Patient remote monitoring system in Wearable Technology
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Patient remote monitoring system in Wearable Technology

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  • 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
  • Aggiungi foto con mappa
  • 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.

Patient remote monitoring system in Wearable Technology Patient remote monitoring system in Wearable Technology Presentation Transcript

  • 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
  • We already talked about wearable tech… Giulio Coraggio - DLA Piper giulio.coraggio@dlapiper.com 2
  • 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 3
  • What type of technologies are relevant? Giulio Coraggio - DLA Piper giulio.coraggio@dlapiper.com 4
  • How does it work? Cloud projects! Giulio Coraggio - DLA Piper giulio.coraggio@dlapiper.com 5
  • 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 6
  • 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 giulio.coraggio@dlapiper.com 7
  • 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 giulio.coraggio@dlapiper.com 8
  • 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 9
  • 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 10
  • 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 11
  • 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 12
  • 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 13
  • What is the impact on the growth of this technology?  Time to market?  CE Marking  Issues for updates/upgrades Giulio Coraggio - DLA Piper giulio.coraggio@dlapiper.com 14
  • 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 15
  • 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 16