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Legal considerations on the
use of monitoring systems at
home.
Griet Verhenneman
researcher KU Leuven Center for IT & IP Law - iMinds
AAL Forum Ghent – 24 September 2015
Monitoring systems at home
3legal brain twisters:
• Health vs. Wellbeing
• Professional vs. Informal care
• General personal data vs. Health
data
qualification / certification
as medical device
product liability
healthcare
• connection to medical
devices
• medication reminders
• vital signs monitoring
• fitness and dietary
recommendations
wellbeing
• directly or indirectly
maintain or improve
healthy behaviors,
quality of life and
wellbeing of individuals
healthcare
• reference to diseases or
conditions
• products for diagnosis
and treatment
wellbeing
only general wellness use
• general state of health
• intended use part of
healthy lifestyle
professional vs informal care
purely household activity?
data controller or data processor?
informed consent
empowerment
includes transparency
on processes, rights and
obligations
46 %
of respondents to EU consultation on mHealth
said strong privacy and security tools are
needed to build users’ trust
HALFcalled for strengthened
enforcement of data protection rules
care more than ever a data-driven
discipline
• collection of general and/or health related
personal data
• big data analytics
• international data transfers
data
protection
health data
• medical context
• concerning individual’s
health
• purpose to monitor
health or well-being
general personal data
• personal data of general
nature
Data transfer outside of EU
Recognized countries or adequate
safeguards by contract
Exhaustive list of exceptions
e.g. unambiguous informed consent
Applicability of EU DP law
Currently: equipment situated within EU
including smart devices
Foreseen: location of the data subject
thank yougriet.verhenneman@law.kuleuven.be

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Legal considerations on the use of monitoring systems at home

  • 1. Legal considerations on the use of monitoring systems at home. Griet Verhenneman researcher KU Leuven Center for IT & IP Law - iMinds AAL Forum Ghent – 24 September 2015
  • 2.
  • 3. Monitoring systems at home 3legal brain twisters: • Health vs. Wellbeing • Professional vs. Informal care • General personal data vs. Health data
  • 4.
  • 5. qualification / certification as medical device product liability
  • 6. healthcare • connection to medical devices • medication reminders • vital signs monitoring • fitness and dietary recommendations wellbeing • directly or indirectly maintain or improve healthy behaviors, quality of life and wellbeing of individuals
  • 7. healthcare • reference to diseases or conditions • products for diagnosis and treatment wellbeing only general wellness use • general state of health • intended use part of healthy lifestyle
  • 8.
  • 9. professional vs informal care purely household activity? data controller or data processor?
  • 10. informed consent empowerment includes transparency on processes, rights and obligations
  • 11.
  • 12. 46 % of respondents to EU consultation on mHealth said strong privacy and security tools are needed to build users’ trust HALFcalled for strengthened enforcement of data protection rules
  • 13. care more than ever a data-driven discipline • collection of general and/or health related personal data • big data analytics • international data transfers data protection
  • 14. health data • medical context • concerning individual’s health • purpose to monitor health or well-being general personal data • personal data of general nature
  • 15.
  • 16. Data transfer outside of EU Recognized countries or adequate safeguards by contract Exhaustive list of exceptions e.g. unambiguous informed consent
  • 17. Applicability of EU DP law Currently: equipment situated within EU including smart devices Foreseen: location of the data subject
  • 18.

Editor's Notes

  1. Cloud client = data controller, cloud provider = data processor