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Jul 9. 2024
AI:Dental and KInIT published policy brief Healthcare Innovation and Artificial Intelligence in European Union
In March 2024 the European Parliament formally adopted the AI Act, first comprehensive regulation of the AI in the European Union. The regulation emphasizes a risk-based approach towards AI, tailoring specific requirements mainly to high-risk AI systems. One of the high-risk areas is healthcare, more specifically AI as a medical device. Medical devices are also governed by Medical Devices Regulation and potentially forthcoming European Health Data Spaces regulation presenting a labyrinth of legal requirements for products in this area.
Together with our industry partner AI:Dental we have prepared a policy brief dealing with complex requirements advocating for coherent and responsible innovation in the healthcare industry. We are focusing on issues related to conducting conformity assessments, the functioning of regulatory sandboxes, support for small and medium enterprises including start-ups and effective local implementation of the aforementioned acts. Ensuring acts are adopted based on their merits is vital in realizing their benefits across the EU.
