Home News & Events News overview Take care of personal (health) data!

Alwin van den Broek

Clinical Study Manager

February 26, 2016

Take care of personal (health) data!

On the International Day of Privacy (28th of January), the Dutch Data Protection Authority (DPA) announced their surveillance calendar for 2016. In line with the focus of last years the DPA will concentrate on the following areas: Protection of personal data, Big Data and Profiling, Personal Data within (digital) public governments, personal data in relation to employment and personal health data. This last focus area is definitely worth a closer look.

More and more (health) data is not only collected by health care providers and patients, but in today’s world, several apps collect (and process) personal data. However, it seems not always clear that some personal data qualifies as health data. A good example is the recently published report by the DPA about a running application for your smartphone. Here is what interest us the most.

The application requires you to create an account, registering your full name, date of birth, gender, country and e-mail address. In order for the app to calculate distance and speed while running, the app uses location information from your smartphone. If you ask your app to calculate the calories burned, you also had to enter your height and weight. By using this app, the developer is able to generate a health profile and compare this with the profile of other users. So, it is not only the type of data that makes it personal health data, it is also how it can be processed.

The data in this example is considered sensitive personal data. Processing such data is subject to strict regulations and it is prohibited to process this data without prior explicit and specific consent of the user.

With this in mind we would like to refer to the obligation to report data leaks in the Netherlands per January 1st 2016. (Personal) data, such as data for smartphone applications, is more often placed in the cloud to make it easy accessible and shareable by users. However, this also includes an increased risk of data leaks. Personal (health) data is to be handled with care and appropriate protection of it is one of the priorities of the DPA. Non-compliance with this new reporting obligation can give rise to administrative fines with a maximum of € 820.000.

Recommendation: If a third party is involved in the processing of data for which you are the controller, it is important to take a close look at your agreements with regards to ensuring data protection and this new reporting obligation for data breaches.

By Alwin van den Broek

Factory CRO for Medical Devices Acknowledgements
Sofie van der Meulen
Axon Lawyers

About the author

Alwin van den Broek Clinical Study Manager

Alwin has a special interest in the regulatory frame work and data privacy regulations.

November 17, 2017

Start Sooner, Run Fast, Finish Faster – The New York Marathon 2017

At Factory CRO we believe that physical fitness stimulates people to get the best out of themselves. Besides the positive energy, it increases company engagement and team spirit. In light of this philosophy, 12 Factory CRO runners successfully completed the...

Pre Market
March 21, 2018

Clinical Investigations – What changes because of the Medical Device Regulation?

  Does the MDR change your Clinical Investigations? April 5th 2017 was a historical moment for the medical device industry: the Medical Device Regulation (MDR) was adopted by the European Union. Beginning May 27th, 2020, after a 3 year transition...

Pre Market
February 27, 2018

One Medical Device Trial Fits All! ISO 14155 as a Standard for Your Foreign Data Submitted to the FDA

There is interesting news in the medical device world that may impact your clinical strategy! On February 21, 2018, the FDA released its final ruling on the acceptance of data from clinical investigations for medical devices. With this amendment to...

Pre Market