Health and healthcare provision have always been an important element 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 brought a difficult challenge in this area. This period represents a turning point in the European Commission's decision to introduce a system that will benefit individuals and European society as a whole in the field of healthcare.
03.05.2022 The European Commission has issued a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on a European Health Data Space. The EHDS (European Health Data Space) is a health and healthcare ecosystem in which all EU member states will be involved and will be able to share patient health data, either within a country between individual healthcare providers or between EU countries. Each country will follow the same standards and rules, which will ensure the effective functioning of the system. As the EHDS will process sensitive personal data (specifically data on people's health), it is essential that the EHDS is based on the General Data Protection Regulation (GDPR) and the NIS 2 Directive.
Reasons for creating the EHDS
The creation of data spaces is part of the European Data Strategy, which aims to integrate data within the EU, manage it through a single system, and ensure its flow between countries and sectors within the EU. The Covid-19 pandemic has highlighted the importance of creating such a space in the field of healthcare. Almost everyone felt this when it was not possible to visit their general practitioner and they were prescribed medication exclusively electronically. At the same time, however, the transfer of data between countries on this disease, its progression in patients and various treatment outcomes helped doctors in their fight against it.
The primary objective of the regulation is to give individuals greater control over their health. In practice, this should mean that every citizen will be able to access their "electronic card," which will contain all their health data, and will not need to go to the doctor to get their results, as they will be immediately available on this card. Healthcare providers from other countries would also be able to access this data if necessary.
The secondary objective of the regulation is to use the collected data in a meaningful and beneficial way. Under strict rules, researchers, innovators, public institutions, and industry will have access to this data. The data will be anonymized, ensuring that it cannot be traced back to a specific person. This high-quality data can lead to advances in research, innovation, and the development of new treatments and medicines.
Introduction of the EHDS
The introduction of the aforementioned unified system within the EU may be quite complicated, especially 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 on the basis of existing health data via the MyHealth @ EU portal. However, this directive was based on voluntary participation, meaning that countries were not obliged 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 of charge, and it would be possible to edit and supplement this data if necessary and share it with doctors, other institutions, or people the person trusts (e.g., family, partner). It would also allow them to see who has viewed their data. The data would be managed in a uniform format across the EU, ensuring consistency and clarity.
For healthcare providers
Doctors, hospitals, and other healthcare facilities will have access to a patient's complete medical record. This will speed up processes and reduce the administrative burden, contributing to better quality services. At the same time, such immediate access to data will prevent misdiagnosis or incorrect medication, even abroad.
For research and healthcare institutions
Such data can be very useful for research and development of new treatments, drugs, or vaccines. Data collection would be massive and diversified (as it would represent Europe-wide data). It is important to note that these institutions would not have access to the identity of individuals, i.e., 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 around €11 billion over ten years: €5.5 billion will be saved through better 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. Then it will be possible to build a unified system for the entire EU.
Personal 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 only supplements or modifies certain rules to adapt them to the healthcare sector.
The biggest 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 regulates these situations to ensure privacy and cybersecurity. The system is necessarily based 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, i.e. they are able to ensure data protection.
EHDS and artificial intelligence
The use of artificial intelligence in healthcare is nothing new and is also expected 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 healthcare delivery while using artificial intelligence. The Watson Health system used patient health records to tailor treatment. However, this system was not successful, partly due to its inaccuracy, as were others. These attempts show that artificial intelligence systems are not being introduced as quickly in healthcare as in other areas. There are several reasons for this.
One of the main reasons is to ensure cybersecurity and personal data protection. 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 (different records, X-ray images). Testing artificial intelligence in laboratory conditions with "perfect" data differed greatly from the "real world." The input data for the system was so different (in format or angle of images) that the results could not be processed or were evaluated incorrectly.
Another angle is its use in the development and research of new drugs. Artificial intelligence is already reducing the time needed 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 many benefits and positive results 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 brings with it a risk during implementation. At present, it is necessary to harmonize the system in the countries, after which it will be possible to interconnect it within the EHDS.
