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Scoping Review Protocols (529) Public (e)Health, Digital Epidemiology and Public Health Informatics (2237) Adverse Drug Events Detection, Pharmacovigilance and Surveillance (262) Safety and Error Prevention in Health (313) Pharmacovigilance (239) Data Science (683) Applications of AI (865) AI Governance and Policy (54)

Published on in Vol 15 (2026)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/101691, first published .
Man explaining AI drug safety data on a large screen to a woman in an office

AI for Causality Assessment in Pharmacovigilance: Protocol for a Scoping Review

AI for Causality Assessment in Pharmacovigilance: Protocol for a Scoping Review

Authors of this article:

Miki Ohta1 Author Orcid Image ;   Miki Ota2 Author Orcid Image ;   Mikihiko Ohta3 Author Orcid Image
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Miki Ohta   1 , MD, MPH, PhD ;   Miki Ota   2 , PharmD ;   Mikihiko Ohta   3 , JD

1 Clinical Research Promotion Center, The University of Tokyo Hospital, Tokyo, Japan

2 Office of Informatic and Management for Safety, Pharmaceuticals and Medical Devices Agency, Tokyo, Japan

3 Fuji Partnership Law Firm, Tokyo, Japan

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