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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

Meeting Abstract

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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

Veröffentlicht: 29. August 2017

© 2017 Hinderer et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.

Gliederung

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.

Gliederung

References

1.
Stanek EJ, Sanders CL, Taber KA, Khalid M, Patel A, Verbrugge RR, Agatep BC, Aubert RE, Epstein RS, Frueh FW. Adoption of pharmacogenomic testing by US physicians: results of a nationwide survey. Clin Pharmacol Ther. 2012;91(3):450-8. DOI: 10.1038/clpt.2011.306 Externer Link
2.
Melton BL, Zillich AJ, Saleem J, Russ AL, Tisdale JE, Overholser BR. Iterative Development and Evaluation of a Pharmacogenomic-Guided Clinical Decision Support System for Warfarin Dosing. Appl Clin Inform. 2016;7(4):1088-1106. DOI: 10.4338/ACI-2016-05-RA-0081 Externer Link
3.
JHicks JK, Stowe D, Willner MA, Wai M, Daly T, Gordon SM, Lashner BA, Parikh S, White R, Teng K, Moss T, Erwin A, Chalmers J, Eng C, Knoer S. Implementation of Clinical Pharmacogenomics within a Large Health System: From Electronic Health Record Decision Support to Consultation Services. Pharmacotherapy. 2016;36(8):940-8. DOI: 10.1002/phar.1786 Externer Link
4.
Overby CL, Devine EB, Abernethy N, McCune JS, Tarczy-Hornoch P. Making pharmacogenomic-based prescribing alerts more effective: A scenario-based pilot study with physicians. J Biomed Inform. 2015;55:249-59. DOI: 10.1016/j.jbi.2015.04.011 Externer Link
5.
Jia P, Zhang L, Chen J, Zhao P, Zhang M. The Effects of Clinical Decision Support Systems on Medication Safety: An Overview. PLoS One. 2016;11(12):e0167683. DOI: 10.1371/journal.pone.0167683 Externer Link
6.
Bell GC, Crews KR, Wilkinson MR, Haidar CE, Hicks JK, Baker DK, Kornegay NM, Yang W, Cross SJ, Howard SC, Freimuth RR, Evans WE, Broeckel U, Relling MV, Hoffman JM. Development and use of active clinical decision support for preemptive pharmacogenomics. J Am Med Inform Assoc. 2014 Feb;21(e1):e93-9. DOI: 10.1136/amiajnl-2013-001993 Externer Link
7.
Bundesrat. Human Genetic Examination Act (Genetic Diagnosis Act - GenDG) 374/09. 2009. https://www.eshg.org/fileadmin/www.eshg.org/documents/Europe/LegalWS/Germany_GenDG_Law_German_English.pdf Externer Link
8.
Deutscher Ethikrat. Die Zukunft der genetischen Diagnostik – von der Forschung in die klinische Anwendung. Deutscher Ethikrat; 2013.