Building the European Digital Health Ecosystem for the Format and the EHDS

The XpanDH project aims to activate and mature the European Electronic Health Records Exchange Format (EEHRxF) ecosystem by fostering digital health innovations and facilitating cross-border interoperability across the EU. Using a Network of Networks approach, XpanDH has expanded stakeholder collaboration in digital health by establishing the Community of Doers (CoD) and the X-Nets. The project employs co-creation methodologies to ensure participatory engagement and created the concept and early versions of tools like the X-Bundles and X-Bubbles to support the maturation and adoption of the EEHRxF. These efforts contribute to building a sustainable, scalable ecosystem that will continue through future initiatives such as the xShare project and the Xt-EHR joint action.

Key Points

• Anyone (individual or organisation) interested in digital health and data sharing across and within European member states can engage and participate, contributing to the creation of better sharing of health data across Europe for the benefit of all.
• XpanDH employed a participatory design methodology in its Network of Networks approach, engaging each healthcare stakeholder type, respecting their specificities in the co-creation of digital health tools and services tailored to the actual needs of patients, industry, hospitals, regulators, etc.
• XpanDH developed these interoperability assets to guide and stimulate the adoption of EEHRxF. X-Bundles aggregate key artefacts supporting health data exchange, while X-Bubbles model real-world implementation scenarios.
• The project’s outputs, including the X-Nets and CoD, will be integrated into the xShare project and the Xt-EHR joint action, ensuring the long-term sustainability and scaling of the EEHRxF ecosystem across Europe.

Introduction

XpanDH is an ambitious project preparing and building capacity in individuals and organisations to be ready to use the European Electronic Health Records Exchange Format (EEHRxF) by establishing a pan-European effort through a Network of Networks approach (Martins et al. 2023). A short video introduction to the EEHRxF can be seen here. The project goal is to help establish, accelerate, and support a mature, sustainable and scalable interoperability environment in Europe for digital health innovations based on the EEHRxF, involving both the supply and demand sides of healthcare provision. It aims to motivate, inspire and support multiple digital health actors involved in Europe to advance the adoption and use of the EEHRxF. This involves working with field examples (through experimentation and the so-called X-Bubbles), aggregating interoperability assets around the EEHRxF (the so-called X-Bundles) and consolidating guidance and recommendations for ongoing and future work on the EEHRxF, also nicknamed “the Format”. Whether you are a healthcare provider, policymaker or technology expert, you can play a crucial role in shaping the future of European digital health. Engage and be part of the community driving the EEHRxF forward.

An ecosystem approach to digital health innovation and the creation of conditions for new cross- and intraborder interoperable environments around a proposed set of standards (the EEHRxF) is different from the EU cross-border initiatives so far which has been mostly government-led. Understanding digital health as an ecosystem means accepting and/or fostering some emerging systemic properties:

• Open innovation
• Multiple leaderships
• Concepts are often as important as action plans
• Governments and official entities can act as coordinators
• Industry and active end-users are involved
• Co-creation spaces are created and need to be populated

XpanDH’s ecosystem methodology was inspired partly by the PatientUp initiative, its collaborative approach, and the concept of health data activism. The XpanDH project’s vision entails a participatory involvement from all relevant end-users, such as patients, formal and informal caregivers, and healthcare and IT professionals, in the implementation, adoption, and dissemination of the EEHRxFIn this vision, these groups are not merely passive recipients, or users of digital services aimed at improving health or healthcare. They are also not simply stakeholders to be consulted in a one-directional manner but are integral participants in the process, from ideation phases and early discussion to revisions of specifications.

XpanDH’s proposal is that key stakeholders should have full access to health data and be called to co-create the AEIOU (Accessible, Engaging, Interoperable, Operational and Useful) digital health tools of the future. This participatory design approach has two main implications: 1) all key stakeholders are actively involved in the co-creation of the EEHRxF ecosystem in all project phases, and 2) the consortium ensures the necessary flexibility and openness to manage potential changes and needs that arise from the co-creation, to ensure real acceptance (Bowen et al. 2013; Boyd et al. 2012; Thabrew et al. 2018).

Co-creation as a Vector of Ecosystem Activation

Co-creation was first introduced as a term for marketing purposes in the collaborative design of new products and services. Several authors and researchers have contributed to proposing methodological approaches and models (De Koning et al. 2016).

