Citizen deserves voice in secondary data use

Citizens must be more closely involved in the design and further development of a data exchange infrastructure for secondary use. This plea was emphatically heard at Health-RI's recent annual conference at Jaarbeurs Utrecht. "Who is it ultimately about?", CEO Leone Flikweert reminded the more than five hundred visitors. "We are all citizens and patients. We cannot do it without them."

Accelerating the reuse of health data for research, innovation and policy. That was also what the ninth edition of the Health-RI annual event was all about. A tough process, in which nevertheless important steps have recently been taken. For example, the hospitals are working on a virtual 'road network' under the name CumuluZ, over which various types of digital information will soon be able to 'drive'. Important steps have also been taken in the area of authorization and registration. VZVZ has developed an online permission facility for authorization and registration under the name Mitz. In addition, the cabinet has endorsed the choice of SNOMED as a uniform standard for medical coding and documentation. "None of this sounds sexy, but we can get started with that," Flikweert said of the importance of these steps.

Data authority

Of even greater importance is the advent of the European Health Data Space (EHDS). This comprehensive package of legal measures should give a major boost to the digital exchange of health data, for both primary and secondary use. One of the obligations arising from the EHDS is the creation of a data authority. As far as secondary use is concerned, this Health Data Access Body (HDAB) must steer the actual exchange between data holders, such as hospitals and knowledge institutes, and data carriers, such as researchers and policy makers, in the right direction. This will give the HDAB a pivotal role in the healthcare data ecosystem.

Patient hooking up

The drive and speed with which data exchange is now being taken up can count on approval in Utrecht, but also gives rise to concern. Isn't secondary data exchange threatening to turn into a meeting of purely institutional parties in which citizens and patients are being overlooked? "The patient is seen too much as a passive player, while we are active data producers," said Gaston Remmers, a member of Health-RI's social advisory board. "There are patient associations organizing data in their own infrastructure. We are not being actively hooked now. When will we come into the game? We don't want a situation where that's no longer possible. We ARE the data. That awareness needs to become much stronger."

Permission

Board member Stephan Meijer of the Dutch Association of Hemophilia Patients (NVHP), points out another problematic aspect of secondary use. "The crazy thing is that, as a patient, you are overcharged and questioned. You have to give permission and answer questions over and over again, even though you want to. But at other times, on the contrary, you are not asked or informed."

As far as Leone Flikweert is concerned, citizen and patient participation is crucial to the success of secondary data exchange: "Who is it ultimately about? We are all citizens and patients. We cannot do it without them. We need everyone in the ecosystem. That will only work if there is trust."

Transparency

Health-RI is building trust in its own way. "We want accountability, because a lot of public money is involved. Honesty and transparency are pillars of trust. We have to be open about where we are going; are we doing the right things? Is it clear? We also want to hear when we're not doing it right."

Legal embedding

Partly for this reason, Health-RI has created its own social advisory board. But in a broader sense, trust obviously also needs a solid legal embedding. As an independent intermediary between data holders and data users, the HDAB can play an important role in this respect. What the HDAB for secondary use should look like, Health-RI, together with CBS, ICTU and RIVM, may define a blueprint in the near future. In doing so, Health-RI wants to learn from experiences in other countries. One of those countries is Norway. Here an HDAB has already been active for a number of years, complete with process for data delivery, catalog and governance structure.

Clear guidelines

For Health-RI, every reason to give senior consultant Truls Korsgaard of the Norwegian Institute of Public Health in Utrecht the stage. "Trust starts with relationships," Korsgaard said in his unofficial crash course on "how to build public trust. "But legislation, governance, secure infrastructure and data minimization are also incredibly important."

Not to mention the practical translation of all these formal ground rules. "Never underestimate the importance of clear guidelines in building trust," says Korsgaard. "We work a lot within our institute with specialized technicians. But these are not topics you just dip into. We really need to train the users out there. Therefore, we also try to actively involve the data holders from moment one. Data exchange is a bottom-up process that starts with them."

Culture

Korsgaard acknowledges that Norway has a historical advantage in trusting exchange. Korsgaard: "Norway has a long tradition of central registration and exchange of health data. Central health records are really part of our culture and thinking. In the Netherlands, I notice even more discomfort about sharing health data."

Challenges

That said, there are plenty of common challenges. In this regard, Korsgaard points to the difficult access to healthcare information systems. There are also legal pitfalls: how should the AVG be interpreted, what does the opt-out regulation mean and what rules actually apply when data crosses borders? And Norway, like the rest of the world, is also struggling with declining trust in authorities and institutions. Korsgaard: "Many are skeptical about science and technology."

Problem-based approach

How to overcome that skepticism is the common thread of professor and cell biologist Christine Chomienne's talk. As vice chair of the Mission Board for Cancer, she is closely involved in European efforts to increase the impact of cancer research. To that end, Chomienne and her colleagues have established a new method of research programming: problem-driven, mission-driven with a strong focus on building trust. "Citizens don't want to wait ten years for a scientific breakthrough, but quick, quantifiable results," Chomienne said. "Our goal is very clear: save three million lives by 2030. Research needs to be more meaningful to citizens. The trick is to involve everyone early on, including in the research design. Such co-design means that researchers must not only think about methodology, but be able to speak to patient and provide answers. We did have to convince the research community of that, because it means bringing people to the table who don't talk like you and may not even trust you."

Priorities

That message is heartily supported by Health-RI. "It's about clarity," said Flikweert. "The citizen and the patient, but also the professional wants a clear system of data exchange. The physician must also be able to explain this to the patient."
Asked about priorities for the coming year, Flikweert mentions, in addition to the HDAB blueprint and the expansion of the data catalog, a larger speaker for the Social Advisory Council: "Maybe it should be its own congress."