September 10, 2025

AI in Diagnostics and the Law: Regulating Machine-Learning Tools in Clinical Decision-Making

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Analysis uncovers legal challenges of AI systems in clinical settings, highlighting patient safety and accountability.

AI tools enhance diagnostic accuracy and efficiency, yet their reliance can introduce legal uncertainties.
The U.S. FDA and EMA provide essential frameworks for AI in healthcare, focusing on oversight and accountability.
Adaptive AI algorithms pose unique regulatory challenges, especially concerning data privacy and transparency.
Policy recommendations advocate for robust regulatory frameworks to balance innovation with patient rights.

Akomolafe et al. (2025) studied this question.

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