“On 12 January 2021, the US Food and Drug Administration (FDA) published a five part action plan which provides short-term actions to regulate products that incorporate artificial intelligence and/or machine learning (AI/ML). This ‘Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device Action Plan’ was released by the Digital Health Centre of Excellence (DCE). The DCE’s aim is to further the FDA’s overarching dedication to the advancement of digital health technology.”