Unlocking the Secondary Use of Health Data

The pillars of the secondary use of electronic health data under the European Health Data Space (EHDS)

Publication date: 10th of April, 2025

// Key Takeaways //

By fostering trust, ensuring accessibility, and upholding ethical standards, the EHDS paves the way to responsibly leverage health data, all while prioritising privacy and data protection measures.

In today's digital health landscape, the European Health Data Space (EHDS) Regulation represents an innovative approach to handling health data. The Regulation is based on certain principles which establish a balance between maximising the value of health information while protecting individual rights. Let's explore the core tenets that substantiate this Regulation that came into force in March 26th 2025.

DEMOCRATISATION OF THE ACCESS TO ELECTRONIC HEALTH DATA

The EHDS creates a transparent and open process available to every citizen, researcher and public official seeking health data. This approach breaks down the traditional silos that have long isolated valuable health information, making knowledge more accessible to those who can use it to drive innovation, policy-making and improve healthcare outcomes.

PATIENT "OWNERSHIP" OF THE DATA

A fundamental principle of the EHDS is that individuals/patients, are the owners of their health data. Hospitals, healthcare systems, insurance companies, and other entities merely function as data holders. While they have responsibilities to safeguard this information and have the mandate to collect and use it for the delivery of healthcare services, they possess neither ownership nor rights over the data itself. This paradigm shift follows GDPR and puts control on individuals/patients.

In relation to this, the authority that grants access to health data is not the data holder, but an independent and impartial authority that, following legal guidelines and evaluating the social, scientific, and ethical merits of each request, can transparently decide on its relevance and pertinence. These authorities will be the Health Data Access Bodies (HDABs) established by each Member State.

SAFEGUARDS

The EHDS Regulation establishes clear requirements and prohibitions that prioritise individual protection while maximising data potential for research, innovation, and public policy development. Secure processing environments ensure data can be analysed without being extracted, copied, or used for other purposes. These controlled environments maintain the delicate balance between utility and privacy.

Data is not moved until there is a data permit or an approved data request. That is, discovery is done through metadata catalogues, which must include all health data available for secondary use with complete and detailed metadata following an EU-wide metadata standard that allows for the federation of all metadata catalogues across the union.

The framework reinforces the data minimisation principle by requiring each request to specifically justify which variables and cohorts are needed. Mass data access is not permitted. Data permits will only grant access to the precise data necessary for the approved study. This targeted approach reduces privacy risks while still enabling valuable research.

DATA UTILITY AND QUALITY

Data, if it is not of quality, has no value and can create biases in studies or tools that train with it. The data quality and utility label defined in the EHDS is a central piece that allows data users to know the quality and utility of the data without having to access it, allowing the application process to begin with the knowledge that the study can be carried out rigorously and without errors due to the quality of the data.

The EHDS Regulation for secondary use takes a practical stance on data interoperability. Rather than mandating universal standardisation, it accepts data as it exists (in primary use) while allowing necessary transformations to be made on an ad-hoc basis for each approved application or request. This approach recognises the reality of diverse health information systems while still enabling productive data utilisation.

By embracing these principles, the EHDS creates a framework that unlocks the tremendous potential of health data while respecting individual rights and ensuring ethical usage. This balanced approach may well become the global standard for responsible health data governance in our increasingly data-driven healthcare landscape.

Written by: Rodrigo Ortega Izquierdo, Laura Juvé Sánchez