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

3 legal brain twisters: • Health vs. Wellbeing

• Professional vs. Informal care• General personal data vs. Health

data

1

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

wellbeingonly general wellness use• general state of health• intended use part of

healthy lifestyle

2

professional vs informal care

purely household activity?data controller or data processor?

informed consent

empowerment includes transparency on

processes, rights and obligations

3

46 % of respondents to EU consultation on mHealth said strong privacy and security tools are needed to build users’ trust

HALF called 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 exceptionse.g. unambiguous informed

consent

Applicability of EU DP law

Currently: equipment situated within EUincluding smart

devices

Foreseen: location of the data subject

thank yougriet.verhenneman@law.kuleuven.be