Let's Talk Risk! Podcast
Let’s Talk Risk! brings together MedTech leaders and practitioners for thoughtful conversations on the challenges that shape risk, quality, innovation, and leadership. With 150+ episodes and more than 30K downloads, it helps professionals gain the clarity and confidence to lead through complex decisions. naveenagarwalphd.substack.com
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- StandardSummaries onlyCase Study: Contrasting U.S. and EU Approaches to AI Regulation
Published Aug 25, 2025
Case StudyIn this audio brief, we unpack the rapidly evolving AI regulatory landscape in the U.S. and EU. While the U.S. emphasizes rapid innovation with lighter-touch oversight, the EU is implementing a strict, risk-based framework.Here are a few key highlights* U.S. AI Action Plan (July 2025): Prioritizes speed, innovation, and global leadership; promotes a “try first” culture; frames AI as a national security imperative.* FDA Guidance: Good Machine Learning Practices, predetermined change control plans