测试欧盟医疗AI透明性规定是否满足用户需求
Transparency in Healthcare AI: Testing European Regulatory Provisions against Users' Transparency Needs
- 针对四类利益相关者调研透明性需求与说明书匹配度
- 发现不同群体对透明性的优先级差异明显
- 提出构建本地化、有意义说明书的实用建议
人工智能在医疗领域扮演关键角色，广泛集成于医疗软件与设备中。在欧盟，医疗属于高风险AI应用领域，依据2024/1689号法规（《人工智能法案》），提供方必须编制使用说明（IFU）。该法规强调透明性原则，要求说明清晰且与用户相关。本研究检验了现有IFU结构是否满足这一要求。通过Qualtrics平台在线调查了四类直接利益相关者：管理者（N=238）、医护人员（N=115）、患者（N=229）和信息技术专家（N=230）。参与者评估了多项透明性需求的相关性，并指出对应说明部分。结果显示，各群体优先级存在显著差异，且透明性需求与IFU结构之间匹配度不佳。研究据此提出构建本地化、有意义使用说明的改进建议。
原文摘要 · Abstract (English)
Artificial Intelligence (AI) plays an essential role in healthcare and is pervasively incorporated into medical software and equipment. In the European Union, healthcare is a high-risk application domain for AI, and providers must prepare Instructions for Use (IFU) according to the European regulation 2024/1689 (AI Act). To this regulation, the principle of transparency is cardinal and requires the IFU to be clear and relevant to the users. This study tests whether these latter requirements are satisfied by the IFU structure. A survey was administered online via the Qualtrics platform to four types of direct stakeholders, i.e., managers (N = 238), healthcare professionals (N = 115), patients (N = 229), and Information Technology experts (N = 230). The participants rated the relevance of a set of transparency needs and indicated the IFU section addressing them. The results reveal differentiated priorities across stakeholders and a troubled mapping of transparency needs onto the IFU structure. Recommendations to build a locally meaningful IFU are derived.
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