MAGIC - Mainzelliste, Samply.Auth and Generic Informed Consent Service as Open Source Tools for Identity Management, Consent Management and Rights Management in Medical Joint Research

“医学研究项目数据保护指南——TMF通用解决方案2.0”是建立具有适当数据保护措施的医学研究联盟的全面、商定的指南。对于指引所要求的一些核心资讯科技组件，已经有免费的实施方案；通过重用这些，可以避免不必要的重复开发时间。然而，它们并没有涵盖概念中描述的所有功能。该项目的目的是在现有软件的基础上开发身份管理（参见指南中的6.1）、权限管理（参见6.2）和同意管理（参见6.6.6）领域中最重要的缺失功能，然后将其提供给科学界。为此，美因茨的项目合作伙伴将开发一种认证服务（参见6.2），使用户注册更简单、更安全。它不仅可以管理用户（使用安全的、加密的密码、到期日期、电子邮件验证等），还可以补充联邦身份验证，以重用现有帐户（例如，每个家庭机构的帐户）。项目合作伙伴还将扩展Mainzelliste[1]，增加迄今为止缺少的患者列表功能（参见6.1.1.1）和假名服务（参见6.1.1.2）。其结果将是一个完整的身份管理解决方案（参见6.1）。Greifswald的项目合作伙伴将分析现有的glCS工具[2]，以满足TMF指南，并将根据指南将其扩展为完整的同意管理解决方案（参见6.6.6）。对于所有指明的软件，合作伙伴将创建不仅用于设施使用，而且用于进一步开发的文档。在开放接口描述的帮助下，将建立互操作性。此外，将被覆盖的用例将在项目的头几个月在指南的帮助下被定义。海德堡的项目合作伙伴将根据它们在用例中实现的适用性以及开放接口的互操作性来评估上面提到的工具。这样才能保证软件能够被科学界广泛使用。TMF办公室的项目合作伙伴将指导项目，并检查指导方针是否得到遵守。为此，计划与数据隐私保护和ITQM工作组进行持续协调。最后，该软件将在IT服务门户中提供，作为医学研究联盟认证、身份管理和同意管理的推荐实施方案。[1] http://www.mainzelliste.de [2] https://mosaic-greifswald.de/werkzeuge-und-vorlagen/einwilligungsmanagement-gics.html

The "Guideline for Data Protection in Medical Research Projects - TMF's generic solutions 2.0" represents a comprehensive, agreed-upon guideline for establishing medical research consortiums with appropriate data protection measures. For some of the central IT components required by the guideline, there are already freely available implementations; by reusing these, unnecessary duplicate development time can be avoided. However, they do not cover all functions described in the concept. The aim of this project is to develop the most important missing functionalities in the areas of identity management (cf. 6.1 in the guideline), rights management (cf. 6.2) and consent management (c.f. 6.6.6) on the basis of already existing software and then make them available to the scientific community. For this, the project partner in Mainz will develop an authentication service (cf. 6.2) that makes the registration of users simpler and more secure. Not only will it be possible to manage users (with secure, encrypted passwords, expiry dates, email verification, etc.), it will also supplement federated authentication for the reuse of already existing accounts (for example, those of each of the home institutions). The project partner will also expand Mainzelliste [1] with thus far missing functions for patient lists (cf. 6.1.1.1) and a pseudonymisation service (cf. 6.1.1.2). The result will be a complete identity management solution (cf. 6.1). The project partner in Greifswald will analyse the existing glCS tool [2] in view of its fulfilment of the TMF guideline and will expand it into a complete consent management solution in accordance with the guideline (cf. 6.6.6). For all software indicated, the partners will create documentation that not only facilities use, but also further development. With the help of open interface descriptions, interoperability will be established. In addition, the use cases that are to be covered will be defined during the first months of the project with the help of the guideline. The project partner in Heidelberg will evaluate the tools named above in terms of their suitability for implementation in the use cases as well as the interoperability of the open interfaces. In this way, it will be ensured that the software can be widely used by the scientific community. The project partner in the TMF office will guide the project and check that the guideline is adhered to. For this, continuous coordination with the Data Privacy Protection and ITQM working groups is planned. Finally, the software will be offered in the IT Service Portal as recommended implementations for authentication, identify management and consent management in medical research consortiums. [1] http://www.mainzelliste.de [2] https://mosaic-greifswald.de/werkzeuge-und-vorlagen/einwilligungsmanagement-gics.html