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62. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e. V. (GMDS)

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie

17.09. - 21.09.2017, Oldenburg

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The German Genetic Diagnostics Act (GenDG) as a Barrier for Implementing Pharmacogenomic Clinical Decision Support Systems into German Hospitals

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  • Marc Hinderer - Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Deutschland
  • Melanie Börries - Albert-Ludwigs-Universität Freiburg, Freiburg, Deutschland
  • Martin Boeker - Albert-Ludwigs-Universität Freiburg, Freiburg, Deutschland
  • Michael Neumaier - Ruprecht-Karls-Universität Heidelberg, Mannheim, Deutschland
  • Frank-Peter Loubal - Universitätsklinikum Giessen und Marburg, Giessen, Deutschland
  • Till Acker - Universitätsklinikum Giessen und Marburg, Giessen, Deutschland
  • Manfred Brunner - Universitätsklinikum Erlangen, Erlangen, Deutschland
  • Hans-Ulrich Prokosch - Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Deutschland
  • Jan Christoph - Friedrich-Alexander-Universität Erlangen-Nürnberg, Erlangen, Deutschland

Deutsche Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie. 62. Jahrestagung der Deutschen Gesellschaft für Medizinische Informatik, Biometrie und Epidemiologie e.V. (GMDS). Oldenburg, 17.-21.09.2017. Düsseldorf: German Medical Science GMS Publishing House; 2017. DocAbstr. 051

doi: 10.3205/17gmds105, urn:nbn:de:0183-17gmds1054

Published: August 29, 2017

© 2017 Hinderer et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.

Outline

Text

Introduction: Pharmacogenomic Clinical Decision Support Systems (CDSS) are considered to be the most feasible tool for adopting pharmacogenomic testing into clinical routine. We aimed at discussing important legal and regulatory factors for implementing pharmacogenomic CDSS into German hospitals.

Methods: Data privacy officers of three German university hospitals were interviewed regarding their data privacy concerns and issues related to both the storage and the distribution of genetic results within the EHR. In addition to that, legal regulations regarding data privacy and data protection were analyzed.

Results: The German Genetic Diagnostics Act (GenDG) seems to be a major legal barrier. It remains unclear whether or not germline mutations may be delivered via an electronic report. In contrast to germline mutations the distribution and the storage of somatic mutations in an EHR seems to be legally feasible. The raw genetic results as well as the associated phenotypes might be delivered to physicians via an electronic CDSS.

Discussion: Since the legal situation in Germany remains unclear with regards to germline mutations, pharmacogenomic CDSS should be limited to somatic mutations until the legal uncertainty is resolved.



Die Autoren geben an, dass kein Interessenkonflikt besteht.

Die Autoren geben an, dass kein Ethikvotum erforderlich ist.

Outline

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