By the EHRA Artificial Intelligence, Public Policy Leadership & Value-based Care and Quality Programs Workgroups

In January 2026, the FDA released revised guidance on Clinical Decision Support (CDS) software, clarifying the scope of the FDA’s oversight of CDS software intended for use by health care professionals, including software identified as artificial intelligence (AI). While the guidance includes some genuine improvements over the previous iterations released in 2022 and 2023, the EHR Association has identified concerns about ambiguous new standards, regulatory overreach, and the potential to negatively affect both innovation and patient care.