Case Study: Contrasting U.S. and EU Approaches to AI Regulation

In 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, and lifecycle management for adaptive AI in medical devices.

• EU AI Act: Four-tier, risk-based system; stringent requirements for high-risk systems (including many medical devices); compliance timelines of 1–3 years.

• Strategic Impact: Global companies must navigate divergent compliance pathways — innovation speed vs. upfront safety guarantees.

• Professional Development Tips: Stay informed, understand AI fundamentals, think globally, and develop AI-specific quality, regulatory, and risk management skills.

The regulatory choices made today will shape not only innovation timelines but also how safely and ethically AI integrates into healthcare. Professionals who understand both U.S. and EU approaches will be best positioned to navigate and influence the future.

🎧Listen to the audio brief above for an overview of the contrasting visions and strategies in the U.S. and EU for AI regulation.

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Note:

This audio brief was prepared using Google NotebookLM¹, an AI-enabled research tool. Here is the list of resources used in our analysis:

1. The White House: Americas AI Action Plan, issued July 2025.

2. US Congress: Regulating Artificial Intelligence: U.S. and International Approaches and Considerations for Congress, Report number R48555, issued June 2025.

3. FDA: Artificial Intelligence in Software as a Medical Device, website accessed on August 10, 2025.

4. Future of Life Institute: High-level summary of the AI Act, Issued February 2024.

The text summary was created using ChatGPT-4o (May 2024) with expert review. It summarizes publicly available sources on emerging U.S. and EU AI regulation approaches. While reviewed for accuracy and relevance, it is not legal or regulatory advice. AI regulation is rapidly evolving, and details may change after publication.

We encourage listeners to interpret these findings in the context of these constraints.

1. Google: NotebookLM, accessed August 10, 2025.