The public consultation on the safety of applications for mobile devices (“apps”) and other non-embedded software was launched in June 2016 as a result of the public consultation on the Green Paper on mHealth in 2014. The latter showed the need to have a special focus on safety aspects of mHealth apps.
This consultation gathered input from various stakeholder groups (78 replies) in particular citizens, industry and public authorities, on their experience related to the safety of apps and other non-embedded software.
According to the respondents, the main category of apps that could pose safety risks are health and wellbeing apps: apps that give health advice, apps upon which a consumer is taking a health or lifestyle-related decision, apps that track and collect data from the user to assess and monitor health-related metrics or apps that interface with electronic health records.
The European Commission launched a *public consultation on the safety of applications for mobile
devices (“apps”) and other non-embedded software on 9 June 2016*, which was open for 12 weeks.
Although the response to the consultation was rather limited, it presented a variety of concerns,
including the need for more legal clarity on the EU legislation applicable. The Commission will
explore the matter but no specific Commission initiative seems necessary at this stage further to the
This consultation gathered input from various stakeholder groups, in particular citizens, industry and
public authorities, on their experience related to the safety of apps and other non-embedded
software. The purpose was to obtain a better understanding of the possible risks and problems those
apps or non-embedded software may pose and how these problems could be dealt with.
Only apps and non-embedded software that are downloadable on a device such as a personal
computer, tablet or smartphone or accessible on a remote location (cloud) were covered by this
For the purpose of this consultation “safety” and “safe use” was to be understood as freedom from
unacceptable danger, risk or harm, including security-vulnerabilities (“cyber-security”) and covered
physical, economic as well as non-material damage.
This consultation looked only into the safety of apps and other non-embedded software which are
not already addressed and foreseen by sector-specific legislation, such as the Medical Devices
Directives or the Radio Equipment Directive, which include provisions on safety ensuring that
equipment within their scope, if compliant, is safe.
The replies of contributors who agreed to publication, as well as a preliminary summary of this
consultation, are available on DG CONNECT’s website.
Download the report: http://ec.europa.eu/newsroom/dae/document.cfm?doc_id=43611