From August 1 to 2, 2026, the "Artificial Intelligence-Assisted Treatment Technology Training Course and Intelligent Orthopedics New Advances Seminar," hosted by the National Orthopedic Medical Center and Beijing Jishuitan Hospital and organized by Shenzhen Pingle Orthopedic Hospital, was held in Pingshan, Shenzhen, with 74 orthopedic doctors participating in the training. This training marked the first time that national-level orthopedic surgical robot technology has been extended to district-level medical institutions, representing an important practice of empowering grassroots healthcare with high-quality medical resources. However, behind the technology promotion and clinical application lies a series of legal issues, including medical device compliance, patient informed consent, and liability for medical damage. This article will analyze the legal risks and response strategies in the application of orthopedic surgical robots from a lawyer's perspective

I. Legal Classification of Orthopedic Surgical Robots: Compliance Requirements for Medical Device Regulation

Orthopedic surgical robots fall under Class III medical devices. According to the Regulations on the Supervision and Administration of Medical Devices, their production, operation, and use must strictly comply with the registration and approval system. The robotic systems demonstrated during training must hold a registration certificate issued by the National Medical Products Administration, and their scope of application should be consistent with the registered content. When medical institutions introduce such equipment, they should verify the supplier's qualifications, product registration certificates, and conformity documentation to ensure the legality of the procurement channel. At the same time, hospitals need to establish equipment acceptance, maintenance, and scrapping procedures, and conduct regular safety inspections to avoid medical disputes caused by equipment failure. For R&D enterprises, clinical trial data must be truthful and complete, and the obligation to report adverse event monitoring after market launch cannot be ignored; otherwise, they may face administrative penalties or even criminal liability.

II. Patient Informed Consent: Disclosure Obligations and Exceptions in AI-Assisted Surgery

Robotic-assisted surgery, while improving precision, is not without risk. According to Article 1219 of the Civil Code, medical personnel shall, during diagnosis and treatment activities, explain to patients their conditions and medical measures, particularly surgical risks, alternative plans, and the like. For robotic-assisted surgery, doctors are required to inform patients of the working principles of the equipment, potential mechanical failures, the possibility of converting to traditional surgery during the operation, and differences in postoperative recovery. If doctors fail to fully fulfill their obligation to inform, patients may still claim compensation on the grounds of infringement of their right to informed consent, even if the surgery is successful. Furthermore, when an AI system provides planning recommendations inconsistent with a doctor's judgment, the final decision-making authority should rest with the doctor, and the basis for the decision should be documented in detail in the medical records to address subsequent disputes.

III. Medical Damage Liability: Determination of Fault and Allocation of Burden of Proof in Robotic Surgery

According to Article 1218 of the Civil Code, the principle of fault liability applies to medical damage liability. In robotic surgery, damage may arise from equipment defects, operational errors, or management omissions. If damage is caused by defects inherent in the equipment itself, the patient may claim compensation from the manufacturer pursuant to Article 1202 of the Civil Code; if the medical institution is unable to identify the manufacturer, it may bear the obligation of advance compensation. In judicial practice, courts often rely on medical appraisal to assess the medical party's fault. For robot-assisted surgery, appraisal institutions are required to review surgical records, robotic logs, and other data to determine whether the operation complied with applicable standards. Therefore, medical institutions should completely preserve robotic surgery data, including preoperative planning, intraoperative parameters, and postoperative evaluations, in order to present evidence in litigation. Lawyers recommend that hospitals purchase medical liability insurance and establish special risk funds for robotic surgery to disperse compensation risks.

Four. Data Security and Privacy Protection: Compliance Blind Spots in Intelligent Orthopedic Technology

Orthopedic surgical robots rely on patient imaging data and real-time intraoperative information, which constitute sensitive personal information. In accordance with the Personal Information Protection Law, medical institutions should obtain separate consent when processing patients' health information and adopt measures such as encryption and de-identification to ensure security. Remote surgical guidance and data transmission involved in training require particular attention to compliance with cross-border or cross-institutional transfer regulations. In the event of a data breach, medical institutions may face administrative penalties and civil compensation. Therefore, hospitals should establish data security management systems, restrict data access permissions, and sign data processing agreements with equipment suppliers to clarify the responsibilities of each party. Additionally, the AI algorithms used in robots may involve intellectual property rights, and hospitals should clarify patent ownership during collaborative research and development to avoid subsequent disputes.

V. Legal Implications: Compliance Paths for Medical Institutions and Technology Enterprises

This training not only showcases the technological frontier but also sounds a legal alarm for the healthcare industry. For medical institutions in Shenzhen, the introduction of orthopedic surgical robots should be accompanied by a full-process legal review mechanism: review equipment qualifications before procurement, standardize operations and documentation during use, and properly handle data after surgery. At the same time, hospitals should regularly conduct legal training to enhance medical staff's risk awareness. For technology development companies, they should ensure products comply with national mandatory standards, improve post-market tracking systems, and proactively respond to regulatory inspections. On the patient side, before undergoing robot-assisted surgery, patients should proactively inquire about surgical risks, retain informed consent documents, and if harm occurs, promptly preserve evidence and seek assistance from professional lawyers.

Guangdong Zhiming Law Firm has long focused on legal affairs in the medical and health field, and can provide compliance review, risk prevention and control, and dispute resolution services for medical institutions and equipment companies. If you have questions about the legal issues of orthopedic surgery robot applications, you are welcome to consult us. We will protect your interests from a professional perspective.