It is a collaborative process where multiple stakeholders engage in the design and delivery of products or services, enhancing value within ecosystems (Eckhardt et al. 2021). It is not limited to science; it spans various sectors, promoting collaborative efforts that strengthen community engagement and innovation. In platform ecosystems, co-creation leads to increased sales and business performance for small vendors, highlighting the economic benefits of collaborative partnerships (Ceccagnoli et al. 2012). This approach fosters innovation and responsiveness to user needs, particularly in complex environments like healthcare (Indurti et al. 2023). Co-creation offers several advantages for ecosystem activation, including increased EU competitiveness in healthcare delivery and digital tool deployment as compared with competing regions.

Co-creation relies on active stakeholder engagement, which encompasses behavioural, cognitive, and emotional dimensions. This engagement leads to cooperation and collaboration, ultimately resulting in co-creation, which is essential for activating ecosystems (Viglia et al. 2023). In healthcare, involving diverse stakeholders—patients, providers, and policymakers—ensures that services are tailored to actual needs, enhancing overall effectiveness (Adlakha et al. 2020). While co-creation offers significant advantages, it can also present challenges, such as managing diverse stakeholder interests and ensuring effective communication. Balancing these dynamics is crucial for successful ecosystem activation. Using co-creation, the XpanDH method applied a democratic participatory strategy to growing the EEHRxF and the pan-European digital health ecosystem.

XpanDH has made the creation, maintenance, and stimulation of a pan-European digital health ecosystem centred around the EEHRxF one of its core objectives. By fostering co-creation and collaboration through both the X-Nets and the Community of Doers (CoD), XpanDH has employed a participatory, multi-stakeholder approach to address the diverse needs of healthcare systems across Europe. This strategy ensures that all relevant actors, from policymakers and healthcare professionals to patients and developers, can contribute to the adoption and refinement of the EEHRxF. The engagement of these stakeholders is essential to achieving a scalable and sustainable ecosystem capable of evolving with the ongoing challenges and opportunities in digital health. The next sections will focus on the practical implementations of this approach, beginning with the X-Nets and followed by the CoD.

The X-Nets

Definition of X-Nets

XpanDH operates as both a Network of Capacity, helping organisations assess their readiness regarding the necessary interoperability assets for EEHRxF implementation, and a Network of Action, enabling large-scale and pan-European collaboration through the deployment of X-Nets. These networks represent a collection of organisations from EU Member States, united by common interests and objectives, actively participating in the broader pan-European digital health landscape.

Concept of X-Nets

The concept of X-Nets is grounded in the need to promote the adoption of the EEHRxF across multiple sectors of the healthcare ecosystem. Each X-Net connects stakeholders who share common features and likely have a relatively homogenous set of interests in digital health and interoperability, creating a space for collaboration and idea-sharing. X-Nets are designed to foster innovation and accelerate the practical implementation of the EEHRxF by enabling cross-border and cross-sector collaboration and are inspired by the Hospitals-on-FHIR (HoF) initiative launched in 2022 (Martins et al. 2022).

The operational mechanism of each X-Net is flexible and not set in stone, but some attributes are key. First, it is led by an “activator” responsible for initiating and maintaining the network. These activators (ten partners from the XpanDH consortium) manage the network’s assembly and coordinate activities, such as online and in-person workshops, webinars, and focus group discussions. X-Nets engage stakeholders through various communication channels, including newsletters and social media platforms, to ensure continuous interaction and idea exchange. As X-Nets mature, they become increasingly self-sustaining, as exemplified by HoF X-Net chair and co-chair assignment to two hospitals in Italy and Portugal, allowing stakeholders to take ownership of their development and long-term goals. The collaborative nature of X-Nets supports the ongoing creation, refinement, and dissemination of digital health solutions across Europe.

The XpanDH project adopted a systematic X-Net strategy, acknowledging the diverse expertise, experiences, and expectations of stakeholders involved in digital health and health data exchanges. To ensure effective engagement, the X-Net outreach strategy was customised for each stakeholder group based on the following characteristics:

Type of Institutions Involved: Identify typical institutions that form the core of each X-Net group, including both physical and legal entities. These institutions range from hospitals, research organisations and patient associations to IT firms, government bodies, and regional health authorities and regulators, ensuring broad representation across the health data landscape.

Influence and Impact: Recognise the varying levels of influence and impact that different stakeholder groups can exert on the digital health ecosystem. Some groups, such as regulators or hospital networks, play critical roles in decision-making processes, while others may be more focused on operational or advocacy functions, or be in a traditional position of receivers. Understanding each group’s influence allows for targeted engagement strategies.

