Mapping the regulatory landscape for artificial intelligence in health within the European Union - npj Digital Medicine
Briefly

The EU AI Act sets the overall regulatory framework for AI, while other legislations set social, health, and human rights standards, ensuring safety and ethical use.
Regulation specifically pertaining to AI in healthcare is still nascent and scarce, though existing policies have begun to form a crucial baseline for safety and innovation.
Future work should explore specific regulatory challenges associated with AI medical devices, data protection, and data enablement to ensure safe and effective healthcare applications.
Despite potential health benefits, AI may also propagate harmful behaviours, highlighting the need for comprehensive regulation that balances innovation with ethical considerations.
Read at Nature
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