CHINA Law and Practice Contributed by: Alan Zhou, Charlene Huang, Jenny Chen and Stephanie Wang, Global Law Office
NMPA The NMPA regulates drugs, medical devices and cosmetics in China. It is responsible for their safety, supervision, and management, from registration and manufacturing to post-market risk management. Technologies and devices, including software that falls within the category of pharmaceuticals or medical devices are also subject to regulation and supervision by the NMPA and its subordinate branches. NHC The NHC primarily formulates and enforces national health policies and regulations pertain- ing to healthcare institutions, healthcare services and healthcare professionals. Internet-based diagnosis and treatment (including internet hos- pitals) and remote consultations between health- care institutions and patients are also supervised by the NHC. Additionally, the clinical application of medical technologies for the purpose of diagnosis and treatment (including AI-assisted diagnosis and treatment) by healthcare institutions and profes- The NHSA is primarily responsible for imple- menting policies related to basic medical insur- ance, such as reimbursement, pricing and the procurement of drugs, medical consumables and healthcare services. 3.2 Non-Healthcare Regulatory Bodies Certain aspects of digital healthcare fall within the remit of other non-healthcare regulatory bodies. These are as follows. sionals is supervised by the NHC. The National Healthcare Security Administration (NHSA)
The Cyberspace Administration of China (CAC) The CAC is responsible for the overall planning and co-ordination of network security and rel- evant supervision and administration. In terms of digital healthcare, the CAC’s involvement may include regulating the collection and utilisation of personal information, cross-border transfer of healthcare data and the cybersecurity review of internet hospitals, etc. The Public Security Bureau (PSB) In terms of cybersecurity, the PSB is mainly responsible for enforcing the Multi-Level Pro- tection Scheme (the “MLPS”) and investigating cybercrimes. With respect to digital healthcare, the PSB’s involvement includes: • record filing and MLPS-related inspections of healthcare institutions (including internet hospitals); and • investigating crimes, such as the infringement of personal data and illegal access to infor- mation systems. The Ministry for Industry and Information Technology (MIIT) The MIIT is responsible for: • regulating the IT and communications indus- try; • recording filing and approval of internet con- tent providers (ICPs); and • formulating policies and standards on data security, etc. In terms of digital healthcare, the MIIT’s involve- ment may include regulating technology-related developments, such as the development of, and security requirements, for AI technology. Addi- tionally, the MIIT actively leads personal data
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