Barriers to Engagement: A key element of the X-Net strategy is identifying and addressing potential barriers to engagement. These can include a lack of awareness, perceived complexity of the EEHRxF, or limited resources to adopt new technologies and/or create a framework for the upskilling of the future workforce on digital skills. By understanding these barriers, XpanDH can develop targeted solutions to mitigate them, such as offering training, simplifying processes, or demonstrating quick and mutually beneficial wins to encourage active participation.

Stratification: To further refine outreach efforts, some X-Nets, such as the Patient Associations, are broken down into specific sub-groups based on factors such as geographical region, operational focus, and organisational type when applicable. This stratification enables the project to address the unique needs and characteristics of different sub-groups within a larger stakeholder network, ensuring more precise and effective communication.

Concrete Benefits from XpanDH/EEHRxF: Provide each stakeholder group with a clear outline of the tangible benefits and added value that participation in XpanDH and the adoption of the EEHRxF offer. Whether through enhanced interoperability, improved patient care, or streamlined research opportunities, stakeholders are able to share how the X-Net and the EEHRxF can meet their specific needs.

Engagement with own Community: X-Nets are encouraged to interact within their own community networks by leveraging established communication channels and producing relevant content tailored to their audience. Whether through webinars, newsletters, or collaborative forums, the X-Nets aim to engage stakeholders in ways that resonate with their organisational culture and sector-specific challenges.

Specific Engagement Methods for X-Net: Each X-Net agitator uses tailored engagement methods based on the characteristics of the group and the intended outcomes. For example, patient associations might require advocacy-driven, participatory approaches, while regulatory bodies may focus on compliance and governance-oriented engagements. The rationale for these methods is grounded in the stakeholders’ role within the ecosystem and their potential to drive the adoption of EEHRxF.

Relations with Other X-Nets: The X-Nets are not isolated entities. Their relations with other X-Nets are carefully considered, as collaboration across networks can amplify their collective impact. For instance, the HoF network may work closely with the Professionals Associations and Biomedical Research groups to align clinical data sharing with research objectives. In this line of thought, various multi-stakeholder focus group workshops have been organised online that brought together multiple representatives of each X-Net, making different stakeholder groups join forces. These “Network of X-Nets” efforts will culminate in an in-person gathering in November 2024 in Brussels.

(Potential) Members: Each X-Net has a defined set of current and envisioned members, with participation spanning a broad range of organisations across Europe. Regular updates are made to this membership list to reflect new partnerships, emerging stakeholders, and ongoing initiatives that align with the objectives of XpanDH, in order to continuously enable X-Nets to grow in numbers.

The X-Nets collaborate through online and in-person workshops. They stimulate the ecosystem via newsletters and LinkedIn. X-Nets are resource networks that may be engaged in a variety of ways, such as inviting stakeholders to events or setting up consultations. Examples are workshops held at prestigious conferences like the Madeira Digital Transformation Week or the EHMA annual conference, where many stakeholders convene to deliberate on the most recent advancements in the field of digital health and beyond. To ensure cross-collaboration and representation, X-Nets also convene multi-stakeholder focus group sessions. The forthcoming Brussels event (more info on the XpanDH project website), which will take place on 14 November 2024, immediately after the Second EEHRxF Expert Summit, is a good example of this kind of cooperation. It will bring together representatives from all X-Nets for an in-person strategic summit aimed at promoting deeper integration and strategic planning among the networks’ activities.

Overview of X-Nets and Focus Areas

XpanDH has established ten X-Nets, each focused on a specific area within the healthcare ecosystem. Table 1 lists the ten X-Nets, their description, and the number of their gatherings to date. These networks bring together a diverse range of stakeholders, and their development varies depending on their focus and the needs of their members.

Each X-Net has progressed at a different rate, but all networks have engaged in one or more gatherings, enabling cross-collaboration and fostering the growth of the EEHRxF ecosystem. The Citizens and Society X-Net sparked debates on individual and civil rights and EHDS (European Health Data Space) regulation, while the ERNs X-Net gathered nearly all existing European Reference Networks, generating interest in EEHRxF for rare diseases. Health Managers and Health Authorities X-Nets played key roles in disseminating updates, refining strategies, and aligning policies on digital health. HoF focused on FHIR standard implementation in around 70 hospitals across several countries, and Innovation Hubs promoted awareness of EEHRxF’s potential for innovation. HoF has approved a maturity model to be followed by hospitals and other healthcare providers willing to be ready to use these technical standards, which lay at the core of the Format (Martins et al. 2022).The Patient Associations X-Net tailored its approach to a Member State to overcome language barriers (events in French, German and Portuguese), and the Industry X-Net contributed to the co-development of the XpanDH Readiness Model, ensuring industry alignment with EEHRxF adoption. Collectively, these networks drive ecosystem activation and collaboration for the future of digital health.

