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The European Health Data Space will standardise electronic health records across the EU and could benefit Ireland greatly – if the country prepares for its arrival.
A long-discussed initiative to improve access to health data – the European Health Data Space – was recently approved by the EU Parliament.
This initiative has multiple goals, as it aims to improve the access citizens have to their own health data, while allowing large amounts of anonymous health data to be accessible across the EU. The initiative was approved last week in a vote, with 445 MEPs in favour and 142 against, along with 39 abstentions.
This concept came about in 2020 when the European Commission set out a strategy for data – as part of Europe’s Digital Decade. The European Health Data Space is now awaiting approval from the EU Council and will then be applied roughly two years later.
But what will this new data space mean for the EU and what benefits will it bring to Ireland?
What is the European Health Data Space?
In simple terms, this initiative aims to open up health data across the EU to benefit citizens and healthcare professionals, while ensuring privacy and data security. This will be done by creating a standardisation of electronic health record systems across Europe.
It will allow patients to access their health data in an electronic format – including data from a different member state to the one in which they live. This legislation will also let health professionals consult patient files from other EU countries, provided they have consent from the patient.
Perhaps the bigger element of this initiative is its goal to make transferring health data to professionals across the EU possible, in an anonymised or pseudonymised format. This data would include health records, clinical trials, pathogens, health claims, reimbursements, genetic data, public health registry information, wellness data and information on healthcare resources.
By removing barriers to access this data, it is hoped health research could be boosted across the EU, as this data could be used for studies, to create statistics and to inform policymakers.
This could also be a huge benefit for research on rare diseases, which can be limited due to small datasets in multiple countries, hindering the ability to find new treatments.
The EU says patients can refuse to have their health data be accessed by practitioners – except where it is necessary for protecting the vital interests of the individual or another person. Patients will also be informed any time their health data is accessed, and health data can’t be used for certain commercial purposes such as advertising or job market decisions.
“The Health Data Space can help us to leverage the data we have in a safe and secure manner, giving vital research into new treatments a major boost,” said MEP Tomislav Sokol. “It will prevent gaps in treatment by making sure health professional can access their patients’ records across borders.
“At the same time, opt-outs will ensure that patients have a say, and that the system is trustworthy. It will be a major step forward for digital healthcare in the EU.”
What will it mean for Ireland?
Experts have previously expressed support for this initiative in the Irish context, as it could boost national health research and improve the control Irish citizens have over their health data across the EU.
Last November, Elaine Murray, the public affairs lead at EIT Health Ireland and UK, said the European Health Data Space could be a “game-changer” for how healthcare is delivered and how health research is carried out in Ireland.
However, a report from this organisation suggests that Ireland currently has a “fragmented health service landscape” for digital services. It also warned that investment in digital technologies will be required for Ireland to make the most of the potential of this new data space.
Ireland has large pharma and medtech companies present that can benefit from the European initiative, but the EIT Health report said the country’s “vast” number of SMEs and start-ups would likely struggle to secure the funds to fulfil the obligation to provide access to their data.
This EIT report also included measures that can be taken in Ireland to prepare the country for the arrival of this new standardised system. For example, some of the suggested measures include accelerating the roll-out of electronic health data records across Ireland’s healthcare system, creating a national strategy for health data and leveraging EU funding.
While there is time for countries to prepare for the European Health Data Space, the EIT Health report warned Ireland still has a reliance on paper records and that its healthcare workforce will need to be upskilled.
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