AI as a Post-Market Safety Channel: When Omitted Contraindications Become a Pharmacovigilance Failure

Public-facing AI assistants increasingly provide medication guidance to patients and caregivers prior to consultation with healthcare professionals or review of approved labeling. While much attention has focused on hallucinated or incorrect outputs, less attention has been paid to omission of safety-critical information that is present in approved product labeling. This paper argues that AI-mediated omission of contraindications constitutes a post-market safety risk that is currently under-monitored by pharmaceutical manufacturers. Using a reconstructed illustrative scenario, the paper demonstrates how Reasoning Claim Tokens (RCTs) can function as evidentiary artifacts to detect, document, and audit such omissions without requiring access to AI model internals or operational control over third-party systems. The analysis situates AI-mediated omission risk within existing pharmacovigilance doctrine and clarifies the governance implications of detectability, repeatability, and foreseeability. https://www.aivojournal.org/ai-as-a-post-market-safety-channel/

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Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-12-31
DOI
https://doi.org/10.5281/zenodo.18105073
Primary Topic
Pharmacovigilance and Adverse Drug Reactions
Type
article
Field-Weighted Citation Impact
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article

AI as a Post-Market Safety Channel: When Omitted Contraindications Become a Pharmacovigilance Failure

Tim de Rosen
Zenodo (CERN European Organization for Nuclear Research)
Pharmacovigilance and Adverse Drug Reactions
article

AI as a Post-Market Safety Channel: When Omitted Contraindications Become a Pharmacovigilance Failure

Tim de Rosen
article en

Abstract

Public-facing AI assistants increasingly provide medication guidance to patients and caregivers prior to consultation with healthcare professionals or review of approved labeling. While much attention has focused on hallucinated or incorrect outputs, less attention has been paid to omission of safety-critical information that is present in approved product labeling. This paper argues that AI-mediated omission of contraindications constitutes a post-market safety risk that is currently under-monitored by pharmaceutical manufacturers. Using a reconstructed illustrative scenario, the paper demonstrates how Reasoning Claim Tokens (RCTs) can function as evidentiary artifacts to detect, document, and audit such omissions without requiring access to AI model internals or operational control over third-party systems. The analysis situates AI-mediated omission risk within existing pharmacovigilance doctrine and clarifies the governance implications of detectability, repeatability, and foreseeability. https://www.aivojournal.org/ai-as-a-post-market-safety-channel/

Zenodo (CERN European Organization for Nuclear Research)
Openalex Percentile: Top 32%
Pharmacovigilance and Adverse Drug Reactions
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AI as a Post-Market Safety Channel: When Omitted Contraindications Become a Pharmacovigilance Failure — Tim de Rosen · Zenodo (CERN European Organization for Nuclear Research) (2025) | TGRS Research Map | TGRS