The Regulation of Uncertainty

In a recent policy brief from Paragon Health Institute, authors Kev Coleman, visiting research fellow at Paragon, and Michael Pencina, CHAI board member and Duke AI Health Director, discuss key concerns and considerations in health AI.

Key Takeaways:

• Policymakers struggle to regulate healthcare AI products because, unlike traditional software, AI can produce unpredictable results.
• To ensure safety and effectiveness as AI products evolve, the FDA can evaluate AI products on an ongoing basis (even when products are already in the market) by partnering with developers and health systems.

To download and view the original report, click here.