Is your "Clinical Decision Support" tool actually an unregulated medical device?

Send us Fan Mail In January 2026, the FDA sharpened the line between helpful software and regulated medical devices. If your AI sits inside an EHR, providing "black box" recommendations that a clinician can’t independently verify in seconds, you aren't just drifting into a regulatory gray area, you’re likely standing outside the "safe zone." In this episode, we break down the high-stakes intersection of FDA transparency, OIG inducement analysis, and the reality of clinical workflows. In this ...