Quick answer The EU AI Act is the European Union's risk-based regulation for artificial intelligence. It applies to organizations that develop, provide or use AI systems, including pharmaceutical, biotechnology and medical device companies. Compliance requirements depend on the AI system's level of risk, with high-risk applications subject to strict rules for risk management, human oversight, documentation, data governance and cybersecurity. Introduction The life sciences industry is notoriously inefficient, with innovative drugs taking roughly a decade of labor-intensive research to develop; a process that involves vast quantities of data and countless repetitive administrative processes. From there, manufacturing and distribution creates another mountain of repetitive quality checks and a mountain of data.