PDF(Pubmed)
Abstract：
UNASSIGNED: Pseudonymization has become a best practice to securely manage the identities of patients and study participants in medical research projects and data sharing initiatives. This method offers the advantage of not requiring the direct identification of data to support various research processes while still allowing for advanced processing activities, such as data linkage. Often, pseudonymization and related functionalities are bundled in specific technical and organization units known as trusted third parties (TTPs). However, pseudonymization can significantly increase the complexity of data management and research workflows, necessitating adequate tool support. Common tasks of TTPs include supporting the secure registration and pseudonymization of patient and sample identities as well as managing consent.
UNASSIGNED: Despite the challenges involved, little has been published about successful architectures and functional tools for implementing TTPs in large university hospitals. The aim of this paper is to fill this research gap by describing the software architecture and tool set developed and deployed as part of a TTP established at Charité - Universitätsmedizin Berlin.
UNASSIGNED: The infrastructure for the TTP was designed to provide a modular structure while keeping maintenance requirements low. Basic functionalities were realized with the free MOSAIC tools. However, supporting common study processes requires implementing workflows that span different basic services, such as patient registration, followed by pseudonym generation and concluded by consent collection. To achieve this, an integration layer was developed to provide a unified Representational state transfer (REST) application programming interface (API) as a basis for more complex workflows. Based on this API, a unified graphical user interface was also implemented, providing an integrated view of information objects and workflows supported by the TTP. The API was implemented using Java and Spring Boot, while the graphical user interface was implemented in PHP and Laravel. Both services use a shared Keycloak instance as a unified management system for roles and rights.
UNASSIGNED: By the end of 2022, the TTP has already supported more than 10 research projects since its launch in December 2019. Within these projects, more than 3000 identities were stored, more than 30,000 pseudonyms were generated, and more than 1500 consent forms were submitted. In total, more than 150 people regularly work with the software platform. By implementing the integration layer and the unified user interface, together with comprehensive roles and rights management, the effort for operating the TTP could be significantly reduced, as personnel of the supported research projects can use many functionalities independently.
UNASSIGNED: With the architecture and components described, we created a user-friendly and compliant environment for supporting research projects. We believe that the insights into the design and implementation of our TTP can help other institutions to efficiently and effectively set up corresponding structures.
UNASSIGNED: Despite the challenges involved, little has been published about successful architectures and functional tools for implementing TTPs in large university hospitals. The aim of this paper is to fill this research gap by describing the software architecture and tool set developed and deployed as part of a TTP established at Charité - Universitätsmedizin Berlin.
UNASSIGNED: The infrastructure for the TTP was designed to provide a modular structure while keeping maintenance requirements low. Basic functionalities were realized with the free MOSAIC tools. However, supporting common study processes requires implementing workflows that span different basic services, such as patient registration, followed by pseudonym generation and concluded by consent collection. To achieve this, an integration layer was developed to provide a unified Representational state transfer (REST) application programming interface (API) as a basis for more complex workflows. Based on this API, a unified graphical user interface was also implemented, providing an integrated view of information objects and workflows supported by the TTP. The API was implemented using Java and Spring Boot, while the graphical user interface was implemented in PHP and Laravel. Both services use a shared Keycloak instance as a unified management system for roles and rights.
UNASSIGNED: By the end of 2022, the TTP has already supported more than 10 research projects since its launch in December 2019. Within these projects, more than 3000 identities were stored, more than 30,000 pseudonyms were generated, and more than 1500 consent forms were submitted. In total, more than 150 people regularly work with the software platform. By implementing the integration layer and the unified user interface, together with comprehensive roles and rights management, the effort for operating the TTP could be significantly reduced, as personnel of the supported research projects can use many functionalities independently.
UNASSIGNED: With the architecture and components described, we created a user-friendly and compliant environment for supporting research projects. We believe that the insights into the design and implementation of our TTP can help other institutions to efficiently and effectively set up corresponding structures.
摘要：
■在医学研究项目和数据共享计划中，假名化已成为安全管理患者和研究参与者身份的最佳实践。这种方法的优点是不需要直接识别数据来支持各种研究过程，同时仍然允许高级处理活动。例如数据链接。通常,假名化和相关功能捆绑在称为可信第三方(TTP)的特定技术和组织单元中。然而,假名化会大大增加数据管理和研究工作流程的复杂性，需要足够的工具支持。TTP的常见任务包括支持患者和样本身份的安全注册和假名化以及管理同意。
■尽管存在挑战，关于在大型大学医院实施TTP的成功架构和功能工具的报道很少。本文的目的是通过描述在Charité-UniversityätsmedizinBerlin建立的TTP的一部分开发和部署的软件架构和工具集来填补这一研究空白。
■TTP的基础架构旨在提供模块化结构，同时保持较低的维护要求。基本功能是通过免费的MOSAIC工具实现的。然而,支持通用研究过程需要实施跨越不同基本服务的工作流程，比如病人登记，随后是化名，并通过收集同意书结束。为了实现这一点，开发了集成层，以提供统一的代表性状态传输（REST）应用程序编程接口（API），作为更复杂工作流的基础。基于这个API，还实现了统一的图形用户界面，提供TTP支持的信息对象和工作流的集成视图。该API是使用Java和SpringBoot实现的，而图形用户界面是在PHP和Laravel中实现的。两种服务都使用共享的Keycloak实例作为角色和权限的统一管理系统。
■到2022年底，自2019年12月推出以来，TTP已经支持了10多个研究项目。在这些项目中,存储了3000多个身份，产生了超过30,000个化名，并提交了1500多份同意书。总的来说,超过150人经常使用软件平台。通过实现集成层和统一的用户界面,以及全面的角色和权限管理，操作TTP的工作量可以大大减少，作为支持的研究项目的人员可以独立使用许多功能。
■描述了架构和组件，我们创造了一个用户友好和合规的环境来支持研究项目。我们相信，对我们TTP的设计和实施的见解可以帮助其他机构高效地建立相应的结构。
■尽管存在挑战，关于在大型大学医院实施TTP的成功架构和功能工具的报道很少。本文的目的是通过描述在Charité-UniversityätsmedizinBerlin建立的TTP的一部分开发和部署的软件架构和工具集来填补这一研究空白。
■TTP的基础架构旨在提供模块化结构，同时保持较低的维护要求。基本功能是通过免费的MOSAIC工具实现的。然而,支持通用研究过程需要实施跨越不同基本服务的工作流程，比如病人登记，随后是化名，并通过收集同意书结束。为了实现这一点，开发了集成层，以提供统一的代表性状态传输（REST）应用程序编程接口（API），作为更复杂工作流的基础。基于这个API，还实现了统一的图形用户界面，提供TTP支持的信息对象和工作流的集成视图。该API是使用Java和SpringBoot实现的，而图形用户界面是在PHP和Laravel中实现的。两种服务都使用共享的Keycloak实例作为角色和权限的统一管理系统。
■到2022年底，自2019年12月推出以来，TTP已经支持了10多个研究项目。在这些项目中,存储了3000多个身份，产生了超过30,000个化名，并提交了1500多份同意书。总的来说,超过150人经常使用软件平台。通过实现集成层和统一的用户界面,以及全面的角色和权限管理，操作TTP的工作量可以大大减少，作为支持的研究项目的人员可以独立使用许多功能。
■描述了架构和组件，我们创造了一个用户友好和合规的环境来支持研究项目。我们相信，对我们TTP的设计和实施的见解可以帮助其他机构高效地建立相应的结构。
