Detangling AI Transparency in the Medical Regulation Space

Despite the excitement surrounding Artificial Intelligence (AI) in health care, one of the key concerns is the lack of transparency, which is essential for ensuring quality, safety, and trust around AI technologies. This article examines the notion of AI transparency and its traditional role in health care. It examines its ambiguous meaning and identifies the emerging consensus in recent policy documents to distinguish it from related concepts such as AI explainability. The article explores the rationales underlying the AI transparency principle for different stakeholders and investigates potential challenges for enhancing transparency to users of AI-based medical devices. It concludes that, although the need for transparency around AI-based medical devices is widely recognised, the main hurdle is a lack of clarity about the level of information to be provided across different contexts and stakeholders, and how best to provide this information to achieve transparency goals.