Health informatics — Personalized digital health — Digital therapeutics health software systems

This standard lists characteristics of digital therapeutics (DTx) software. 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.

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. 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.

Main sections:

· Scope

· Normative references

· Context

· Considerations

· DTx in relation to ecosystem constructs

· Medical device software standards

· Annex A: Landscape analysis

· Annex B: DTx use cases