Navigating the complexities of the European AI Act

The EU AI Act classifies AI risks into four categories—unacceptable, high-risk, limited, and minimal risk. In the pharmaceutical industry, high-risk AI applications, such as diagnostic tools and clinical trial algorithms, require strict compliance. This episode explores key compliance challenges, including data governance and algorithm explainability, as well as opportunities like increased patient trust and streamlined trials. We also discuss the consequences of non-compliance, the Act’s alignment with GDPR, and how it may shape global AI standards. Tune in to learn how pharma companies can prepare for this regulatory shift.