In a flurry of activity from the European Commission in the field of digital health technologies, the Commission has now published a consultation on the safety of apps and other non-embedded software. The consultation covers software that is downloadable on a device, such as a personal computer, tablet or smartphone, or accessible from a remote location (cloud), but does not include software that is already covered by, for example, the Medical Devices Directives.
This consultation is the latest in a line of draft guidance and consultations from the Commission as it seeks to develop appropriate parameters and guidance on the development of mHealth apps. As set out in previous posts, the European Commission recently published a final draft of a Code of Conduct on privacy for mHealth apps and a first draft of the Guidelines for assessing the validity and reliability of apps.
In the present consultation, the Commission is seeking views on the safe use of software and apps, which means “freedom from unacceptable danger, risk or harm, including security-vulnerabilities (“cyber-security”) and cover[ing] physical, economic as well as non-material damage”. The questions seek a better understanding of the possible risks and problems that may arise from software, and how these problems could be dealt with. For example, the consultation includes a matrix of different types of damage, and asks responders to give their opinion on the level of risk that apps may pose. The consultation also asks responders to give details of any personal experiences with unsafe apps, and to comment on existing guidance and legislation.
The consultation is open until 15 September 2016, and you can respond here.