Recently, at a meeting of the Employment, Social Policy, Health and Consumer Affairs Council in Luxembourg, health ministers from across the EU reviewed the idea of the European Health Data Space (EHDS), which intends to facilitate the sharing of health data across the continent.

The necessity to preserve citizens' data was a frequent subject throughout the conversation, as it is considered critical to garnering citizen buy-in and support for the initiative.

While most health ministers applauded the initiative, a few expressed concerns regarding its implementation. In Germany, where digital health adoption is limited, Thomas Steffen, state secretary of the Ministry of Health, highlighted concerns about data security.

“There’s one thing we mustn’t do – we mustn’t hand this data to third parties or other countries that have different values to the ones we have here in Europe,” he said.

“What we need are clear rules,” he added. "We are all aware that what we need is a high level of data protection so that we can have the confidence of the citizens, otherwise we won’t achieve that for the EHDS.”

The Estonian representative, Marten Kokk, highlighted the sensitive nature of the data that the EHDS will house. “There are more delicate areas like genetic data where quality control and ethical aspects are of particular importance,” he pointed out. “Data security, as well as people’s digital skills, will require special attention to ensure trust in the system.”

Frank Feighan, Ireland’s Minister of State for public health, described what could happen when data security was not maintained. Speaking of the devastating cyber-attack suffered by the country’s health service in 2021, he said, “The security of health information, particularly against cyber threats, is of growing concern to the public.” Ensuring the security of data must be a priority, he said. “Data breaches will significantly erode public trust.”

According to Mahsa Shabani, an assistant professor of privacy law at the University of Ghent, the EHDS proposal takes a fresh approach to privacy. The primary use of data debate focuses on citizens' control over their information. In contrast to regulations like the GDPR, the part on secondary use of data moves away from consent as a requirement for making data accessible. Instead, it focuses on whether the information will be used in public or general interest research.

“The general message is that consent is not anymore the preferred legal basis for data sharing for secondary use of data—which is quite a big step towards taking a unified approach of how to tackle data sharing,” Shabani said.

The conference on Tuesday was the first round of discussions among ministers regarding the plan, but there were clues for future negotiations. One minister stressed the importance of a realistic schedule and technical assistance to help countries prepare for the EHDR. Chris Fearne, the Maltese Minister for Health, remarked on the EHDS' benefits for the pharmaceutical and healthcare businesses in terms of research and innovation.

“We might even need to tweak some clauses of the GDPR to make this possible while keeping the safety of our patients’ data as paramount,” he said.

The Commission informed ministers on the legislation on medical devices and health technology assessment, while the Council and Parliament agreed to prolong the EU's digital COVID certificate for another year, making it a busy week for EU health policy.

Source: Healthcare IT News

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