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What is data altruism under the EHDS?

The European Health Data Space (EHDS), Regulation (EU) 2025/327, entered into force on 26 March 2025. It is often described as opening a “data altruism” pathway: a legal route for people who want to contribute their health data to research. The route exists, but it is not written in the EHDS itself. Data altruism is defined and organised by the EU Data Governance Act, Regulation (EU) 2022/868: the voluntary sharing of personal data, on the basis of consent, for objectives of general interest such as scientific research, without reward beyond the compensation of costs.

Where it fits in the EHDS

The EHDS creates a common framework across all EU Member States for two uses of health data. Primary use is your own care: patient summaries and e-prescriptions that work across borders. Secondary use is public health, policy, research and the improvement of care, and it runs through data permits issued by national Health Data Access Bodies rather than individual consent; the word “consent” does not appear in the secondary-use chapter. Individuals keep a right to opt out of secondary use at any time, without giving a reason.

Data altruism sits beside that administrative system, not inside it. It is a separate, consent-based framework run by not-for-profit “recognised data altruism organisations” registered with national authorities. The EHDS connects to it in two places: recital 78 points to the Data Governance Act for the general rules, organisations handling health data in a secure processing environment must meet the EHDS security requirements, and Health Data Access Bodies must cooperate with the authorities that supervise them.

The timeline is long

EHDS obligations apply in stages. The regulation applies in general from 26 March 2027, two years after entry into force, the date by which Member States must also designate their Health Data Access Bodies. The cross-border exchange of the first data categories (patient summaries, e-prescriptions) and the whole secondary-use chapter apply from 26 March 2029; imaging, test results and discharge reports follow in 2031, with a last stage in 2035. Anyone building on the EHDS is building for the second half of the decade.

What altruism requires in practice

Wanting to donate data is not enough; the donation has to be usable and trustworthy. That requires infrastructure that can:

Health Data Safe already operates this machinery: granular, revocable, auditable consent on open-source infrastructure, each access mediated by a time-limited, purpose-specific consent record. Patients can donate data to research today, years before the regulation’s deadlines, from inside or outside the EU.

For the legal landscape around it, read GDPR, EHDS, nLPD explained. To contribute or partner, see Join as a partner.

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