Context: Artificial intelligence (AI) could be a key driver in different healthcare dossiers, ranging from preventive to diagnostic and treatment purposes. The establishment of the Artificial Intelligence High-Level Expert Group in the European Commission, as well as their White Paper, show first attempts of creating policies in the domain of artificial intelligence in the EU. Despite these policy approaches, there is a need for a coherent regulatory framework that enables the efficient use of AI in the field of health. The aim of this policy brief is to evaluate current legislative gaps in terms of the introduction of AI in healthcare, focusing on the domains of Data Protection, Liability & Transparency, as well as Robustness & Accuracy. Policy Options: This policy brief identified a high degree of eHealth infrastructure fragmentation on member state level and limited action towards a structured and coherent framework for AI in healthcare, under the domains of Data Protection, Liability & Transparency, and Robustness & Accuracy. Recommendations: A unified approach at EU-level, based on proposed recommendations and merged into the form of a Directive, is advised. The development of the Health-AI-Directive will bring progress and improvement to legal certainty in the European AI-landscape. The introduction of the Health-AI-Directive is recommended to ensure trust and excellence in the use of AI in healthcare.

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