The Journal of mHealth Vol 1 Issue 2 (Apr 2014) | Seite 57

UK's MHRA Issues Guidance on Stand-Alone Software and Apps
home. Increasingly, this latter function could be placed on
a server and software could be used to interpret the patient
data. This could be considered a medical device.
However, consideration should be given to the interface
between social care, well-being and health, which can become
blurred. For instance an app that uses an accelerometer or
gyroscope as a falls detector in epileptic patients is likely to
be regulated as a medical device but the same app or device
could alert as to whether an elderly person has got up from a
chair or bed in a social care context. As a detector of falls of
a medical condition the app will qualify under the MDD and
be regulated as a medical device but in the latter case it will
not meet the definition of a medical device and the medical
device regulation would not apply.

Home Telehealth Systems with Connected
Monitoring Devices
MHRA requires individual devices to be CE marked as medical devices but does not require a system to be CE marked
as a medical device unless it is placed on the market as a single product. Items such as the hub and possibly the motion
detector (depending on the claims of the manufacturer) are
not likely to be CE marked medical devices as they do not
have a medical purpose. However, the software that runs on
the server and interprets or interpolates the patie