European Health Data Space (EHDS)

EHDS will create a common space where natural persons can easily control their electronic health data. It will also make it possible for researchers, innovators and policy makers to use this electronic health data in a trusted and secure way that preserves privacy.

An EU regulation establishes the European Health Data Space (‘EHDS’) by providing for rules, common standards and practices, infrastructures and a governance framework for the primary and secondary use of electronic health data. It strengthens the rights of natural persons in relation to the availability and control of their electronic health data; lays down rules for the placing on the market, making available on the market or putting into service of electronic health records systems (‘EHR systems’) in the EU; lays down rules and mechanisms supporting the secondary use of electronic health data; establishes a mandatory cross-border infrastructure enabling the primary use of electronic health data across the Union; establish Access control mechanisms must enable authorization of access to an entire Electronic Health Record or its part. Auditing mechanisms must enable tracking of who accessed what. es a mandatory cross-border infrastructure for the secondary use of electronic health data.

With regards to AAI, the regulation dictates that a natural person using telemedicine services or personal health data access services have the right to identify electronically using eID; may authorize a data recipient to access person’s data or receive it from a data holder; may restrict access to all or part of their electronic health data; and may obtain information which healthcare provider accessed their electronic health data. The regulation also dictates that any and all systems within EHDS must be compliant with eIDAS and NIS2.

Read more

• Proposal for a regulation … on the European Health Data Space

• HealthData@EU Pilot

• EHDS Overview and Roadmap by BC Platforms