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The legal obstacles of big data in health tech and how to remove them
29 November 2019

The time when the doctor only looked at the paper file when a patient came into his consulting room is over. The use of big data can greatly improve patient care and reduce costs. However, there are some legal hurdles to be overcome.

There are now a number of innovative applications in healthcare that use big data. Think of the early detection of skin cancer with an app or the use of a wearable blood pressure monitors. Computer simulations can also speed up medical research and ensure quicker access to new medicines. “All these possibilities are created by unlocking data and combining it with other data,” says Dimitri van Hoewijk, partner at Van Doorne and member of the Healthcare & Life Sciences team. “Collecting and linking data from different sources offers a lot of opportunities”.

However, the application of data and big data in healthcare can be at odds with patient privacy. And agreements also have to be made about the technology itself. Not everything is legally possible. Yet there is often more to it than healthcare providers and HealthTech companies think.

The first problem that many organisations face is that the data from different sources cannot be combined or communicate with other data. This is due to both the inputting of data into systems and the underlying technology. “Agreements need to be made between departments or between different organisations. Both in the Netherlands and at a European level, there are already a number of initiatives in the healthcare sector to make data more compatible. This concerns the use of the same medical terms, but also the technical standardisation of information systems so that technology no longer forms an obstacle to the sharing of data,” explains ICT Counsel Louis Jonker.


A second obstacle is the lack of clarity among many parties as to what is and what is not allowed when using patient and other data for innovative purposes. This lack of clarity is mainly due to the recent introduction of the General Data Protection Regulation (GDPR). “Publications in the media and even in professional journals do not help the case. Writers think they know the subject, but the essence eludes them”, says Van Hoewijk.

This lack of clarity can lead to healthcare institutions limiting themselves and acting cautiously when it comes to big data. “I recently spoke to a doctor at an academic centre. He said that as many as fifty innovative applications are available to provide better care, but that he can only use a handful of them due to a lack of clarity about the rules”, says Van Hoewijk. “And that is such a shame,” Jonker adds. “Although privacy is, of course, very important, you should not nip all innovations in the bud out of fear that they are not allowed under privacy legislation”.

Holistic approach

Van Doorne advises healthcare institutions and HealthTech companies to discuss the possibilities and limitations of big data applications with its specialised legal team at an early stage.

Van Hoewijk: “With a privacy check, we can answer the question of whether or not the regulations allow you to implement an initiative. And since innovative applications often have to take account of multiple regulatory frameworks, we use a holistic approach. Which data do you want to use and which regulations do you have to comply with; is it for a medical device and will the organisation itself become a manufacturer; should you organise the cooperation as a general partnership or as a private limited company? We can look at all the aspects for the client and give pragmatic advice, so that the innovation will be a success as soon as possible and so that it can improve patient care.”