Safeguarding Patients in the AI Era: Ethics at the Forefront of Pharmacovigilance

Ashish Jain (), Maribel Salas (), Omar Aimer () and Zahabia Adenwala ()
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Ashish Jain: Curis Inc.
Maribel Salas: Bayer Pharmaceuticals
Omar Aimer: Innovigilance
Zahabia Adenwala: Seres Therapeutics

Drug Safety, 2025, vol. 48, issue 2, No 2, 119-127

Abstract: Abstract Artificial intelligence is increasingly being used in pharmacovigilance. However, the use of artificial intelligence in pharmacovigilance raises ethical concerns related to fairness, non-discrimination, compliance, and responsibility as the central ethical principles in risk assessment and regulatory requirements. This paper explores these concerns and provides a roadmap to how to address these challenges by considering data collection, privacy protection, transparency and accountability, model training, and explainability in artificial intelligence decision making for drug safety surveillance. A number of responsible approaches have been identified including an ethics framework and best practices to enhance artificial intelligence use in healthcare. The document also recognizes some initiatives that have demonstrated the importance of ethics in artificial intelligence pharmacovigilance. Nevertheless, the major needs mentioned in this paper are transparency, accountability, data protection, and fairness, which stress the necessity of collaboration to construct a cognitive framework aimed at integrating ethical artificial intelligence into pharmacovigilance. In conclusion, innovation should be balanced with ethical responsibility to enhance public health outcomes as well as patient safety.

Date: 2025
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DOI: 10.1007/s40264-024-01483-9

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