DARWIN EU will connect the European medicines regulatory network to the European Commission's European Health Data Space (EHDS), an initiative to promote better exchange and access to different types of health data.

While the needs and use cases of medicine regulators and decision-makers will drive DARWIN EU's development, DARWIN EU also contributes to developing the EHDS and the joint action to deliver European principles for the secondary use of health data, known as Towards European Health Data Space (TEHDAS).

Acting as an early flagship 'pathfinder' for the EHDS, DARWIN EU will enable the exchange of healthcare data for use in healthcare delivery, policy-making and research across Europe, while fully complying with data protection requirements.

EHDS HealthData@EU Pilot

Recently, the EHDS2 Pilot Project was initiated which will run till September 2024. This project is led by the French Health Data Hub (HDH) a French organisation that aims to ensure easy, unified, transparent and secure access to health data to improve quality of care and support for patients.

Multiple consortiums are involved in the EHDS pilot, from EU agencies (EMA included), national platforms and international research infrastructures. The consortium will aim to answer the European Commission’s call for project to concretely test the EHDS in practice by creating a network of data platforms at European level, by conducting cross-border research use cases, and provide recommendation for the future EHDS.

The pilot project will create the first European network for secondary use of data projects, containing a metadata search portal, data access request portal and other central services. Within the network, project leaders will be able to querymetadata catalogues of all nodes and ask for data access in several nodes with a single data application form.

EMA will be an authorised participant and consortium partner within the EHDS2 pilot project. EMA’s use case on thrombosis (see below) will aim to leverage DARWIN EU®, among other platforms. DARWIN EU® and the EHDS2 pilot are two complementary and synergetic projects for the secondary use of health data.

EMA Use Case

EMA’s use case will aim to investigate the natural history of coagulopathy and use of antithrombotic agents in COVID-19 patients and persons vaccinated against SARS-CoV-2. The study has previously been conducted via the EMA Framework Contract and the results of this study may be used for benchmarking (EUPAS40414). This is an important use case that will test the way DARWIN EU® will be integrated in EHDS in the future. Six specific objectives of the study were presented, increasing in levelof complexity, which will be chosen by data partners while considering their capability and the data they hold.

It will be important to evaluate how the data from the different nodes will be combined, considering data available in the Common Data Model (CDM) via DARWIN EU® and data available in other nodes in native format. It was also clarified that the CDM is not a pre-requisite for becoming a node in the EHDS pilot. In the future, some data sources, such as some registriesfor example will not be converted into a CDM. The objective will be to see how the different data sources can be combined in a single study in a meaningful way.

For more information:

• European Commission: European Health Data Space
• Press Release EHDS2 Pilot Project