The European Commission recently announced its decision to choose a consortium led by the French Health Data Hub to set up a pilot project for the European Health Data Space (EHDS).
This project will aim to feed the legislative discussions around the draft regulation proposed by the European Commission on May 3rd on the European Health Data Space.
The ECDC, together with the European Medicines Agency (EMA) participates in this consortium consisting of several European Union (EU) Member States (MS) working on a pilot of the EHDS. The project is financed as a grant of the Commission/EU4Health programme, which has just been awarded.
Its objective will be to address the challenges surrounding access to health data throughout the EU, to open new perspectives to research and innovation.
The European Health Data Space (EHDS) is a central component of a strong European Health Union: President von der Leyen tasked the European Commission (EC) to work on the creation of a EHDS to promote health data exchange and support research and innovation on new preventive strategies, treatments, medicines, medical devices and outcomes. In the light of the COVID-19 pandemic, the European Council has also urged the EC to prioritise the EHDS. The EHDS is intended to become a system for data exchange and access, governed by common rules, procedures, and technical standards to ensure health data can be accessed within and between MS, in line with the General Data Protection Regulation (GDPR).
Aims of the European Health Data Space
The European Health Data Space will address health-specific challenges to electronic health data access and sharing. The general objective is to ensure that natural persons in the EU have increased control in practise over their electronic health data. It also aims to ensure a legal framework consisting of trusted EU and Member State governance mechanisms and a secure processing environment. This would allow researchers, innovators, policymakers and regulators at EU and Member State level to access relevant electronic health data to promote better diagnosis, treatment and well-being of natural persons, and lead to better and well-informed policies. It also aims to contribute to a genuine single market for digital health products and services, by harmonising rules, and so boost healthcare system efficiencies.
The EHDS2 ecosystem consists of the digital infrastructure ecosystem and data ecosystem for secondary uses of health data. The EHDS2 pilot brings together eight national health data infrastructures, two EU agencies, one European Research Infrastructure Consortium, four research infrastructures, and one association. The pilot consists of nine use cases. The ECDC joined the EHDS project with the aim to establish more robust, sustainable, and effective surveillance systems for infectious disease prevention and control in the EU/EEA countries. The ultimate aim for ECDC is for the EHDS to provide actionable data for preventing and controlling infectious disease threats to EU/EEA citizens.
The European Data Strategy proposed the establishment of domain-specific common European data spaces. The European Health Data Space (EHDS) is the first proposal of such domain-specific common European data spaces. It will address health-specific challenges to electronic health data access and sharing, is one of the priorities of the European Commission in the area of health and will be an integral part of building a European Health Union. EHDS will create a common space where natural persons can easily control their electronic health data. It will also make it possible for researchers, innovators and policy makers to use this electronic health data in a trusted and secure way that preserves privacy.
In addition, the COVID-19 pandemic has shown even further the importance of electronic health data for the development of policy in response to health emergencies. It has also highlighted the imperative of ensuring timely access to personal electronic health data for health threats preparedness and response, as well as for treatment, but also for research, innovation, patient safety, regulatory purposes, policy-making, statistical purposes or personalised medicine. The European Council has recognised the urgency to make progress towards and to give priority to the EHDS.