Today's approach to medicine requires extensive trial and error to determine the proper treatment path for each patient. While many fields have benefited from technological breakthroughs in computer science, such as artificial intelligence (AI), the task of developing effective treatments is actually getting slower and more costly. With the increased availability of rich historical datasets from previous clinical trials and real‐world data sources, one can leverage AI models to create holistic forecasts of future health outcomes for an individual patient in the form of an AI‐generated digital twin. This could support the rapid evaluation of intervention strategies in silico and could eventually be implemented in clinical practice to make personalized medicine a reality. In this work, we focus on uses for AI‐generated digital twins of clinical trial participants and contend that the regulatory outlook for this technology within drug