The GDPR will cause challenges for connected care developers
According to a new research report from the IoT analyst firm Berg Insight, the upcoming implementation of the General Data Protection Regulation (GDPR) in 2018 will cause challenges for companies in the telecare industry.
Telecare and telehealth apps and devices are potentially generating huge amounts of data that could be used for various purposes. Today, data is increasingly more used to help patients without the need of the patient’s own active involvement. This includes various kinds of health data as well as user location and movement data which could be used to identify abnormalities. If a user does things differently, for example not leaving or going to the bed as usual, a notification can be sent to relatives or care givers.
Legislative authorities in the EU are developing and designing legal frameworks that should be in line with the new data driven world of mobile health. As part of this, the European Commission will in 2018 implement a General Data Protection Regulation (GDPR) that aims to harmonise data protection rules in the EU, ensuring legal certainty for businesses and increasing trust on eHealth services with a consistent high level of protection of individuals.
The GDPR aims primarily to give control back to citizens and residents over their personal data and to simplify the regulatory environment for international businesses by unifying the regulation within the EU. When the GDPR takes effect, it will replace the data protection directive and it becomes enforceable from May 25 next year after a two-year transition period. It does not require national governments to pass any enabling legislation and will be directly binding and applicable.
“While the future is data driven, end-users do care more and more about integrity aspects. The GDPR aims to increase privacy for the end-user which is a step in the right direction. The regulation by default actually prohibits processing of health data unless explicit consent has been given. At the same time, this will cause challenges for those telecare and telehealth solution providers that are not proactively working on their preparations.
If the solution providers are not enough prepared for handling, processing and storing sensitive data in accordance to GDPR, they could risk heavy fines if not fulfilling the requirements”, says Anders Frick, senior analyst, Berg Insight.
Download report brochure here.