The Council for International Organizations of Medical Sciences (CIOMS) Working Group XIV has released a comprehensive draft report on Artificial Intelligence (AI) in Pharmacovigilance, which is now open for public consultation until 6 June 2025.
This important initiative aims to establish foundational guidance for the responsible and effective integration of AI technologies into pharmacovigilance activities. The draft report outlines a broad set of principles and best practices that seek to ensure that AI tools are used safely, ethically, and in ways that enhance public health.
The document addresses several key areas that are central to the successful adoption of AI in this field, including:
- Risk-Based Approaches: Developing structured frameworks for evaluating and mitigating the potential risks that may arise when AI is applied in safety monitoring activities.
- Human Oversight: Emphasizing the need for human involvement in AI processes, particularly in decision-making tasks, to maintain accountability and trust.
- Validity and Robustness: Setting standards to ensure that AI systems perform reliably and consistently across a variety of real-world conditions and data sets.
- Transparency: Providing guidance on the importance of explainability and the clear documentation of AI methodologies, allowing users and regulators to understand how outcomes are generated.
- Data Privacy: Addressing the ethical implications and regulatory requirements related to data protection, especially when using large and sensitive healthcare datasets.
- Fairness and Equity: Promoting strategies to avoid algorithmic bias and to ensure that AI applications deliver equitable outcomes across diverse patient populations.
- Governance and Accountability: Recommending clear governance structures and accountability mechanisms for the deployment and oversight of AI tools in pharmacovigilance systems.
- Future Considerations: Offering forward-looking perspectives on how AI is likely to evolve and influence the practice of pharmacovigilance in the coming years.
We invite all stakeholders in the life sciences, regulatory, technology, and public health sectors to review the draft and contribute feedback. Your insights will play a critical role in shaping final recommendations and supporting the safe and meaningful use of AI in global drug safety systems.
Access the Draft Report here:
CIOMS WG XIV Draft Report – May 2025
Submit your comments here:
CIOMS Public Consultation Page
Asphalion is proud to support innovation and safety in pharmacovigilance. If you need expert guidance on AI integration, regulatory strategy, or pharmacovigilance system optimization, please feel free to reach out to us at [email protected]. We’re here to help!
