Clinical Decision Support (CDS) Software Final Rule

Summary

This article discusses final guidance issued by the U.S. Food and Drug Administration (FDA) addressing clinical decision support (CDS) software. Software intended for medical diagnosis or treatment, including CDS software, has historically been considered a medical device subject to FDA regulation. CDS software includes computerized alerts and reminders for providers and patients, clinical guidelines, condition-specific order sets, focused patient data reports and summaries, documentation templates, diagnostic support, and contextually relevant reference information.