摘要
This paper explores the expansion from fintech-based regulatory sandboxes to those that include medical artificial intelligence(AI)by examining their potential to foster innovation and accelerate market access while ensuring safety and compliance,especially considering how they provide a flexible framework for medical AI companies to develop and test new technologies.This work also highlights the key risks involved,including data privacy,ethical concerns,real-world validation,and regulatory consistency,and proposes strategies for mitigation.Using case studies from the United States,the United Kingdom,the European Union,Indonesia,Japan,and China,this paper illustrates how regulatory sandboxes can support AI-driven healthcare innovation.Overall,although regulatory sandboxes present several risks,they are valuable for advancing medical AI,granted that they balance innovation with robust oversight to ensure patient safety and long-term benefits.
基金
National Science and Technology Major Project(2020AAA0105000)
Beijing Science and Technology Plan(Z241100007724003).
