The Directorate General for Parliamentary Research Services of the European Parliament has prepared a report to the Members of the European Parliament where they enumerate seven main risks of Artificial Intelligence (AI) in medicine and healthcare: patient harm due to AI errors, misuse of medical AI tools, bias in AI and the perpetuation of existing inequities, lack of transparency, privacy and security issues, gaps in accountability, and obstacles in implementation. In this study, we propose fourteen functional requirements that AI systems may implement to reduce the risks associated with their medical purpose: AI passport, User management, Regulation check, Academic use only disclaimer, data quality assessment, Clinicians double check, Continuous performance evaluation, Audit trail, Continuous usability test, Review of retrospective/simulated cases, Bias check, eXplainable AI, Encryption and use of field-tested libraries, and Semantic interoperability. Our intention here is to provide specific high-level specifications of technical solutions to ensure continuous good performance and use of AI systems to benefit patients in compliance with the future EU regulatory framework.

翻译：欧洲议会议会研究服务总局为欧洲议会议员准备了一份报告，其中列举了人工智能在医学和医疗保健领域的七项主要风险：人工智能错误导致患者伤害、医疗人工智能工具滥用、人工智能中的偏见及现有不平等现象的延续、缺乏透明度、隐私与安全问题、问责制漏洞以及实施障碍。在本研究中，我们提出了人工智能系统可实施的十四项功能需求，以降低其医疗用途相关的风险：人工智能护照、用户管理、法规检查、仅限学术用途声明、数据质量评估、临床医师复核、持续性能评估、审计追踪、持续可用性测试、回顾性/模拟案例审查、偏见检查、可解释人工智能、加密与现场测试库使用，以及语义互操作性。我们的目标是为技术解决方案提供具体的高层级规范，确保人工智能系统持续良好运行和使用，从而在符合未来欧盟监管框架的前提下惠及患者。