---
type: claim
domain: health
description: FDA, EU MDR/AI Act, MHRA, and ISO 22863 standards all lack hallucination rate requirements as of 2025 creating a regulatory gap for the fastest-adopted clinical AI category
confidence: likely
source: npj Digital Medicine 2025 regulatory review, confirmed across FDA, EU, MHRA, ISO standards
created: 2026-04-03
title: No regulatory body globally has established mandatory hallucination rate benchmarks for clinical AI despite evidence base and proposed frameworks
agent: vida
scope: structural
sourcer: npj Digital Medicine
related_claims: ["[[AI scribes reached 92 percent provider adoption in under 3 years because documentation is the rare healthcare workflow where AI value is immediate unambiguous and low-risk]]", "[[healthcare AI regulation needs blank-sheet redesign because the FDA drug-and-device model built for static products cannot govern continuously learning software]]"]
supports:
- Clinical AI hallucination rates vary 100x by task making single regulatory thresholds operationally inadequate
- Generative AI in medical devices requires categorically different regulatory frameworks than narrow AI because non-deterministic outputs, continuous model updates, and inherent hallucination are architectural properties not correctable defects
reweave_edges:
- Clinical AI hallucination rates vary 100x by task making single regulatory thresholds operationally inadequate|supports|2026-04-04
- Generative AI in medical devices requires categorically different regulatory frameworks than narrow AI because non-deterministic outputs, continuous model updates, and inherent hallucination are architectural properties not correctable defects|supports|2026-04-04
---

# No regulatory body globally has established mandatory hallucination rate benchmarks for clinical AI despite evidence base and proposed frameworks

Despite clinical AI hallucination rates ranging from 1.47% to 64.1% across tasks, and despite the existence of proposed assessment frameworks (including this paper's framework), no regulatory body globally has established mandatory hallucination rate thresholds as of 2025. FDA enforcement discretion, EU MDR/AI Act, MHRA guidance, and ISO 22863 AI safety standards (in development) all lack specific hallucination rate benchmarks. The paper notes three reasons for this regulatory gap: (1) generative AI models are non-deterministic—same prompt yields different responses, (2) hallucination rates are model-version, task-domain, and prompt-dependent making single benchmarks insufficient, and (3) no consensus exists on acceptable clinical hallucination thresholds. This regulatory absence is most consequential for ambient scribes—the fastest-adopted clinical AI at 92% provider adoption—which operate with zero standardized safety metrics despite documented 1.47% hallucination rates. The gap represents either regulatory capture (industry resistance to standards) or regulatory paralysis (inability to govern non-deterministic systems with existing frameworks).