HealthData@EU Pilot

The HealthData@EU Pilot is an EU-funded project that built a pilot version of the European Health Data Space (EHDS) infrastructure for the secondary use of health data which serves research, innovation, policy making and regulatory purposes. 


In July 2022 the European Commission announced its decision to choose the consortium led by the French Health Data Hub to set up a pilot project for the EHDS. The aim of the pilot is to investigate and establish the value of such an infrastructure for the reuse of health data and assess the ability to scale towards a Union-wide infrastructure, as a core component of the European Health Data Space. 
 

From October 2022 until December 2024, the project connected data platforms in a network infrastructure and developed services supporting the user journey for research projects using health data from twelve European countries. Deliverables from this project provide guidelines for data standards, data quality, data security and data transfer to support this cross-border infrastructure. Priority services include a metadata discovery service and a common health data access request. 
 

Work Packages

HealthData@EU Pilot is divided into 9 work packages led by different partners. Work packages 1-4 are horizontal work packages aimed at coordinating, communicating and ensuring delivery. Work packages 5-9 are technical work packages that build and test the user journey.

 

Work Package 05 - IT infrastructure

Co-led by the Health Data Hub (France) and the Health Data Lab (Germany), Work Package 5 (WP5) oversaw the implementation of the IT infrastructure enabling information exchange between the European central platform and national nodes. This infrastructure was designed in an agnostic way, in order to support specific technical use cases, including metadata exchange and transmission of data access applications. WP5 worked hand in hand with the European Commission Central Services team to build a first version of the HealthData@EU infrastructure.

Work Package 06 - Metadata Standards

Towards a common health Resource Description Framework (RDF) representation of metadata for interexchange between data portals.
Led by Sciensano (Belgium), Work Package 6 (WP6) focused on standardising the descriptive metadata templates used to present and describe the available data collections in every node. The standard for this common descriptive metadata model is based on a health DCAT-AP extension designed in this WP.

Work Package 07 - Regulatory and legal compliance

Led by BBMRI-ERIC, Work Package 07 provided guidelines in order to build a single data access form for the EHDS, to harmonise legal and ethics data access procedures, security requirements and GDPR citizen access rights compliance for cross-border use of data applied to selected use cases.

Work Package 08 - Data interoperability, quality and protection

Led by BBMRI-ERIC, Work Package 08 dealt with interoperability of actual data in different phases of HealthData@EU User Journey: from a study of different common data models, available terminologies and how to make data interoperability between nodes, to data exchange among HealthData@EU Nodes and ultimately data delivery to the researchers. 

Work Package 09 - Use cases management

Co-led by the Health Data Hub and the Danish partners (Aarhus University Hospital and Danish Health Data Authority), Work Package 09 (WP9) coordinated the implementation of use cases chosen by the European Commission among consortium proposed use cases (building teams, project management, and allocation of resources). 

Beyond the pilot: next steps in building the EHDS

The recommendations and concrete results of the HealthData@EU Pilot project highlight the need for a robust infrastructure, clear governance and sustainable funding to guarantee the long-term success of EHDS. The role of HDABs and the tools offered by these national authorities is central in organizing and managing access to health data.

The Health Data Hub continues its commitment to this dynamic by participating in several structuring initiatives, such as :

• The TEHDAS2 joint action, which prepares the delegated acts for the EHDS regulation.
• Coordination of the SHAIPED project, which aims to mobilize the EHDS framework to facilitate the development, testing and deployment of artificial intelligence solutions in medical devices.
• The Community of Practice (CoP), which promotes the exchange of best practices between industry players.
• The QUANTUM project, dedicated to improving the interoperability and standardization of healthcare data.

The HealthData@EU Pilot is funded under the EU4Health Programme (project number 101079839)
Co-funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or HaDEA. Neither the European Union nor the granting authority can be held responsible for them.