A survey on the current status and future perspective of informed consent management in the MIRACUM consortium of the German Medical Informatics Initiative

Translational Medicine Communications

Hans-Ulrich Prokosch¹  Fabian Simons²  Burkhard Jandrig³  Martin Boeker⁴  Maximilian Fünfgeld⁵  Christian Bruns⁶  Albert Vass⁷  Wolfgang Hoffmann⁷  Christopher Hampf⁷  Thomas Bahls⁷  Martin Bialke⁷  Torsten Leddig⁷  Romina Blasini⁸  Anna Pirkl⁹  Michael Rautenberg^1,10  Dana Stahl^1,11  Lars Geidel^1,11  Arne Blumentritt^1,11  Philipp Heinrich^1,12  Achim Michel-Backofen^1,13 

[1] Chair of Medical Informatics, Friedrich-Alexander-Universität Erlangen-Nürnberg, Wetterkreuz 15, 91058, Erlangen, Germany;Dataintegrationcentre, Philipps-Universität Marburg, Biegenstraße 10, 35037, Marburg, Germany;Department of Urology, University Medical Center Magdeburg, Leipziger Str. 44, 39120, Magdeburg, Germany;Faculty of Medicine and Medical Center, Institute of Medical Biometry and Statistics, University of Freiburg, Stefan-Meier-Str. 26, 79104, Freiburg i. Br., Germany;Heinrich-Lanz-Center for Digital Health, University Medicine Mannheim, Theodor-Kutzer-Ufer 1-3, 68167, Mannheim, Germany;Institute for Biometrics and Medical Informatics, Otto-von-Guericke University Magdeburg, Leipziger Str. 44, 39120, Magdeburg, Germany;Institute for Community Medicine, University Medicine Greifswald, Ellernholzstr. 1-2, 17475, Greifswald, Germany;Institute of Medical Informatics, Justus-Liebig-University Giessen - Medicine Faculty, Rudolf-Buchheim-Str. 6, 35392, Gießen, Germany;Medical Center for Information and Communication Technology, Universitätsklinikum Erlangen, Krankenhausstr. 12, 91054, Erlangen, Germany;Medical Center, University of Freiburg, Freiburg, Germany;Trusted Third Party of the University Medicine Greifswald, Ellernholzstr. 1-2, 17475, Greifswald, Germany;Unabhängige Treuhandstelle Dresden, Bereich Medizin, Technische Universität Dresden, Fetscherstraße 74, 01307, Dresden, Germany;University Hospital Giessen and Marburg, Gießen, Germany;

关键词: Consent management;    Informed consent;    General data protection regulation;    GDPR;    Medical informatics initiative;    MIRACUM;   

DOI  :  10.1186/s41231-021-00086-1

来源: Springer

【 摘 要 】

BackgroundThe consent management is an essential component for supporting the implementation of consents and withdrawals and thus, the realisation of patient’s rights. In MIRACUM, one of the four consortia of the Medical Informatics Initiative (MII), ten university hospitals intend to integrate the generic Informed Consent Service® (gICS) in their Data Integration Center (DIC). To provide a tool that supports the local workflows of the MIRACUM sites, the gICS should be improved.MethodsWe used three standardised questionnaires with 46 questions to elicit requirements from the ten sites. Each site answered the questions from the current and the desired future perspective. This made it possible to understand the individual processes at each site and it was possible to identify features and improvements that were generally necessary.ResultsThe results of the survey were classified according to their impact on the gICS. Feature requests of new functionalities, improvements of already implemented functionalities and conceptual support for implementing processes were identified. This is the basis for an improved gICS release to support the ten sites’ individual consent management processes.ConclusionsA release plan for the feature requests and improvements was coordinated with all sites. All sites have confirmed that the implementation of these features and enhancements will support their software-based consent management processes.

【 授权许可】

CC BY