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.
Wearable technologies and remote patient remote monitoring system
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
giulio.coraggio@dlapiper.com
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4. What type of technologies are
relevant?
Giulio Coraggio - DLA Piper
giulio.coraggio@dlapiper.com
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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
giulio.coraggio@dlapiper.com
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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
giulio.coraggio@dlapiper.com
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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
Giulio Coraggio - DLA Piper
giulio.coraggio@dlapiper.com
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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
giulio.coraggio@dlapiper.com
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14. What is the impact on the growth of
this technology?
Time to market?
CE Marking
Issues for updates/upgrades
Giulio Coraggio - DLA Piper
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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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Notas del editor
MedronicInsertable Cardiac Monitor: An insertable cardiac monitor is a small implantable device that continuously monitors heart rhythms and records them automatically or by using a hand-held patient activator. The device is implanted just beneath the skin in the upper chest area during a simple procedure. The insertable cardiac monitor is programmed to continuously monitor your heart’s activity in the form of an electrocardiogram (ECG). When a fainting spell occurs, you or your family member should immediately place a small hand-held activator over the cardiac monitor and press a button.
deliberaworking party sulle appautorizzazione generale del Garantenotifica al Garante della privacy per profilazione e utilizzo di dati biometrici
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In this case, the software is a component and integral part of the MD and is not regarded as a medical device in its own. Therefore, hardware and software should fall automatically into the same class.