HealthData@EU

Legal Context for Health Data Catalogues

Over the past decade, the state of dataset catalogues in Europe has evolved significantly, driven by various EU legal acts aimed at improving data sharing, transparency, and interoperability across the European Union. Today, the overarching European Data Portal https://data.europa.eu includes nearly 2 million datasets, of which nearly 27,000 records are labelled as health-related datasets. This ecosystem of dataset catalogues is constantly evolving, fuelled by the continuous publication of legal acts:

- The Open Data Directive (Directive (EU) 2019/1024) pushes for public sector data to be made easily accessible and reusable, encouraging the creation of open dataset catalogues across EU countries.

- The INSPIRE Directive (Directive 2007/2/EC) plays a crucial role in developing standardised and interoperable spatial dataset catalogues, enabling better sharing of environmental information across Europe.

- Meanwhile, the Data Governance Act (DGA, Regulation (EU) 2022/868) , effective from September 2023, promotes secure data sharing by introducing data intermediaries and data altruism, further connecting dataset catalogues across different sectors.

- The Data Act (DA, Regulation (EU) 2023/2854) is expected to boost this progress by setting clear rules for data access and use, particularly in business contexts, and by promoting data interoperability. This will further drive the development and federation of dataset catalogues.

- Additionally, the European Interoperability Framework (EIF) provides guidelines to ensure that dataset catalogues from different countries and sectors can work together seamlessly. These legal acts collectively support Europe's strategy to build a secure and innovative data economy, with dataset catalogues playing a central role in this digital landscape. The system of interoperable dataset catalogues, through metadata, serves as a general proxy to data. As part of this broader strategy, the EU is also developing a broad range of European Data Spaces - sector-specific environments where data can be shared and accessed securely across borders and industries. These data spaces will aim to bring together data from various sources, making it easier for businesses, governments, and researchers to collaborate and innovate. The creation and integration of dataset catalogues within these spaces are essential for ensuring that data is accessible, interoperable, and valuable across the entire European Union.

Recognising the value of data has been a long-standing effort in data management, embodied by the EMODnet (European Marine Observation and Data Network) motto: 'Create once, use many times.'"

EMODnet principles

The EHDS Regulation adopts principles similar to EMODnet, focusing on collecting data once, reusing it many times, and applying cross-disciplinary standards to ensure maximum value from health datasets across the EU. While these principles provide a common foundation for EU data spaces, each thematic data space will have to establish its own governance framework to ensure effective stakeholder engagement. This approach is particularly crucial for health data, as its sensitive nature demands careful curation and reuse under the guidelines set by the GDPR and national laws of member states.

Role of the Health Data Access Bodies of the EHDS

Chapter 4 of the European Health Data Space (EHDS) Regulation is as this regard is a valid example as it focuses on the governance and rules for accessing and using health data within the EHDS. This chapter outlines the requirements for the establishment of Health Data Access Bodies in each EU member state. These bodies are responsible for granting access to health data for secondary use, such as research, policy-making, and innovation, while ensuring that data protection and privacy are strictly maintained. Chapter 4 of the EHDS Regulation outlines the conditions for health data access, emphasising data minimisation and the use of anonymisation or pseudonymization to protect individual privacy, while ensuring that health data can be reused for secondary purposes such as research, policy-making, and innovation.. Additionally, this chapter addresses the interoperability standards that must be adhered to, ensuring that health data from different countries can be effectively shared and used across the EU. As this regard, the Health Data Access Bodies are responsible for cataloguing health data in scope of Art. 33 and serve as reference national health clearinghouses.

Harmonisation across Data Spaces

In the development of the European Health Data Space (EHDS), it is recognised that while governance structures can be customised to fit health data specific requirements and improve the operational efficiency of the EU Health Data Space, certain standards must remain consistent across all EU Data Spaces. In particular, standards for interoperability or security are critical and should not be compromised. They should be defined not only for EU Health Data Space but also beyond. The common EU data spaces will form a unified, federated data infrastructure across Europe, ensuring data openness, transparency, and sovereignty. By aligning with established standards and guidelines, the implementation process for the EU data Spaces will become simpler and more efficient, as it leverages the collective expertise to implement the data spaces. This harmonisation not only simplifies the process, but also promotes collaboration and consistency, ensuring compliance with best practices and efficient use of resources.

For instance, the Article 8 (i.e.: single information point) of the Data Governance Act Regulation (EU) 2022/868 ensures a unified and secure approach across the European data ecosystem, preventing implementation of ad-hoc solutions and ensuring that all data spaces operate with the same level of compatibility.

Regulation (EU) 2022/868 (DGA - Data Governance Act)

The "single information points" under Article 8 of the Data Governance Act refer to the establishment by Member States of a single information point to act as the primary interface for re-users seeking to re-use data held by public sector bodies. For instance, to fulfil their reporting obligations in regard to the HVD regulation, Member States have to maintain a High-value Dataset National single information point.

EHDS Regulation Recital 86)

EHDS Regulation Art.57 Tasks of health data access bodies

According to EHDS Art. 37 and 55, the Health Data Access Bodies (HDABs) of the healthData@EU infrastructure will have to maintain similar end-points to expose health metadata records.

EHDS Regulation Section 5 Health data Quality and utility for secondary use

The same requirement also applies to the EU Dataset catalogue (EHDS Recital 60).

EHDS Regulation Recital 86)

Harvesting metadata from National single information points is a standard procedure for populating metadata records in a catalogue broker like the data.europa.eu.

The European Single Access Point on data.europa.eu: Harvesting guidelines