Membership and Participation in X-Nets

Joining an X-Net is an inclusive and open process. Stakeholders from various sectors, including healthcare providers, patient associations, industry representatives, and policymakers, are invited to participate in XpanDH’s X-Nets. Participation can be initiated through direct engagement with network activators by attending workshops, webinars, and events hosted by XpanDH or simply by reaching out to the authors of this paper and to the project coordinator.

X-Nets also maintain communication through newsletters, social media platforms, and other collaborative forums, where potential members can learn about opportunities for engagement. Each X-Net encourages stakeholders to invite others from their professional networks, helping to expand participation and influence. Major events, such as the Second EEHRxF Expert Summit in Brussels in November 2024, provide further opportunities for stakeholders to join and collaborate with existing X-Nets. Don’t wait—become a member of this growing network. If you are working in healthcare, technology, or related fields, you can join an X-Net today and help create solutions that will shape the future of interoperable health data exchange in Europe. Visit our website or contact the authors to learn how you can participate in this critical effort.

The Community of Doers (CoD)

As the other aspect of its collaborative approach, XpanDH operates through the Community of Doers (CoD), which comprises the Co-Creation Community of Patients, Professionals, and Programmers (or other Internet Service Providers and developers). This community seeks to bridge the long-standing divide between these three categories of digital health players, which has posed serious challenges to the development of useful tools and services for patients and providers alike. The CoD fosters a participatory, bottom-up approach to the co-creation of digital health tools and services, ensuring that the needs and values of end users are central to the development process.

Concept of the CoD

An inclusive pan-European environment requires mutual understanding, a shared repertory, and a common language. The “3C- 3P” community was founded on, but it extends beyond, the previous OpenNCP (Fonseca et al., 2015) community concept that was developed in epSOS (Europe Launches Its Health Data Exchange Pilot EPSOS 2008). The CoD is rooted in a participatory design approach where end users’ input is crucial from start to finish. Since end users are the ones who ultimately use the developed service and/or benefit from it as patients, this is a method of directly gathering ideas and feedback from business owners and users. This aims to increase the likelihood that the service or deployed solution will be adopted. The effectiveness of a digital solution in a healthcare setting depends on how well patients and professionals use it. The intent is to create value from the earliest stages of design. Establishing this community followed an opensource community and collaborative approach (Boyd et al. 2012; Thabrew et al. 2018), inviting end-users to participate and support developers, and was framed by the patient participation from a Personal Health Data Space perspective (Moen et al. 2022).

How does CoD work?

In the context of XpanDH, the CoD focuses on bottom-up research and the definition of new or revisited use cases with the active participation of end users, looking at new concepts and innovative use of the EEHRxF. The approach is to define real-life needs where the adoption of the EEHRxF would provide added value to all stakeholders, with the notion of jointly developing an end-to-end service that adheres to the principles of the recently adopted European Health Data Space law “by design.”

Co-creation brings together those who need service, solution or process with those who can realise it. In our case, we start by bringing together patients’ associations, healthcare providers, and implementers (vendors, academia) to investigate future uses of the EEHRxF in business use cases that reflect real needs. The result is that co-created solutions have a better chance of being adopted and operated by the end users. During the process, we also Iterated with other XpanDH stakeholders to provide feedback on the X-Bundles, expand X-Bubbles, test EEHRxF specifications, build proof of concepts, and review the proposed readiness model. During the CoD working group meetings, we managed to define risks, issues, and problems, as well as opportunities and needs, and foresee the future, trying to mature new ideas and investigate new domains.

The methodological approach used is a 7-step process into the issues and challenges of progressing a new use case, as depicted in Figure 1.

The CoD is organised into Working Groups that seek to form teams of eHealth actors, each with a single main objective: investigating and delivering concrete recommendations for formalising an evolution of the current services in the context of EHDS into new adoption domains or new approaches to the specification of existing data categories. Specifically, there are four working groups, working respectively on the evolution of services for the following use cases:

a. Multidisciplinary tumour boards for cancer patients

b. Electronic prescription, electronic dispensation, and electronic product information

c. Medical imaging for patients; enabling patient-mediated access and view of medical imaging reports

d. Telehealth—Teleconsultation Encounter Report

Overview of the CoD Working Groups and Their Focus Areas

Table 2 briefly provides some information about these four working groups. During the process of operating those working groups under XpanDH, the co-creation processes demonstrated that collaboration and bottomup design are enablers for the design of easily adoptable new innovative services and solutions.

