EU reaches agreement shared health data space to boost research

19 Mar 2024 | News

The new law is intended to allow EU citizens to access their health records when in any member state, and to choose whether or not to allow anonymized data to be shared for secondary use in research and public health

Frank Vandenbroucke, Belgian deputy prime minister and minister of Social Affairs and Public Health. Photo credit: Alain Rolland / European Union

The European Parliament and the Council of the EU have reached a deal on the European Health Data Space (EHDS), a piece of legislation that aims to improve individual access and control over their health data in Europe and to facilitate cross-border research and innovation in health.

Until last week, political groups in the Parliament and the member states were struggling to reach agreement  over giving people the right to opt out of the secondary use of their data, an option that was not included in the Commission’s original proposal.

According to the provisional agreement just reached, it will be up to member states to decide on whether or not there should be an opt out, except in cases of public interest such as public health research, policy-making and statistical analyses.

“The new law agreed on today will allow patients to access their health data wherever they are in the EU, while also providing scientific research for important reasons of public interest with a wealth of secure data that will greatly benefit the development of health policies,” said Frank Vandenbroucke, Belgian deputy prime minister and minister of Social Affairs and Public Health.

The EPP, S&D, and Renew groups were satisfied with the agreement, having pushed for inclusion  of the opt-out mechanism.

“I am proud that we stood our ground and secured people’s control over their health data, while ensuring also the possibility for data to be made available, under strict conditions, for purposes of important public interest,” said Petar Vitanov, S&D negotiator for the European Parliament’s civil liberties, justice, and home affairs committee.

“Today’s agreement on the European Health Data Space marks a new era for the healthcare sector,” said MEP Lucia Duris Nicholsonova, Renew shadow rapporteur in for the Committee on Civil Liberties, Justice and Home Affairs. “On the one hand, it will enable the improvement of patient healthcare in both domestic and cross-border cases, on the other hand, it will contribute to medical progress in research, innovation or better policy making.”

However, hospitals and stakeholder groups told Science|Business and before the deal of their concerns over the opt-out concession because of the substantial risk of data bias.

While the EHDS is set to allow significantly easier mobility of patients around Europe because of the access by hospitals and doctors to their health records, a lack of harmonisations among EU states could thwart this.

To address this issue, the proposed regulation mandates that all electronic health record systems adhere to the specifications of the European electronic health record exchange format, guaranteeing interoperability across the EU.

The next step for EHDS to become law is for the Council and the Parliament to endorse and later adopt it.

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