A landmark deal that would make it easier to exchange and access health data across the EU has been struck by the European Parliament and Council.
The bill signals the culmination of a process that extends back to 2022 when the European Commission proposed the creation of a European Health Data Space (EHDS) consisting of rules, common standards and practices, infrastructures, and a governance system for EU citizens’ electronic health data.
The objective is to accelerate the digitalisation of health data, which in turn would make it easier to deliver care for EU patients when travelling abroad and make it a more effective resource for medical research and policy development.
The new rules aim to make it possible for “a Spanish tourist to pick up a prescription in a German pharmacy, or for doctors to access the health information of a Belgian patient undergoing treatment in Italy,” according to a Council statement.
The EHDS framework has now been agreed upon in principle by MEPs and EU ministers, after talks collapsed earlier this month, largely over patients’ rights to opt out of provisions that would make so-called ‘secondary use’ data available to non-health, third-party organisations, according to a euronews.health report.
That secondary use could give researchers including the biopharma industry access to data from a broad range of sources – such as health registries and clinical trials, genetic and genomic data, health-related administrative data, and digital health apps – that could be a powerful tool for research.
It’s not yet clear exactly what concessions have been made to allow a deal to be reached, but the newswire suggests that there is now an agreement that enshrines citizens’ opt-out rights but also allows member states to bypass that under certain conditions, for example a public health crisis such as a pandemic.
The centre-left Socialists and Democrats (S&D) group of MEPs said that a compromise has been reached that will make cross-border healthcare easier for patients and doctors, while at the same time promoting research and innovation in health policy and “safeguarding individual privacy by guaranteeing the patient’s right to opt-out of sharing their sensitive health data for research purposes.”
“The Parliament had to make many concessions, as the member states were intransigent about any changes to their healthcare systems,” said Bulgarian MEP Petar Vitanov, S&D negotiator for the European Parliament’s civil liberties, justice and home affairs committee.
“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,” he added.
There are still some hurdles in front of the plan, including formal approval at Parliament and Council plenaries, and there is not a lot of time for to get those in place before the next European elections in June.
Stella Kyriakides, Commissioner for Health and Food Safety, said the EHDS is a “game changing moment for health in Europe and for the care our citizens receive.”
She added: “It will unleash the potential of health data for the development of innovative and lifesaving treatments and devices, as well as for better health policy-making, all with strong data protection and security safeguards.”
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