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

MAGIC - Mainzelliste、Samply.Auth 和通用知情同意服务作为医学联合研究中身份管理、同意管理和权限管理的开源工具

• 批准号: 315057496
• 负责人: Professor Dr. Björn Bergh
• 金额: --
• 依托单位: Zentrum für Informations- und Medizintechnik (ZIM)
• 依托单位国家: 德国
• 项目类别: Research Grants
• 财政年份: 2016
• 资助国家: 德国
• 起止时间: 2015-12-31 至 2020-12-31
• 项目状态: 已结题
• 来源: https://gepris.dfg.de/gepris/projekt/315057496?language=en
• 关键词: MAGIC; Mainzelliste; Samply.Auth; Generic; Informed

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

《医学研究项目中的数据保护指南--TMF的通用解决方案2.0》代表了建立具有适当数据保护措施的医学研究联合体的全面、公认的指导方针。对于指南要求的一些中央IT组件，已经有了免费的实现；通过重用这些实现，可以避免不必要的重复开发时间。然而，它们并不涵盖概念中描述的所有功能。该项目的目的是开发身份管理领域中最重要的缺失功能(参见6.1在指南中)、权限管理(参见6.2)和同意管理(参见6.6.6)以现有软件为基础，然后向科学界提供这些软件。为此，美因茨的项目合作伙伴将开发身份验证服务(参见6.2)这使得用户注册变得更简单、更安全。它不仅可以管理用户(具有安全、加密的密码、到期日期、电子邮件验证等)，还将补充联合身份验证，以重复使用现有的帐户(例如，每个家庭机构的帐户)。项目合作伙伴还将扩展Mainzellist[1]，增加迄今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准则的要求，并根据准则将其扩展为完整的同意管理解决方案(参见6.6.6)。对于所有指定的软件，合作伙伴将创建不仅可供设施使用，还可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，将在指导方针的帮助下，在项目的头几个月定义要涵盖的用例。海德堡的项目合作伙伴将评估上述工具在用例中实施的适宜性以及开放接口的互操作性。通过这种方式，将确保该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，计划继续与数据隐私保护工作组和ITQM工作组进行协调。最后，该软件将作为医学研究联合体中认证、身份管理和同意管理的推荐实施方案提供给信息技术服务门户网站。[1]http://www.mainzelliste.de[2]https://mosaic-greifswald.de/werkzeuge-und-vorlagen/einwilligungsmanagement-gics.html