CHINA Trends and Developments Contributed by: Hanshuo Zhou, Xiaoyun Wang and Taige Shi (Casper), Jingtian & Gongcheng
AI+ wearable devices AI-powered wearable devices are reshaping personal health management by shifting the paradigm from reactive treatment to proactive prevention. What began with basic function- ality – such as fitness tracking (eg, heart rate monitoring, and sleep stage analysis) and vital sign monitoring (eg, blood oxygen levels, ECG and blood pressure) – has rapidly expanded to include more advanced features such as health analytics, early stage disease risk assessment, and preliminary screening tools. Based on the authors’ recent advisory work with several leading wearable device manu- facturers in China, the authors have observed that the pace of technological advancement in this sector often outstrips the development of corresponding compliance frameworks. While functionality continues to evolve – from basic health tracking to predictive analytics and early stage screening – many companies underesti- mate the regulatory risks embedded throughout the product life cycle, including during research and development (R&D), classification, registra- tion and commercialisation. A core regulatory issue is determining whether AI-integrated wearable devices qualify as medi- cal devices under applicable laws. This clas- sification dictates the appropriate regulatory pathway, including whether the device must be registered as standalone software (SaMD) or as an integrated hardware-software system (SiMD). Additionally, when the device’s monitoring and analytical functions approach or resemble diag- nostic activities, the product may trigger legal obligations associated with medical practice, including requirements for ethical review or restrictions on advertising medical services or devices.
On the data governance side, once user data is collected and transmitted to the health data plat- forms operated by wearable device providers, companies face heightened compliance obliga- tions. These include the identification and pro- tection of sensitive personal information, adher- ence to privacy requirements, and compliance with rules governing the cross-border transfer of health-related data. Addressing these risks proactively is essential to ensuring both legal compliance and long-term trust in digital health technologies. AI-powered internet hospital consultations The integration of AI into internet-based health- care platforms has significantly improved the speed, accessibility and consistency of clinical services. These AI-powered models typically include: • self-service tools for triage, patient intake, and symptom checking; • remote consultations conducted by licensed physicians; • automated prescription review linked to drug distribution services; • AI-driven chronic disease management and long-term health tracking; and • intelligent customer support and digital patient education. Depending on how these tools are designed and deployed, some may fall within the regulatory scope of software-based medical devices – par- ticularly where AI is used to support diagnostic functions – while others are more likely to be regulated under the frameworks that govern internet-based healthcare delivery and licensed internet hospitals. Crucially, under the current regulatory landscape and given the present levels of technological
40
CHAMBERS.COM
Powered by FlippingBook