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Wearable technologies and remote patient remote monitoring system


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This presentation focuses on issues related to wearable technologies in the healthcare sector whose main expression has been given so far by the so called remote patient monitoring systems

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Wearable technologies and remote patient remote monitoring system

  1. 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 December 19, 2013
  2. 2. We already talked about wearable tech… Giulio Coraggio - DLA Piper 2
  3. 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 3
  4. 4. What type of technologies are relevant? Giulio Coraggio - DLA Piper 4
  5. 5. How does it work? Cloud projects! Giulio Coraggio - DLA Piper 5
  6. 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 6
  7. 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? Giulio Coraggio - DLA Piper 7
  8. 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 Giulio Coraggio - DLA Piper 8
  9. 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 9
  10. 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 10
  11. 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 11
  12. 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 12
  13. 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 13
  14. 14. What is the impact on the growth of this technology?  Time to market?  CE Marking  Issues for updates/upgrades Giulio Coraggio - DLA Piper 14
  15. 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 15
  16. 16. Thank you! Giulio Coraggio DLA Piper Italy T +39 02 80 618 619 M +39 334 68 81 147 E Giulio Coraggio - DLA Piper 16