European patient data gold fever is on the rise

According to the European Health Data Space Regulation, adopted last year, all EU member states must designate or establish a data controller for patient data by the end of 2025. This will be the European Health Data Space (EHDS) – memorize the term – basically an health ecosystem in which doctors will be able to exchange and access data at the EU level.

Patient data has been a typically marginal issue in the Brussels consensus for quite some time, until the Covid-19 pandemic broke out, thus transforming it into a perceived European issue. “Before the last European Commission, before the COVID crisis and before Europe beats cancer initiative, health was a marginal topic in EU legislative issues,” recalled the European Parliament rapporteur for the European Health Data Platform, Croatian EPP MEP Tomislav Sokol, in his speech on the subject.

Data of hundreds of millions, a multi-billion dollar business

With increased public interest, companies attracted by the nascent sector have also started showing up and being active. For example, at the end of 2024, a series of European Health Data Space workshops and talks were held in Brussels by digital majors ready to store, access, control, and securely share digital patient data in the cloud.

Microsoft in particular, is pushing Brussels, but Amazon and Google are also openly lobbying for the cloud services to be used to store the health data of 450 million European citizens.

Driven by the prospect of tens of billions of euros in business, also BC Platforms, the world’s largest real-time healthcare data management and analytics software services company, announced its new EHDS-compliant research environment in early November 2024. Their new system promises to automate hospitals’ internal research needs and secure data exchange, thus increasing the levels of research productivity thanks to the innovative system they offer. 

EIT Health calculates that approximately 30 percent of the data currently generated worldwide is related to healthcare and the industries that serve it. This includes not only medical records, prescriptions, digitized diagnoses, and online medical records, but also health-related data produced by smartwatches and medical devices, not to mention genomics and diagnostic imaging.

It is estimated that the market for digital health data will exceed €97 billion by 2030. According to the European Commission’s own estimates – published when the draft regulation was presented in 2022 – EHDS is expected to save the EU around €11 billion over ten years: €5.5 billion through better access and exchange of health data and a further €5.4 billion through better use of health data for research, innovation and policy making. To find out more about the main elements of EHDS, see last year’s EUrologus article.

One year to implementation

As in the field of digital privacy, Europe has adopted a patient rights-centred regulation, with the final implementation provision agreed by health ministers in Brussels in January this year.

However, a critical aspect of the regulation, which entered into force in mid-February, is the existing degree of digitization of patient data for health and research purposes in member states. In other words, we shall discuss which member states are prepared to comply with the passages of the new EU regulation from the beginning of 2026.

Further digitization cannot take place without national-level developments that are needed to make a real-time interoperable EU-wide digital health infrastructure a reality. Basically, Member States will have to dip into their own budget pockets, in addition to the €12 billion from the current EU multiannual budget (and the RRF funds) allocated under the Recovery and Flexibility Instrument. In addition, the European Regional Development Fund and Invest EU funds will also be used to meet the targets. The EC will also provide €810 million from the Community budget to support EHDS, and €280 million more can be used to prepare national health systems under the EU4Health program.

The key issue of Member States’ preparedness is also explored in the Oxford European Journal of Public Health’s analysis of the issue at the end of 2024, entitled “Are EU Member States ready for the European Health Data Space?“

Hungary is not at the bottom of the league

In a positive surprise for EUrologus, the analysis concludes that we are facing a common EU policy in which Hungary is not one of the 12 Member States at the bottom of the list.

First and foremost, Hungary has digital records and stores patient data and findings digitally, unlike a quarter of the countries surveyed where paper-based patient records still dominate (Germany, Ireland, Czech Republic).

In 58% of the countries analysed, including ours, electronic health records (EHRs) are organised in a decentralized way, with health-related data stored in different locations, registries, health care providers and stakeholder organisations. In the Hungarian health sector, patient data generated by general practitioners, public health care and hospitals are digitised – this is not the case in the private health sector alone. Another positive aspect of the digitisation of the domestic care system, according to Oxford researchers, is the use of individual digital identifiers for patients. However, as in half of the Member States, the Hungarian system lacks any opt-out option for patients from the secondary use of their patient data – such as anonymised data for research purposes, to name but the most typical occurrence.

EIT Health expert Zsolt Bubori wrote that the progress made so far in the field of digitalisation in Hungary gives reason for optimism. The EgészségAblak (formerly known as EESZT) app has already been downloaded by more than 3 million people, opened 2.5 million times a month and 9 million findings have been downloaded. The system combines a range of functions from referral management to e-prescribing and is one of the leading solutions for the general public in Europe. According to the Hungarian Medical Chamber’s 2024 survey, 90 percent of Hungarians regularly look for health information online. However, the Chamber’s survey also shows that only 30% of the respondents are explicitly receptive to AI-based health solutions.

The main findings of the survey show that, although the situation in the countries surveyed seems heterogeneous, Member States face similar challenges. According to the researchers, none of the Member States is yet fully ready to comply with future legislation, and it is clear that national policy and regulatory efforts are very far reaching.

In addition, despite the general political will that exists, respondents complained to the researchers that the timetable for the implementation of the EHDS is too ambitious and that more human and financial resources are needed to fully implement the regulation.

Finally, another study, carried out in cooperation with several European universities, cites a lack of public trust as another key challenge, stemming from inadequate data security, questioning of the patient-centeredness of healthcare and a general distrust of institutions. Balancing fears about data protection with the benefits of sharing data for the public good is therefore likely to remain a thorny issue for patients, researchers and doctors alike in the near future.

Original source: https://hvg.hu/360/20250328_Felfutoban-az-europai-paciens-adat-digitalizacio-aranylaz