European lawmakers agreed on a pioneering bill easing exchange and access to personal health data across the EU – with some privacy safeguards on data sharing to non-medical third parties.
ADVERTISEMENTThe political deal, struck this morning (15 March) at the eleventh-hour of the Belgian EU presidency, followed a dramatic collapse in talks last week.
The rules – now provisionally agreed upon by MEPs and EU ministers – are meant to govern the transmission and sharing of sensitive health data across the bloc for private individuals, researchers, and policymakers.
“After months of hard work and dedication, we have a deal that will strongly support patient care and scientific research in the EU,” said Belgium’s health minister Frank Vandenbroucke, who committed to do his utmost to secure a deal in an interview with Euronews early this year.
The breakthrough happened as parliament’s negotiators partially gave in on their stance on re-using health data for ‘secondary use’, according to sources attending the behind-closed-doors meeting,
Such secondary use sees data registered for use by health services used by third parties for other purposes.
Both the EU Council and the parliament agreed to grant patients the right to withdraw their consent for their electronic data to be processed by third parties at any point, a clause not foreseen in the commission's original legislative proposal presented by the commission in 2022.
However, member states will be allowed to set up a system to bypass the opt-out under certain conditions, as demanded by the EU council but opposed by the parliament.
Despite losing on this point, the agreement overall “empowers patients with true control and choice over their electronic health data, all underpinned by robust guarantees of trust and security,” claimed MEP Sara Cerdas (Portugal/S&D).
The EU executive welcomed the deal, with health commissioner Stella Kyriakides saying that unleashing the potential of health data “is a game-changing moment for health in Europe and for the care our citizens receive.”
MEPs had to give in
Two parliamentary sources told Euronews that the legislature had succumbed to the council’s will on other issues to get the deal over the line.
“I am glad that reason prevailed," said MEP Tomislav Sokol (Croatia/EPP), the parliament’s chief negotiator.
As next steps, both the EU ministers and MEPs have to formally confirm the provisional deal. While no issues are expected to be raised in the EU council, the parliament’s approval at the plenary might be trickier as MEPs have partially drifted apart from their mandate.
“These were difficult negotiations. The parliament had to make many concessions, as the member states were intransigent about any changes to their healthcare systems,” said parliament negotiator Petar Vitanov (Bulgaria/S&D)
Parliament managed to secure personal control over health data, he claimed, while ensuring the possibility for data to be made available for third parties, under strict conditions, for purposes of important public interest.
“While not all aspects are to our complete satisfaction, we believe this agreement is a positive step forward,” another parliament negotiator told Euronews.
“Patients and citizens are waiting for European Health Data Space, but not at any cost,” said Luxembourgish lawmaker Tilly Metz, the shadow rapporteur on the file for the Greens adding that it is crucial to ensure the right balance is struck between optimal health care and research and the right to control sensitive personal data.
MEPs must assess the deal in detail in that context, she said, adding: "Calling it a breakthrough might be premature but my hopes for EHDS remain high."
