全球法律指南_数字医疗2025之中国篇（英）_17页_1mb

Summary of China's Digital Healthcare Law and Practice

1. Digital Healthcare Usage

Digital healthcare includes technologies like healthcare management, telemedicine, and digital medicine, used for improved accessibility, customised medicine, and patient engagement. Benefits include efficiency gains, reduced costs, and enhanced patient involvement. Usage spans preventative care, diagnosis, and treatment; however, certain activities fall under strict regulation if they involve medical professionals.

2. Legal Framework

• Definition: Digital healthcare is not explicitly defined but is referenced in regulations and commercial contexts.
• Laws and Regulations: Key laws include the Personal Information Protection Law (PIPL), drug and medical device regulations, cybersecurity laws, and advertising rules. Different scenarios are governed by specific acts, such as physician practising laws and telemedicine-related regulations.
• Role of Policymakers: Encourages digital healthcare implementation while balancing development with risk. Policies support AI and continuous learning technologies.
• Technical Standards: SaMDs (Software as a Medical Device) are regulated under medical device classifications; updates require approvals if they affect core functions. Technical standards address AI and machine learning in healthcare.
• Issue-Specific Framework: Addresses data protection, prescription statistics collection (banned for commercial purposes), and human genetic resources management.
• Sufficiency: The framework is underdevelopment and refinement, with ongoing legislative efforts.

3. Regulatory Oversight

• Oversight Bodies: Health authorities (NMPA, NHC) regulate safety and compliance. Non-healthcare bodies include the Cyberspace Administration of China (CAC) for data and cybersecurity, Public Security Bureau (PSB) for enforcement, Ministry of Industry and Information Technology (MIIT) for IT standards, and National Data Bureau (NDB) for data coordination.
• Enforcement: Focuses on cybersecurity, personal data protection, and internet-based diagnosis/treatment. Non-compliance can lead to penalties.
• Sufficiency: Oversight is evolving and may lack comprehensiveness, requiring stronger mechanisms.

4. Liability

• Legal Risks: Includes criminal and administrative liabilities for data breaches, AI bias, and commercial bribery. Contractual liabilities apply if vendors fail to perform obligations.
• Liability Frameworks: Defects in SaMDs or telemedicine platforms can lead to product liability or malpractice claims. Civil and tort liabilities are covered under the Civil Code and PIPL.
• Defences: Compliance with laws like the Cybersecurity Law and data protection regulations can mitigate risks.

5. Emerging Legal Issues and Reform

• Emerging Issues: AI governance, data security, and patient management programme risks (e.g., improper data collection by vendors or employees).
• Recent Reforms: Telemedicine regulations, digital transformation in pharmaceuticals, and enhanced data protection standards. Ongoing developments include AI-specific policies and international data transfer guidelines.