Transparency in Healthcare AI: Testing European Regulatory Provisions against Users' Transparency Needs
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.
Code (0)
등록된 구현이 없습니다.
Methods 이 논문이 사용한 방법론
Similar Papers 제목 키워드 기반
Security, privacy, and agentic AI in a regulatory view: From definitions and distinctions to provisions and reflections
The rapid proliferation of artificial intelligence (AI) technologies has led to a dynamic regulatory landscape, where legislative frameworks strive to keep pace with technical advancements. As AI paradigms shift towards …
The Dilemma of Uncertainty Estimation for General Purpose AI in the EU AI Act
The AI act is the European Union-wide regulation of AI systems. It includes specific provisions for general-purpose AI models which however need to be further interpreted in terms of technical standards and state-of-art …
Acceptable risks in Europe's proposed AI Act: Reasonableness and other principles for deciding how much risk management is enough
This paper critically evaluates the European Commission's proposed AI Act's approach to risk management and risk acceptability for high-risk AI systems that pose risks to fundamental rights and safety. The Act aims to pr…
ManagementFunctional requirements to mitigate the Risk of Harm to Patients from Artificial Intelligence in Healthcare
The Directorate General for Parliamentary Research Services of the European Parliament has prepared a report to the Members of the European Parliament where they enumerate seven main risks of Artificial Intelligence (AI)…
ManagementCybersecurity of AI medical devices: risks, legislation, and challenges
Medical devices and artificial intelligence systems rapidly transform healthcare provisions. At the same time, due to their nature, AI in or as medical devices might get exposed to cyberattacks, leading to patient safety…