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
Global Lawyers Association
Giulio Coraggio
DLA Piper Italy
December 19, 2013
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Wearable technologies in the healthcare sector
Remote patient monitoring (RPM), also called homecare telehealth, is a type of ambulatory healthcare that allows a
patient to use a mobile medical device to perform a routine test and send the test data to a healthcare professional in real-time.
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Potential legal issues…
Privacy – collection, transfer and processing of patients' personal data;
Medical device regulations – potential qualification of hardware and software as medical devices;
IP rights – how to protect the technology and the exclusivity rights on its exploitation
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Processing of patients' data
Which data protection law applies?
Opinion of the EU Working Party
What consent and authorizations are required and from who?
And in the case of biometric data?
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Who does what?
Understanding of the entities involved hospitals
patients
sponsor
technology provider
What are their roles? data controller
data processor
sub-processor
Consequences on the purposes of processing of collected data anonymous data
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Transfers of patients' data outside of the European Union
Approval from hospitals (data controller) as part of public tenders When can it be implied? Is it negotiable? Can the denial be
challenged?
Privacy-related options Patients' consent
Binding corporate rules
Safe Harbor program
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Most common approach to manage data transfers
EU Model clauses data controller, data processor, sub-processor
possible restrictions if the data processor is within the European Union and the sub-processor(s) is (are) located outside of the European Union
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What other privacy issues to consider?
What consent and authorizations are required? and in the case of biometric data?
What security measures shall be adopted?
What data can be accessed? and by who?
For what purposes personal data can be used? patient treatment
clinical trials?
articles on journals?
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Is hardware treated as a medical device?
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
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Is software treated as a medical devices?
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.
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What is the impact on the growth of this technology?
Time to market?
CE Marking
Issues for updates/upgrades
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How are these devices protected?
IP rights on the technology?
Patentability of the software/hardware?
Trademark protection of generic terms by technology companies?
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Thank you!
Giulio CoraggioDLA Piper ItalyT +39 02 80 618 619 M +39 334 68 81 147 E [email protected]
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