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Journal of Translational Medicine

, 13:176

Computational Modelling andEpidemiology

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.

KeywordsMedical data management Data protection Informed consent Pseudonyms Record linkage AbbreviationsDZHKDeutsches Zentrum für Herz-Kreislauf-Forschung German Centre for Cardiovascular Research

E-PIXEnterprise Patient Identifier Cross-referencing

gICSgeneric Informed Consent Administration Service

gPASgeneric Pseudonym Administration Service

IDATidentifying data

MDATmedical data

PSNpseudonym

MPI IDunique identifier following concepts of a Master Patient Index

TMFTechnology, Methods and Infrastructure for Networked Medical Research

TTPTrusted Third Party

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Autor: Martin Bialke - Peter Penndorf - Tim Wegner - Thomas Bahls - Christoph Havemann - Jens Piegsa - Wolfgang Hoffmann

Fuente: https://link.springer.com/







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