Source: Pharmaceutical Executive

Pharmaceutical Executive discusses the increasing legal risks pharmaceutical companies face as they integrate artificial intelligence into their product development and diagnostic tools. The article highlights how AI systems used in clinical trials, drug design, and patient data analysis can trigger liability under product safety laws if their outputs are flawed or lead to harm.

It explores scenarios where AI-driven recommendations may be wrong due to biased training data, software malfunction, or inadequate human oversight. In such cases, it is unclear whether liability rests with the AI developer, the pharma company, or a third-party integrator.

The piece advises companies to adopt risk mitigation strategies, including transparency in development, thorough validation protocols, and clear user instructions. Regulatory clarity is still evolving, but the sector is urged to prepare for stricter accountability requirements.