Implementers are keen to work on activities that are taking place in a variety of countries on ways to advance the implementation of the European Health Data Space (EHDS).
Implementers are also eager to know about what dates may affect their work. In 2024, the dates are all about immediate planning, as the European institutions move towards the official publication of the Regulation, likely to be towards the end of November 2024. In 2024, the dates are all about immediate planning, as the European institutions move towards the official publication of the Regulation.
Some longer-term timelines (2024-2026), and onwards - even over the course of ten years - give an indication of a whole decade full of upcoming implementation-related activities.
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⚜️ EHTEL itself is organising an EHDS Implementers Task Force for its members. Ten organisations, members of EHTEL, have already joined the Task Force. Meetings will focus on the primary use of data and concrete implementation aspects of the data space. For example, one topic could be the "harmonised components" that relate to interoperability and logging. Indeed, an overview of interoperability and logging in relation to electronic health records can be expected during summer 2024. Another topic of concern may involve artificial intelligence (AI). If, as an EHTEL member, you want to become a member of this task force, and did not yet signal your interest, please approach Secretary General, Marc Lange: marc.lange@ehtel.eu.
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Many pan-European initiatives, programmes, and projects are also increasingly supporting the implementation and expansion of the EHDS, like xShare.
For implementers' general background: achievements
The European Commission has published a two-page factsheet on core topics related to the EHDS and especially what benefits the date space can offer to five types of stakeholders.
Implementers can already obtain an overview of the state-of-play related to citizens' access to their electronic health records by reading a report on a 2022-2023 survey undertaken in the 27 European Member States, Iceland, and Norway. An update from 31 December 2024 will be available soon.
An informative EIT Health report published in April 2024 covered concrete examples of digital health implementations and ways of unblocking the future path to widespread implementation of the EHDS.
What is happening on the EHDS during 2024?
As indicated earlier, members of the European Parliament approved the general text of the Regulation on 24 April 2024. Four hundred and forty-five (445) members of the then Parliament voted in favour of the text, whereas 142 voted against it and there were 39 abstentions.
During May 2024, the legal linguistic reading followed. (This is the time-period when legal staff in the institutions ensure that the text is correctly written and there are no errors in it.)
On 6-9 June 2024, the European elections took place. It is now anticipated that the EHDS Regulation will be formally adopted - at the same time as several other Regulations - by the end of November 2024.
The Regulation itself will enter into force twenty days after it is published in the Official Journal of the European Union. This is likely to make a nice festive gift for everyone either around Christmas 2024 or the New Year 2024/2025!
Data space activities up until 2030
The final clause (Clause 76) in the preamble of the draft Regulation states that "a staged approach to its implementation should be taken".
Overall, the Regulation is expected to apply 24 months after it has entered into force - probably, in the second half of 2026. (There may, however, be some exceptions to that date.)
Two of the final three articles of the current wording of the EHDS Regulation - Articles 71 and 73 - contain indications of timelines when activities relevant to the Regulation will start to be applied formally.
Other timelines come into operation four years after the entry into force of the Regulation. Yet others come on board six years after entry into force of the Regulation. Thus, their application is likely to be the second half of 2028 and the second half of 2030.
Six years after the EHDS Regulation enters into force, Article 72 of the Regulation refers to the deletion, repeal and replacement, of Article 14 of the Directive 2011/24/EU. (Published on 9 March 2011, this document entitled the "application of patients' rights in cross-border healthcare", included a specific article (14) related to the operation of a voluntary network called the eHealth Network.)
Annual evaluations of progress, and more
Annual reports are anticipated on the progress made on the implementation of the Regulation. The reports are to be put together by the European Commission, taking into account information provided by the Member States.
Eight years after entry into force of the Regulation, the European Commission is committed to undertaking a targeted evaluation of progress made on the EHDS. (This activity is therefore likely to occur in the second half of 2032.)
Ten year after entry into force of the Regulation, the European Commission will carry out an overall evaluation of it. The findings will be submitted to all the relevant European institutions e.g., the European Parliament, the European Council, the European Economic and Social Committee, and the Committee of the Regions. (This activity is therefore likely to occur in the second half of 2034.)