Project - EHDS2 Pilot - Official website

HealthData@EU Pilot

Watch video introducing the HealthData@EU Pilot project:

Background

In 2018, The European Commission published a communication on enabling the digital transformation of health and care in the Digital Single Market, empowering citizens and building a healthier society. It outlined three priorities, including better data to advance research, disease prevention and personalised health and care allowing researchers and other professionals to pool resources through shared European data infrastructures across the EU. At the same time, the European Council promotes adaptation of e-Health infrastructures to facilitate accumulation, exchange and use of health data. In 2020, the European Council set up a Joint Action under the 2020 Work Programme of the 3rd programme for EU action in the field of health (3rd Health Programme). The Joint Action Towards the European Health Data Space (TEHDaS) supports a key objective of the EU, which is ensuring the seamless flow of health data in the context of the Single Market. It engages key actors of the process, Member States and other participating countries to draft options on the secondary use of health data and to propose options for governance models for data-sharing at EU level, in particular networking for secondary use.

To promote digital transformation and widen the use of health data, the European Commission (EC) has made the creation of a European Health Data Space (EHDS) a priority for 2019-2025 . On 24 March 2021, the EU4Health Regulation established ‘the EU4Health Programme’ that will enable instruments and solutions to support Member States in building stronger, more resilient and accessible health systems. In order to support the development of a common European Health Data Space, the EU4Health Programme launched the “EU4H-2021-PJ-06 – Action grants for developing a EHDS2 Pilot for an EU infrastructure ecosystem for the secondary use of health data for research, innovation, policy making and regulatory purposes”.

Secondary use of health data corresponds to using health data from population-level sources such as electronic health records, health insurance claims data or health registry data to improve personal care planning, medicines development, safety monitoring, research, and policymaking.

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 European Health Data Space. 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. To do so, the HealthData@EU Pilot project will bring together key actors of secondary use of data in Europe, such as existing health data authorisation bodies or access authorities (i.e. national authorities empowered by national mandate and legal basis to enable access to health data) and other international or EU-level organisations (e.g., research infrastructures, European health related agencies, associations). Those actors will build solutions for operating secondary use at an EU level (common rules, means and procedures) and implement them by building an EU network infrastructure between data providers (nodes) for the secondary use of health data.

Useful links

The European Health Data Space (EHDS):

https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en

The proposal for a regulation on the European Health Data Space:

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A52022PC0197

Introduction

The HealthData@EU Pilot project will connect data platforms in a network infrastructure and develop services supporting the user journey for research projects using health data from various EU Member States. It will also provide guidelines for data standards, data quality, data security and data transfer to support this cross-border infrastructure.

The HealthData@EU Pilot project will be designing, developing, deploying and operating a network of nodes (representing different data brokers, holders and data consumers) federated by central services that may be provided jointly with the European Commission. 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. To do so, the HealthData@EU Pilot project will bring together key actors of secondary use of data in Europe, such as existing health data authorisation bodies or access authorities (i.e. national authorities empowered by national mandate and legal basis to enable access to health data) and other international or EU-level organisations (e.g., research infrastructures, European health related agencies, associations). Those actors will build solutions for operating secondary use at an EU level (common rules, means and procedures) and implement them by building an EU network infrastructure between data providers (nodes) for the secondary use of health data.

The consortium will also collaborate closely with the European Commission and their team working on developing the central services for HealhData@EU Pilot.

In short, the HealthData@EU Pilot project is an EU-funded project and will build a pilot version the European Health Data Space (EHDS) infrastructure for the secondary use of health data which will serve research, innovation, policy making and regulatory proposes. The project will connect data platforms in a network infrastructure and develop services supporting the user journey for research projects using health data from various EU Member States. It will also provide guidelines for data standards, data quality, data security and data transfer to support this cross-border infrastructure. Priority services include a metadata discovery discovery service and a common health data access request.

Aims

Develop and deploy an IT infrastructure for setting up a network of nodes and delivering basic central services jointly with the European Commission, such as common data discovery, common data access application, and allowing data usage (and possibly data transfer).

The general objective of our HealthData@EU Pilot project is two-fold:

Run use cases to prove:

the value of a Union-wide infrastructure and data ecosystem for the reuse of health data by testing this new infrastructure and evaluating its benefits; and
the potential of cross-country reuse of health data for research, innovation, policy-making, regulatory activities. To that end, the EHDS2@EU Pilot will develop, explore, and analyse standards on data governance, data quality and data infrastructure for data-sharing between different participating countries across Europe.

Use cases

In order to illustrate the feasibility and the potential of reusing data from several European countries, the project will run five use cases that encompass a wide range of research and policy topics. Based on this experiment, the HealthData@EU Pilot will provide complete evaluation of the project and build recommendations for the European Commission about data standards, legal requirements, costs and economic model needed to scale up the tested network.

Partners

Lead by the Health Data Hub, the HealhData@EU Pilot project brings together 17 European partners including health data access bodies, health data sharing infrastructures and European agencies.