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Market Launch and Regulative Assessment of ICT-Based Medical Devices: Case Study and Problem Definition

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Business Information Systems Workshops (BIS 2021)

Part of the book series: Lecture Notes in Business Information Processing ((LNBIP,volume 444))

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Abstract

The market launch and regulative assessment of ICT-based medical devices in Europe is very complex due to a multitude of regulations to be considered during requirements engineering and product management. Additionally, there are no established standards, best practices or support tools how to launch medical devices on the market. The paper is part of a project aiming for methodical support for medical device launch and assessment, and is dedicated to investigating problem relevance. To understand the processes and requirements three case studies were analysed and the necessary processes and requirements were matched towards enterprise architectures (EA). Based on this finding, we argue that EA could be a suitable way to visualize and recommend required processes and structures for medical device management. The main contributions of our work are (a) a literature analysis of EA use in health care and especially for telemedicine, (b) results from use case analysis investigating the business perspective from inside three health tech companies and (c) the analysis of problems of telemedicine integration into EA.

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Notes

  1. 1.

    Bitkom = Germany’s association of Information and Communication Technology companies.

  2. 2.

    BfArM = Federal Institute for Drugs and Medical Devices in Germany.

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Author information

Authors and Affiliations

  1. Institute of Computer Science, University of Rostock, Rostock, Germany

    Maciej Piwowarczyk vel Dabrowski & Kurt Sandkuhl

  2. Fraunhofer FOKUS, Berlin, Germany

    Maciej Piwowarczyk vel Dabrowski

Authors
  1. Maciej Piwowarczyk vel Dabrowski
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  2. Kurt Sandkuhl
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Correspondence to Kurt Sandkuhl .

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Editors and Affiliations

  1. Poznań University of Economics and Business, Poznan, Poland

    Witold Abramowicz

  2. TIB Leibniz Information Center Science and Technology and University of Hannover, Hannover, Germany

    Sören Auer

  3. Poznań University of Economics and Business, Poznan, Poland

    Milena Stróżyna

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Piwowarczyk vel Dabrowski, M., Sandkuhl, K. (2022). Market Launch and Regulative Assessment of ICT-Based Medical Devices: Case Study and Problem Definition. In: Abramowicz, W., Auer, S., Stróżyna, M. (eds) Business Information Systems Workshops. BIS 2021. Lecture Notes in Business Information Processing, vol 444. Springer, Cham. https://doi.org/10.1007/978-3-031-04216-4_27

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  • DOI: https://doi.org/10.1007/978-3-031-04216-4_27

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