Legal issues, not infrastructure hampers research in health data revolution

A European Health Data Space (EHDS) could enormously impact health research if it can overcome barriers to cross-border secondary use of health data and create trust amongst citizens, according to a Finnish health data stakeholder.

These barriers have been carefully analysed by the Joint Action Towards the European Health Data Space (TEHDAS), coordinator Markus Kalliola, project director for the Health Data 2030 project at the Finnish Innovation Fund Sitra, told EURACTIV in an interview.

Carried out by 25 countries, TEHDAS 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 (3 May) after several postponements by European Commission Vice-President Margaritis Schinas and Commissioner for health Stella Kyriakides.

With Schinas referring to it as a “real revolution in European medical history” and Kyriakides calling it “the backbone of the European Health Union”, expectations for what impact the EHDS will have 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 laboratory results. The other part relates to the secondary use of personal health data, such as in research.

Secondary use, in particular, could have a huge impact on improving future medical care in the whole EU but conducting research with data from different European countries is currently complex and very limited.

TEHDAS has analysed research papers and interviewed experts, identifying 11 barriers to cross-border secondary use of health data.

“For me, it was surprising that six of those were legal issues. That means the biggest hurdle for the secondary use of health data is that we have such diverse legal settings in different countries and interpret the EU law very differently,” Kalliola said.

“When we talk about health data, people often think that we’re trying to solve technical problems. That as long as we have good architecture and good solutions, it will work. When we went through the scientific papers and expert interviews, we found out that technology was not the main problem — it is these legal issues instead. I think people get that wrong quite often,” he added.

In fact, only one barrier is infrastructure. Other non-legal barriers include a lack of interoperability between data, bad access to suitable data, and different codes used to label the same health conditions, which challenge comparisons between data.

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Basic definitions need to be agreed on

The legal barriers include member states’ differing implementations of the GDPR, varying interpretations of sufficient anonymisation, and individual rules on health data for research outside the GDPR.

One legal issue that Kalliola highlights is the lack of a common interpretation of “secondary use”.

“[We need to determine] what the secondary use of health data is, so which 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 is it just for the public sector?” Kalliola added.

The TEHDAS report on these barriers states that “the lack of clarity and inconsistent uses of these terms can create significant challenges when obtaining consent, where it can be difficult to interpret what individuals have consented to.”

Their suggestions for solutions include the Commission creating a clear legal definition, a joint definition between the Commission and member states or that each member state clarifies what secondary use of health data is.

Currently, page two of the EHDS proposal offers a broad definition of secondary use as “health research, innovation, policy-making, regulatory purposes and personalised medicine purpose.”

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In need of new governance models and high levels of trust

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 empowerment and a common good.”

While the project is still ongoing and these “options” are yet to be published, Kalliola said that “the main outcome at the moment is that none of the current mechanisms is working well enough for a health data space and secondary use of health data.”

He referred to current mechanisms for governing health data on a European level, such as the European Medicines Agency (EMA), the European Centre for Disease Prevention and Control (ECDC), the eHealth network and Eurostat.

They have also been looking into partnerships for health data sharing between countries. In one case, a memorandum of understanding was created within the joint action between the Finnish Findata institution and the French Health Data Hub.

“We also looked into how collaboration could take place between countries that don’t have as centralised institutions as Finland and France. So how it might work between, for example, the Netherlands and Spain,” he said.

No matter how we end up handling health data for secondary use, the citizens’ trust is an essential part. Kalliola suggests a set of ethical principles for digital health published by the French presidency earlier this year as a good example.

“One element could be to enforce some institutions to take responsibility for accessing the health data and encourage trust. We need to trust that the researchers, who get access to the data, manage it in a safe and controlled environment and to avoid security problems.”

“One of the outcomes [from a TEHDAS study last year] was that the more people know about the secondary use of health data, the more they are in favour of it. The less they know, the more they fear and the more they are opposed,” Kalliola said.

“I think it’s a clear message for decision-makers and anyone who is involved in research activities, whether they are from the public or private sector — we need to be very clear in our communication and in explaining what the mechanisms are and how to make use of it in the right way. I think that’s one of the things that increases trust in the long run.”

[Edited by Gerardo Fortuna/Alice Taylor]

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