Real world data (RWD) involves data collected outside of clinical trials, and produces real world evidence (RWE), becoming actionable when powered by analytics, machine learning & artificial intelligence (AI). RWE provides insight beyond traditional clinical trial data, adding potential to link data from different sources; improve trial efficiency; identify new indications, and a real-world perspective of risks/benefits to make informed decisions beyond traditional clinical trials. This session reviews RWE regulatory and market impact including the updated FDA guidelines requiring RWE use in regulatory decisions and how AI and information exchange can be securely managed. It will also highlight ethical and privacy concerns, reviewing recent big data consent guidelines and how to clinically integrate RWD. This session shows best practices from a clinical setting that has multiple RWE publications.