ArticlePLOS digital health2026
Transparency in healthcare AI: Testing EU regulatory provisions against users' transparency needs.
Article in PLOS digital health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
Identifiers
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.