How do we ensure good and secure data availability that is future-proof? With the arrival of the European Health Data Space (EHDS) in 2029, there is urgency to optimally set up the health data infrastructure. Health-RI provides guidance with a data journey that contributes to data availability for research, policy and innovation.
Health-RI is committed to better health for patients through the reuse of health data arising from the consultation room, between doctor and patient. This data can be used for research, policy and innovation, or secondary use of data.
The organization is pushing for a future-proof health data infrastructure, something that is currently lacking. "It's a jumble of different systems working differently and not communicating with each other," said Leone Flikweert, CEO of Health-RI, in an earlier conversation with Dutch Health Hub.
Together with CumuluZ Care Data Foundation Health-RI is working towards a future in which health data are available for care and wellness as well as for research, policy and innovation. Where Health-RI focuses on realizing data availability for secondary use, Cumuluz makes health data from the primary care process suitable and available for reuse. The result: one coherent infrastructure.
EHDS: better healthcare in Europe
This data infrastructure is essential, as the European Health Data Space (EHDS) goes into effect in 2029. The EHDS is a European regulation, i.e. an obligation, to ensure better and more secure availability of health data and regulation of the electronic health record (EHR) market. By March 26, 2029, all European countries must comply with the EHDS.
Researchers can then (subject to conditions) gain easier access to data to develop new treatments, drugs or prevention programs. Flikweert: "The idea behind the EHDS is to improve healthcare in Europe. The legal framework of the EHDS is a blessing because this way everyone knows where they stand."
Also read: 'EHDS offers opportunity to better organize fragmented healthcare data'
The importance of data quality
However, just having a legal framework is not enough. Before addressing data availability, the quality of this data must be considered. Says Jessica Workum, intensivist, clinical pharmacologist and AI specialist, at the Health-RI conference on Nov. 6.
She talks about how the entry of AI into healthcare can improve data quality. "AI can summarize data, visualize it, translate it into simple language, all very quickly." Workum knows from his own experience how much time administration takes and how little sense healthcare professionals have in it. "Healthcare professionals want to do what they are trained to do: provide care."
One downside of AI is that there are automation bias can occur, looking less critically at the data generated and preferring that which is presented. A known risk of generative AI, however, is the emergence of source hallucinations, made-up data. "Contaminated data makes secondary use of that data dangerous. It is important for AI to adapt to humans rather than the other way around."
Data journey: from request to research
Once you have ensured the quality of data, it is important to optimize the availability and exchange of that data. What specifically does that secure exchange of data look like for, in this case, secondary use, that is, for research, policy and innovation?
Health-RI explains it using the data journey, a journey that shows the steps involved in reusing health data. During the conference on Nov. 6, this data journey came to life through six speakers based on a fictional research scenario.
1. Data user: researcher Bart Torensma
Bart Torensma is a clinical epidemiologist at Erasmus MC and as a researcher needs data for his research on the early signs of obesity. He looks up the desired data in the National Health Data Catalog and submits a request. This is forwarded to the data request evaluator.
2. Data application reviewer: Hanneke den Breeijen
Hanneke den Breeijen is senior policy advisor for research at UMC Utrecht. She receives and reviews Torensma's application. "Important factors include the content of the application, the methodology of the research, the scientific nature and the ethical justification. How does Torensma handle data?"
The researcher himself is also assessed. "What knowledge and expertise does he have? Everyone involved in the research is assessed." After approval, Den Breeijen sets the rest of the chain in motion.
Also read: 'Trust propels data exchange'
3. Data holder: Lucy Overbeek
Lucy Overbeek is program manager Nivel Zorgregistraties eerste lijn and has the data Torensma needs for his research in this scenario. In consultation with Torensma, Overbeek takes a critical look at which data are needed for the study in question. "As the data keeper, you make the translation from the request to the data that are actually needed for the research," he says. Once Overbeek has selected the data, they are handed over to Hans van Vlaanderen.
4. Data linking and pseudonymization: Hans van Vlaanderen
Hans van Vlaanderen is Director at ZorgTTP, an organization that helps healthcare organizations ensure their security and privacy, and is responsible for creating the security key.
The data in question will be linked to a pseudonymized Citizen Service Number (BSN). "Each study is given its own unique security key. As a result, the data are only linkable within a specific study. If ABC always stood for 123, you could still trace data back to a patient."
Van Vlaanderen thus ensures that the data issued by the data holder can be used in a secure way.
5. Provider of the secure environment: Stefan van Aalst
Stefan van Aalst is Director at anDREa, a company that creates digital environments for research, and is responsible for the secure environment in which Torensma can work. "Only people who are in the data application can access this environment," he says.
Van Aalst provides the secure environment where data (Overbeek) and security key (Van Vlaanderen) come together, so Torensma can get to work with it.
Also read: Data availability in the future: 'A transparent system for all parties'
6. Citizen and patient: Wouter Bos
The data journey cannot be made without patients. After all, they are the people about whom all this data is collected. Wouter Bos is a chronic patient with an immune disorder and is a member of Health-RI's social advisory board. According to Bos, the ideal scenario is to have a transparency portal by 2029. "As a patient, you want to know: what is the data about me being used for? What is being done with it and for what research? And what are the results?" Transparency breeds trust, according to Bos.
Future vision: work together and be patient
Flikweert agrees with the transparency portal. "Providing information in general is important. Also for the healthcare professional. Together with the Ministry of Health, Welfare and Sport, we have developed a toolkit that healthcare professionals can use to inform patients about the why and how of secondary use."
Finally, Flikweert calls for joining forces and anticipating the arrival of the EHDS. "We really have to do it together and that takes time. We have to be patient, but also daring. Start giving input as organizations on the guidelines that are coming from Europe. Now is the time to influence how we are going to implement the EHDS in the Netherlands."
