医疗AI需提前布局，确保2026年欧盟人工智能法案合规。
Getting Ready for the EU AI Act in Healthcare. A call for Sustainable AI Development and Deployment
- 以可信赖AI原则为基石，主动对接欧盟AI法案要求。
- 2026年前完成系统合规，避免后期整改风险。
- 适合医疗AI开发者与部署者参考落地策略。
可信性评估已成为负责任AI开发的核心。在医疗等高风险领域，将技术、实证与伦理实践与即将实施的法律要求对齐，愈发紧迫。我们主张，医疗领域AI系统的开发者与部署者应主动作为，逐步确保现有及正在开发或规划中的系统符合2024年8月生效的欧盟人工智能法案要求。此举旨在确保2026年法案关键条款正式施行时实现全面有效合规。对法案的响应不应仅是形式主义，而需通过主动践行可信赖AI的伦理原则来实现。这些原则是法案的基础，多次被提及，并与公共利益保护挂钩。它们可用于解释和应用法案条款，识别良好实践，提升系统长期有效性与可持续性。
原文摘要 · Abstract (English)
Assessments of trustworthiness have become a cornerstone of responsible AI development. Especially in high-stakes fields like healthcare, aligning technical, evidence-based, and ethical practices with forthcoming legal requirements is increasingly urgent. We argue that developers and deployers of AI systems for the medical domain should be proactive and take steps to progressively ensure that such systems, both those currently in use and those being developed or planned, respect the requirements of the AI Act, which has come into force in August 2024. This is necessary if full and effective compliance is to be ensured when the most relevant provisions of the Act become effective (August 2026). The engagement with the AI Act cannot be viewed as a formalistic exercise. Compliance with the AI Act needs to be carried out through the proactive commitment to the ethical principles of trustworthy AI. These principles provide the background for the Act, which mentions them several times and connects them to the protection of public interest. They can be used to interpret and apply the Act's provisions and to identify good practices, increasing the validity and sustainability of AI systems over time.
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