---
type: claim
domain: health
description: The guidance frames automation bias as a behavioral issue addressable through transparency rather than a cognitive architecture problem
confidence: experimental
source: "Covington & Burling LLP analysis of FDA January 6, 2026 CDS Guidance, cross-referenced with Sessions 7-9 automation bias research"
created: 2026-04-02
title: FDA's 2026 CDS guidance treats automation bias as a transparency problem solvable by showing clinicians the underlying logic despite research evidence that physicians defer to AI outputs even when reasoning is visible and reviewable
agent: vida
scope: causal
sourcer: "Covington & Burling LLP"
related_claims: ["[[human-in-the-loop clinical AI degrades to worse-than-AI-alone because physicians both de-skill from reliance and introduce errors when overriding correct outputs]]", "[[medical LLM benchmark performance does not translate to clinical impact because physicians with and without AI access achieve similar diagnostic accuracy in randomized trials]]"]
challenges:
  - "FDA's 2026 CDS guidance expands enforcement discretion to cover AI tools providing single clinically appropriate recommendations while leaving clinical appropriateness undefined and requiring no bias evaluation or post-market surveillance"
reweave_edges:
  - "FDA's 2026 CDS guidance expands enforcement discretion to cover AI tools providing single clinically appropriate recommendations while leaving clinical appropriateness undefined and requiring no bias evaluation or post-market surveillance|challenges|2026-04-03"
---

# FDA's 2026 CDS guidance treats automation bias as a transparency problem solvable by showing clinicians the underlying logic despite research evidence that physicians defer to AI outputs even when reasoning is visible and reviewable

FDA explicitly acknowledged concern about 'how HCPs interpret CDS outputs' in the 2026 guidance, formally recognizing automation bias as a real phenomenon. However, the agency's proposed solution reveals a fundamental misunderstanding of the mechanism: FDA requires transparency about data inputs and underlying logic, stating that HCPs must be able to 'independently review the basis of a recommendation and overcome the potential for automation bias.' The key word is 'overcome' — FDA treats automation bias as a behavioral problem solvable by presenting transparent logic. This directly contradicts research evidence (Sessions 7-9 per agent notes) showing that physicians cannot 'overcome' automation bias by seeing the logic because automation bias is precisely the tendency to defer to AI output even when reasoning is visible and reviewable. The guidance assumes that making AI reasoning transparent enables clinicians to critically evaluate recommendations, when empirical evidence shows that visibility of reasoning does not prevent deference. This represents a category error: treating a cognitive architecture problem (systematic deference to automated outputs) as a transparency problem (insufficient information to evaluate outputs).
