DANSK DSF/ISO/DTR 11147 PDF

This document lists characteristics of a category of health software: digital therapeutics (DTx). DTx provides medical interventions that are based on clinical evidence and produce real-world outcomes. Product use cases (see Annex B) demonstrate the variety of products represented in this quickly growing industry. This document provides an overview of how DTx relates to other ecosystem constructs, including medical devices, software as a medical device (SaMD), software in a medical device (SiMD), and digital health technologies (DHT). It also addresses relevant health and medical device software standards that have various degrees of applicability to DTx. The focus of this document is on therapeutic products for human use and that are used in the context of a disease, disorder, condition, or injury. It does not address products that are intended for veterinary uses or for general wellbeing. Additional exclusions of this document include DTx market access pathways (i.e. prescription, non-prescription pathways), medical device requirements, product risk assessment, clinical evidence requirements, data security and patient privacy considerations, and product authorization pathways.