Membership and Participation in the CoD

Participation in the CoD is open to any stakeholder interested in contributing to the co-creation of digital health services that align with the EEHRxF and EHDS frameworks. The CoD encourages continuous collaboration, inviting new members to contribute their expertise and insights, ensuring that the co-creation process remains dynamic and responsive to evolving healthcare needs. The CoD welcomes participation from patient associations, healthcare providers, and IT professionals across Europe. By joining the CoD, you can directly influence the design of digital health tools that meet real-world needs. Your voice matters—whether you’re a patient, healthcare professional, or developer.

Looking Ahead

The work initiated by XpanDH to stimulate the EEHRxF ecosystem is only the beginning. While the project has laid the groundwork with careful planning, strategic development, and stakeholder engagement, the ecosystem will not stop evolving when the project concludes at the end of 2024. XpanDH’s contributions were always envisioned as the first phase of a much larger and longer-term effort to build a sustainable, scalable digital health ecosystem across Europe.

Upon project completion, the established networks— X-Nets and the Community of Doers (CoD)—will be handed over to new initiatives to ensure continuity and growth. The X-Nets will be transferred to and maintained within the xShare project (Expanding the European EHRxF to share and effectively use health data within the EHDS), while the outputs of the CoD will be integrated into the Xt-EHR joint action (Extended EHR@ EU Data Space for Primary Use). More specifically, Xt-EHR will prepare implementation guides, technical specifications, and a conformity assessment framework for the adoption of the EEHRxF at a European Level, effectively informing policy, regulatory, and practical facets of the format’s advances. These projects will not only continue the work initiated by XpanDH but also expand it, developing further tools, guidelines, and technical specifications to facilitate the widespread adoption of the EEHRxF.

However, the potential for these networks goes far beyond these transitions. XpanDH has demonstrated that these functional networks are robust and capable of growing autonomously, driven by the ongoing engagement of their members. As the network effect takes hold, the X-Nets and CoD have the capacity to double, triple, or even multiply exponentially, reaching new stakeholders and further embedding the EEHRxF into the fabric of European healthcare. The groundwork has been laid, but much more can be done in the future.

Through the efforts described in this article, XpanDH has provided a solid foundation. Yet, the true potential of the EEHRxF ecosystem will be realised when these networks take on a life of their own, expanding across Europe and beyond. With the continued collaboration of all stakeholders, the network effect will transform these initial efforts into a self-sustaining, dynamic ecosystem that grows organically, enabling faster and more comprehensive interoperability across borders and sectors.

Conclusion

The XpanDH project has taken significant strides in activating and maturing the European Electronic Health Record Exchange Format (EEHRxF) ecosystem, laying the foundation for a more interoperable and collaborative digital health landscape across Europe. Through the establishment of the X-Nets and the Community of Doers (CoD), the project has demonstrated the power of co-creation and stakeholder engagement in shaping solutions that address the diverse needs of healthcare providers, patients, policymakers, and industry players.

However, the true potential of this ecosystem lies not just in the progress achieved during the lifetime of XpanDH but in its capacity to grow and evolve beyond the project’s conclusion. With the handover of these initiatives to xShare and Xt-EHR, the groundwork laid by XpanDH will continue to flourish, potentially multiplying through network effects and extending its impact across sectors and borders. The success of the EEHRxF ecosystem depends on the continued engagement and expansion of the communities formed during XpanDH’s tenure.

From a scientific perspective, the approaches documented in this article contribute valuable insights into the potential of co-creation, digital health ecosystems, and cross-border interoperability. Future research can build on the experiences and methodologies outlined here, further exploring how such ecosystems can be activated, sustained, and scaled across different healthcare settings. The lessons learned from XpanDH offer rich material for academic discourse, contributing to both practical and theoretical advancements in digital health.

Yet, above all, this paper serves as a call for engagement. Don’t be a spectator in this transformation—be a participant. Join us in building and expanding the EEHRxF ecosystem and make a lasting impact on European healthcare. Contact us now and take your place in the co-creation of Europe’s digital health future. We invite all stakeholders—whether from healthcare, government, industry, academia, or civil society—to join us in building and expanding the common European asset the EEHRxF is. Together, we can ensure that this ecosystem not only survives but thrives, delivering better health outcomes, fostering innovation, and accelerating the digital transformation of healthcare in Europe.

Conflict of Interest

None.