Artificial intelligence and machine learning (AI/ML) is a set of technologies that includes automated systems able to perform tasks that normally require human intelligence, such as visual perception, speech recognition, and decision-making. AI/ML has promising applications in health care, including drug development. For example, it may have the potential to help identify new treatments, reduce failure rates in clinical trials, and generally result in a more efficient and effective drug development process. However, applying AI/ML technologies within the health care system also raises ethical, legal, economic, and social questions. GAO was asked to conduct a technology assessment on the use of AI technologies in drug development with an emphasis on foresight and policy implications. This report discusses (1) current and emerging AI technologies available for drug development and their potential benefits; (2) challenges to the development and adoption of these technologies; and (3) policy options to address challenges to the use of machine learning in drug development. -- from Foreword