The document summarizes a webinar presentation about legal issues related to patient remote monitoring systems and wearable technologies in healthcare. Remote patient monitoring allows patients to perform routine medical tests and send results to healthcare providers in real-time using mobile devices. Key legal issues discussed include privacy regulations around collection and processing of patient data, potential qualification of hardware and software as medical devices, and intellectual property protection of the monitoring technologies.

1. 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
giulio.coraggio@dlapiper.com
December 19, 2013

2. We already talked about wearable tech…
Giulio Coraggio - DLA Piper
giulio.coraggio@dlapiper.com
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3. 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.
Giulio Coraggio - DLA Piper
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4. What type of technologies are
relevant?
Giulio Coraggio - DLA Piper
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5. How does it work? Cloud projects!
Giulio Coraggio - DLA Piper
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6. 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
Giulio Coraggio - DLA Piper
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7. 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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8. 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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9. 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
Giulio Coraggio - DLA Piper
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10. 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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11. 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?
Giulio Coraggio - DLA Piper
giulio.coraggio@dlapiper.com
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12. 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
Giulio Coraggio - DLA Piper
giulio.coraggio@dlapiper.com
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13. 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.
Giulio Coraggio - DLA Piper
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14. What is the impact on the growth of
this technology?
 Time to market?
 CE Marking
 Issues for updates/upgrades
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giulio.coraggio@dlapiper.com
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15. How are these devices protected?
 IP rights on the technology?
 Patentability of the software/hardware?
 Trademark protection of generic terms by technology
companies?
Giulio Coraggio - DLA Piper
giulio.coraggio@dlapiper.com
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16. Thank you!
Giulio Coraggio
DLA Piper Italy
T +39 02 80 618 619
M +39 334 68 81 147
E giulio.coraggio@dlapiper.com
Giulio Coraggio - DLA Piper
giulio.coraggio@dlapiper.com
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