R0044/2026-04-01/Q001/S03/R01¶
Cooley LLP analysis of FDA CDS guidance automation bias updates
Summary¶
| Field | Value |
|---|---|
| Title | Automation Bias and Clinical Practice: FDA Makes Incremental Updates to Clinical Decision Support Software Guidance |
| URL | https://www.cooley.com/news/insight/2026/2026-01-20-automation-bias-and-clinical-practice-fda-makes-incremental-updates-to-clinical-decision-support-software-guidance |
| Date accessed | 2026-04-01 |
| Publication date | January 20, 2026 |
| Author(s) | Cooley LLP |
| Publication | Cooley LLP Insights |
Selection Decision¶
Included in evidence base: Yes
Rationale: Most detailed analysis of how the FDA addresses automation bias in clinical decision support, revealing that FDA focuses entirely on human independent review rather than system output constraints.