The groundwork is being laid for several aspects of the implementation of the European Health Data Space (EHDS). The activities involve the preparation of various implementing acts.
Preparatory work on the EHDS is already underway. Several developments that will support the EHDS will need to take place through implementing acts produced by the European Commission.
Implementing acts are often developed by the European Commission when activity in a particular field throughout Europe needs to be implemented in a uniform manner. To prepare these acts, the Commission has to consult with the Member States. This consultation is likely to happen through approaches made to suitable committee(s). For more information on the implementing acts, go to Implementing acts: What are the relevant timelines?
Two relevant Joint Actions
Considerable preparatory work is today taking place through Joint Actions. Joint actions are European initiatives that involve large-scale combinations of European Member States and that focus on dedicated activities. They are chiefly organised by the Commission's Directorate-Health called DG Health.
Among these Joint Actions is one that focuses on the primary use of health data, and another that concentrates on the secondary use of health data. They are XT-EHR and TEHDAS2:
XT-EHR, and the primary use of electronic health data
Launched in November 2023, this Joint Action contributes to laying the groundwork for the improved primary use of electronic health data, particularly in anticipation of the upcoming EHDS Regulation. In total, the action will run for 30 months.
The action involves some 25 European Member States. Each is represented by between 1-5 Ministries, competence centres, not-for-profit organisations, and universities.
The action's work focuses on the primary use of electronic health data, mainly "for the provision of healthcare to assess, maintain or restore the state of health of the natural person to whom that data relates ...".
Two areas on which XT-EHR concentrates are interoperability and the exchange of healthcare data.
XT-EHR's aim is to produce several sets of guidelines in important domains like compliance, implementation, interoperability, and telemedicine. These guidelines will serve to build the foundations of the eventual implementing acts.
XT-EHR is co-funded by MyHealth@EU, Europe's eHealth Digital Service Infrastructure.
TEHDAS2, and the secondary use of electronic health data
TEHDAS2 started in May 2024. The Joint Action provides a logical follow-on to earlier work conducted to prepare the EHDS.
The action is preparing the ground for the harmonised implementation of the secondary use of health data in the EHDS. It involves 29 European countries and over 60 organisations.
The action concentrates on creating guidelines and technical specifications to enable the smooth cross-border use of health data. These guidelines and specifications are aimed at data holders, data users, and the new health data access bodies (entities that will be set up by European Member States once the data space comes into force). One of the new health data access bodies roles will be to provide access to health data for research, innovation, and policymaking (i.e., the secondary use of data).
The action focuses on many aspects of the secondary use of health data, such as making health data available.
The initiative is working alongside the HealthData@EU Pilot, a project which is testing the EHDS European cross-border infrastructure in respect of the secondary use of data.
Implementing acts: What are the relevant timelines?
An eHealth Stakeholders group meeting held in February 2024 indicated the indicative, overall timelines during which the eventual implementing acts will be operationalised. It is expected that the detail implicit in these implementing acts will have been completed by the first few months of 2026.
Details on what are called "EHDS1" and "EHDS2" were shared with the attending stakeholders. EHDS1 stands for MyHealth@EU, and therefore for the cross-border exchange of patients' data (i.e., the primary use of data). EHDS2 refers to HealthData@EU and the piloting of an infrastructure for the secondary use of data.
These graphics include pointers to the timelines affecting the development, pilots, scaling-up, actual operations, and the types of sources of funding - such as direct grants and Calls for Tender - of the two sides of the data space.
More general information on the EHDS's broad timelines are available.
In the meantime, more than 10 EHTEL members are collaborating together on an EHDS implementers' task force. More news out soon on the task force's planned November 2024 launch webinar!