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dc.contributor.authorKramer, Daniel Bruce
dc.contributor.authorBaker, Matthew Charles
dc.contributor.authorRansford, Benjamin
dc.contributor.authorMolina-Markham, Andres
dc.contributor.authorStewart, Quinn
dc.contributor.authorFu, Kevin
dc.contributor.authorReynolds, Matthew R.
dc.date.accessioned2013-03-19T16:19:00Z
dc.date.issued2012
dc.identifier.citationKramer, Daniel B., Matthew Baker, Benjamin Ransford, Andres Molina-Markham, Quinn Stewart, Kevin Fu, and Matthew R. Reynolds. 2012. Security and privacy qualities of medical devices: An analysis of FDA postmarket surveillance. PLoS ONE 7(7): e40200.en_US
dc.identifier.issn1932-6203en_US
dc.identifier.urihttp://nrs.harvard.edu/urn-3:HUL.InstRepos:10445585
dc.description.abstractBackground: Medical devices increasingly depend on computing functions such as wireless communication and Internet connectivity for software-based control of therapies and network-based transmission of patients’ stored medical information. These computing capabilities introduce security and privacy risks, yet little is known about the prevalence of such risks within the clinical setting. Methods: We used three comprehensive, publicly available databases maintained by the Food and Drug Administration (FDA) to evaluate recalls and adverse events related to security and privacy risks of medical devices. Results: Review of weekly enforcement reports identified 1,845 recalls; 605 (32.8%) of these included computers, 35 (1.9%) stored patient data, and 31 (1.7%) were capable of wireless communication. Searches of databases specific to recalls and adverse events identified only one event with a specific connection to security or privacy. Software-related recalls were relatively common, and most (81.8%) mentioned the possibility of upgrades, though only half of these provided specific instructions for the update mechanism. Conclusions: Our review of recalls and adverse events from federal government databases reveals sharp inconsistencies with databases at individual providers with respect to security and privacy risks. Recalls related to software may increase security risks because of unprotected update and correction mechanisms. To detect signals of security and privacy problems that adversely affect public health, federal postmarket surveillance strategies should rethink how to effectively and efficiently collect data on security and privacy problems in devices that increasingly depend on computing systems susceptible to malware.en_US
dc.language.isoen_USen_US
dc.publisherPublic Library of Scienceen_US
dc.relation.isversionofdoi:10.1371/journal.pone.0040200en_US
dc.relation.hasversionhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3400651/pdf/en_US
dash.licenseLAA
dc.subjectBiologyen_US
dc.subjectBiotechnologyen_US
dc.subjectBioengineeringen_US
dc.subjectMedical Devicesen_US
dc.subjectComputer Scienceen_US
dc.subjectComputer Securityen_US
dc.subjectMedicineen_US
dc.subjectDrugs and Devicesen_US
dc.subjectNon-Clinical Medicineen_US
dc.subjectMedical Ethicsen_US
dc.subjectPublic Healthen_US
dc.subjectScience Policyen_US
dc.subjectTechnology Regulationsen_US
dc.subjectSocial and Behavioral Sciencesen_US
dc.subjectPolitical Scienceen_US
dc.subjectPublic Policyen_US
dc.titleSecurity and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillanceen_US
dc.typeJournal Articleen_US
dc.description.versionVersion of Recorden_US
dc.relation.journalPLoS ONEen_US
dash.depositing.authorKramer, Daniel Bruce
dc.date.available2013-03-19T16:19:00Z
dc.identifier.doi10.1371/journal.pone.0040200*
dash.contributor.affiliatedBaker, Matthew
dash.contributor.affiliatedKramer, Daniel


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