CHINA Law and Practice Contributed by: Gil Zhang, Diana Li, Muran Sun and Yongqi Tao, Fangda Partners
disease identification. Second, AI improves access to care by supporting primary care healthcare profes - sionals (HCPs) in under-resourced settings. Intelligent triage, symptom checkers and risk prediction tools help address the shortage of specialists and improve healthcare accessibility in rural and underserved areas. Third, AI enables more personalised and precise treat - ment decisions. By integrating genomics, pathology and patient-specific health data, AI systems can rec - ommend tailored therapies, particularly in oncology, where AI supports the design of targeted or immune- based treatment strategies. Fourth, AI contributes to public health by strengthening early warning and monitoring systems. During the COVID-19 pandemic, AI tools were used for outbreak modelling, contact tracing and real-time policy support, highlighting their value in health emergency management. Fifth, AI supports clinical consistency and equity by reduc - ing reliance on HCP intuition and minimising human error or bias. This helps standardise care pathways across medical institutions, promoting more equitable treatment regardless of geography. Finally, AI acceler - ates pharmaceutical innovation by optimising target identification, virtual compound screening and trial design. These tools are increasingly being integrated into R&D workflows, shortening timelines and boost - ing productivity. Despite these advantages, AI also brings challenges around safety, liability, regulatory oversight and inte - gration into professional workflows. 1.3 Market Trends China’s healthcare AI market is rapidly evolving under strong policy support and industrial demand. The AI Application Scenarios Reference Guide and the 2025 Innovation Task Notice emphasise scenario-based adoption and regulatory readiness. Local govern - ments have issued tailored plans to accelerate inte - gration, such as the Shanghai Work Program for the Development of Artificial Intelligence in Medicine (2025–27) and the Suzhou Accelerates the Promotion of “Artificial Intelligence + Healthcare” Construction and Application Development Implementation Plan. Pharmaceutical companies and technology devel - opers are the primary drivers of innovation, and big
technology firms and AI startups play a key role as enablers in these ecosystems. Notable collaborations reflect how tech and medical institutions are jointly reshaping healthcare delivery through AI. Zhongshan Hospital partnered with Hua - wei and iFlytek to build a multi-modal smart hospital integrating AI imaging, voice assistants and clinical decision tools. Jiangsu Provincial People’s Hospital worked with Tencent to launch an AI imaging and virtu - al doctor system for patient engagement and diagnos - tic support. The Second Affiliated Hospital of Zhejiang University teamed up with Alibaba Health to deploy AI across triage, follow-up and patient management, while China-Japan Friendship Hospital collaborated with Baidu to develop a multi-modal foundation model for interdisciplinary clinical decision-making. 2. Legal Framework for Healthcare AI 2.1 Regulatory Definition and Classification of Healthcare AI Current law and regulations lack a statutory definition for “healthcare AI systems”. However, the AI Appli - cation Scenarios Reference Guide provides concrete definitions for specific AI healthcare application sce - narios. AI-based medical software packages meeting the statutory definition of medical devices are regulat - ed as medical devices. The AI Application Scenarios Reference Guide categories healthcare AI applications into four domains with specific use cases: • AI + Medical Service Management – including medical services, pharmaceutical services, health insurance services, traditional Chinese medicine administration and hospital management; • AI + Primary Public Health Services – including health management services, public health ser - vices and elderly and childcare services; • AI + Health Industry Development – including medical robotics, drug research and development and traditional Chinese medicine industry; and • AI + Medical Education & Research – including medical education and medical research. AI medical software packages qualifying as medical devices are categorised under the Guiding Principles
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