The European Commission has just presented an ambitious project for a European health data area. Governance, quality and interoperability of data, as well as level infrastructures seem to be there.
The European Union is taking a giant step towards the digitization of healthcare. “The European Commission is today launching 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 health care is delivered to citizens across Europe. It will give citizens the power to control and use their health data, both in their country of origin and in other Member States”. European Commission Vice-President Margaritis Schinas said it will “be a ‘fresh start’ for the EU’s digital health policy, making health data work for people. citizens and for science”. The covid-19 pandemic has shown certain weaknesses in the current system and the need to renew itself, quickly, with secure solutions.
This space should federate a single market for digital health products and services, and provide a coherent, reliable and efficient framework for the use of health 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 Space is a fundamental game-changer when it comes to the digital transformation of healthcare in the EU. This data, which will be accessible under strong security and privacy safeguards, will also be a gold mine for scientists, researchers, innovators and policy makers working on the next life-saving treatment”.
Citizens, masters of their health data
Thanks to the EHDS, citizens will have immediate, free and simplified access to their health data in electronic form. Concretely, they will be able to share this data with other health professionals in and between Member States in order to improve the delivery of health care. 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 for other people and obtain information on how their data is used. and for what purposes.
In this sense, Member States will have to ensure that all documents are issued and accepted in a common European format. This includes patient records, electronic prescriptions, medical imaging images and reports, lab results, and hospital discharge letters. The Commission wants to put interoperability and security at the heart of this transformation. In fact, manufacturers of electronic medical record systems will have to certify compliance with these standards. In addition, all Member States must designate digital health authorities which will have to participate in a cross-border digital infrastructure (MyHealth@EU) that will help patients share their data across borders.
Sharing 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 objective being, thanks to this sharing, to develop life-saving treatments, vaccines or medical devices and guarantee better access to health care and more resilient health systems. To access this data, researchers, companies or institutions will have to request authorization from the body responsible for access to health data, set up in each Member State.
Access will only be authorized if the data requested is used for specific purposes, in closed and secure environments and without the identity of the persons being revealed. It is specified that it will be “strictly prohibited to use the data for decisions detrimental to citizens, for example to design harmful products or services or to increase the amount of an insurance premium”. Bodies responsible for access to health data will be connected to the newly created EU decentralized infrastructure for secondary data use called HealthData@EU, and will support cross-border projects.
A legal point
The EHDS is an extension of the General Data Protection Regulation (GDPR), the proposal for an act on data governanceof the proposed data regulation and some NIS directive. It complements these initiatives and provides rules that are better suited to the health sector. The EHDS will make use of the ongoing and future deployment in the EU of public digital goods such as artificial intelligence, high performance computing, cloud and intelligent middleware. Additionally, frameworks for AI, electronic identity, and cybersecurity will support this space. The proposal presented by the European Commission must now be examined by the Council and the European Parliament.
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Brussels pushes for a European health data space Computerworld
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