The Introduction of AI in Healthcare: A Multi-layered Issue

The updated text of the Artificial Intelligence Act (AI Act) has raised some questions about tools using Artificial Intelligence in different fields. In particular, the specimen of AI technology for medical purposes has now become a concerning topic for the introduction of additional legal and procedural requirements. The AI Act is just one of several pieces of legislation regulating AI medical tools, as many have already been established (e.g. Medical Device Regulation) and the intersection of requirements and obligations needs to be assessed. With multiple layers of relevant provisions about AI medical tools, our main objective is to create a practical guideline for the introduction of AI tools in healthcare systems by ensuring their legal compliance. We also aim to show legal short circuits related to AI medical tools to have a comprehensive perspective on the issue of introducing AI in Healthcare.