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Regulating AI in Healthcare

2025·0 Zitationen·Advances in computational intelligence and robotics book series
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2025

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Abstract

Artificial intelligence (AI) is changing healthcare quickly by improving how doctors diagnose illnesses, plan treatments, and offer personalized care. But as AI becomes more common, it also brings up important legal and ethical questions, especially about who is responsible when things go wrong, how to protect patient data, and how to properly regulate AI use. This paper examines the challenges and possible solutions for controlling AI in healthcare, with a special focus on the legal changes happening in the European Union. It discusses how the EU AI Act, the General Data Protection Regulation (GDPR), and the Medical Device Regulation (MDR) work together to manage high-risk AI systems in hospitals and clinics. The paper also looks at key issues like who is to blame when AI makes decisions, how to safely handle private health information, and the difficulties developers face in meeting these rules. The study suggests a transparent, open, and fair way to regulate AI that supports new ideas.

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