As the EU executive’s proposal for a European health data area moves forward, experts and commissioners have stressed that it will not be achievable without a significant level of public trust.
“Health data is the blood that runs through the veins of our health systems”said Fulvia Raffaelli, Head of the Digital Health Unit at the European Commission’s DG SANTE, during a debate at the European conference on public health in BerlinThursday (November 10).
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 policymakers.
The proposal is expected to save more than €10 billion over a decade, said the Commission’s Raffaelli. In ten years, expanding the use of primary health data – those of people – should reduce the number of unnecessary tests and generate economic benefits of at least 5.5 billion euros. Improved efficiency of secondary use health data – those intended for researchers and policy makers – is expected to generate benefits of at least €5.4 billion.
The Commissioner hopes that EHDS, one of the main building blocks of the European Health Union, will be finalized by June 2024.
The goal is for the system to be operational in 2025, although Iveta Nagyova, president of the European Public Health Association (EUPHA), has called this goal a “very ambitious”.
Making data fair, easy to find, accessible, interoperable and reusable across the EU is not an easy task. Health information systems in Europe are very diverse indeed and countries are at different stages of digitalisation, not to mention existing gaps in digital skills.
However, it’s not just about technology, it’s also about trust.
“The EHDS must also be transparent to ensure the confidentiality of the personal information contained in the EHDS”Ms. Nagyova said.
“And is citizens’ trust sufficient, especially after the Covid-19 pandemic, where there is a loss of trust in the authorities? » she asked.
Trust is the key
According to a survey conducted by the European Patients Forum (EFF) in 2020, more than 50% of respondents were willing to share their data for research and public health purposes, even without consent, or with little or no consent. About 35% wanted stricter consent provisions.
However, this is only possible if citizens trust EHDS, said Kaisa Immonen, director of policy at the EFF.
The primary concern of the patient community is that data may fall in the middle “bad hands”, such as insurance providers, employers or non-medical companies, Ms Immonen said. In case of data misuse, there should be “adequate sanctions” who “could be strengthened in the proposal”she added.
The PEF survey found that privacy and anonymity protect, ensuring effective ethical oversight of the system, and knowing who is doing the research and for what purpose they influence people’s willingness to share their data.
“The thing is, people want to know who’s using the data”Ms. Immonen said. That’s why she would like the proposal to be “more robust in terms of systems for informing people to the extent they want to.”
The Commission said, when announcing the proposal, that citizens will have full control over their data and will be able to add information, rectify incorrect data, limit access to other people and obtain information on how their data is being used and for what scope.
“Individuals will be able to decide who to transfer the data to, delete or mask some of the data they are not comfortable with and, of course, access the data immediately and for free”assured Raffaelli.
However, the situation is different with regard to secondary use of data, which gives access only to anonymous data, in which case the Commission does not foresee a specific consent.
“We actually anticipate that all requests made by data users will be published with the search results. Therefore, the collective cumulative results of use will be published.”Mrs. Raffaelli said.
He added that “Only in very specific cases where data users need access to anonymous data, will that be done in a very secure environment.”
“If we opt for consent […]we urgently need a more standardized consent form and procedure”Irene Schlünder, EU expert on data protection and database governance, told EURACTIV.
“It’s not just a bureaucratic burden for researchers or anyone else collecting consent, it’s also a burden for patients”she added.
The definitions in the health data space proposal are also “a bit too broad for a lawyer’s taste”said Ms Schlünder, referring to the definitions of “data owner” and of “health data”. The definition of “health data” the proposal includes administrative health data, such as phone numbers or data from wellness apps.
“Who is really obliged to provide data and which data? »He wondered. “Perhaps it is also a duty for the member states to sit around the table […] and propose concepts very quickly so that we have something that the EHDS proposal can then refer to so that citizens better understand what it is about. »
“My main concern is that due to the broad scope of the proposal, the whole package will not really be applicable”he warned, adding that now is the time to fill the gaps in the proposal.
“Expectations are high, the idea and vision have great potential: we have the responsibility to make them operational”concluded Ms. Schlünder.