Catarina Carrão, FAHA is an expert in regulatory affairs, benefit–risk assessment, and clinical evaluation at BioSciPons, specializing in digital health technologies (DHTs) and AI-enabled medical devices. She also serves as a DHT expert for the European Commission (EC) and EIT Health, contributing to the advancement of innovative health technologies across Europe. With a background in biochemistry and cardiovascular research, Catarina has held research positions at Yale University, Charité Medical University, and Vienna Medical University. She is a Fellow of the American Heart Association (FAHA) since 2013. Catarina identifies clinical evidence gaps in AI-driven DHTs and guides products through global regulatory approval pathways, bridging the gap between complex clinical development and market-ready applications. A strong advocate for trustworthy AI in healthcare, she frequently publishes and speaks at regulatory events, sharing insights on emerging regulatory landscapes and AI-DHTs.