title: A workflow-driven approach to integrate generic software modules in a Trusted Third Party.
abstract: BACKGROUND
  Cohort 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.
  
  
  METHODS
  This 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.
  
  
  RESULTS
  The 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.
  
  
  CONCLUSIONS
  The 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).
authors.affiliation: Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17487, Greifswald, Germany. martin.bialke@uni-greifswald.de.
authors.forename: Martin
authors.initials: M
authors.lastname: Bialke
authors.affiliation: Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17487, Greifswald, Germany. peter.penndorf@uni-greifswald.de.|German Centre for Cardiovascular Research (DZHK), Greifswald, Germany. peter.penndorf@uni-greifswald.de.
authors.forename: Peter
authors.initials: P
authors.lastname: Penndorf
authors.affiliation: Institute of Applied Microelectronics and Computer Engineering, University of Rostock, Rostock, Germany. tim.wegner@uni-rostock.de.
authors.forename: Tim
authors.initials: T
authors.lastname: Wegner
authors.affiliation: Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17487, Greifswald, Germany. thomas.bahls@uni-greifswald.de.|German Centre for Cardiovascular Research (DZHK), Greifswald, Germany. thomas.bahls@uni-greifswald.de.
authors.forename: Thomas
authors.initials: T
authors.lastname: Bahls
authors.affiliation: Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17487, Greifswald, Germany. christoph.havemann@uni-greifswald.de.
authors.forename: Christoph
authors.initials: C
authors.lastname: Havemann
authors.affiliation: Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17487, Greifswald, Germany. jens.piegsa@uni-greifswald.de.
authors.forename: Jens
authors.initials: J
authors.lastname: Piegsa
authors.affiliation: Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Ellernholzstr. 1-2, 17487, Greifswald, Germany. wolfgang.hoffmann@uni-greifswald.de.|German Centre for Cardiovascular Research (DZHK), Greifswald, Germany. wolfgang.hoffmann@uni-greifswald.de.
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Hoffmann
mesh_terms: D003628:Database Management Systems; D006801:Humans; D012984:Software; D057188:Workflow