CHINA Law and Practice Contributed by: Alan Zhou, Charlene Huang, Jenny Chen and Stephanie Wang, Global Law Office
1. Digital Healthcare Usage 1.1 Types of Digital Healthcare
Self-Care, Wellness and Fitness IT Products If a preventative care concerns general health- care consulting, elder care, nursery, massage, fitness or wellness, without making judgement about diseases or giving targeted recommen- dations towards specific health issues or con- ditions, it may not fall within the definition of diagnosis and treatment and will therefore not be subject to special regulation. However, if a preventative care falls within the area of diagno- sis or treatment activities (eg, disease screening or vaccination), it can only be performed by a qualified doctor in a medical institution. Artificial Intelligence (AI) and Machine Learning Unlike traditional medical devices, the develop- ment of an AI medical device may need a tre- mendous amount of data for machine learning and training. Companies engaging in new digital healthcare technologies should be aware of the relevant regulatory and legal issues (including cybersecurity and data protection). They should also be aware that they will be subject to the same requirements. Telemedicine Internet hospitals, as a major telemedicine mod- el, can be divided into two categories: • internet hospitals associated with specific offline healthcare institutions, eg, an internet hospital of a particular public hospital; and • independent online hospitals set up with reli- ance on offline healthcare institutions, eg, an internet hospital set up by internet companies together with public hospitals. Under both categories, internet hospitals may provide internet-based diagnosis and treatment to patients, which are limited to the follow-up
Digital healthcare usually refers to healthcare technologies developed based on information technologies used by, and, for the public in gen- eral, including: • healthcare management; • disease awareness; • telemedicine; • online sale of pharmaceutical products; and • other healthcare-related activities conducted through digital platforms. Alongside digital healthcare, digital medicine usually refers to the application of IT in the pro- cess of diagnosis and treatment, which can only be performed by qualified medical institutions. Digital therapeutics usually refers to the soft- ware-based products that are used for thera- peutic interventions, either as monotherapy or together with other conventional medical therapies. These products usually fall within the category of medical devices and are therefore subject to regulatory oversight to ensure their safety and efficacy. 1.2 Use/Application of Digital Healthcare Digital healthcare is widely used in healthcare settings in China, especially in terms of the fol- lowing. Software as a Medical Device (SaMD) When a software product processes medical device data and its core function is to manage, measure, model, calculate or analyse this data for medical purposes, the product falls within the scope of a SaMD.
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