xShare envisions everyone sharing their health data in EEHRxF with a click-of-a-button. The xShare button to be featured across health portals and patient apps and allow people to exercise their data portability rights under GDPR. Hence, the European EHRxF will be the driver for research and innovation in EHDS. xShare will establish the European EHRxF Standards and Policy Hub, the “Hub” partnership of six standards developing organizations (CEN/TC251, HL7 Europe, IHE Europe, SNOMED, CDISC, IEEE) market actors (DIGITAL Europe, MedTech-Europe and EUCROF), supported by competence centers, nationals and regional authorities and European SMEs. xShare will develop:

1) Harmonized common specifications, create and maintain xBundles i.e., collection of common data specifications including FHIR implementation guides, tools and data sets, and educational support for key EHRxF health information domains as noted in the EHDS draft regulation Annex 1.

2) A set of common elements across EHRxF health information domains applicable across EHDS-1 (Xt-EHR), public/population health (EHDS-2), 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) xShare feature the xShare Button in 8 adoption settings in Hospital network (Italy), National portal (Greece, Ireland, Cyprus), regional network with emphasis in medical tourism and the connection of the public to the private sector (Catalunya and Madeira), entry of digital health applications to the myHealthSpace ecosystem in France.

Care plans will be demonstrated in Denmark. xShare investigate the feasibility and value of the EU xShare Industry label as a vehicle towards implementing the draft EHDS regulation. Lastly open calls at the last year of the project aim to onboard with EHRxF almost 100 settings across Europe.

xSHARE will employ multi-disciplinary and cutting edge methods to achieve our goals of solving two main challenges:

a) to make it simple and affordable for EHR systems and digital health apps to allow individuals to share their health data using the EEHRxF as common uniform harmonized specification for the priority HIDs

b) to set up processes that allow sustainable maintenance, further development, and change management for standards resources in Europe, while contributing based on global standards.

xSHARE will address these challenges building on the work of previous keystone projects creating an environment where SDOs will collaborate with stakeholders to deliver, maintain and further develop bundles that will support HIDs in the EHDS, aligned across three traditionally separate domains, i.e. health and care, public/population health, and clinical research

xSHARE will address these challenges building on the work of previous keystone projects creating an environment where SDOs will collaborate with stakeholders to deliver, maintain and further develop bundles that will support HIDs in the EHDS, aligned across three traditionally separate domains, i.e. health and care, public/population health, and clinical research. Following the co-creation, governance, alignment model introduced in eStandards6 and the value chains of the ValueHealth project7, we have drafted the processes to be followed in the Hub. The European EHRxF Standards & Policy is co-led by CEN/BH and DIGITALEUROPE. It brings together established SDOs, SMEs, competence centres, and links to multistakeholder initiatives such as DigitalHealthUptake.

The Hub itself convenes an industry and regulators forum to help shape its work program and evaluate its performance in collaboration with WP6. The industry forum is led by M. Strubin of DIGITALEUROPE with engagement of MedTech Europe (V. Thaler), and representatives of EHR and PHR vendors after a call for expression of interest to the xSHARE experts and advisors team (5 have already done so).

Scientific impact: Harmonized data formats across health, public health, and clinical research, captured in HL7 FIHR IGs to be used by thousands of professionals in the area. Increased sensitivity to environmental aspects through the correlation of environmental data with health data. 

Societal impact: More than 10 million people reached by M36 and 18 months afterwards. Recognition of fundamental values in EU that relate to security, privacy, and data protection. 

Economic & Technological impact: Mobilisation of the community of developers (measured in thousands of people across EU) through the creation of a level playfield.

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