PHEMS - Pediatric Hospitals as European drivers for multi-party computation and synthetic data generation capabilities across clinical specialties and data types

跨境合作可以解决获取相关健康数据方面的挑战，这些数据对于科学家和临床医生、研究人员和卫生行业之间的国际合作至关重要。对个人数据的隐私问题和法规使得数据控制者共享健康数据变得越来越复杂和耗时，从而严重限制了中小企业、研究人员和创新者对健康数据的访问。跨境合作的进一步复杂性来自对欧盟GDPR、国家法规的解释差异，以及医院站点的异构和不断变化的数据许可流程。PHEMS项目将为欧洲儿童医院提供一个分散和开放的健康数据生态系统概念，包括技术组件和治理框架。其目标是促进健康数据的获取，推进联合健康数据分析，并为按需生成可共享、合成和匿名数据集提供服务。为实现这一目标，该项目将侧重于弥合数据访问和使用方面的差距，特别是在整合道德、法律的和技术要求方面，包括数据控制者的责任和数据主体的权利。这将允许健康数据控制者参与协作，而不会失去对GDPR、国家立法或其组织内部政策合规性的控制。用于生成算法匿名和合成数据集的技术和工具将通过欧洲儿童医院组织（ECHO）社区进行的三个临床用例进行强大的验证过程。我们的目标是评估定制生成的合成数据与现实生活中的问题的使用。研究人员、中小企业、创新者以及制药和医疗技术行业等数据用户将通过社区建设、黑客马拉松以及与相关欧洲大型项目的互动参与进来。

Cross-border collaboration can tackle the challenges in accessing relevant health data essential for international collaboration between scientists and clinicians, researchers, and health industry. Privacy concerns and regulations on personal data have made the sharing of health data increasingly complex and time-consuming for data controllers, thus severely limiting the access of SMEs, researchers, and innovators to health data. Further complications in cross-border collaboration arise from differences in interpreting the EU GDPR, national regulations, and heterogenous and changing data permit processes at hospital sites. The PHEMS project will provide European children’s hospitals with a decentralized and open health data ecosystem concept consisting of technical components and governance frameworks. The objective is to facilitate access to health data, advance federated health data analysis and build services for the on demand generation of shareable, synthetized, and anonymized datasets. To achieve this, the project will focus on bridging the gaps in data access and use, especially in the integration of ethical, legal, and technical requirements, including the responsibilities of data controllers and the rights of data subjects. This will allow health data controllers to engage in collaboration without losing control on compliance with respect to GDPR, national legislation or internal policies of their organization. The techniques and tools for generating algorithmically anonymized and synthetic datasets will undergo robust validation processes through three clinical use cases conducted by the European Children’s Hospitals Organisation (ECHO) community. The goal is to assess the usage of custom-generated synthetic data with real-life questions. Data users, such as researchers, SMEs, innovators and the pharmaceutical and MedTech industry, will be engaged through community building, hackathons, and interaction with relevant European large-scale initiatives.