Since the publication of the first mobile app store in 2008, the world has experienced a fast growing market for wellness, health and medical apps. In 2017 there were 325,000 of these types of apps available on all major app stores according to one report1. Today, in most cases, the mobile app is the focal point within an eco-system of devices. The app constitutes the centre of the network and can be connected to wearables and tracking sensors, medical devices, electronic health records and health data aggregators2. The types of mobile health app publishers have increased in diversity, among them nowadays also bigger actors like medical device companies and health care organisations1.
Concerns about the quality and reliability of apps has been present since the first steps at the wellness, health and medical apps era. Many are still being published with inadequate information for user or evidence to support clinical claims. The European Commission published recently the study regarding safety of health, lifestyle and wellbeing apps3. The overall conclusion of this study was that at present no safety incidents concerning non-embedded software of wellness and health apps that do not fall under the medical devices legislation can be found in public sources. Based on the report, this does not mean that safety incidents with these apps do not exist. A number of reasons for underreporting have been identified3.
The European Committee for Standardisation has announced the start of a project “Quality and Reliability of Health and Wellness Apps”. It will help to establish a common framework across Europe for the development and evaluation of these apps, giving users and health professionals confidence that the apps are fit for purpose. This framework will not establish the boundary between weather app is regulated medical device or not. Nor will it include a rigorous definition for “health” or “wellness”4.
The Specification is being developed by the European standardisation committee CEN/TC 251 Health Informatics in collaboration with experts from the standardisation organisations ISO and IEC. An initial work for this standard has already been done in the UK by BSI specification PAS 2775. The project team includes members from the following CEN member countries: France (AFNOR), United Kingdom (BSI), Germany (DIN), Netherlands (NEN), Sweden (SIS), Finland (SFS) and Italy (UNI)4.
The term digital health is introduced by WHO as a broad umbrella term encompassing eHealth (which includes mHealth), as well as emerging areas, such as the use of advanced computing sciences in ‘big data’, genomics and artificial intelligence. This standard will offer an effective tool for developers to cover the important factors affecting the quality and reliability of mobile app as a part of connected health system.
Health Tech, Digital Health and Usability Specialist