As EU pushes for digitised medical records, Germany's e-patient files fall behind

As part of the European Health Union, the Commission has been pushing for more cross-border exchange of medical data through the European Health Data Space – but Germany’s e-patient file launch faces ongoing delays. 

Germany’s slow-moving effort to digitise its medical records appears headed for another setback, with the nationwide roll-out of the electronic patient file (ePA) postponed until early April at the earliest, after missing the original February launch date. That puts the EU’s most populous country behind in implementing EU Health Data regulations.

While that’s partly indicative of Germany’s year-long struggle to embrace the internet and move away from stacks of paper files, it also points to broader challenges facing Europe’s ambitious effort to make medical data available across borders in the entire bloc.

That goal requires overcoming technical limitations, proprietary concerns among healthcare providers and varying standards of privacy in countries like Germany, Estonia or Spain.

If you need to see a doctor or go to hospital in an EU country other than your country of residence, you may have to deal with significant differences in the healthcare system – and provide a full medical history to a new doctor.

To prevent this, the European Parliament and the Council issued the Directive on the Application of Patients’ Rights in Cross-Border Healthcare, which also provides for the coordination of medical histories.

While the directive promotes the exchange of medical information, and systems such as electronic health records or the European Health Insurance Card (EHIC) help facilitate it, the actual transfer of medical data within the EU has so far not been uniformly regulated or standardised.

That underlines the importance of frameworks such as the European Health Data Space (EHDS), which aims to address these challenges and enable more seamless data exchange across the EU.

Germany launched the test phase of the country’s national electronic patient file (ePA), a key component of the EHDS framework, on 15 January.

However, the introduction of the ePA is proving to be a major challenge, in particular due to bureaucratic hurdles, data protection concerns and a lack of interoperability between various computerised medical record systems.

In addition to other medical records, ePA is supposed to include a digital medication list that is linked to the electronic prescription, designed to prevent adverse drug interactions.

A bumpy start

On the EU level, the European Health Data Space (EHDS) came into force on 26 March. But in Germany, parts of the ePA remain subject to ongoing debate, and the roll-out of portions of the law have been postponed until later this year – with some functions of the ePA system delayed until at least next year.

“Despite all the efforts and with the full commitment of everyone involved, we currently need to plan for more time and resources for the introduction and stabilisation of the electronic health record this year,” the German health ministry said in a letter explaining the delay, which was published by the Deutschen Ärzteblatt, a trade publication for German physicians.

The letter also states that cybersecurity upgrades, coordinated with Germany’s Federal Office for Information Security (BSI), are needed before the system can be rolled out nationwide.

Before the ePA test phase had even started in January, personal data of patients was stolen in a hacker attack.

The data breach raised security concerns about electronic patient files. IT security expert Bianca Kastl told the Süddeutsche newspaper that the incident shows “several aspects of a lack of security culture” in the digital healthcare ecosystem.

The German Medical Association (IG Med) responded by calling for an immediate stop to the ePA-roll-out, according to the ÄrzteZeitung, another medical industry publication.

New government faces critics

Despite the delay and need for improvements, there should be a release in July 2025 of the TI Messenger (TIM), a secure messaging system that is supposed to allow doctors and patients to communicate confidentially. According to the ministry letter, that should help stabilise the ePA.

Germany is currently in the process of forming a new coalition government following February’s election. A preliminary working group on health between the Christian Democrats and the Social Democrats agreed to “gradually roll out the electronic patient file” over the course of 2025, “moving from a nationwide test phase to mandatory use with sanctions”.

But at the end of March, the representative assembly of the Association of Statutory Health Insurance Physicians in Bavaria (KVB) appealed to the government to further postpone the official nationwide roll-out date beyond April in order to “avoid a false start and the resulting frustration”.

Bavarian Health Minister Judith Gerlach, speaking at a panel discussion on reliable healthcare in uncertain times at the Bavarian Representation in Brussels in March, said that the ePA is a good first step – but still a long way off from the vision of the EHDS.

Germany’s southern state of Bavaria was one of the areas selected to test the ePA electronic records system, with around 300 medical practices, dental offices, pharmacies and hospitals across the state using the system on a trial basis.

KVB said it’s not yet possible to carry out nationwide load tests during ongoing patient operations, something that would involve far more than the current 300 practices. The group said that improvements on frequently inadequate hardware and software architecture, such as the ePA’s problem-ridden practice management system, are needed before moving toward nationwide testing and final introduction of the ePA.

Hanno Kautz, the spokesperson for the German health ministry, told Euractiv on Wednesday that the ePA will be introduced across-the-board in the healthcare system this year, with a step-by-step expansion of additional functions of the ePA in the coming years.

Kautz also said the ministry is creating the technical and organisational rules needed to allow cross-border sharing of “relevant information” from the German digital medical records with previders across Europe, as called for by the EU’s EHDS framework.

Cornerstone of the European Health Union

The aim is to facilitate the exchange of health data between EU countries for research and secondary use. As part of the European strategy to establish an interoperable health data infrastructure, the EHDS framework maintains regulatory oversight.

Member states have two years to implement the initial parts of EHDS, after which the Commission will issue further detailed rules for putting the system into practice. By March 2029, the first set of health data categories are supposed to be exchanged across the EU, with further data categories – and international participation – set to be added between 2031 and 2034.

The European Commission did not respond to Euractiv’s request for comment.

According to Kautz, the health ministry spokesman, the ePA is designed to meet the EHDS requirements.

Gerlach, meanwhile, said Germany has some catching up to do – but instead of worrying, the country should learn from its European neighbours, who “have been much further ahead for years”.

While other EU countries are significantly further ahead in sharing health data with each other, Germany’s health ministry is currently involved in the process of “secur(ing) access to cross-border exchange of information”, and is “examining the necessary adjustments and harmonisation, also with regard to the ePA”, Kautz said.

Europe’s digital health data role models 

Meanwhile, in the rest of the EU, Estonia is considered a success story when it comes to sharing health data. The biggest difference compared to Germany is that the Estonians have proved more willing and trusting in sharing their health data – as have the Danes, according to the OECD Digital Government Index 2023.

Alongside Estonia, Finland – an important partner for Tallinn – as well as Spain are also participating in the eHealth Digital Service Infrastructure (eHDSI).

The eHSDI provides two cross-border electronic health services. First, EU citizens can use electronic prescriptions at pharmacies in other EU countries; and second, it provides a summary of health data which allows doctors to easily look at the medical history of new patients.

Last week, Finland’s government drafted a proposal to parliament to ensure the rights set out in the EHDS regulation are implemented at national level and secure access to electronic health records for healthcare professionals.

Gerlach, the Bavarian health minister, thinks that successes elsewhere in the EU can help set the standard for Germany.

“If we say we have a ‘European health data space’, then of course we also have to look nationally to see that we even get to the level of the others in order to achieve data compatibility,” the Bavarian health minister pointed out.

“In my view, we still have a bit more work to do in this regard,” she concluded.

(bts)