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Merhof, Dorit

Biomedical Engineering / Biomedizinische Technik

Joint Journal of the German Society for Biomedical Engineering in VDE and the Austrian and Swiss Societies for Biomedical Engineering and the German Society of Biomaterials

Editor-in-Chief: Dössel, Olaf

Editorial Board: Augat, Peter / Habibović, Pamela / Haueisen, Jens / Jahnen-Dechent, Wilhelm / Jockenhoevel, Stefan / Knaup-Gregori, Petra / Leonhardt, Steffen / Plank, Gernot / Radermacher, Klaus M. / Schkommodau, Erik / Stieglitz, Thomas / Boenick, Ulrich / Jaramaz, Branislav / Kraft, Marc / Lenarz, Thomas / Lenthe, Harry / Lo, Benny / Mainardi, Luca / Micera, Silvestro / Penzel, Thomas / Robitzki, Andrea A. / Schaeffter, Tobias / Snedeker, Jess G. / Sörnmo, Leif / Sugano, Nobuhiko / Werner, Jürgen /


IMPACT FACTOR 2018: 1.007
5-year IMPACT FACTOR: 1.390

CiteScore 2018: 1.24

SCImago Journal Rank (SJR) 2018: 0.282
Source Normalized Impact per Paper (SNIP) 2018: 0.831

Online
ISSN
1862-278X
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Volume 64, Issue 1

Issues

Volume 57 (2012)

Design of a secure remote management module for a software-operated medical device

Urban BurnikORCID iD: https://orcid.org/0000-0002-8652-4977 / Štefan Dobravec / Marko Meža
Published Online: 2017-12-09 | DOI: https://doi.org/10.1515/bmt-2017-0005

Abstract

Software-based medical devices need to be maintained throughout their entire life cycle. The efficiency of after-sales maintenance can be improved by managing medical systems remotely. This paper presents how to design the remote access function extensions in order to prevent risks imposed by uncontrolled remote access. A thorough analysis of standards and legislation requirements regarding safe operation and risk management of medical devices is presented. Based on the formal requirements, a multi-layer machine design solution is proposed that eliminates remote connectivity risks by strict separation of regular device functionalities from remote management service, deploys encrypted communication links and uses digital signatures to prevent mishandling of software images. The proposed system may also be used as an efficient version update of the existing medical device designs.

Keywords: medical devices; PEMS; programmable electrical medical systems; remote management; risk management

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About the article

Received: 2017-01-10

Accepted: 2017-11-07

Published Online: 2017-12-09

Published in Print: 2019-02-25


Conflict of interest: The authors indicate no potential conflicts of interest in this work.


Citation Information: Biomedical Engineering / Biomedizinische Technik, Volume 64, Issue 1, Pages 67–80, ISSN (Online) 1862-278X, ISSN (Print) 0013-5585, DOI: https://doi.org/10.1515/bmt-2017-0005.

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