Clinical Decision Support System (CDSS) in primary care: from pragmatic use to the best approach to assess their benefit/risk profile in clinical practice.

Clinical Decision Support Systems (CDSSs) are computer-based tools intended to support physicians in clinical decision making. MilleDSS is an illustrative example for the Italian context. It is featured by four domains of GP-software interaction, such as clinical management and follow-up evaluation, prescribing appropriateness and clinical risk, prevention strategies and medical computerized stewardship on scientific update and training. MilleDSS registered 23,222 accesses in early September 2021. In specific, the sections on prevention and training were viewed 19,440 and 21,797 times, respectively.The Medical Device Regulation (MDR: (EU) 2017/745) indicates that clinical evidence needs to be provided for any software intended to medical purpose. Clinical research on CDSS effectiveness will be therefore conducted through epidemiological studies. In theory, this generation of evidence would follow the pyramid of evidence as per medications approval but, given the large use and constant update of CDSS for daily clinical practice, attentions should be posed on the most cost-effective study.