The ethical review exemption system was introduced to meet the needs of modernized ethical governance， implement hierarchical management for ethical review projects involving human subjects， and explore an ethical management model that reduces procedural supervision for specific types of research involving no greater than minimal risk. Through a comparative study， this paper seeks to elaborate on the differences between China and the United States （US） in the ethical review exemption system from multiple aspects， such as ethical regulations， risk definition， preconditions， applicable scenarios， and operational procedures. The aim is to provide references for ethical review committees to better implement the ethical review exemption system， enhance policy research， and ensure the fairness and objectivity of ethical review. Through the comparative study of the ethics review exemption system in China and the US， the following recommendations are proposed for institutions implementing the ethical review exemption system for reference. First， the system should clearly define the meaning of ethical review exemption to prevent researchers or even committee members from misunderstanding it as falling outside the scope of ethical review， thereby exposing research participants’ rights and interests to unnecessary risks. Second， the system should specifically explain the preconditions， including the requirements for research types and research risks. Among them， risks should be considered from multiple dimensions such as physiology， psychology， society， and economy. Clear explanations should be provided for involving commercial interests and sensitive personal information. Finally， the system should establish basic principles and judgment criteria for applicable scenarios， including specifying exactly what the public data refers to and legal requirements that need to be met， providing a concept of anonymization to distinguish it from deidentified information data， and clarifying the relevant regulations and ethical principles to be followed， as well as the clear requirements for informed consent.

China’s traditional principle of liability attribution for medical damage adopts a tripartite theory， with fault liability as the general principle， supplemented by the presumption of fault liability and no-fault liability. At present， artificial intelligence （AI） has been widely used in the medical field. Based on the characteristics of moral autonomy and technological independent development， it brings unprecedented risks to patients’ rights and interests while generating benefits， resulting in the traditional principle of liability attribution for medical damage not being fully adapted to medical AI. On the one hand， in the case where the autonomous behavior of AI is not enough to affect the subject and causality of diagnosis and treatment activities， the traditional principle of liability attribution for medical damage can still be applied. On the other hand， after the fundamental change of causality caused by the high autonomy of AI in diagnosis and treatment activities， the traditional principle of liability attribution for medical damage is not suitable for AI. If the tradition is adhered to， it will easily lead to an imbalance of the doctor-patient interests and disorder medical order. Therefore， to rebuild the balance between the freedom of medical behavior and the protection of patient’s rights and interests， promote medical innovation， and make good use of AI to improve the level of diagnosis and treatment， thereby expanding patients’ autonomy and improving patients’ well-being， this paper explored how to adjust the principle of liability attribution for medical damage after the inclusion of AI in diagnosis and treatment activities， and make it fit with AI. AI-based risk management should be legislated to set compliance obligations for AI operators and formulate reasonable AI standards， and those who violate compliance obligations or do not meet standards should be presumed at fault. Therefore， the principle of liability attribution for medical damage involving AI should apply the presumption of fault liability； fault liability or no-fault liability should be applied cautiously.

Under the current legal framework， living will， as an important legal tool for safeguarding patients’ autonomy and dignity， have been widely recognized and implemented in many countries and regions. In China， the promotion of living will also has a solid legal foundation， with their legitimacy reflected in several provisions of the Civil Code of the People’s Republic of China. One of the highlights of the Medical Regulations of the Shenzhen Special Economic Zone （revised in 2022） is the clarification of the legal effect of living will. To ensure that patients’ living will can be accurately implemented at critical moments， the rights and obligations of patients， family members， and healthcare professionals should be clearly defined within the legal framework， and clear guidance should be provided at every stage of implementation.