I recently spent time unpacking the FDA’s clinical decision support software guidance and what it really means for healthcare organizations deploying AI.

At the center of the guidance is a simple question: when does software cross the line into being regulated as a medical device? The FDA lays out specific criteria that hinge on how recommendations are generated, how they are presented, and whether a human can independently review and understand the basis for those recommendations.

If clinicians cannot reasonably evaluate or challenge an AI’s output, organizations may find themselves in regulated territory whether they intended to be there or not.

Understanding where human judgment sits in the loop is essential for compliance, trust, and responsible scaling of AI.

If you are deploying or governing clinical AI, this is guidance worth revisiting with both legal and clinical stakeholders at the table.