Transparency in healthcare AI: Testing EU regulatory provisions against users’ transparency needs

Algorithmic systems play an essential role in healthcare and are pervasively incorporated into medical software and equipment. In the European Union, providers must share transparency information with deployers (users) via a document called Instructions for Use (IFU, Directive 2024/1689 or AI Act). This study tests the extent to which deployers' transparency needs map onto the structure of an IFU document. A survey was administered online via the Qualtrics platform to four types of deployers, i.e., managers (N = 238), healthcare professionals (N = 115), patients (N = 229), and information technology workers (N = 230). The participants rated the relevance of a set of transparency needs and selected the IFU section more likely to address them. The results reveal differentiated priorities across user types and reveal potential weaknesses in locating some transparency information. Recommendations to build a locally meaningful IFU are derived.