You may already have seen mention of a new project on Expanding Digital Health across Europe – the XpanDH project. CEN/TC 251 is proud to be involved in the XpanDH project, which kicked off early in 2023. This project aims to expand the use of the European Electronic Health Record Exchange Format (EEHRxF) for use in Digital Health across Europe and beyond.

The EEHRxF was established following a recommendation from the European Commission in 2019. Drafted during the X-eHealth project, it is expected to form the cornerstone of the European Health Data Space as soon as the proposed regulation has been accepted by the European Parliament and the European Council and formally published. It also is at the heart of the MyHealth@EU infrastructure for cross-border health information exchange.

CEN/TC 251 experts actively participate in the following XpanDH work packages:

• WP2 – Standards & Technical artefacts, led by HL7 Europe
  CEN is in the lead for T2.3 – Technical requirements for quality labelling of consumer health products and EHR systems. The work builds upon the CEN/ISO TS 82304-2 Quality and Reliability of Health and Wellness Apps, and plans to extend its scope to EHR systems as well. Our role includes editorial responsibility for the deliverable and other artefacts to be produced. We are also participating in T2.1 and T2.2 to provide the necessary links to work on CEN/TC 251 standards.
• WP3 – Organisational Readiness, led by IHE Europe
  We are participating in tasks 3.1 and 3.2 which define the readiness model for the adoption of the EEHRxF within and across organisations, and the process feedback loop to improve upon the model.
• WP4 – Feasibility & Experimentation, led by UNINOVA
  We are participating in task 4.2 to support the feasibility demonstration regarding the outcomes of
  WP2, and specifically T2.3

Should you have any questions or interest in participating, please don’t hesitate to reach out to CEN/TC 251 Chair, Robert Stegwee. We have set up a Review Group for this project within CEN/TC 251, to share insights, progress, and solicit comments on draft deliverables from the project. Should you wish to become member of this Review Group, please make sure you are a designated representative of your national standards body and inform the TC 251 secretariat of your interest in joining.

Below we include a press release on the first XpanDH consortium meeting in February 2023 in Lisbon. More information can also be found on the recently launched XpanDH website.

 

Press release: the XpanDH project kicked off on 15 and 16 February 2023

ISCTE Knowledge and Innovation Centre, together with 25 other European partners, launched the most recent European-funded project, “XpanDH: Expanding Digital Health through a pan-European EHRxF-based Ecosystem” in Lisbon, Portugal. The in-person gathering of research organisations, businesses and intergovernmental and multistakeholder associations marks the consortium’s grand undertaking to mobilise and build individuals’ and organisations’ capacity to create, adapt and explore the purposeful use of interoperable digital health solutions based on a shared adoption of the European Electronic Health Record Exchange format (EEHRxF).

On 15 – 16 February, the XpanDH consortium held an in-person kick-off meeting in Lisbon (Portugal) to discuss how to implement the promising project. In line with the focus of the European Health Data Space on unleashing the full potential of health data in Europe, the two-year project will concentrate on leveraging an established network of networks and a vibrant ecosystem to support the adoption of the European Electronic  Health  Record  Exchange  format.

XpanDH will trigger genuine and participatory involvement from all relevant end-users – from patients and caregivers to professionals and more – in the implementation and dissemination of EEHRxF. Compounding this impact will be the consortium’s capacity to ensure the necessary flexibility and openness to manage potential changes and needs that arise from the co-creation process, to ensure real acceptance.

Helping to Deliver a Sustainable and Scalable Interoperability Environment at an Opportune Moment in the European Union (EU)

The arrival of the XpanDH project comes at a unique time for the European Union.

Member States (MS) have taken various measures to lay the common groundwork for eHealth interoperability. Following the success of the established eHDSI and its “MyHealth@EU” services, as well as the Digital COVID Certificate, the EU can now use standards to define interoperable and cross-border services amongst MS. At the same time, the European Commission is proposing a regulation to set up the European Data Health Space, which aims to provide better digital access to personal health data; enhance the data economy via a genuine single market for digital health services and products; and set up strict rules for the use of individuals’ non-identifiable health data for research, innovation and more. Finally, as part of the Communication on Digital Transformation of Health and Care (DTHC 2018), the European health record exchange format took effect in 2018.

Yet, despite these advances, challenges remain. Large-scale adoption of interoperable solutions between healthcare provider (HCP) organisations inside or between MS await agreement on common definitions that could be applicable at both an intra- and inter-organisational level. Similarly, following the COVID-19 pandemic, a dire, growing need has arisen for European digital health actors to converge on familiar, usable, and reliable tools for real interoperable services that enhance healthcare cooperation for better health and European healthcare solidarity.

This is where the 1.97M-Euro project comes in. XpanDH understands the current environment as it relates to eHealth. It has made it its commitment to execute a “network-of-networks” approach that would ensure digital health actors find the motivation and support to help early adopters advance to the concrete use of EEHRxF-embedded digital health solutions. Through these means, health and care can count on added value, and Personal and European Health Data Spaces can grow in strength.

Taking Action to Empower End-Users to Receive and Maximise Health Data for Better Care

To achieve the aforementioned, XpanDH will embark on four undertakings.

These include establishing and sustaining a scalable public infrastructure for digital health innovation; demonstrating the feasibility of real-life interoperable digital solutions for cross-border use by individuals, researchers, health services and the workforce; creating and fostering a Pan-European ecosystem of digital health; and conceiving and validating a framework for enabling further exploitation of the public infrastructure for digital health innovation. As a special feature, the project will produce X-bundles, an aggregation of interoperability assets that support the connection of health systems in different ways, based on EEHRxF specifications.

As XpanDH Coordinator Henrique Martins of ISCTE says “…the development of X-bundles will establish common ground for eHealth interoperability by using common international standards and established connections to ensure that the exchange of health data takes place smoothly. It will benefit all European citizens who use MyHealth@EU services, which currently feature prescription/eDispensation, patient summaries and, in the near future, laboratory reports, imageology and hospital discharge letters, as specified in the EEHRxF specifications.”

Lastly, the consortium will build on past and ongoing eHealth interoperability projects and services, and particularly on the X-eHealth and DigitalHealthEurope project recommendations, through digital health data activism and strong patient engagement.

Together, the 26 digital health partners will bring about the much-needed change in the health data domain to ensure better care for all.

Follow XpanDH on Twitter and LinkedIn for continual information about the project.