European health data space impossible without trust, says Commissioner –


As the EU executive’s proposal for a European health data space moves forward, experts and commissioners have stressed that it would not be achievable without a significant degree of trust from citizens.

“Health data is the blood that runs through the veins of our health systems,” said Fulvia Raffaelli, Head of Digital Health Unit at the European Commission’s DG SANTE during a discussion at the European conference. on public health in Berlin on Thursday 10 November..

The European Health Data Area (EHDS), presented by the Commission last May, aims to regulate the transmission and sharing of health data in the EU, both for individuals and for researchers or political decision-makers.

The proposal is expected to save more than €10 billion over a decade, the Commission’s Raffaelli said. Over 10 years, the expanded use of primary health data – that of individuals – is expected to reduce the number of unnecessary tests and result in financial benefits of at least €5.5 billion while improving the efficiency of secondary use of health data – those for use by researchers and policy makers – is expected to bring benefits of at least €5.4 billion.

The Commissioner hopes that the EHDS, one of the central elements of the European Health Union, will be finalized by June 2024.

The aim is for the EHDS to be operational in 2025, although Iveta Nagyova, president of the European Public Health Association (EUPHA) described it as “quite ambitious”.

Making data fair, findable, accessible, interoperable and reusable across the EU is not an easy task, as Europe’s health information systems are diverse and countries are at different stages of digitization , not to mention the gaps in digital literacy.

But it’s not just about technology, it’s about trust.

“EHDS will also need to be transparent to ensure the privacy of personal information included in EHDS,” Nagyova said.

“And is there enough trust among citizens, especially after the COVID-19 pandemic, where we are experiencing a loss of trust in authorities? she asked.

Doctors concerned about medical ethics in the European health data area

European doctors have raised concerns about medical ethics, the burden on doctors and the national competence of Member States in the European Commission’s proposal for the European Health Data Area (EHDS), currently underway for discussion in the European Council and Parliament.

Jrust is the key

Based on a survey by the European Patients Forum (EPF) in 2020, more than 50% of respondents were happy to share their data for research and public health purposes even without consent, or with very broad consent. About 35% wanted stricter consent provisions.

But this is only possible if citizens trust EHDS, said Kaisa Immonen, political director at the ETH.

The patient community’s main concern is that data could fall “into the wrong hands,” such as insurers, employers or non-medical companies, Immonen said. If the data is misused, there should be “appropriate sanctions” which “could be reinforced in the proposal”, she added.

The EPF survey found that safeguards around confidentiality and anonymity, ensuring effective ethical oversight of the system, and knowing who is doing the research and for what purpose affect people’s willingness to share data.

“The fact is, people want to know who is using the data,” said Immonen. Therefore, she would like to see the proposal “more robust in terms of systems to inform people to the extent that they want to know”.

When announcing the proposal, the Commission said that citizens will have full control over their data and will be able to add information, rectify incorrect data, restrict access to others and obtain information on how their data is used and for what purpose.

“Individuals will be able to decide who to transfer the data to, delete or hide some of the data they don’t feel comfortable with and of course access the data immediately and free of charge,” Raffaelli said.

But it is different when it comes to secondary use of the data, which only gives access to anonymised data, in which case the Commission does not plan to sspecific consent.

“We actually anticipate that all requests made by data users will be published with the search results. Thus, the collective cumulative results of the use will be published”, Raphael said.

She added that “only in very specific cases where data users need access to anonymized data, this will only happen in a very secure environment.”

Standardization to avoid administrative burden

“If we ask for consent […] we urgently need a more standardized consent form and procedure,” Irene SchlunderEuropean expert in data protection and database governance, told EURACTIV.

“It’s not just a bureaucratic burden for researchers or anyone who collects consent, it’s also a burden for patients,” she added.

The definitions of the proposed health data space are, moreover, “a little too broad for the taste of a lawyer”. Schlünder, referring to the definitions of “data holder” and “health data”. The definition of “health data” in the proposal includes administrative health data, such as phone numbers or data from wellness apps.

“Who is really obliged to provide data and what data? she asked. “Perhaps it is even a duty of member states to sit down […] and propose concepts very quickly in order to have something that the EHDS proposal can then reference so that citizens better understand what it is about.

“My main concern is that due to the scope of the proposal, the whole thing won’t really be feasible,” she warned, adding that now was the time to fill in the gaps in the proposal.

“There are great expectations, there is great potential in the idea, in the vision: we have a share of the responsibility to make it fly”, Schlunder concluded.

[Edited by Nathalie Weatherald]


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