AI for the healthcare global market is projected to grow exponentially to 164.10 billion USD by 2029, and AI tools are already used for the allocation of medical resources, diagnosis, and treatment recommendations in various healthcare settings around the globe. [...] The EU has extensive regulatory frameworks for medical devices and data protection, and is developing one for AI systems, but these are not adapted to the multitude of harms for which health AI will be responsible. [...] These include: Rules to ensure robust protection of personal data and confidentiality and strengthen the protection of personal health data in the EU. [...] Provision of training for duty-bearers and health practitioners regarding risks of bias in AI and the dangers for key populations. [...] Hannah van Kolfschooten researches patients’ rights protection in the regulation of AI at the Law Centre for Health and Life, University of Amsterdam.
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