Expanding the European EHRxF to share and effectively use health data within the EHDS

Project Information

xShare

Grant agreement ID: 101136734

DOI

10.3030/101136734

EC signature date 8 December 2023

Start date 1 December 2023

End date 30 November 2026

Funded under

• Health

Total cost

€ 7 803 632,50

EU contribution

€ 7 803 632,50

Coordinated by

MEDCOM
Denmark

Periodic Reporting for period 1 - xShare (Expanding the European EHRxF to share and effectively use health data within the EHDS)

Reporting period: 2023-12-01 to 2025-05-31

Summary of the context and overall objectives of the project

xShare envisions everyone sharing their health data in EEHRxF with a click-of-a-button. The mission of xShare is to experiment with EEHRxF and identify future priority health data categories, preparing the digital health community for accelerated EHDS adoption. The xShare button featured across health portals and patient apps would allow people to exercise their data portability rights under GDPR, setting EEHRxF as the driver for research and innovation in EHDS. xShare will establish the European EHRxF Standards and Policy Hub, the “Hub” in partnership of key standards developing organizations, market actors, and supported by competence centers, nationals and regional authorities and European SMEs.
Key xShare results are:

1) Harmonized common specifications, xBundles i.e. collection of common data specifications including FHIR implementation guides, tools and data sets, and educational support for key EHRxF health data categories as noted in the EHDS.

2) Common elements across EHRxF health data categories applicable across health and care, public/population health, and clinical research.

3) Extended harmonized IPS specification to include care plans and making it fit for the purpose of clinical research use cases i.e. clinical trial eligibility, real world data, patient reported outcomes, and returning clinical research data to patients.

4) Feature the xShare Button in 8 adoption settings in a Hospital (Italy), National portal (Greece, Ireland, Cyprus), Regions with emphasis in medical tourism connectin the public and private sector (Catalunya and Madeira). Apps to join the French national ecosystem with the xShare Button. Care plans will be demonstrated in Denmark.

5) Investigate feasibility of the EU xShare Industry label.

6) Launch open calls for Early Adopters and a community of Excellence to demonstrate applications of the EEHRxF in almost 100 settings across Europe.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

xShare worked toward the objectives set in the description of work:

1. created the European EHRxF Standards and Policy Hub, i.e. Hub, to drive the harmonization, maturity, and maintenance of interoperability formats for sharing health data. The Hub is a Belgian AISBL (ESHIA), to support, harmonize and maintain health data interoperability tools and formats for accelerated adoption of EHDS. ESHIA has 17 founding xShare members and an elected board. Industry and regulator fora were created and held quarterly meetings supporting the Hub. MoUs with XpanDH and Xt-EHR for specification development (~200-member expert community). X-Bundle retreats with XpanDH and Xt-EHR, and X-Bundle registry release. KPI 100%, Milestones 2, 11.

2. demonstrated the benefit and value of the xShare Button supporting the right of individuals to data portability under GDPR data in continuity of care use cases. Business use cases were analysed, and gaps were identified. Adoption site requirements were analysed in an iterative fashion. Business use case repository set up. Benefit was demonstrated in webinars, presentations, and xShare Button demonstrations showing strong engagement of the community. X-Bundle retreat in Thessaloniki Greece, led to successful demo in the 2nd EEHRxF summit.xShare Industry Label testing at IHE Plugathon (14 xShare label recipients), focusing on EHDS priority data categories. KPI 75%, Milestones 1, 5, 8.

3. developed harmonized data formats starting from Business use cases using HIDs listed in EHDS draft regulation aligning them across health care, population health, and clinical research. Work on EHDS regulation priority data categories led to the xBundle release 1 and 2, and toolbox. Business use cases for Public/Population health and IPS for research released. Harmonized elements list under the leadership of CDISC with SNOMED, CEN, HL7, and IHE Europe led to IPS+. The xShare Button IG v1.0 was released with services and tool box. Main focus, download, upload, and share via smartHealthLinks priority health data in EHDS. Next steps link case (subscribe/notification). KPI 75%. Milestones 6,7

4. made progress in monitoring adoption of the EEHRxF in the member states and the European regions, assessing the impact of the Hub, while identifying gaps and needs of additional HIDs. A monitoring framework was established, the supporting survey was launched, with initial results presented in the dashboard. KPI 80%, Milestone 4, 9

5. contributed to capacity building in digital skills related to the use EEHRxF HIDs in Business service use cases including European Digital Identity and the digital Wallet, security & privacy, data quality, and EEHRxF procurement. Highlights were the adoption kit webinar for citizens,>500 registrations, ~250 attendees. 33 questions asked enhanced the FAQ of the Hub. >1000 stakeholders were reached directly or indirectly. KPI 30%.

6: liaised with initiatives and programs connected to the EHDS and the adoption of digital health technologies in the transformation of the health sector to help them develop EEHRxF capabilities. Agreements with xt-EHR, XpanDH, Gravitate-Health, more underway with Jardin, KPI at 100%.

7: ensured the business viability of the European EHRxF Standards and Policy Hub in the context of the wider digital health ecosystem on an annual basis (WP2). Annual reports were submitted for consultation internally and to the Industry and Regulator fora. KPI 66%.

8: engaged with EEHRxF stakeholders and the industry engage proactively with European Policy on interoperability to accelerate adoption of the EEHRxF for a competitive Europe using multiple instruments, regulator and industry fora, community of excellence, and early adopters (70 companies, 17 EU coutnries) using the stakeholder engagement plan. The First policy brief under revision with Frontiers. Two xShare Button campaigns launched. KPI 50%, M3, 11.

9: Developed and piloted a testing and assurance scheme for EHR systems through an open call in EU membe rstates and EFTA accession countries (WP2, WP6). Development of the assurance scheme is still underway, since work on the business use cases from the open calls is underway. Relevant KPI status 30% and the focus of the second part of the project is elaborating the schema under development connecting it to the Hub and the xShare industry label to be revised for 2026. KPI 50%

10: explored the feasibility and business viability of an EU xShare industry label for the EHRxF. The xShare industry label v2025 was tested in the IHE plugathon. 6 adoption sites and and 8 companies among the early adopters received the xShare industry label in silver level. Gold label in collaboration with a regional or national ecosystem is developed. KPI 50%, M12.

11: HIMSS2025 workshop with JIC an initiative of NEHA/xt-EHR and CEN at HIMSS2025, preparing the ground for global harmonization and uptake of EEHRxF.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

xShare achieved impact beyond the state of the art. Major relevant achievements are: (a) establishment of ESHIA/Hub (b) xShare industry label, v2025 (d) advancement and experimentation with EHRxF specifications.

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