Transparency in Healthcare AI: Testing European Regulatory Provisions against Users' Transparency Needs

TL;DR

This study evaluates whether European healthcare AI Instructions for Use (IFU) meet transparency requirements by surveying stakeholders on transparency needs and their alignment with IFU content.

Contribution

It provides an empirical assessment of the alignment between regulatory transparency requirements and actual IFU content in healthcare AI, highlighting gaps and stakeholder-specific priorities.

Findings

Stakeholders have different transparency priorities.

There is a poor mapping between transparency needs and IFU sections.

Recommendations for improving IFU relevance are proposed.

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.