2022-08-10-环球律师事务所-数字医疗2022（英）_25页_498kb

报告摘要

China: Digital Healthcare Law & Practice

Authors: Alan Zhou, Charlene Huang, Jenny Chen, Sylvia Dong (Global Law Office)

1. Overview

Digital healthcare combines IT with medical services:

Technologies: AI, telemedicine, IoMT, wearables.
Legal terms not defined in PRC law, but regulated by device/pharma/diagnosis categories.

2. Regulatory Framework

Key Agencies:

NMPA: Regulates medical devices, drugs, AI-assisted tech.
NHC: Oversees healthcare policies, telemedicine.
NHSA: Manages medical insurance coverage, data localisation.
CAC & MIIT: Cybersecurity, data protection, tech development policies.

Recent Developments:

Telemedicine: NHC policies allow remote consultations for chronic diseases (2020+).
AI Medical Devices: NMPA issued review guidelines (e.g., 2019 ML-based software).
Data Protection: PRC PIPL & Data Security Law enforce data minimisation.

3. Cybersecurity & Data Protection

MLPS Mandate: IT infrastructure operators face grading requirements (PSB enforcement).
Personal Health Data: Broadly defined; requires informed consent or exceptions (e.g., HGR).
Cross-Border Transfer: Subject to security assessments for sensitive data types.

4. Liability & Legal Issues

Product Liability: Manufacturers liable for defective SaMD (AI-assisted devices).
Tort Compensation: Healthcare institutions/makers responsible for malpractice.
Bias in AI: Unresolved legal frameworks for algorithmic errors impacting diagnoses.

5. AI & Machine Learning

Registration: AI tools as medical devices must undergo NMPA review.
Data Use: Training data collected as limited data sets, subject to privacy laws.
Security Risks: High-profile breaches highlight risks of data leaks and cyberattacks.

6. Remote Healthcare & IoMT

Telemedicine: NHC encourages offline-prescription integration (2021+).
IoMT Applications: Wearables, 5G-enabled devices for real-time patient monitoring.
NB-IoT Adoption: Low-power, wide-area connectivity supports medical IoT devices.

7. Data Sharing & Governance

Healthcare Big Data: Localised storage, strict access controls for aggregation.
Third-Party Platforms: Data sharing partnerships require robust contracts.
Exceptions: Personal health data vs. anonymised fitness data.

8. IT Infrastructure & Digitalisation

Upgrades: Hospitals required to upgrade IT systems with cybersecurity measures.
Standardisation: NHC’s IT construction standards ensure interoperability.

9. Intellectual Property

Patents: Eligible for AI tech & medical devices meeting novelty/creativity criteria.
Copyright: Works by developers retain rights unless employer agreements state otherwise.
Trade Secrets: Confidentiality measures protect sensitive algorithms/data.

10. Hot Topics & Trends

Blockchain: Exploring secure healthcare data sharing via consortia networks.
Childcare: Government policies promote preventive care via apps & AI tools.
Future Challenges: Integrating digital solutions into national healthcare systems.

Digit Healthcare Law Group
Global Law Office (46+ lawyers across PRC offices) focusing on AI/MedTech compliance, M&A, IP, and cross-border transactions.

展开完整摘要