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Content DescriptionThis document lists characteristics of a category of health software: digital therapeutics (DTx). DTx products generate and deliver medical interventions that are based on clinical evidence, have demonstrable positive therapeutic impacts on patient health, 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 other 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 that are used in the context of a disease, disorder, condition, or injury for human use. It does not address products that are intended for veterinary use 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, patient privacy considerations, and product authorization pathways. About ISOISO, the International Organization for Standardization, brings global experts together to agree on the best way of doing things – for anything from making a product to managing a process. As one of the oldest non-governmental international organizations, ISO has enabled trade and cooperation between people and companies all over the world since 1946. The International Standards published by ISO serve to make lives easier, safer and better. |
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