection measures and conduct regular risk assessments.

5、 Advice for hospitals and patients

For hospitals planning to introduce robotic surgery: first evaluate their own technical capabilities and personnel qualifications, and do not blindly follow the trend; Improve internal systems, including equipment procurement, operational standards, data management, and adverse event reporting; Ensure the authenticity of informed consent; Purchase medical liability insurance to diversify risks.

For patients preparing to undergo robotic surgery: proactively inquire with the doctor about the number of cases, possible risks, and alternative solutions of using the system before surgery; Retain all medical records; If damage occurs, promptly request the sealing of medical records and surgical data, and then consider the path of rights protection. The sealing step is crucial, the later it is, the more passive it will be.

Guangdong Zhiming Law Firm focuses on legal affairs in the field of healthcare, providing compliance review, risk prevention and control, dispute resolution for medical institutions, as well as representing patients in medical injury litigation. Intelligent orthopedic technology is flourishing, and only when the rules keep up can the technology go far.