RESUMO
BACKGROUND AND OBJECTIVES: Digital therapeutics are an emerging type of medical therapy and are defined as evidence-based therapeutic interventions for patients by means of qualified software programs to prevent, manage, or treat medical conditions. Today, digital therapeutics products are on the market or under development for a wide range of medical conditions such as diabetes, oncology treatment management, and neuropsychiatric disorders including anxiety disorder, depression, and substance use disorder. Digital therapeutics can be more flexible than other treatment methods to address patients' individual needs. METHODS AND RESULTS: The advantages of digital therapeutics fall in line with market demand; thus, the digital therapeutics market is expanding globally, focusing on advanced medical markets. There are many digital therapeutics products such as Sleepio for insomnia, Daylight for anxiety, Livongo and Omada products for diabetes, pre-diabetes, hypertension, etc. None of these are cleared by the Food and Drug Administration (FDA), but all are commercially available through health insurance or employers. The EU, including Germany, and a number of Asian countries, including Korea, Japan, and China, are also introducing policies for the regulation of new fields and digital therapeutics. CONCLUSIONS: The adoption of digital therapeutics is intricate and often involves various interests in numerous fields, decision-making processes, and individual or organizational value judgments. For digital therapeutics to be thoroughly introduced into real life, technical aspects must be supported, and an approach that considers users must be further investigated.