CHINA Law and Practice Contributed by: Alan Zhou, Charlene Huang, Jenny Chen and Stephanie Wang, Global Law Office
4.3 Defences China employs comprehensive and inclusive laws and regulations to systematically manage digital healthcare risks and to keep up with tech- nological advancements, particularly in terms of data security and product liability, especially in terms of: • data security and privacy protection mecha- nisms; • classifications and regulatory approval of AI medical software; • online sales supervision; • internet diagnosis and treatment manage- ment; • e-medical records application; and • ethics review, etc. 5. Emerging Legal Issues and Reform 5.1 Emerging Legal Issues in Digital Healthcare Regulatory Developments on Telemedicine “Internet Plus Healthcare”, ie, healthcare com- bined with the application of the internet, is now a key national strategic priority in China. To regu- late diagnosis and treatment provided remotely, ie, teleconsultation by healthcare professionals or internet-based diagnosis, the NHC and the National Administration of Traditional Chinese Medicine (the “NATCM”) in July 2018 issued the: • Administrative Measures for Internet-based Diagnosis (for Trial Implementation); • Administrative Measures for Internet Hospi- tals (for Trial Implementation); and • Good Practices for Telemedicine Services (for Trial Implementation).
The NHC and the NATCM also released the Rules for the Regulation of Internet-based Diag- nosis (for Trial Implementation). These measures clarify how technical support on internet-based diagnosis and treatment should be conducted and set out the regulatory requirements to do so. In addition, the growth of internet-based diag- noses also boosted demand for online medicine sales. The Provisions for Supervision and Admin- istration of Online Drug Sales and the Circular on Regulating the Display of Online Sales Informa- tion of Prescription Drugs, which were enacted in recent years, state that, except for medici- nal products subject to special administration, internet sales of over-the-counter drugs and pre- scription drugs are allowed. Nevertheless, it is crucial for third-party platforms and enterprises engaging in online drug sales to comply with the relevant requirements for displaying information about the online sales of prescription drugs. Regulatory Developments on E-Medical Insurance The NHSA issued the “Internet Plus” Medical Service Prices and Medical Insurance Pay- ment Policy in August 2019 and launched the e-medical insurance system, which regulates prices and insurance policies to allow for inter- net-based healthcare services to be covered by China’s medical insurance system. Additional implementation policies were issued in 2020 and local enforcement rules have been issued gradu- ally by local authorities since 2021. In September 2024, the NHSA issued the Announcement on Further Improving the Col- lection of Medical Insurance Drug and Con- sumables Traceability Code Information (the “Announcement”). The Announcement clarified
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