Digital Therapeutics - Product Requirements
Abstract
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
Begin
2024-03-19
WI
00251419
Planned document number
DIN EN ISO 24973
Project number
17600090
Responsible national committee
NA 176-02-02 AA - Interoperability
Responsible european committee
CEN/TC 251/WG 2 - Technology and Applications
