EHDS timeline: 2025–2035
When does each EHDS obligation start to apply? All dates in one overview: for primary and secondary use.
The European Health Data Space has been in force since 26 March 2025, but its provisions apply in phases. Article 105 of the regulation specifies which obligations apply and when. This page outlines the timeline.
26 March 2025 — entry into force; getting started
The regulation was published in the Official Journal on 5 March 2025 and entered into force twenty days later. Preparatory periods began at this point; no obligations currently apply to healthcare providers or data holders.
26 March 2027 — public authorities must be ready
By 26 March 2027 at the latest, Member States and the European Commission must have completed various preparatory steps. Member States must designate supervisory authorities for primary and secondary use. The European Commission must elaborate—via secondary legislation—the requirements that healthcare ICT systems, among other things, will have to meet.
26 March 2029 — shared start for primary and secondary use
Primary use: initial categories. The rules regarding patient access to their records and interoperability will apply to the initial categories—essential patient data, electronic prescriptions, and electronic dispensations—and to the EHR systems designed for those categories.
Secondary use: Chapter IV largely enters into force; this includes the data submission obligation for data holders, the National Catalogue, the opt-out mechanism, the data permit and statistical request processes, and other provisions. From that date, the HDAB can request data for research, policy, and innovation purposes.
26 March 2031 — second wave
Primary use: other categories. The same rules will apply to medical imaging diagnostics and image reports, medical test results (including laboratory results), and discharge reports—again, including the associated EHR systems.
EHR systems already in use: Chapter III applies to EHR systems put into service in the Union before that date.
Secondary use: including sensitive data. The HDAB system is also implemented for: data on factors influencing health; human genetic, epigenomic, and genomic data; other human molecular data, such as proteomic, transcriptomic, metabolomic, lipidomic, and other “-omic” data; data from clinical trials, clinical studies, clinical investigations, and performance studies; and data from research cohorts, questionnaires, and health-related surveys.
26 March 2035 — third countries
Article 75(5) applies: the provision regarding the connection of third countries (where privacy standards are high—likely those covered by an adequacy decision) and international organizations, which may participate as authorized participants in the HealthData@EU system.
What does this mean for your organization?
It is safe to assume that an organization managing health or care data will be classified as a data holder in 2029. Preparation—identifying the data you hold, determining which Article 51 category applies, and establishing who the data controller is—typically takes more than a year. See also: When does the EHDS enter into force? and What is the EHDS?
Do you have questions about what this data means for your organization? Please contact us.
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