2025-02-09-世界银行-数字健康监管沙盒（英）_24页_1mb

报告摘要

Summary of Regulatory Sandboxes for Digital Health

Regulatory sandboxes are controlled environments for testing digital health innovations, allowing innovators to experiment with products, services, and business models under regulatory waivers. They aim to promote innovation, mitigate risks, and generate evidence for regulatory updates.

Key Benefits

Innovators: Access to funding, markets, regulatory guidance, and reduced risk.
Patients: Early access to safe innovations at lower costs, increased trust.
Regulators/Governments: Better understanding of innovations, improved regulations, and enhanced market oversight.

Core Uses and Models

AAA Model: Categorizes regulatory sandboxes into advisory (guidance and expertise), adaptive (regulation changes based on innovation value), and anticipatory (focusing on societal impacts).
Digital Health Context: Helps integrate new technologies like AI, telemedicine, and genomics into health systems safely.

Implementation Steps

Define leadership and objectives.
Identify problems, emerging technologies, and relevant regulations.
Build capacity and establish working groups with stakeholders.
Define eligibility, risk model, and sandbox design (e.g., timing, restrictions, exit options).
Launch, monitor, and evaluate, including public consultation and reporting.

Steps include regulatory mapping, resource allocation, and ensuring fit-for-purpose design.

Examples and Usage

Several countries use regulatory sandboxes for digital health. Notable implementations include the UK's FCA, CQC, and ICO; Singapore's telemedicine sandbox; and global initiatives like the EU's AI regulatory sandbox. The approach is growing, with tools adapted for cross-sector innovations.

Challenges and Pitfalls

Requires significant resources and time; may underestimate costs.
Unpredictable risks for novel innovations; need for inter-agency collaboration.
Potential for market imbalances, data breaches, and regulatory gaps; mitigate through clear rules and stakeholder involvement.

Success Factors

Adequate funding, legal mandates, stakeholder engagement, and tailored design to meet specific objectives.
Agile operation and alignment with country needs for sustainability.