EU Member States are increasingly mobilising to ensure the safety of health, lifestyle and wellness applications on mobile phones, tablets or personal computers, according to a report prepared for the European Commission and published in early April.
This document, which is approximately 60 pages long, shows that despite the absence of incidents reported at this stage, many countries are fully aware of the need to provide some kind of transparency with regard to the security of such applications. In particular, professional medical organizations and public organizations responsible for quality assurance develop activities to help control the safety of health, lifestyle and wellness applications.
As regards the applicable legislation, the study shows that it is not clear at the moment which, if any, text applies to the safety of health, lifestyle and well-being applications. In addition, for some legislation, such as the General Product Safety Directive and the Directive on liability for defective products, it is currently unclear whether and to what extent they can cover health, lifestyle and well-being applications. Other forms of legislation seem relevant for non-integrated software, but they do not concern incidents (such as the Consumer Rights Directive and the Directive on unfair business-to-consumer commercial practices in the internal market). The directive on the market in radio equipment covers non-integrated software and "must be taken into account", the report notes.
At the European level, it recalled that the European Committee for Standardisation (CEN) had set up a working group on safety, health and welfare applications. An initiative that will help to "prevent potential security incidents related to health, lifestyle and wellness applications, while ensuring the quality of these applications, given the objectives they serve", concludes the report. [report: https://bit.ly/2G4BE4i ] (Original version in French by Sophie Petitjean)