The use of AI in healthcare is governed by an evolving regulatory landscape in Europe, aimed at ensuring safety, effectiveness, and privacy.

European regulations create a framework that:

• Protects patient safety and data privacy
• Ensures AI systems meet high quality standards
• Maintains ethical principles in healthcare delivery
• Provides clarity for manufacturers and hospitals

This section examines the key regulations affecting AI in hospital settings, along with the ethical considerations that shape implementation strategies across Germany and the EU.