The development and application of health decision support system (HDSS) in clinical service and health management is efficient in controlling health expenditure rising from overlapped examinations, and in reducing medical errors rising from insufficient decision-making support tools. Typical HDSS in America includes CPOE, MYCIN, QMR, NEDSS etc., which are mainly used in disease diagnosis and treatment, public health emergency management, hospital management, and health insurance management. The successful experiences accumulated in the development of the US health decision support system are worth referring to, such as, integration of management system, decision-makers and ICT, meeting the urgent needs of clinical service and health management, effective E-health construction, and rational development pathway from clinical decision support system to health management decision support system.
Artificial intelligence has been extensively applied in healthcare services recently, and clinical decision support systems driven by artificial intelligence are one of the applications. Early-stage clinical evaluation of artificial intelligence (AI)-based clinical decision support systems lies between preclinical development (in silico), offline validation, and large-scale trials, but few AI-related clinical studies have addressed human factors evaluations and reported the implementation environment, user characteristics, selection process and algorithm identification of AI systems. In order to bridge the development-to-implementation gap in clinical artificial intelligence and to promote the transparent and standardized reporting of early-stage clinical studies of AI-based decision support systems. A reporting guideline for the developmental and exploratory clinical investigations of decision support systems driven by artificial intelligence (DECIDE-AI) was published in 2022. This paper aimed to interpret the background, development process and key items of the DECIDE-AI guideline and promote its understanding as well as dissemination in China.