Webinar Patient remote monitoring system Privacy, medical devices and IP related issues of patient remote monitoring systems and wearable technologies in the healthcare sector Global Lawyers Association Giulio Coraggio DLA Piper Italy [email protected]December 19, 2013
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Patient remote monitoring system in Wearable Technology
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WebinarPatient remote monitoring systemPrivacy, medical devices and IP related issues of patient remote monitoring systems and wearable technologies in the healthcare sector
Qualification of the hardware: hardware which may also be used within the medical environment
are normally not considered as medical devices, unless they are specifically assigned a medical role
hardware utilized together with the software in such a way that the software may not otherwise run (i.e. the software would not run on any other device), then the hardware should be regarded as MD itself
Qualification of the software – this may be regarded as a medical device when either: his purpose of use falls under one of the categories listed in the
definition of medical device; or
it is intended to control or influence the functioning of a medical device; or
it is intended for the analysis of patient data generated by a medical device with a view to diagnosis and monitoring; or
it is intended for use for/by patients to diagnose or treat a physical or mental condition or disease.