Romania: Digitalisation of the healthcare system in the European Union – Trojan horse or new stage of the digital revolution?

The European Union proposes to its Member States the European Health Data Space project, aiming at digitalising and unifying the health systems across the countries

To assert that “the future is digital” is a tautology that this article seeks to avoid – and yet, paradoxically, uses as the first sentence in the (hopefully) logical chain of words that follows. However, relying on the idea that the above sentence presents, we can complete it, thus introducing the reader to the issue of the present article, by stating that “the future of medicine is digital”.

In a post-pandemic temporal context and in an industrial context of growing digitalisation in all areas of daily life, the European Union is proposing a new and ambitious project to the citizens of its Member States: the European Health Data Space („EHDS”).

The EHDS is one of the most ambitious projects ever undertaken by the European Union, which could transform the European healthcare system, as we know it today.

Member States’ health systems already generate, process and store a large amount of data. However, it often remains difficult for patients to access their health data electronically, for doctors to bypass administrative obstacles that make such data difficult to use, and for researchers to exploit such data to improve the available treatments.

On a national level, although two thirds of Member States have implemented both the online patient record and the electronic prescription, only a few of them provide for these documents to be sent or received cross-border. Moreover, 11 Member States still use paper forms for issuing prescriptions to patients. The COVID-19 pandemic has highlighted the need for a harmonisation at EU level of the (currently heterogeneous) attempt to digitalise the healthcare system.

For this very reason, the creation of a common interoperable environment for the processing and use of health data within the European Union represented for many the natural step towards European integration and the starting point of a single market for digital health products and services.

EHDS is part of the European Strategy for Data, presented in February 2020 by the European Commission. It aims to harness the full potential of the data-driven economy and innovation by building a single European market for data, divided into spaces, according to their domain. These common data spaces will ensure wider availability, improved quality and accuracy, and the possibility to re-use data held by both the public and the private sector. The European Health Data Space (EHDS) is the first such space.

The EHDS is incorporated in a legislative proposal in the form of a Regulation of the European Parliament and of the Council published in May 2022[1]. Yet the EHDS proposal is not simply a European regulation, but a vision for the future of healthcare in the European Union. The key element it emphasises is access to health data – in real time, free of charge and unaffected by national borders.

In concrete terms, EHDS bases its action plan on two pillars: MyHealth@EU and HealthData@EU.

MyHealth@EU targets the primary use of medical data and is intended exclusively for patients. Patients will be able to access, control and distribute their health data in real time and across borders from any EU Member State.

HealthData@EU targets the secondary use of medical data collected in advance from patients through MyHealth@EU, which can be used for research, innovation, public health, policy development, regulatory activities and personalised medicine.

A concrete example of the applicability of EHDS in support of patients can be found in the Q&A section of the European Commission website[2]:

A woman living in Portugal is going on holidays to France. Unfortunately, she gets sick in France and therefore needs to see a local general practitioner. Thanks to the EHDS and MyHealth@EU, a doctor in France will see on his/her computer the medical history of this patient in French. The doctor can prescribe the necessary medicine based on the medical history of the patient, avoiding for instance products to which the patient is allergic.”

Similarly, such an example is also given with regard to the applicability of EHDS for innovation and research purposes:

A health tech company is developing a new AI-based medical decision support tool that assists doctors to make diagnostic and treatment decisions following a review of the patient’s laboratory images. The AI compares the patient’s images with those of many other previous patients. Through the EHDS, the company is able to have efficient and secure access to a large number of medical images to train the AI algorithm and optimise its accuracy and effectiveness before seeking market approval.

However, until the actual implementation of the EHDS in all EU Member States (the EU aims for the EHDS to become operational in early 2025), the examples remain, although desirable, strictly theoretical.

Since the proposal was published, the European public has been quick to offer its views and suggestions on this new European initiative.

While the advantages are clearly emphasised by the initiators of the project, the challenges have either been confidently addressed or camouflaged among the statements of the proposal.

Among the most frequently cited obstacles to the successful implementation of the EHDS is the lack of digital harmonisation between Member States. An immediate priority for the Commission is to tackle this uneven level of digitalisation in Member States. According to a recent study conducted by Surfshark[3], a Dutch VPN service company, Europe’s Nordic countries are leading the way in terms of digitalisation, while Eastern Europe is slowly but surely falling behind. This premise of uneven digitalisation within the European Union could, in the absence of rigorous intervention at EU level, lead to the unfortunate conclusion of uneven implementation of the EHDS – an outcome which would intensify the differences between Member States and could ultimately destabilise them in the long term.

Furthermore, the issue of the security of the processing of medical data has also been consistently raised from the perspective of the General Data Protection Regulation (“GDPR”), as it falls under the special categories of personal data covered by Article 9 of the GDPR. It is precisely for this reason that EHDS aims to implement an additional set of rights for individuals whose health data are processed, to ensure that the exchange, use and re-use of health data is carried out in accordance with GDPR standards and, in parallel, to provide individuals whose data are processed with the trust that they are processed securely and lawfully.

According to a Thales Group study (Thales Consumer Digital Trust Index 2022[4]), based on a survey of more than 21,000 people worldwide, healthcare providers had one of the highest levels of consumer trust regarding the protection of sensitive information (37%, ranking second after the financial sector – 42%). According to the same survey, geographically, people in Germany were the least confident about the protection of personal data and digital services, expressing concern mainly about the possibility of a security breach.

Beyond the plans, dreams and risks, the reality is that the European Health Data Space will require the entire Union to simultaneously make a great step forward. A step in which we will necessarily have to take an active part, regardless of the speed (“I am a slow walker, but I never walk back.” – Abraham Lincoln).

The lawyers from bnt attorneys in CEE have the necessary skills and provide support to their clients in all matters related to both Life Sciences & Pharma, as well as IP, Technology and Data.





Subscribe to our newsletter

By pressing Subscribe you consent to our data processing terms