环球律师事务所《数字健康2021》之中国篇（英）-20页_434kb

报告摘要

Digital Healthcare 2021 Summary: China

Core Content Overview

This document provides a comprehensive analysis of the digital healthcare landscape in China, focusing on legal and regulatory frameworks, emerging technologies, and key challenges. It is authored by Alan Zhou, Charlene Huang, and Jenny Chen from the Global Law Office, covering topics such as digital healthcare vs. digital medicine, cybersecurity, data protection, AI, telehealth, IoT, and 5G networks.

Main Topics and Key Information

1. Digital Healthcare Overview

Digital Healthcare vs. Digital Medicine
- Not legal terms in PRC laws but commonly used in industry contexts.
- Digital Healthcare includes public health monitoring, cost control, telemedicine, online pharmacy sales, etc., based on IT.
- Digital Medicine refers to IT applications in diagnosis and treatment, limited to qualified medical institutions.
New Technologies
- Digital healthcare: big data, IoT, GPS, 5G.
- Digital medicine: AI and machine learning in diagnostics and treatment.
Emerging Legal Issues
- Lack of a unified regulatory framework.
- Cybersecurity and data protection concerns.
- Liability issues in AI-assisted diagnosis and treatment.
Impact of COVID-19
- Rapid adoption of digital healthcare services (telemedicine, online appointments, AI-assisted diagnosis).
- Over 1,100 internet hospitals in China by April 2021, up from 367 at the end of 2019.
- Government issued notices in 2020 to promote telemedicine use and reimbursement policies.

2. Digital Healthcare and Climate Change

Digital healthcare can help address public health risks related to climate change, such as extreme weather and pathogen spread.
It enables early warnings for health emergencies and improves access to personalized care, reducing resource costs.

3. Healthcare Regulatory Environment

Regulatory Agencies
- NMPA: Regulates medical devices, including SaMD.
- NHC: Oversees telemedicine, internet hospitals, and AI-assisted diagnosis/treatment.
- NHSA: Manages medical insurance reimbursement and pricing for digital healthcare services.
Recent Regulatory Developments
- Telemedicine: NHC issued "Internet-based Diagnosis Measures" and "Internet Hospital Measures" in 2018, promoting internet-based diagnosis and treatment.
- Medical Insurance: NHSA launched an electronic medical insurance system in 2019.
- AI-Assisted Diagnosis: NHC issued regulations in 2017, and NMPA released guidelines on deep learning software in 2019.
- Cybersecurity and Data Protection: NHC and NHSA issued standards and policies in 2018 and 2020, respectively, and are expected to release more data-related regulations soon.
Regulatory Enforcement
- Focus on cybersecurity and personal data protection.
- Implementation of Multi-Level Protection Scheme (MLPS) is a legal requirement under the PRC Cybersecurity Law.
- Healthcare institutions must be graded as Grade III under MLPS for internet-based services.
- Enforcement includes administrative penalties such as warnings and fines by the Public Security Bureau (PSB).

4. Non-Healthcare Regulatory Agencies

CAC (Cyberspace Administration of China): Oversees cybersecurity and cross-border data transfers.
PSB (Public Security Bureau): Enforces MLPS and investigates cybercrimes.
MIIT (Ministry of Industry and Information Technology): Regulates IT and communication, including AI and data security.
These agencies collaborate with healthcare regulators to ensure compliance with data and cybersecurity standards.

5. Software as a Medical Device (SaMD)

Definition: SaMD refers to software with medical uses that does not require hardware.
Regulatory Authority: NMPA and its subordinate branches.
Classification:
- Class I: Low risk, subject to customary regulation.
- Class II: Moderate risk, includes image processing and data analysis.
- Class III: High risk, includes AI-assisted diagnosis and treatment.
Registration and Updates:
- Class II SaMD must register at the provincial level; Class III must register with NMPA.
- Major updates require prior approval; minor updates need post-market reporting.

6. Telehealth

Internet Hospital Categories:
- Offline institutions with associated internet hospitals.
- Independent online hospitals set up by internet companies in collaboration with public hospitals.
Services:
- Limited to follow-up visits for common and chronic diseases.
- Physicians can issue electronic prescriptions for previously diagnosed offline conditions.
- Prescription delivery via third-party logistics.
Regulatory Environment:
- NHC issued policies in 2020 to promote telemedicine.
- Some gaps remain, such as the scope of internet-based diagnosis and first-time visit regulations.
Payment and Reimbursement:
- NHSA and NHC issued guiding opinions for BMI reimbursement of internet-based diagnosis.
- Reimbursement covers medical consultation and drug costs.

7. Internet of Medical Things (IoMT)

Key Applications:
- Medical device lifecycle monitoring using RFID, infrared sensors, and GPS.
- Intelligent operating rooms for improved efficiency.
- Wearable health monitoring devices for real-time data collection and processing.
Technological Drivers:
- 5G networks for secure and stable data transmission.
- NB-IoT for low-rate, secure healthcare applications.
- Sensors for data collection and integration.
Regulatory Issues:
- Ongoing development of IoT-specific regulations.
- Focus on cybersecurity and data protection, especially for handling vulnerabilities and ensuring data integrity.

8. 5G Networks

Impact on Digital Healthcare:
- Enables real-time data transmission in emergency care, such as ECG and ultrasound data.
- Supports AI development through data sharing and cleaning in remote monitoring and analysis.
Commercial Considerations:
- Need for well-developed industry standards.
- Adequate 5G frequency resources.
- Security risk assessment and management.
- Support for cross-industry innovation.

9. Data Use and Data Sharing

Legal Relationship:
- PRC Cybersecurity Law, Civil Code, and Personal Information Protection Law govern data protection.
- Healthcare data is subject to more specific regulations.
Definition of Personal Health Data:
- Data that can identify an individual or reflect their health status.
- Informed consent is generally required, unless involving public interest or safety.
Data Requirements:
- Limited data set: De-identified data that may still identify individuals.
- Data aggregation: May not change data nature if no personal identifiers are present.
Consent Mechanisms:
- Digital healthcare has not changed the nature of patient consent.
- Alternative consent methods are being explored.

10. AI and Machine Learning

AI is increasingly used in diagnosis and treatment.
Regulatory Focus:
- NHC and NMPA have issued guidelines to ensure safety and effectiveness.
- AI-assisted diagnosis requires self-assessment and filing with health commissions.
Legal Concerns:
- Liability in case of patient harm due to AI errors.
- Need for clear legal responsibility frameworks.

11. Upgrading IT Infrastructure

Cloud Computing: Essential for digital healthcare scalability and data management.
Infrastructure Development: Critical for supporting digital healthcare services and ensuring compliance with cybersecurity standards.

12. Intellectual Property

Scope of Protection: Includes software, AI algorithms, and medical devices.
Academic Research: Involves IP protection for innovations in digital healthcare.
Collaborative Contracts: Agreements between institutions and tech companies for joint development.

13. Liability

Patient Care: Legal responsibility for AI and software errors in diagnosis/treatment is still under analysis.
Commercial: Requires clear liability allocation in contracts and collaborations.

14. Hot Topics and Trends

Future trends include AI regulation, data protection laws, and IoMT standards.
PRC Personal Information Protection Law and Data Security Law are expected to be officially promulgated, further strengthening data governance in digital healthcare.

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