DIGITALIZATION | CIOMS on the use of AI

July 16, 2025

At Asphalion, we are strongly committed to driving digitalization and integrating innovative tools to enhance our work. We believe that the thoughtful and responsible use of digital solutions, such as Artificial Intelligence, can significantly help improve project outcomes. That’s why we continuously explore new automation strategies to optimize our processes. 

Continuing our revision of the different key authorities shaping the future of AI in healthcare, we find the Council for International Organizations of Medical Sciences (CIOMS). Recently, the CIOMS published a draft report about “Artificial intelligence in pharmacovigilance”.  

The CIOMS report discusses the integration and implementation of artificial intelligence (AI) in the field of pharmacovigilance. Here the highlights of said document:  

  1. Risk-Based Approach: This approach involves assessing and managing the risks associated with AI systems, considering potential hazards and ensuring implementation strategies proportionate to the identified risks. 
  1. Human Oversight: Emphasizing the role of humans in the design, implementation, monitoring, and analysis of AI systems to manage performance and mitigate potential issues. 
  1. Validity and Robustness: Ensuring AI systems achieve their intended purpose within acceptable parameters and can reliably achieve objectives despite variations in data. 
  1. Transparency: Involves sharing relevant documentation and providing stakeholders enough information to understand the AI system, its use, risks, limitations, and impact. 
  1. Data Privacy and Fairness: Focus on safeguarding personal information and ensuring the benefits of AI in pharmacovigilance are equitably distributed across all stakeholders. 

 

Read the whole document here: https://bit.ly/4nXpzRI  

Need help in your regulatory endeavours?  Contact us at: [email protected] 

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