Standards Development
This document provides product requirements defining the components of digital therapeutic (DTx) products in order for stakeholders to confidently understand product expectations.
This document is applicable to digital therapeutics, which are a special form of health software intended to treat or alleviate a disease, disorder, condition, or injury by generating and delivering a medical intervention that has a demonstrable positive therapeutic impact on a patient’s health.
This document is intended for use by DTx manufacturers as well as DTx assessment organisations in order to communicate the quality and reliability of DTx products. Consumers, patients, carers, health care professionals and their organisations, health authorities, health insurers and the wider public can use the digital therapeutic standard when recommending, evaluating, or selecting a digital therapeutic for use or for adoption.
NOTE 1 Digital Therapeutics can be subject to local or national legislation, such as for medical devices.
Outside the scope of this document are:
Regulatory Requirements
Market Access Pathways
Intellectual Property Related Legal Requirements
Practice of Medicine
Digital therapeutics is a new category of therapy and ought to be appropriately regulated and evaluated like other devices used in healthcare settings. As a new category, the product requirements are not understood across global and even local jurisdictions, causing confusion and slowing the rate of adoption. With international standards, healthcare decision makers will have a clear understanding of product expectations and will be able to evaluate them appropriately, providing a clear pathway for patients and their families to have access to this type of care.
TC215 recognized the importance of the new category and carefully weighed how to handle DTx within the TC. An initial document ISO/TR 11147:2023 Health informatics - Personalized digital health - Digital therapeutics health software systems was developed to establish a definition of DTx. In parallel, an AHG between TC 215 and IEC 62A was created to further explore where best to develop future DTx documents. This NWIP is a result of the AHG’s work.
The aim for the AHG is to:
(a) provide recommendations on how to integrate digital therapeutics into the shared scopes of TC215 and EIC/SC 62A
(b) provide a report on Safety, Effectiveness, and Security of Digital Therapeutics, including an initial list of potential new work item proposals and revisions to existing standards
(c) provide a progress update and initial recommendations at the next plenary
Resolution 2023-78:ISO/TC 215 agreed to circulate a NWIP developed by JAGH5 entitled Health informatics - Digital Therapeutics - Product Requirements for NP ballot. This document will be developed as an IS with Jessica Hauflaire as the Project Leader, under WG 11. The Project Lead is requested to submit Form 4 and an updated outline to the Committee Manager by 15 December 2023.
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