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2.6 | AI & Machine Learning in Medicine: Emerging Issues & FDA Regulations | Medical Software Course

YaleCourses, 5 min, 257 views, Aug 19, 2025

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In this lesson, we dive into the exciting yet complex world of artificial intelligence and machine learning in medicine. We explore the foundational role of vast, high-quality data in AI's success, alongside the unique regulatory challenges posed by self-updating AI algorithms in medical software. šŸŽÆ Learning Objectives • Explain the role of deep learning in the current excitement around AI/ML. • Identify the critical importance of data (clean, annotated, diverse) for AI/ML model training. • Discuss the regulatory challenges posed by adaptive AI/ML software in medical devices. • Outline the FDA's proposed frameworks and initiatives, like the Precertification Program, for regulating AI/ML medical software.