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In recent years, the healthcare and life sciences sectors have been subject to numerous legislative and regulatory proposals to further reform an industry which can lag behind on digital transformation. The European Health Data Space, the EU’s draft AI Act, and some recent national initiatives could provide a real boost to Health Tech in 2024. The AI Act (AIA) is expected to enter into force in 2024 and will affect medical device companies with machine learning capabilities, as well as the healthcare and life sciences sectors more generally. The AIA takes a risk-based approach and compliance obligations around development and use are directly related to the potential level of risk.
