December 1, 2023 marked a significant milestone in the European digital health landscape as the xShare project officially launched a consortium of 40 partners, aiming to introduce the xShare ‘yellow’ Button and industry label to the European market. The ‘yellow button’ will allow us to share our health data in the European Electronic Health Records Exchange Format (EHRxF) as noted in the upcoming European Health Data Space (EHDS) regulation.
xShare proposes that with the click of the ‘yellow button’, featured across health portals and digital health apps, we will exercise our data portability rights under GDPR and download our health data in a computable format, the European EHRxF. Thus, the vision of the EHDS will be realized and with the ease that we share images on our mobile, we will share our health data across primary care, population health and clinical research for safe, trusted and informed care.
European trade associations take the lead in EEHRxF with the xShare ‘yellow’ Button
The xShare Industry Label, associated with the xShare ‘yellow button’ will provide certainty for products being conformant to the European EHRxF. The feasibility of the xShare Industry Label will be explored under the leadership of DIGITALEUROPE with support from MedTech Europe.
Creating the European EHRxF Standards and Policy Hub to support the xShare Label
The European EHRxF Standards and Policy Hub, led by Robert Stegwee of CEN/TC 251, will be established to support the sustainability of the xShare label and the format itself. The Hub will support the xShare label with specifications, tools, and services in the form of X-Bundles. Six standards development organizations (SDOs) are currently part of the Hub: CEN/TC 251, HL7 Europe, IHE Europe, SNOMED, CDISC, and IEEE. We will ensure collaboration with competence centres, industry and regulator representation, as well as other SDOs
Monitoring adoption of the EEHRxF and Capacity Building for the Digital Decade 2030
Significant efforts will be invested in monitoring adoption and capacity building activities led by Veli Stroetmann of empirica and Professor Henrique Martins of ICSTE respectively, in close cooperation the XpanDH coordination and support action and the Xt-EHR Joint Action. In fact, part of the budget will be invested in incentivising the implementation of the ‘yellow button’ in digital health applications across Europe (GNOMON and UNINOVA), population dashboards (EHTEL and Charité), and clinical research (i~HD and EUCROF).
Early Adopters- taking Action to Empower Individuals, Health Systems and Businesses
Eight early adoption settings across Europe have already been confirmed: in a hospital network (Tuscany, Italy), national apps (Greece, Ireland, Cyprus), regional network with emphasis in medical tourism and the connection of the public to the private sector (Catalunya and Madeira), clinical research applications in the myHealthSpace ecosystem of France (TTSA, GNOMON).
The ambition of xShare button is to establish the European EHRxF as the common element of healthy digital health ecosystems across Europe. Part of the xShare budget will be used to incentivise adoption of the format by innovative European companies across all member states. This will be combined with investing in capacity building and digital skills to ensure that “EEHRxF becomes “glue” of European digital healthcare ecosystems in the EHDS era. That will support the goals of the Digital Compass 2030 and empower businesses and people in a human-centred, sustainable, and prosperous digital future.” said Catherine Chronaki, scientific coordinator of xShare.
Robert Stegwee of CEN/TC 251 said: “xShare is a testament to the power of collaboration in driving digital health transformation. By establishing the European EHRxF Standards and Policy Hub, we are laying the foundation for a resilient and competitive health sector in Europe. The xShare Button is not just a feature; it’s a symbol of empowerment. It will enable individuals to take control of their health data in a computable format, creating the essence of the European digital health ecosystem.”
Professor Dipak Kalra MD, of I~HD, shared his own vision of usability and accessibility of the ‘yellow button’, saying: “What I dream is that in the near future I will be able to ask Siri to update my patient summary with my new medications, archiving some of the old ones, sharing my experience with my general practitioner.”
The XpanDH coordinator, Professor Henrique Martins of ISCTE commented:
Following from the work on the European EHR Exchange Format that XpanDH project has been supporting in 2023, the new year bring an extra joint effort for pushing Europe’s Health towards better, more integrated care. With xShare research and innovation action, we are creating a way for every European to use and share his or her health data in an easy press of a digital button. Only though an ecosystem-wide citizens-participated approach will we all help to get to a European Health Union based on data and individual responsibility.
