Medical AI in the EU: Regulatory Considerations and Future Outlook

Abstract

In many countries around the world, the healthcare sector is facing difficult problems: the aging population needs more care at the same time as the workforce is not growing, the cost of treatments is going up, and the more and more technical medical products are placing serious challenges to the expertise of the healthcare professionals. At the same time, the field of artificial intelligence (AI) is making big leaps, and naturally, AI is also suggested as a remedy to these problems. In this article, we discuss some of the ethical and legal problems facing AI in the healthcare field, with case study of European Union (EU) regulations and the local laws in one EU member state, Finland. We also look at some of the directions that the AI research in medicine will develop in the next 3–10 years. Especially, Large Language Models (LLMs) and image analysis are used as examples. The potential of AI is huge and the potential has already become a reality in many fields, but in medicine, there remain obstacles. We discuss both technical and regulatory questions related to the expansion of AI techniques used in the clinical environment.

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