A unifying force for the realization of medical AI

Artificial Intelligence (AI) in medicine has grown rapidly, yet few algorithms have been deployed. It is not the problem with the AI itself but with the way functions and results are communicated. Regulatory science provides the appropriate language and solutions to this problem for three reasons: First, there is value in the intentionally interdisciplinary regulatory language. Second, regulatory concepts are important for AI researchers because these concepts enable tackling of risk and safety concerns as well as understanding of recently proposed regulations in the US and Europe. Third, regulatory science is a scientific discipline that evaluates and challenges current regulation—aiming for evidence-based improvements. Knowledge of the regulatory language, concepts, and science should be regarded a core competency for communicating medical innovation. Regulatory grade communication will be the key to bringing medical AI from hype to standard of care. Foregoing the possible benefits of regulatory science as a unifying force for the realization of medical AI is a missed opportunity.