1. mHealth subject to European regulation Dutch Stefan Visscher, PhD
Senior inspector
24 June 2014

2. Introduction Why attention for healthcare IT?
Increasing dependency on ICT
New possibilities/ benefits for providing health care: eHealth, mHealth/ medical apps, etc.
Also: more (new) risks!
mHealth subject to European regulation | 24 June 2014 | Stefan Visscher

3. risk
mHealth subject to European regulation | 24 June 2014 | Stefan Visscher

4. Software as a medical device
In 2013, the Dutch health care inspectorate organized two conferences to inform developers/ manufacturers and health care providers that software products can also qualify as medical device:
Software as a medical device
‘medical device’ means any instrument, apparatus, appliance, software,
material or other article, whether used alone or in combination,
including the software intended by its manufacturer to be used specifically
for diagnostic and/or therapeutic purposes and necessary for its proper application,
intended by the manufacturer to be used for human beings for the purpose of:
— diagnosis, prevention, monitoring, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, …
Goal
Safe products on the European market
Legal framework
European Medical Device Directive 93/42/EEC
MEDDEV 2.1/6: guidance on qualification and
classification of software
See also: mHealth Green Paper – DG Connect
mHealth subject to European regulation | 24 June 2014 | Stefan Visscher

5. More about… Software as medical device
mHealth subject to European regulation | 24 June 2014 | Stefan Visscher