European Health Data Space Regulation (EHDS)

Entry into force

The Regulation will enter into force as from March 26th of this year. However, its applicability will be progressive: the general provisions will be applicable as of March 26, 2027, while some specific obligations will not become applicable until March 2029 and March 2031.

Objectives of the Regulation

The main objective of the Regulation is to create a common framework to enable secure, interoperable and efficient access to electronic health data across the EU, both to improve healthcare (primary use) and to foster research, innovation and data-driven policy-making (secondary use).

Among its specific goals, the EHDS seeks to strengthen the control of patients’ health data, facilitating the interoperability of electronic health record (hereinafter, “EHR”) systems, and establishing quality and security standards for data processing. It also promotes the reuse of health data for scientific and social purposes, respecting fundamental rights and the protection of personal data, in line with the GDPR.
 

Scope of application

• Individuals who generate electronic health data

Will have specific rights over their electronic health data as will be covered later in this document.

• Health data holders

Article 2(2)(t) of the Regulation defines health data holders as any natural or legal person, public authority, agency or body that meets the following criteria: