Ambitious project

“Our original goal was nothing less than the holy grail of healthcare”, says Marta Giralt. “How can you build a platform that allows for the secure exchange of medical data? The infrastructure in the Netherlands is fragmented and the information is scattered across healthcare providers. Individuals like us don’t hold the data; it’s healthcare providers like hospitals and pharmacies that have your personal information. The holy grail of data exchange is still our vision, but we’ve decided to zoom in on a specific part of this process, and automate it with the use of blockchain technology.”

That specific part is informed consent, which is key to any medical research or trial. It’s about giving individuals control over their data and raising their awareness of the aims, risks and benefits of a study so they can make an informed, voluntary and rational decision to participate. The initiative could not be more timely: in May a new regulation will come into force giving all Europeans full control over their data. Under the General Data Protection Regulation (GDPR), EU citizens will enjoy a new set of ‘digital rights’ at a time when the economic value of their personal data is rapidly increasing. For the companies and organisations that use these data, the new regulation will have major repercussions.

Sea change

The GDPR constitutes nothing less than a sea change in our rapidly digitising world, according to Oskar Person. It presents major challenges for the healthcare industry, and healthcare researchers in particular. “Their core business is all about collecting, analysing and using patient data, and from next May, they will no longer own this digital information. The regulation could inhibit research, but we see it as an enabler of free science and empowerment of both researcher and data subject.”

“The GDPR specifies how to approach consent and how to deal with people who want to withdraw their data from a study”, Giralt continues. “The regulation is strict and the penalties are quite high, but there’s no mention of the technology that needs to be used. So there’s space for innovation.”

And that’s where the prize-winning Hackathon team stepped in. They wanted to streamline the process of giving consent and develop a proper permission procedure that ensures individuals are in control of their data. “The current consent process is quite cumbersome”, says Thiel. “Much of it is still done on paper, which you need to print and sign. The consent forms are frequently sent back and forth. We focused on digitising this process and providing metrics on how the process is going. We also want to set up communication channels so individuals can request information about the study and become more involved.”