Artificial Intelligence adoption in the life sciences industry is transforming not just how research, diagnostics, and drug development are conducted but also the regulatory standards for accuracy, safety, and compliance. While traditional human validation has relied on expertise and clinical testing for accuracy, the introduction of AI and automation tools reliant on trained data presents new challenges not just for companies but also for regulatory authorities who must now adapt oversight frameworks to account for algorithmic biases and data limitations. The European Union has been proactive when it comes to Artificial Intelligence, drafting an ‘Ethics Guideline’ as far back as 2019 to determine what is and what is not ‘trustworthy AI’.