Recently, intelligent medical methods such as AI assisted diagnosis and brain computer interfaces have become increasingly mature, becoming "divine weapons" that benefit people's health and providing important support for a healthy China. In November 2024, Shanghai Oriental Hospital released the artificial intelligence medical model "Med Go" for ICU monitoring. In February of this year, the South China Hospital affiliated with Shenzhen University developed a multi parameter version of the DeepSeek-R1 large model, constructing a full scenario intelligent computing center covering "clinical research operation management", achieving a good start in the application of AI in clinical decision-making assistance, chronic disease management, remote diagnosis and treatment, intelligent nursing and other fields. At present, people can collect heart rate, sleep, blood pressure and other data through smart bracelets, blood pressure monitors and other devices, upload them to platforms such as Doubao and Deep Seek, and obtain auxiliary medical diagnostic advice. Chronic disease patients can also regularly provide feedback on their condition data to doctors through the smart healthcare platform, and doctors can adjust treatment plans based on the data. With the deepening development of smart healthcare, risks are also beginning to be exposed. In February 2024, a healthcare software company in the United States experienced a large-scale patient data breach, resulting in the leakage of sensitive information such as medical record numbers, health conditions, and treatment prescriptions for over 900000 patients. This incident serves as a warning: only by building a comprehensive legal system for smart healthcare can we lay a legal foundation for the long-term and healthy development of smart healthcare, and make the achievements of smart healthcare better benefit people's livelihoods. Firstly, establish a sound smart healthcare regulatory system. In recent years, China has formulated a large number of normative documents on smart medicine, such as the Administrative Measures for Internet Diagnosis and Treatment (for Trial Implementation) issued in July 2018, and the Reference Guide for AI Application Scenarios in Health Industry formulated in November 2024, which have established a basic legal framework for the development of smart medicine. With the rapid development of artificial intelligence and the rapid iteration and updating of smart healthcare application scenarios, new issues such as medical data sharing, privacy protection, and algorithm discrimination urgently need legal responses. The widespread occurrence of issues such as patient personal information leakage has cast a shadow over the development of smart healthcare. It is urgent to accelerate legislation in key areas and key links, prevent the occurrence of such behavior, clarify the ownership of medical data, comply with authorization procedures, and complete traceability and accountability. In addition, for application scenarios such as brain computer interfaces, legislation should be accelerated to promote innovation in smart healthcare technology while ensuring the legitimate rights of patients in accordance with the law. Secondly, provide high-quality law enforcement and judicial guarantees for smart healthcare. With the rapid development of smart healthcare, crimes such as fraud and insurance fraud have become increasingly covert and specialized. Some criminals use network system vulnerabilities to commit insurance fraud. On the one hand, it is necessary to establish a law enforcement and regulatory system that adapts to the development of smart healthcare, and crack down on illegal activities that harm the healthy development of smart healthcare in accordance with the law. Some districts and counties in China have established joint supervision mechanisms between medical insurance, public security, and health departments to investigate and punish fraudulent insurance practices, and relevant violators have been transferred for prosecution. We need to strengthen law enforcement and regulatory capabilities from the source, rely on artificial intelligence technology to build a risk warning model, automatically identify legal risks in diagnosis and treatment behavior, and discover potential illegal clues. On the other hand, social disputes are inevitable in the practice of smart healthcare, which requires the establishment of a more fair and efficient medical dispute resolution mechanism. China has established Internet courts in Beijing, Guangzhou, Hangzhou and other places. At the same time, it is exploring the innovation of legal service mechanisms such as online mediation, blockchain judicial depository, which provides a good solution to various disputes in smart medicine. Thirdly, create a legal business environment that adapts to smart healthcare. Smart healthcare not only requires technological innovation to provide underlying technical support, but also industrial promotion to enter the homes of billions of people. The rule of law is the best business environment and an important force in promoting the development of the smart healthcare industry. It is necessary to establish a rule of law business environment that adapts to the development of the smart healthcare industry as soon as possible. To ensure equal participation of market entities in the competition of the smart healthcare industry and better leverage the role of the market in the allocation of smart healthcare resources. At the same time, we will strengthen intellectual property protection for innovation in smart healthcare technology and encourage breakthroughs in smart healthcare technology. In addition, it is necessary to enhance the data security awareness and ethical responsibility awareness of smart healthcare technology developers, and embed legal requirements into the entire process of smart healthcare through technological empowerment. As an important application scenario of artificial intelligence, smart healthcare contains inherent risks of artificial intelligence, and its development direction still has significant uncertainty. The rule of law has the function of stabilizing social expectations, resolving uncertainties in the development of smart healthcare, and reducing the negative impact of artificial intelligence applications in the field of healthcare. In the current era of accelerating breakthroughs in artificial intelligence, it is necessary to accelerate the improvement of the legal guarantee for the development of smart healthcare, and lay a solid institutional foundation for the stable and far-reaching development of smart healthcare. (New Society)