EHTEL’s European Health Data Space (EHDS) implementers' task force was launched online on 5 November 2024. An overview of the future and application of the EHDS was given. A panel of five representatives followed: they came from several types of stakeholders and offered their opinions on current main challenges. A lively discussion ensued – often online. More than 30 other participants were in attendance.

It is obvious that there are plenty of implementation challenges facing people who will need to implement the EHDS over the upcoming decade. The dilemma: Which priority challenges to focus on? How to function as an eco-system? 

Practical next steps and actions

• Take action by 10 January, 2025: Task force members and attendees are invited to respond to this poll on priority next steps and concerns on EHDS implementation.
• A second EHDS task force meeting will be held in the first half of 2025.

Ultimately, the task force will hold two future meetings in the first half of 2025 (one during Q1, another in Q2).

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Watch the kick-off meeting video and download the meeting's presentations below, in the Resources section ⤵️

Introduction

The focus of this implementation task force meeting was on capturing stakeholders’ experiences and opinions, chiefly on the actual implementation of the EHDS. One focus was on Member States (countries)’ implementation of the EHDS. Another showed how an EHDS-based ecosystem needs to face a range of challenges.

This brief report introduces the main messages of the task force launch; the main challenges foreseen to European Health Data Space (EHDS) implementation by a diversity of stakeholders; and other stakeholders’ main questions and suggestions. Attendees have several upcoming opportunities, led by EHTEL, in which to explore various aspects of the EHDS.

The potential next steps for the implementation task force to undertake are now explored through an online poll. Fill it in before January 10, 2025.

Marc LANGE (EHTEL General Secretary) and Michael STRÜBIN (EHTEL digital health specialist) co-led and co-organised the task force launch.

EHDS background provided by the European Commission

European Commission officer in DG SANTE, Ander Elustondo JAUREGUI, introduced the background to the EHDS and its status. His 30-minute talk offered a clear overview of the preparation and planning taking place for the space. Running through a detailed set of PowerPoint slides, Ander introduced the purposes of the EHDS and the benefits that the space can offer. Two of the priority categories of data that the space will cover include “basic” data (related to its primary use) and “advanced” data (associated with its secondary use). Key areas of importance are interoperability and logging (called “harmonised components”) and the certification of systems, environments, and electronic health records. Ander was keen to describe both how the future governance of the EHDS implementation will function (and its shift forward from past arrangements), and the timelines for implementation of the EHDS Regulation over a broad 12-year period – now estimated to be until 2036.

More precisely, in terms of the EHDS governance (see the graphic below):

The Implementation Acts will be adopted by the European Commission. This will be under the control of a Comitology Committee (specific to the EHDS: hence, the committee has still to be created).

The EHDS Board, and its predecessor, the eHealth Network, will not play a formal role in the adoption of the Implementation Acts but will be involved in their preparation.

Likewise, the Stakeholder Advisory Forum, and its own predecessor, the eHealth Stakeholder Group, may be consulted on the Implementation Acts.

Several European Union-financed projects are, or will be, running that can define, and test, the concepts and technical specifications needed for these Implementation Acts.

Main EHDS implementation challenges facing different types of stakeholders

A variety of types of stakeholders provided their opinions on the challenges ahead for EHDS implementation. The stakeholder types included representatives from a national centre responsible for the certification of digital health platforms, services, and messaging (a competence centre); a European member state health authority; a commercial firm which provides many digital health solutions and often acts on behalf of a state or a country’s regions; a provider institution; and a patient/citizen organisation.

Their presentations signalled a range of experiences and approaches. They indicated: what countries can learn from each other (knowledge acquisition); how EHDS implementation challenges differ depending on past (legacy) and current experiences; what industry players perceive as EHDS-related challenges and which EHDS-related solutions are likely to work easily or not. The challenges included difficulties faced by the people involved in the process, “the human factor”, and/or posed when artificial intelligence (AI) is used to support the implementation of the primary use of health data. The session also explored what help and what data citizens/patients are themselves eager to contribute to EHDS implementation.

Inputs on EHDS implementation challenges from specific stakeholder types: A round table

Participating in a round table, each of the five stakeholder representatives expressed their opinions on the challenges for EHDS implementation. They did so from the perspective of their own type of organisation. All the meeting’s PowerPoints are available to attendees.

A competence centre perspective

Michael JOHANSEN, MedCom (Denmark) outlined Denmark’s extensive experience with the certification of digital health. Many achievements have been accomplished, including a national service platform, services, and messaging. The country’s experience includes involvement in some European projects/initiatives that focused on digital health (previously eHealth) e.g., Antilope. Mr Johansen highlighted that there are many challenges for a country/system with up to three decades of experience in the field. These include the expense/financing required, and complexity, for a testing/certification body which needs to comply with two forms of legislation: international (European) legislation and national legislation.

Ahealth authority (health ministry) perspective

Klára JIRÁKOVÁ spoke on behalf of the Ministry of Health (Czechia) and described the progress that the country has made over the past decade in the field of digital health. The country has found it of considerable use to get involved in sharing information and experience with others: this has really “paid off”. The country has several strengths, including ePrescribing. Despite this progress, EHDS implementation will still present considerable challenges, including the many ways that data is handled (e.g., its current decentralisation, lack of structure, and lack of coding); the lack of institutions (e.g., hospitals) and the shortage of IT professionals with expertise in relevant fields.

An industry perspective

Brikena KOLAJ, from Engineering Informatica (Italy), the industry panellist listed, and described in detail, 10 challenges facing industrial players. Almost all of the 10 difficulties were, in several ways, also raised by her fellow panellists. Attendees later, however, proposed prioritising the items on the list of challenges, including reducing the overall length of the list.

A provider perspective

Sabato MELLONE, a Bologna University researcher (Italy), spoke of his past and current involvement in a several European and Italian projects and viewed the EHDS from a provider perspective. One example was that of the DARE Foundation,  which works on maximising the use of data to facilitate disease prevention. His work includes numerous interactions with healthcare providers and industry. He foresees the EHDS as being “very messy in [its] first few years” of existence. His focus was on the frequent lack of involvement/understanding of the “human component” in research/information systems development, and the challenges facing personnel/members of the workforce in domains like data entry and coding. He expressed scepticism about the role of legislation in ensuring compliance, and a pervasive lack of realism about “expecting this entire process to be sustainable without local investments” – including for work on artificial intelligence (AI).

A patient organisation perspective

Shane FITCH, Director of the Lovexair Foundation (Spain), a not-for-profit organisation with a focus on the support of patients/people with respiratory conditions, emphasised the importance of patient and citizen data-sharing. Her many questions on challenges centred around the potential for such organisations in being ‘behind the curve’ on developments; having to fit in with new systems; the difficulties of being in contact with national contact points; promoting and strengthening several ways forward; and some general concerns about calendars. Nevertheless, what came through strongly was the overall willingness of patients/citizens to get involved in implementing the EHDS. She concluded, however, that today: “For everyone, there are more questions than answers!”

Questions posed and discussions raised

A wide variety of questions were posed to the European Commission speaker, the panellists, and more generally. They included issues focused on handling legacy; dealing with knowledge acquisition; facing “the human component;” and the possibility that AI adds complexity when it is introduced to help with EHDS implementation.

Main meeting outcomes

A core suggestion that emerged from the launch meeting was for the task force to prioritise the items in the list of the (10) actual implementation challenges cited by the stakeholder types. A “step-plan” could then be developed to allocate time to exploring these challenges. The task force could also refine (shorten) the list of challenges/steps involved.

Ultimately, the task force will hold two future meetings in the first half of 2025 (one during Q1, another in Q2).