EU AI Act: Key Considerations for the Life Sciences Sector

In this article, the authors introduce the overall legislative framework set forth under the EU Artificial Intelligence Act, focusing on the aspects of the law that will likely apply to artificial intelligence (AI) systems used in the life sciences sector. They then proceed to discuss at a high-level how the EU AI Act will apply to the following use cases in the life sciences sector: (1) AI incorporated into medical devices and in vitro diagnostic medical devices, (2) AI systems that triage patients for emergency care, (3) chatbots used in digital health applications, and (4) AI employed in drug discovery. The authors conclude by pointing out the aspects of the EU AI Act that will likely create practical challenges for entities operating in the life sciences sector, and where further regulatory guidance and clarification will likely be needed.