The European Health Data Space: the foundation for European digitalised healthcare focused on the patients’ needs

The European Commission’s proposal on the European Health Data Space (EHDS), published on 3 May 2022, supports individuals to take control of their health records and promotes the use of health data for improved healthcare delivery, better research and innovation, as well as optimised policymaking. Furthermore, the draft regulation marks the first steps towards the much-needed development of Europe-wide harmonised and patient-centred care – beyond physical and linguistic boundaries.

The four fundamental freedoms of the European Union – the movement of goods, persons, services and capital – are the basis of our daily lives. However, what has become self-evident for young and healthy Europeans is still a long way off for parts of the elderly population, the chronically ill and all those who need regular medical care. When it comes to health treatment, national boundaries continue to exist.

Additionally, the availability of medicines varies greatly between member states. On a continent that is growing ever closer together, it is difficult for patients to understand that supply of medical advice and pharmaceuticals can be significantly better in one country than in another.

The EHDS offers hope. EU Commissioner for Health Stella Kyriakides rightly called the proposed Common Health Data Space a “truly historic step forward”, which Heléne Fritzon, Member of the European Parliament and Vice-President of the S&D Group responsible for health, noted as progress towards a European Health Union. Fritzon also placed emphasis on patient needs: “We have seen how important eHealth has become in the efforts to increase the access to healthcare […] Now we need to use the full potential of these tools to ensure better and affordable healthcare for all.”

Indeed, the proposal has the potential to vastly accelerate digitalisation for the benefit of research, innovation, policymaking and, above all, effective and accessible healthcare for patients across the EU. The Commission has finally taken a much-needed step to provide a borderless European society with borderless European patient care. With advancing digitisation and standardisation of health data, the true ‘European patient journey’ can finally move forward. Not only will patients greatly benefit, but it will also save a lot of resources. According to estimates of the Commission, the EHDS is expected to save around €11bn over the next 10 years.

What is already technically possible? A chronically ill Erasmus student can contact a doctor in their home country via video consultation and subsequently receive an e-prescription that can be redeemed in all member states. If the medicine is not available at their current place of residence, it can also be delivered by means of a mail-order pharmacy from abroad. Through the EHDS, the same can be possible for many other groups of EU expats, such as: pensioners who want to spend their retirement in another EU country, but do not want to sacrifice the medical care they are accustomed to; seasonal workers that are temporarily working abroad; and EU citizens who periodically work or want to start a business in another member state.

If these considerations are developed just a little further, it could even be possible to enable patients from underserved and often rural areas of the EU to consult medical expertise in areas that have better access to healthcare or to order unavailable medicines from other EU countries.

The regulatory framework must follow existing technology. While major challenges must be addressed in order to create a true European patient journey, the EHDS already contains key aspects that allow for the further development of cross-border healthcare. It will be crucial that these important improvements are not watered down over the course of the ensuing legislative process.

For instance, the proposal foresees a mandatory deployment of cross-border infrastructure for the exchange of health data and sets out mandatory requirements for interoperability, security and access to data in electronic health records by 2025. Despite some voluntary movements towards cross-border exchange of e-prescriptions, among other things, cooperation on health data remains low and efforts to digitalise healthcare continue to be insufficient in many member states. The mandatory nature of the regulation is thus necessary to trigger action and to kick-start cross-border healthcare for the benefit of all European citizens.

In practical terms, this means that until 2025, member states must at least ensure that local doctors can retrieve all necessary medical information from existing electronic health records beyond national borders. If the non-national patient is already in possession of a corresponding (e-)prescription issued in their home country, the regulation explicitly foresees that any on-site or online pharmacy, either in the visiting country or alternatively another member state, will be able to dispense the medication.

Although this scenario is already an improvement to the status quo, it would only mark the beginning of harmonised medical care and pharmaceutical dispensation. Currently, national regulations still restrict more efficient and effective healthcare to the detriment of the EU’s patients. For example, concerning the online sale of prescription medicine and cross-border delivery, a patient in Spain would be forced to seek a local brick-and-mortar pharmacy as national and cross-border mail-delivery of prescription medicine is prohibited.

The Commission’s proposal on the EHDS sets important foundations for the infrastructure of a harmonised healthcare in Europe. Nevertheless, it will not fundamentally change the conditions for cross-border medical care or pharmaceutical supply for EU citizens, since diverging national legislation continues to apply and sets different standards. Even after the implementation of the EHDS in 2025, national boundaries will inevitably continue to exist when it comes to health treatment.

However, the EHDS offers the opportunity to set and build on initial ideas that can be implemented through smart regulatory steps, such as: cross-border health treatments via video consultation, if needed, followed by the issuing of an e-prescription that can then be used either offline or online all over the EU; EU-wide acceptance of cross-border mail deliveries of prescribed medicines to allow every patient to be treated with the medication he is accustomed to; and the combination of which could serve the patients of undersupplied regions.