A European Health Data Space (EHDS) could have a huge impact on health research if it could overcome barriers to cross-border secondary uses of health data and build trust among citizens, according to a Finnish health data advocate.
These obstacles have been carefully analyzed by the Joint Action Towards the European Health Data Space (TEHDAS), coordinator Markus Kalliola, project manager for the Health Data 2030 project at the Finnish innovation fund Sitra, told EURACTIV in an interview.
TEHDAS was implemented by 25 countries and supported the European Commission in developing principles for the cross-border secondary use of health data for the EHDS.
The long-awaited proposal for EHDS was finally presented last week (May 3) after several postponements by European Commission Vice-President Margaritis Schinas and Health Commissioner Stella Kyriakides.
With Schinas calling it a “true revolution in European medical history” and Kyriakides calling it “the backbone of the European Health Union”, expectations for the impact of EHDS in the EU are high.
It has two main components: the primary use of health data – how people can access their own health data, such as prescriptions and lab results. The other part relates to the secondary use of personal health data, for example in research.
Secondary use in particular could have a huge impact on improving future medical care across the EU, but conducting research with data from different European countries is currently complex and very limited.
TEHDAS analyzed research and interviewed experts, identifying 11 barriers to the cross-border secondary use of health data.
“What surprised me was that six of these were legal issues. This means that the biggest hurdle to secondary uses of health data is that we have such different legal frameworks in different countries and interpret EU law very differently,” said Kalliola.
“Often when we talk about health data, people think we’re trying to solve technical problems. As long as we have good architecture and good solutions, it will work. As we went through the academic papers and expert interviews, we realized that it wasn’t the technology that was the main problem, but rather these legal issues. I think people get that wrong quite a lot,” he added.
In fact, only one barrier is infrastructure. Other non-legal barriers include a lack of interoperability between data, poor access to appropriate data, and different codes used to label the same health conditions, making comparisons between data difficult.
Basic definitions must be agreed
The legal barriers include different implementations of the GDPR by the member states, different interpretations of sufficient anonymization and individual regulations on health data for research outside the GDPR.
A legal issue that Kalliola highlights is the lack of a common interpretation of the term “secondary use”.
“[We need to determine] what the secondary uses of health data are, what purposes the data can be used for, and what data needs to be available,” he said.
“Can it be used for teaching, statistics, research and innovation? Can the private sector use the data for scientific research or only for the public sector?” Kalliola added.
The TEHDAS report on these barriers notes that “the lack of clarity and conflicting use of these terms can lead to significant challenges in obtaining consent, where it can be difficult to interpret what individuals have consented to”.
Their proposed solutions envisage the Commission creating a clear legal definition, a common definition between the Commission and the Member States, or each Member State clarifying what secondary use of health data is.
Currently, page two of the EHDS proposal provides a broad definition of secondary use as “health research, innovation, policy making, regulatory purposes and purposes of personalized medicine”.
New governance models and a high level of trust are needed
One of the goals of TEHDAS is to provide “options for governance models and secondary use of health data between European countries based on transparency, trust, citizen participation and a common good”.
While the project is still ongoing and these “options” have yet to be published, Kalliola said that “the main finding for now is that none of the current mechanisms work well enough for a health data room and the secondary use of health data. ”
He referred to current mechanisms for managing health data at European level, such as the European Medicines Agency (EMA), the European Center for Disease Prevention and Control (ECDC), the eHealth network and Eurostat.
They also searched for partnerships for sharing health data between countries. In one case, a memorandum of understanding was drawn up as part of the joint action between the Finnish institution Findata and the French Health Data Hub.
“We also examined how cooperation could take place between countries that do not have such centralized institutions as Finland and France. How it could work between the Netherlands and Spain, for example,” he said.
Regardless of how we handle health data for secondary use, citizen trust is an essential ingredient. As a good example, Kalliola proposes a set of ethical principles for digital health published by the French Presidency earlier this year.
“One element could be forcing some institutions to take responsibility for accessing health data and promoting trust. We must trust that the researchers who are given access to the data will manage it in a safe and controlled environment and avoid security issues.”
“One of the results [from a TEHDAS study last year] was that the more people know about the secondary use of health data, the more they support it. The less they know, the more afraid they are and the more they resist,” Kalliola said.
“I think it’s a clear message for decision makers and everyone involved in research activities, whether from the public or private sector – we need to be very clear in our communication and explain what the mechanisms are and how to use them.” the right way. I think that’s one of the things that builds confidence in the long run.”
[Edited by Gerardo Fortuna/Alice Taylor]