Smart Health is EU Strategic Value Chain that contributes to growth, jobs and competitiveness. Health Data is the main enabler for the value chain, but it also depends on cutting edge technologies - AI, cloud computing, IoT, to integrate the dispersed knowledge and support innovative healthcare solutions and services. EC sets the creation of a European Health Data Space as a main priority, to promote better exchange and access to health data. On a regional level, the RIS3 strategies of the involved widening countries - Bulgaria, Romania, Greece and Cyprus emphasize the need for based on Big Data, AI and IoT digitalized healthcare, to enable personalized medicine, informed decisions, and improved disease prediction. RIS3 strategies also outline the need for more funding for R&I, policy coherence and development of territorially join innovation strategies. A cross country coordinated approach is needed to align the separate endeavours towards an Excellent South-East Europe Smart Health Innovation Ecosystem enabled by a Regional Smart Health Data Space. VELES raises the level of innovation excellence in the South-East EU through creating a sustainable place-based innovation ecosystem, enabled by Regional Smart Health Data Space, including novel transformational framework, R&I and investment strategy and action plan for research, development and adoption of innovative and secure digital solutions that underpin the delivery of sustainable healthcare services. The Regional Smart Health Data Space will be demonstrated through the design of 4 interrelated pilots on Cancer treatment (Greece); Personalised/precision medicine of Alzheimer (Bulgaria); Cerebral tumours (Romania) and Dementia (Cyprus). The aim of VELES is to foster health data sharing regional and national strategies, to secure improved clinical practice, to preserve patient’s privacy and to empower citizens’ smart healthcare through access to innovative, cyber secure and data driven digital health services.

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 (JA-9), 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.