CHINA Law and Practice Contributed by: Alan Zhou, Charlene Huang, Jenny Chen and Stephanie Wang, Global Law Office
diagnoses of certain common and chronic dis- eases. Cybersecurity and Data Protection As digital healthcare involves a large amount of personal data, especially that of a sensitive nature, the design and implementation of life cycle protection of this data needs to be care- fully considered under the cybersecurity and privacy protection laws and regulations, particu- larly the regulations of the Personal Information Protection Law of the PRC (the “PIPL”), which came into effect on 1 November 2021. 1.3 Benefits of Digital Healthcare The advantages of digital healthcare could gen- erally be summarised as: • improved accessibility and efficiency; • customised and precise medicine fulfilment; and • the promotion of patient engagement and transparency. With proper support of digital healthcare, patients could be provided with e-consultation services in qualified third-party platforms with subsequent time saving benefits. From the perspective of healthcare profession- als, AI-assisted diagnostic tools, multi-discipli- nary consultations and e-medical record sys- tems could largely improve the efficiency and collaboration in the work practice. Although investment in the digital infrastructure would be considerable in the early implementa- tion stage, the application of digital healthcare could optimise resources and avoid unneces- sary treatments which could largely reduce the cost of patients and healthcare institutions. With this technology, the telemedicine platform can
automatically collect various vital signs data, upload the data to the hospital control centre and analyse the data in real time, to provide doc- tors with an early warning and allow telemedi- cine services to be provided. 2. Legal Framework 2.1 Definition of Digital Healthcare Digital healthcare is not legally defined in the laws and regulations of the PRC but is frequently referred to in commercial contexts and industry policies (see 1.1 Types of Digital Healthcare ). Despite this, if any service or product in the fields of digital healthcare and digital medicine falls within the category of pharmaceuticals or medical devices or is going to be used for the diagnosis and treatment of human diseases, administrative regulations will apply accordingly. 2.2 Laws and Regulations Digital healthcare activities, based on different scenarios, are mainly governed by: • physician practising laws and telemedicine- related regulations in the PRC; • drug administrative laws and regulations in relation to online sale of pharmaceutical prod- ucts in the PRC; • advertising laws in the PRC; • laws and regulations on cybersecurity and data protection in the PRC; and • laws, regulations and industry standards on telecommunications and IT in the PRC. However, a unified and systematic law or regula- tion to specifically govern the digital healthcare industry is still being developed.
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