A workflow-driven approach to integrate generic software modules in a Trusted Third Party

Abstract

BackgroundCohort studies and registries rely on massive amounts of personal medical data. Therefore, data protection and information security as well as ethical aspects gain in importance and need to be considered as early as possible during the establishment of a study. Resulting legal and ethical obligations require a precise implementation of appropriate technical and organisational measures for a Trusted Third Party.MethodsThis paper defines and organises a consistent workflow-management to realize a Trusted Third Party. In particular, it focusses the technical implementation of a Trusted Third Party Dispatcher to provide basic functionalities (including identity management, pseudonym administration and informed consent management) and measures required to meet study specific conditions of cohort studies and registries. Thereby several independent open source software modules developed and provided by the MOSAIC project are used. This technical concept offers the necessary flexibility and extensibility to address legal and ethical requirements of individual scenarios.ResultsThe developed concept for a Trusted Third Party Dispatcher allows mapping single process steps as well as individual requirements and characteristics of particular studies to workflows, which in turn can be combined to model complex Trusted Third Party processes. The uniformity of this approach permits unrestricted re-combination of the available functionalities (depending on the applied software modules) for various research projects.ConclusionThe proposed approach for the technical implementation of an independent Trusted Third Party reduces the effort for scenario specific implementations as well as for maintenance. The applicability and the efficacy of the concept for a workflow-driven Trusted Third Party could be confirmed during the establishment of several nationwide studies (e.g. German Centre for Cardiovascular Research and the National Cohort).

Data privacy management and data quality monitoring in the German Centre for Cardiovascular Research's multicentre TranslatiOnal Registry for CardiomyopatHies (DZHK‐TORCH)

“…The CDM infrastructure and DZHK‐wide harmonization and standardization enable a high data security. High data quality is the basis for good clinical and epidemiological research …”

“…High data quality is the basis for good clinical and epidemiological research. 5,10 All in all, the approval for quality control for about 55% of the entered data is given by the recruiting study centres via the review right. For the other data, the documentation is not completed, and the quality control cannot be applied.…”

“…The TORCH data protection concept is based on the template of the MOSAIC project. 5,6 It regulates individual TORCH-specific aspects to be considered in the main study centre and the individual recruiting study centres regarding data protection and safety. The concept was positively evaluated by the TMF in March 2015.…”

Telemedical care improves quality of life in patients with schizophrenia and bipolar disorder. Results of a randomized controlled trial

“…They received training in how to use the documentation system and have completed appropriate psychiatric/psychotherapeutic education programmes. The telemedical conversation was conducted on the basis of eCRFs in a computer-aided documentation system in accordance with the current standards for data security and data privacy [15,16]. The standardised conversation contained a structured standardised part and an individualised part.…”

Location Privacy Protection Based on ImprovedK-Value Method in Augmented Reality on Mobile Devices

“…Location privacy protection method mainly refers to the fact that the user provides false user location privacy information or anonymous user's identity information and location information to the server in the process of location service. The model of location privacy protection is divided into 2 categories, which are trusted third party (TTP, shown in Figure 1) and free trusted third party (FTTP) [13]. This paper only discusses the previous class method.…”