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

xShare设想每个人都可以通过点击按钮在EEHRxF中共享他们的健康数据。xShare按钮将在健康门户网站和患者应用程序中使用，并允许人们根据GDPR行使其数据可移植性权利。因此，欧洲EHRxF将成为EHDS研究和创新的驱动力。xShare将建立欧洲EHRxF标准和政策中心，这是六个标准制定组织（CEN/TC 251，HL 7 Europe，IHE Europe，SNOMED，CDISC，IEEE）市场参与者（DIGITAL Europe，MedTech-Europe和EUCROF）的“中心”合作伙伴关系，由能力中心，国家和地区当局以及欧洲中小企业提供支持。xShare将开发：1）协调通用规范，创建和维护xBundles，即，收集通用数据规范，包括FHIR实施指南、工具和数据集，以及EHDS法规草案附件1中所述的关键EHRxF健康信息领域的教育支持。2)EHRxF健康信息领域的一组通用元素，适用于EHDS-1（JA-9）、公共/人群健康（EHDS-2）和临床研究。3)扩展了协调IPS规范，以纳入护理计划，并使其适合临床研究用例的目的，即临床试验合格性、真实的世界数据、患者报告的结局以及将临床研究数据返回给患者。4)xShare在医院网络（意大利）、国家门户网站（希腊、爱尔兰、塞浦路斯）、重点关注医疗旅游的区域网络和公共与私营部门的连接（卡塔卢尼亚和马德拉）、法国myHealthSpace生态系统的数字健康应用入口等8个采用环境中提供xShare按钮。护理计划将在丹麦进行示范。xShare调查欧盟xShare行业标签作为实施EHDS法规草案的工具的可行性和价值。最后，在项目的最后一年，EHRxF的目标是在欧洲的近100个设置上进行公开招标。

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.