Privacy & Data Security

On September 30, 2025, the U.S. Food and Drug Administration (FDA) issued a Request for Public Comment seeking input on “practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real-world,” including strategies for detecting, assessing, and mitigating performance changes over time (the “Request”). 

The Request acknowledges the opportunities for AI,

Data is fueling innovation like never before. From AI development to strategic decision-making, high-quality data is a powerful business asset. However, it also comes with significant legal considerations. Privacy laws, intellectual property rights, and ethical obligations are all evolving quickly, and businesses must stay ahead of the curve.

We’ve written about three areas companies should