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Cybersecurity and medical devices: A practical guide for cardiac electrophysiologists
dc.contributor.authorRansford, Benjamin
dc.contributor.authorKramer, Daniel B.
dc.contributor.authorFoo Kune, Denis
dc.contributor.authorAuto de Medeiros, Julio
dc.contributor.authorYan, Chen
dc.contributor.authorXu, Wenyuan
dc.contributor.authorCrawford, Thomas
dc.contributor.authorFu, Kevin
dc.date.accessioned2017-10-05T18:19:20Z
dc.date.available2018-11-01T16:42:00Zen
dc.date.issued2017-08
dc.identifier.citationRansford, Benjamin; Kramer, Daniel B.; Foo Kune, Denis; Auto de Medeiros, Julio; Yan, Chen; Xu, Wenyuan; Crawford, Thomas; Fu, Kevin (2017). "Cybersecurity and medical devices: A practical guide for cardiac electrophysiologists." Pacing and Clinical Electrophysiology 40(8): 913-917.
dc.identifier.issn0147-8389
dc.identifier.issn1540-8159
dc.identifier.urihttps://hdl.handle.net/2027.42/138357
dc.description.abstractMedical devices increasingly depend on software. While this expands the ability of devices to perform key therapeutic and diagnostic functions, reliance on software inevitably causes exposure to hazards of security vulnerabilities. This article uses a recent high‐profile case example to outline a proactive approach to security awareness that incorporates a scientific, risk‐based analysis of security concerns that supports ongoing discussions with patients about their medical devices.
dc.publisherWiley Periodicals, Inc.
dc.subject.otherpacemakers
dc.subject.otherimplantable cardioverter‐defibrillators
dc.titleCybersecurity and medical devices: A practical guide for cardiac electrophysiologists
dc.typeArticleen_US
dc.rights.robotsIndexNoFollow
dc.subject.hlbsecondlevelPhysiology
dc.subject.hlbtoplevelHealth Sciences
dc.description.peerreviewedPeer Reviewed
dc.description.bitstreamurlhttps://deepblue.lib.umich.edu/bitstream/2027.42/138357/1/pace13102_am.pdf
dc.description.bitstreamurlhttps://deepblue.lib.umich.edu/bitstream/2027.42/138357/2/pace13102.pdf
dc.identifier.doi10.1111/pace.13102
dc.identifier.sourcePacing and Clinical Electrophysiology
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dc.identifier.citedreferenceU.S. Food and Drug Administration. Postmarket Management of Cybersecurity in Medical Devices. Guidance for Industry and Food and Drug Administration Staff. Issued December 2016. Available from: < https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm482022.pdf > (accessed March 20, 2017).
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dc.identifier.citedreferenceDahms DF. Implantable Pacemaker Testing Guidance. U.S. Food and Drug Administration, editor. 1990 https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm081382.pdf (accessed June 13, 2017).
dc.identifier.citedreferenceMuddy Waters LLC. MW is Short St. Jude Medical (STJ:US), August 25, 2016. Available from: < http://d.muddywatersresearch.com/wp-content/uploads/2016/08/MW_STJ_08252016_2.pdf > (accessed August 30, 2016).
dc.identifier.citedreferenceSlotwiner D, Varma N, Akar JG, et al. HRS Expert Consensus Statement on remote interrogation and monitoring for cardiovascular implantable electronic devices. Heart Rhythm 2015; 12: e69 – 100.
dc.identifier.citedreferenceMuddy Waters LLC. STJ Pacemaker Crash Attack. Vimeo. [updated August 29, 2016]. Available from: < https://vimeo.com/180593205 >
dc.identifier.citedreferenceU.S. Food and Drug Administration. Cybersecurity Vulnerabilities Identified in St. Jude Medical’s Implantable Cardiac Devices and Merlin@home Transmitter: FDA Safety Communication. Available from: < https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm535843.htm > (accessed March 20, 2017).
dc.identifier.citedreferenceSt. Jude Medical Press Release, January 9, 2017. St. Jude Medical Announces Cybersecurity Updates. Available from: < http://media.sjm.com/newsroom/news-releases/news-releases-details/2017/St-Jude-Medical-Announces-Cybersecurity-Updates/default.aspx > (accessed March 20, 2017).
dc.identifier.citedreferenceU.S. Food and Drug Administration. Warning Letter to Abbott (St. Jude Medical Inc.) 4/12/2017. Available from: < https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm552687.htm > (accessed April 18, 2017).
dc.identifier.citedreferenceHalperin D, Heydt‐Benjamin TS, Fu K, Kohno T, Maisel WH. Security and privacy for implantable medical devices. IEEE Pervasive Comput. 2008; 7: 30 – 39.
dc.identifier.citedreferenceKramer DB, Baker M, Ransford B, et al. Security and privacy qualities of medical devices: an analysis of FDA postmarket surveillance. PLoS One. 2012; 7: e40200.
dc.owningcollnameInterdisciplinary and Peer-Reviewed


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