Routine Anonymized Data for Advanced Ambulatory Health Services Research, RADARplus

雷达项目的总体目标是提供一个框架和基础设施，以安全和可管理的方式安全地导出和处理初级保健实践中的电子患者记录(EPR)数据，作为迈向大型德国研究数据库的第一步。其目标是向研究人员提供具有代表性的、纵向的、未识别的患者和医疗保健数据，促进具有高有效性的医疗服务研究，并招募患者进行进一步研究或临床试验。在第一阶段，雷达能够制定和描述必要的数据保护概念以及程序和计算程序，以便通过BDT接口收集和化名电子病历。这些概念和例程创建了一个框架和原型基础设施，以安全和可管理的方式安全地导出和处理初级卫生保健实践中的EPR数据。在雷达项目的第二阶段，RADARplus，我们将巩固、改进和扩展这个基础设施。两个分项目将建立在现有雷达流程的基础上，并加以改进或扩大。RADARplus的其他子项目将为初级保健研究开发新的基础设施要素。因此，RADARplus可分为两个主要工作领域：第一部分--继续、调整和改进现有的雷达基础设施和工作流程：-维护/继续雷达基础设施，包括根据技术和界面的变化调整雷达软件。-提高所有过程的可用性，同时保持高水平的数据保护。-利用焦点小组和/或访谈，我们将调查招募全科医生(GP)的障碍，包括全科医生参与雷达的要求。-为全科医生和患者开发额外的用例和信息视频，-使用和评估视频，通过从下萨克森州招募另外20家全科医生实践来扩大雷达实践的参与。第二部分-开发新的研究基础设施和技术：-概念、开发和试点在具有最先进技术解决方案的全科医生环境中的数字、无纸化知情同意和签名管理。-常规全科医生数据采集，包括适应当前的接口开发。我们将建立一个具有FHIR界面的模拟医疗实践管理软件，可以被RADARplus软件查询。-关于基于风险的常规GP数据匿名化，我们将审查可识别性的法律确定和匿名性的边界。在此基础上，我们将评估各种识别程序，以确定如何使用它们来达到法定的不可识别标准。-利用初级保健研究数据库，我们将在现有雷达基础设施的基础上开发一个以研究为导向的实践门户网站，为研究人员和参与的全科医生创建一个量身定做的用户界面。

The overall aim of the RADAR project is to provide a framework and infrastructure to securely export and process electronic patient records (EPR) data from primary health care practices in a secure and manageable way as a first step towards a large German research data repository. The goal is to make representative, longitudinal de-identified patient and health care data available to researchers, facilitating health services research with high validity and recruitment of patients for further studies or clinical trials. In its first phase, RADAR was able to develop and describe the necessary data protection concepts and procedural and computational routines for collection and pseudonymization of EPR via the BDT interface. These concepts and routines have created a framework and prototype infrastructure to securely export and process EPR data from primary health care practices in a secure and manageable way.In the second phase of the RADAR project, RADARplus, we will consolidate, improve and expand this infrastructure. Two sub-projects will build on existing RADAR processes and improve or expand them. Other sub-projects in RADARplus will develop new infrastructure elements for primary care research. RADARplus can thus be divided into two major work areas:Part 1 – Continuing, adapting and improving the existing RADAR infrastructure and workflows:- Maintenance/continuation of the RADAR infrastructure, including adaptation of the RADAR software with regard to changes in technologies and interfaces.- Improvement of the usability of all processes while maintaining a high level of data protection.- Using focus groups and/or interviews, we will investigate obstacles to general practitioner (GP) recruitment including GPs’ requirements for participating in RADAR.- Development of additional use cases and informational videos for GPs and patients,- Use and evaluation of videos to extend practice involvement in RADAR by recruiting 20 additional GP practices from Lower Saxony.Part 2 – Developing new research infrastructure and techniques:- Conception, development and pilot for digital, paperless informed consent and signature management in GP environments with state-of-the-art technical solutions.- Routine GP data acquisition including the adaptation to current interface developments. We will build a simulated medical practice management software with FHIR interface, which can be queried by the RADARplus software.- With regards to the risk-based anonymization of routine GP data, we will examine the legal determination of identifiability and the boundary to anonymity. On this basis, we will assess various de-identification procedures to determine how they can be used to achieve the legally defined criteria of non-identifiability.- Using the primary care research database, we will develop a research-oriented practice portal based on the existing RADAR infrastructure to create a tailored user interface for both researchers and participating GPs.