We are going through what is known as the third major global economic wave at an unprecedented pace. This wave is driven by the growth and achievement of industries that rely on data as the most precious resource and catalyst for the creation of new technologies. Healthcare is no different. Physicians, researchers and developers, healthcare professionals and pharmaceutical industry workers have never been so informed and rely more and more on health data for effective decision-making.
On 15 March 2024, the European Commission welcomed a political agreement between the European Parliament and the Council of the EU regarding the European Health Data Space (EHDS), a pivotal component of the European Health Union. Achieving the political deal was no easy feat, as the 2022 Commission Proposal sparked significant discussions in the health sector and beyond (details here). While we wait for the European Parliament and the Council to formally adopt the new Regulation, let us revisit the purpose, structure and benefits of the EHDS and dive into the impacts of the EHDS for health stakeholders.
The COVID-19 pandemic has highlighted the importance of efficient data management and access to up-to-date health data in guiding public health interventions and crisis responses, leading to a rapid adoption of digital tools. Despite progress, significant barriers still hinder the full potential of digital health and health data utilization. The EHDS is designed to overcome these obstacles. By establishing clear guidelines, standardized practices, robust governance and a trustworthy health data environment, this framework is designed to establish the effective sharing and use of electronic health data by stakeholders for various purposes, including research, innovation, policy-making, and patient safety enhancement, as well as empower people to control and utilize their health data within the EU.
How will the EHDS strengthen the people’s rights to their health data?
The EHDS is designed to complement the people’s rights provided under the GDPR in relation to their electronic health data: People shall have the right to access their personal electronic health data processed in the context of the provision of health services (also defined as “primary use”) or receive an electronic copy of it, immediately and without any cost. Member States shall set up an “electronic health data access service” to enable people to effectively exercise their access rights as well as “proxy services” enabling people to authorize other individuals to act on their behalf. In this regard, the EHDS identifies “priority” types of electronic health data which form the baseline of the data which must be accessible to natural persons: patient summaries; electronic prescriptions; electronic dispensations; medical images and image reports; laboratory results and discharge reports. Further, individuals will be able to share their data with health professionals nationally or cross-border. They will be able to add information, rectify errors, restrict access and obtain information on how their data is being used. Health data can only be accessed by researchers, industry or public institutions under strict conditions that protect people’s privacy and security.
How will the EHDS benefit health professionals?
Electronic health data will become available more easily for health professionals within the EU. To achieve this and to improve interoperability and data portability, the EHDS requires the implementation of a mandatory self-certification program, which requires manufacturers of electronic health records (EHR) systems to provide proof of conformity, issue a declaration of conformity, and affix a CE marking to their products, thereby ensuring that electronic health records can work across different systems and enable smooth transfer of electronic health data among them.
EHR system means any appliance or software intended by the manufacturer to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records. This could cover providers of electronic health record software, manufacturers of medical imaging software and devices, providers of clinical decision support systems, practice management software companies, and others. Producers of "wellness applications" (for example, using health data for well-being and following healthy lifestyles) can choose to label their products voluntarily if they can work with EHR systems.
With this improved interoperability and data portability, health professionals will be able to access a patient's medical history, increasing the evidence bases for decisions on treatment and diagnosis. They will also be able to easily access health data from different sources, reducing the administrative burden from having to manually copy records across different systems. The ease of access will also positively impact healthcare system efficiencies.
Health professionals involved in research will enjoy the benefits of easier access to health data for research and innovation as well as being able to know what data is available, where, and of what quality.
Will the EHDS also benefit the healthcare and pharmaceutical industries?
The EHDS further regulates the “secondary use” of certain types of electronic health data for specific purposes other than the “primary use” (which is the provision of health care services). Permitted purposes include the use of data for activities related to health and care sectors such as for research, education and teaching activities, innovation, policy making, patient safety or regulatory activities. Prohibited purposes include exploiting data to harm individuals, engaging in commercial advertising or adjusting insurance rates.
To enable the “secondary use” of data, Member States will have to set up a “health data access body” which will sit at the heart of the data exchanges. These bodies will be responsible for granting access to electronic health data for secondary use through the issuance of a “data permit” to a data user. To make this possible, data holders must communicate to the health data access body a general description of the datasets they hold and put the electronic health data at the disposal of the health data access body. The health data access bodies must ensure that health data can be uploaded by data holders and be accessed by the data user in a secure processing environment. Alternatively, a data user may also request access to health data directly from a single data holder.
One should keep in mind that different Member States have different levels of digital health and health data collection. Each country has its own difficulties due to administrative systems, cultural norms, and policy approaches. However, even though the EU is not advancing at the same pace, there seems to be a shared desire to adjust and get ready for the future.
Healthcare and pharmaceutical industries will have the opportunity to request access from the health data access bodies to health data. This implies that they will be able to use a broader variety of high-quality data for research and development goals, thus simplifying data standardization. Certain types of data, such as health registries and clinical trials that are relevant to public interest, healthcare quality, innovation, and safety assurance may also have to be shared by the healthcare and pharmaceutical industries.
Under the EHDS, data will further only be accessible in the secure processing environment of the health data access bodies. In the context of healthcare, the industry (in contrast to health care providers) will only have access to non-personal data.
What type of governance system does the EHDS envisage?
The EHDS builds upon the current cooperation for the primary use of data in healthcare (the use of data for the patients themselves) within the eHealth Network. It extends the scope of this primary use and will now also regulate secondary use of health data (the re-use of aggregated health data by, for example, researchers, policy makers, innovators, and industry). The EHDS rules for using health data again rely on the structure established by the EU Data Governance Act.
A new European Health Data Space Board will be created, composed of the representatives of digital health authorities and new health data access bodies from all the Member States, the Commission and observers. Member States will also cooperate at EU level on two cross-border digital infrastructures to enable data sharing (one for primary uses of health data and another one for secondary uses of health data). To enable the cross-border access to health data for secondary use in practice, the EHDS provides that Member States and the Commission shall set up “HealthData@EU”. This shared infrastructure will serve as a “hub”, connecting the national contact points for secondary use of electronic health data of all Member States and authorized participants in that infrastructure.
