Transparency in Healthcare AI: Testing European Regulatory Provisions against Users' Transparency Needs
Journal:
arXiv
Published Date:
May 21, 2025
Abstract
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.
