Health and the provision of healthcare have always been essential elements of any functioning society, and this is no different within the European Union and its member states. Each of these countries aims to provide its citizens with high-quality healthcare. The COVID-19 pandemic has presented a significant challenge in this area. It is precisely this period that represents a turning point in the European Commission’s decision to introduce a system that will benefit not only individuals but also European society as a whole in the area of healthcare.
May 3, 2022 The European Commission issued a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the European Health Data Space. The EHDS (European Health Data Space) represents a so-called ecosystem focused on health and healthcare, in which all EU member states will participate and will be able to share patients’ health data, whether within a country among individual healthcare providers or between EU countries. Each country will adhere to the same standards and rules, ensuring the system functions effectively. Since the EHDS will process sensitive personal data (specifically data regarding individuals’ health status), it is essential that the EHDS be based on the General Data Protection Regulation (GDPR) and the NIS 2 Directive.
Reason for creating the EHDS
The creation of data spaces is part of the so-called European Data Strategy, which aims to integrate data within the EU, manage it through a unified system, and ensure its flow across countries and sectors within the EU. The Covid-19 pandemic highlighted the importance of creating such a space in the healthcare sector. Almost everyone felt this when it was impossible to visit their general practitioner, who prescribed medications exclusively electronically. At the same time, however, the transfer of data between countries regarding this disease, its progression in patients, and various treatment outcomes helped doctors in the fight against this disease.
The primary objective of the regulation is to give individuals greater control over their health. In practice, this should mean that every citizen can view their “electronic health record,” which will contain all health data, and there will be no need to visit a doctor for results, as they will be immediately available in this record. Healthcare providers from other countries would also be able to access this data if the individual needed it.
A secondary objective of the regulation is to use the collected data effectively and beneficially. Under strict rules, researchers, innovators, public institutions, or industry will have access to this data. The data will be anonymized, ensuring that it is not possible to identify a specific individual. This high-quality data can drive progress in research, innovation, and the development of new treatments or medicines.
Implementation of the EHDS
Implementing this unified system within the EU may pose significant challenges, particularly given the current situation.
In March 2011, DIRECTIVE 2011/24/EU OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on the application of patients’ rights in cross-border healthcare was adopted, which was intended to ensure the provision of healthcare abroad based on existing health data via the MyHealth @ EU portal. However, this directive was based on a voluntary basis, meaning that countries were not required to implement it. Currently, only a few EU countries use this portal, which significantly complicates the implementation of the EHDS.
Benefits for individual stakeholders:
For citizens
The system will give people maximum control over their health data. Access to health data would be immediate and free; it would be possible to edit and update this data as needed, while also sharing it with doctors, other healthcare facilities, or people the individual trusts (such as family or a partner). It would also allow users to track who has viewed their data. The data would be managed in a uniform format across the entire EU, ensuring consistency and clarity.
For healthcare providers
Doctors, hospitals, and other healthcare facilities will have access to the patient’s complete medical record. This will streamline processes while reducing the administrative burden, contributing to higher-quality service delivery. At the same time, however, such immediate access to data will prevent misdiagnosis of patients or the incorrect administration of medication, even abroad.
For research and healthcare institutions
Such data can be very beneficial for the research and development of new treatment methods, medications, or vaccines. Data collection would be massive and diversified (as it would represent pan-European data). It is important to note that these institutions would not have access to individuals’ identities; thus, it would not be possible to link a person’s identity to a diagnosis due to data anonymization.
For individual sectors
Entire sectors could also draw on this data to develop innovative healthcare solutions using artificial intelligence.
EHDS funding from the European Commission’s perspective
“Overall, the EHDS is expected to save the EU approximately 11 billion euros over ten years: €5.5 billion will be saved through improved access to and exchange of health data within healthcare, and €5.4 billion will be saved through better use of health data for research, innovation, and policy-making.” (European Commission, 2022)
The funding itself will come from various EU projects such as Digital Europe, EU4HEALTH, and the Recovery and Resilience Facility. The most important step is for individual member states to digitize their healthcare systems. Subsequently, it will be possible to build a unified system for the entire EU.
Data Protection and Security
The EHDS is based on the General Data Protection Regulation (GDPR), the proposed Data Governance Act, the proposed Data Act, and the NIS Directive. The proposal itself merely supplements or amends certain rules to adapt them to the healthcare sector.
The greatest concern for citizens may be the transfer of data abroad or the provision of data to other external entities for development or research purposes. The proposal addresses these situations to ensure privacy protection and cybersecurity. The system is necessarily built on rules that cannot be circumvented in any way. Secondary data processing is strictly defined by the proposal, and the data cannot be used for any other purpose. It is processed under strict conditions, and the entities involved are certified, meaning they are capable of ensuring data protection.
EHDS and Artificial Intelligence
The use of artificial intelligence in healthcare is nothing new and is also anticipated in connection with the EHDS. In the past, many tech giants such as IBM have attempted to introduce a system that would speed up or simplify the delivery of healthcare while utilizing artificial intelligence. The Watson Health system used patients’ medical records to determine treatment plans. However, this system did not achieve success, partly due to its inaccuracy, as was the case with others. These attempts also show that artificial intelligence systems are not being implemented as quickly in healthcare as in other sectors. There are several reasons for this.
One of the main reasons is ensuring cybersecurity and the protection of personal data. This ethical aspect plays a major role and must be strictly ensured within the EHDS. Another problem is data collection, which has not yet been standardized (varying records, X-ray images). Testing artificial intelligence in laboratory conditions with “perfect” data differed drastically from the “real world.” The input data for the system was so different (in terms of format or image angle) that it was unable to process the results or evaluated them incorrectly.
Another perspective is its application in the development and research of new drugs. Artificial intelligence is already reducing the time required for development and testing, for example, by selecting suitable candidates for testing a given drug. Based on input data, artificial intelligence can make this selection several times faster than a human.
The EHDS could bring a great many benefits or positive outcomes for society, but it is necessary to take into account all the negative impacts and threats that may arise. The very fact that individual countries have different levels of technical security poses a risk during implementation. Currently, it is necessary to standardize the system across countries, after which it will be possible to integrate it within the EHDS.
