DAta FIDUciaries in MEdical Research: ethical and legal foundations and implementations (DAFIDUMER)

人们对医学研究数据信托模型的发展抱有很高的期望。人们期望他们为筹集迄今为止分散的数据宝库，特别是为研究目的作出决定性贡献。然而，数据受托人的法律基础却很少被探索，为了使个人数据研究符合数据保护的基本权利，仍然存在许多法律上的不确定性。由于数据受托人的概念在伦理学中已经广为人知，并且已经以差异化的方式进行了研究，因此，正是伦理与法律之间的跨学科桥梁，为数据受托模型的监管和自我监管的平衡解决方案的发展提供了决定性的附加价值。这些解决办法可以建立在欧盟和国家法律文书的基础上，并将纳入现有倡议，如医学信息学倡议的广泛同意模式、生物银行模式或基因组数据倡议，并进一步发展这些倡议。该项目的总体目标是设计一个法律上安全和值得信赖的基础设施，以便将健康数据用于研究目的的二次使用，并为其法律实施制定一个治理框架，以及一个适合数据受托人监管和自我监管的工具箱。

High expectations are associated with the development of data fiduciary models for medical research. They are expected to make the decisive contribution to raising so far fragmented data treasures especially for research purposes. However, the legal basis of the data fiduciary has been little explored, and many legal uncertainties remain in order to bring research on personal data in line with the fundamental right to data protection. Because the concept of data fiduciaries is already well known in ethics and has been studied in a differentiated manner, it is precisely the interdisciplinary bridging between ethics and law that promises decisive added value for the development of balanced solutions for the regulation and self-regulation of data fiduciary models. These solutions can be built on instruments of Union and national law and will be embedded in existing initiatives such as the broad-consent model of the Medical Informatics Initiative, biobank models or genome data initiatives, and further develop these initiatives. The overarching goal of the project is to design a legally secure and trustworthy infrastructure for the secondary use of health data for research purposes and to develop a governance framework for its legal implementation as well as a toolbox suitable for the regulation and self-regulation of data fiduciaries.