Healthcare AI 2025

CHINA Law and Practice Contributed by: Gil Zhang, Diana Li, Muran Sun and Yongqi Tao, Fangda Partners

Fangda Partners 24/F, HKRI Centre Two HKRI Taikoo Hui 288 Shi Men Yi Road Shanghai 200041 China Tel: +86 21 2208 1166 Fax: +86 21 5298 5599 Email: email@fangdalaw.com Web: www.fangdalaw.com

1. Use of Healthcare AI 1.1 Types and Applications of Healthcare AI In China, AI is widely used across the healthcare and life science sectors, primarily in relation to medical institutions, pharmaceutical R&D, sales and marketing, medical devices, diagnostics, treatment assistance and consumer health devices. In clinical settings, AI powers diagnostic imaging, virtual consultations and surgery planning tools, and provides clinical decision support for general practitioners. These technologies improve diagnostic accuracy and efficiency, particu - larly in underserved areas. In the pharmaceutical sec - tor, AI is primarily used for drug discovery, including target identification, virtual screening and clinical trial design, as well as to educate patients and doctors on medical products. Meanwhile, AI-enabled wear - able devices support remote patient monitoring and chronic disease management. In recent years, Chinese authorities have taken active steps to guide and accelerate the development of healthcare AI. In November 2024, the Reference Guide for AI Application Scenarios in the Healthcare Industry (the “AI Application Scenarios Reference Guide”) identified 84 use cases across four catego - ries: medical service management, public health and primary care, health industry innovation (such as robotics and drug development), and medical edu - cation and research. This guide provides a national framework to integrate AI into health services more systematically. Further, in early 2025, the Notice on Carrying out the 2025 Innovation Task of AI-based

Medical Devices (the “2025 Innovation Task Notice”) was issued, promoting breakthroughs in intelligent diagnostic and therapeutic tools. In March 2025, the Opinions on Comprehensively Deepening the Reform of Drug and Medical Device Regulation to Promote the High-Quality Development of the Pharmaceutical Industry strengthened the regulation of next-genera - tion medical technologies, including AI and medical robotics, by improving national technical standards and regulatory systems. 1.2 Key Benefits and Challenges Healthcare AI adoption in China is driven by both systemic needs and innovation opportunities. On the one hand, medical institutions face growing pressure from limited medical resources, uneven care quality between urban and rural areas in China, and a rising demand for faster and more accurate diagnoses. On the other hand, pharmaceutical companies are under pressure to accelerate drug discovery, reduce R&D costs and improve trial design. These challenges have created strong incentives across the healthcare sys - tem to adopt AI solutions that can improve outcomes, enhance efficiency and support clinical decision-mak - ing. AI technologies bring several significant benefits to healthcare delivery. First, they enhance diagnostic accuracy and efficiency, especially in radiology and pathology. AI tools used in image interpretation – such as for lung nodule, breast cancer and stroke detec - tion – can match or exceed human performance in screening tasks, leading to earlier and more reliable

CHAMBERS.COM