关键词: font-size:medium, ">数字疗法；循证医学；变更；强度；可用性

Abstract: Digital therapeutics reley on high-quality softwares to provide evidence-based interventions for patients， integrating advanced technologies such as design， clinical evaluation， usability， and data security， which can respond to various diseases through high-quality， safe， and effective data-driven interventions. Regulatory agencies review or certify the products as needed to support product claims related to risks， efficacy， and intended use. This study discusses the common technical issues of digital therapeutic products， respectively defining and limiting the key attributes of digital therapeutics products based on the definition of medical devices， including structural composition， intended use， evidence-based medicine， and participants. Design and development issues of the product was discussed， including data quality， design changes， and algorithm construction. The technical risks of network security， usability， and strength configuration in the use of the product were clarified， and the problems faced in the process of conducting randomized controlled clinical trials were proposed. Through analysis and discussion， in order to provide reference for future supervision of such products.
   

Key words: font-size:medium, ">Digital therapeutics； Evidence-based medicine； Change； Intensity； Usability