1 Scope
This document provides quality requirements for healthapps and defines a healthappquality label in order to visualize the quality and reliability of healthapps.
This document is applicable to healthapps, which are a special form of health software. It covers the entire life cycle of healthapps.
This document is intended for use by appmanufacturers as well as app assessment organizations in order to communicate the quality and reliability of a healthapp. Consumers, patients, carers, health care professionals and their organizations, health authorities, health insurers and the wider public can use the healthappquality label and report when recommending or selecting a healthapp for use, or for adoption in care guidelines, care pathways and care contracts.
NOTE 1 Healthapps can be subject to national legislation, such as for medical devices.
NOTE 2 See Annex C for additional details on the scope.
Outside the scope of this document are guidelines to comply to the medical device regulation.