The European Commission has just presented an ambitious project for a European Health Data Area. Management, quality and interoperability of data as well as level infrastructures seem to be there.
The European Union is taking a huge step towards the digitalisation of healthcare. “The European Commission today launches the European Health Data Space (EHDS), a cornerstone in building a strong European health union.” This is how the European institution presented its project. She states that “the EHDS will enable the Union to transform the way healthcare is provided to citizens across Europe. It will empower citizens to monitor and use their health data, both in their country of origin and in other Member States”. Commission Vice-President Margaritis Schinas said it would “be a ‘fresh start’ for the EU’s digital health policy to make health data work for people, citizens and for science.” the need to innovate quickly with secure solutions.
This space should bring together a single market for digital healthcare products and services and provide a coherent, reliable and effective framework for the use of healthcare data for research, innovation, policy-making and regulatory purposes. , while respecting the GDPR. Stella Kyriakides, Commissioner for Health and Food Safety, continued: “The European Health Data Date is a fundamental game-changer when it comes to the digital transformation of healthcare in the EU. This data, which will be available under strong security and privacy guarantees, will also be a goldmine for scientists, researchers, innovators and policy makers working on the next life-saving treatment. “
Citizens, masters of their health data
Thanks to EHDS, citizens will have instant, free and simplified access to their health data in electronic form. Specifically, they will be able to share this data with other healthcare professionals in and between Member States in order to improve the delivery of healthcare. They will be able to exercise full control over their data and will be able to add information, correct erroneous data or even restrict access to their data to other people and get information about how their data is used and for what purposes.
In this sense, Member States must ensure that all documents are issued and accepted in a common European format. This includes patient records, electronic prescriptions, medical imaging diagnostic images and reports, laboratory results, and hospital discharge letters. The Commission wants to put interoperability and security at the heart of this transformation. In fact, manufacturers of electronic record systems will have to certify compliance with these standards. In addition, all Member States must designate digital health authorities to participate in a cross-border digital infrastructure (MyHealth @ EU), which will help patients share their data across borders.
Sharing of health data for research purposes
EHDS also creates a strong legal framework for the use of health data for research, innovation, public health, policy making and regulatory purposes. Under strict conditions, researchers, innovators, public institutions or companies will have access to large amounts of high-quality health data. The goal, thanks to this division, is to develop life-saving treatments, vaccines or medical devices and guarantee better access to health care and more resilient health systems. In order to access this data, researchers, companies or institutions must request the authorization of the body responsible for accessing health data set up in each Member State.
Access will only be authorized if the requested data is used for specific purposes, in closed and secure environments and without revealing the identity of the persons. It clarifies that it will be “strictly forbidden to use the data for decisions that are detrimental to citizens, for example to design harmful products or services or to increase the size of an insurance premium”. Bodies responsible for access to health data will be connected to the newly created EU decentralized secondary data infrastructure called HealthData @ EU, and will support cross-border projects.
A legal point
EHDS is an extension of the General Data Protection Regulation (GDPR), the proposed Data Management Act, the proposed Data Regulation and the NIS Directive. It complements these initiatives and provides rules that better suit the healthcare sector. EHDS will make use of the current and future distribution of public digital goods in the EU, such as artificial intelligence, high-performance computing, cloud and intelligent middleware. In addition, frameworks for artificial intelligence, electronic identity and cybersecurity will support this space. The proposal from the European Commission must now be considered by the Council and the European Parliament.