R0043/2026-03-28/Q002/SRC02
FDA Clinical Decision Support Software Guidance — Automation bias provisions
Source
| Field |
Value |
| Title |
Automation Bias and Clinical Practice: FDA Makes Incremental Updates to Clinical Decision Support Software Guidance |
| Publisher |
Cooley LLP (analysis of FDA guidance) |
| Author(s) |
Cooley LLP |
| Date |
January 2026 |
| 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 |
| Type |
Legal analysis of government guidance |
Summary
| Dimension |
Rating |
| Reliability |
Medium-High |
| Relevance |
High |
| Bias: Missing data |
Some concerns |
| Bias: Measurement |
N/A |
| Bias: Selective reporting |
Low risk |
| Bias: Randomization |
N/A — not an RCT |
| Bias: Protocol deviation |
N/A — not an RCT |
| Bias: COI/Funding |
Some concerns |
Rationale
| Dimension |
Rationale |
| Reliability |
Cooley is a major law firm with healthcare regulatory expertise; analysis tracks closely to FDA's own text |
| Relevance |
Contains the most specific analysis of how FDA addresses automation bias in clinical AI |
| Bias flags |
COI: law firm perspective may emphasize regulatory burden; missing data: analysis of FDA guidance, not the guidance itself |
| Evidence ID |
Summary |
| SRC02-E01 |
FDA's automation bias provisions: transparency obligation, not system design constraint |