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Health ministers from across the EU discussed a proposal for a European Health Data Space (EHDS) that aims to facilitate the sharing of health data across the continent on June 14 at a meeting of the Council for Employment, Social Policy, Health and Consumer Affairs in Luxembourg.

Privacy and the need to protect citizens’ data were a major topic of discussion as they are seen as central to gaining citizen consent and support for the project.

Why is it important

While health ministers generally welcomed the proposal, some voiced caution about its implementation. Thomas Steffen, State Secretary of the German Ministry of Health, where digital health is actively used relatively lowraised questions about data protection.

“There is one thing we must not do – we must not share this data with third parties or other countries whose values ​​are different from ours here in Europe,” he said.

“We need clear rules,” he added. “We all understand that we need a high level of data protection so that we can win the trust of citizens, otherwise we will not achieve this for EHDS.”

The representative of Estonia, Marten Kokk, emphasized the confidential nature of the data to be stored in the EHDS. “There are more sensitive areas, such as genetic data, where quality control and ethical issues are of particular importance,” he said. “Data security, as well as people’s digital skills, will require special attention to ensure the system is trusted.”

Frank Fagan, Ireland’s Minister of State for Health, described what can happen if data is not kept secure. Speaking of a devastating cyber attack that hit the nation’s health service in 2021, he said: “The security of health information, especially from cyber threats, is a growing public concern.” Ensuring data security should be a priority, he said. “Data leaks will significantly undermine public trust.”

The health data space takes a new approach

The EHDS proposal offers a new approach to privacy, said Mahsa Shabani, assistant professor of privacy law at Ghent University. The discussion of the primary use of data focuses on citizens’ own power over their information. But the section on data reuse moves away from consent as a criterion for granting access to data, in contrast to legislation such as the GDPR. Instead, it focuses on whether the data will be used in research conducted in the public or general interest.

“The overall message is that consent is no longer the preferred legal basis for data sharing for data reuse, which is a pretty big step towards a unified approach on how to deal with data sharing,” Shabani said.

Tuesday’s meeting was the first exchange of views between ministers on the proposal, but there were hints of upcoming talks. One minister spoke of the need for reasonable timeframes and technical assistance to enable countries to prepare for the EHDR. Maltese Minister of Health Chris Fern spoke about the benefits of EHDS for the pharmaceutical and healthcare industry when it comes to research and innovation.

“We may even have to change some parts of the GDPR to make this possible while keeping the security of our patient data at the forefront,” he said.

It has been a busy week for EU health policy as the Commission briefed ministers on the rules on medical devices and medical technology assessment and the Council and Parliament agreed to the Commission’s proposal. expand EU COVID digital certificate for another year.

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