Physicians and clinicians have used clinical decision support (CDS) software for decades to inform decision-making. Current tools that use artificial intelligence (AI) algorithms and machine learning (ML) models generate impressive recommendations and predictions. Are physicians at risk of becoming over-reliant on these tools? That concern is one reason the FDA issued guidance—now final—around regulating CDS software. Issued in September 2022, the final guidance outlines which types of CDS it considers medical devices—and therefore subject to FDA regulation—and which types are not.   The Varied CDS Landscape CDS encompasses a wide range of tools, from EHR integrations to predictive AI-enabled software. When powered by AI/ML, CDS systems can analyze large datasets to derive insights in a way not possible by humans. ...