One of the newer areas in which the US Food and Drug Administration (FDA) is exploring its regulatory role is the use of artificial intelligence (AI) in digital mental health medical devices. There is recognition that mental illnesses are common around the world. As noted in a 2024 report from the World Health Organisation (WHO), World mental health today: Latest data, more than 1 billion people worldwide are living with a mental disorder.1 The report notes that the prevalence of different mental disorders varies by sex, with females overall more affected. Anxiety disorders and depressive disorders are the most common conditions in both sexes.