CHINA Law and Practice Contributed by: Alan Zhou, Charlene Huang, Jenny Chen and Stephanie Wang, Global Law Office
that the NHSA is developing a nationally uni- fied interface for the production and circulation enterprises of drugs and consumables to upload traceability code information, so as to achieve one-time uploading with nationwide applicabil- ity. The NHSA plans to establish a comprehensive three-code mapping database to link trace- ability code, medical insurance code and then commodity code to reduce the burden of code scanning. Regulatory Developments on AI-Assisted Diagnosis and Treatment In terms of AI, China’s overall legal framework is still developing. There is currently a lack of specialised laws and administrative regulations dedicated to AI. The main regulation in force is the Interim Measures for the Management of Generated AI Services which was jointly issued by seven ministries on 15 August 2023 and other relevant departmental regulations (see 2.3 Role of Policymakers ). In addition, as early as 2017, the State Council released the Development Plan for a New Gen- eration of AI, setting a strategic goal of initially establishing AI laws, regulations, ethical norms and policy systems to form AI safety assessment and control capabilities by 2025. Since then, the State Council, various ministries and specific local governments have issued a series of poli- cies, regulatory documents and local regulations addressing AI governance and development. Between 2022 and 2024, a series of AI-relat- ed national standards were released one after another. In April 2025, the MIIT and six other ministries jointly issued the Implementation Plan for Digi-
tal and Intelligent Transformation of the Phar- maceutical Industry (2025-2030). One of its key tasks for the next five years is the “Digital and Intelligent Technology Empowerment Initiative”, which includes: • strengthening the development and applica- tion of digital and intelligent products for the pharmaceutical industry; • integrating and releasing the value of pharma- ceutical data elements; • transforming and upgrading information infra- structure; and • deepening the application of AI empower- ment. Regulatory Developments on Data Protection In July 2018, the NHC issued the Administra- tive Measures on the Standards, Security and Services regarding National Healthcare Big Data (the “Administrative Measures”). The Administra- tive Measures specified the direction of travel for regulating the use and application of the health- care-related data from a compliance perspec- tive and implementing industry-specific data protection requirements. In December 2020, a recommended national standard, the Informa- tion Security Technology – Guide for Healthcare Data Security was released to provide compre- hensive guidelines on how to protect healthcare data, particularly considering the rapid develop- ment of digital healthcare. Additionally, in April 2021, the NHSA issued the Guiding Opinions on Strengthening Network Security and Data Protection, which requires the establishment of a more solid foundation for network security and data protection mecha- nisms in digital medical insurance and digital healthcare.
33
CHAMBERS.COM
Powered by FlippingBook