Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance
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Mendeley | Further Information

{"title"=>"Security and privacy qualities of medical devices: An analysis of FDA postmarket surveillance", "type"=>"generic", "authors"=>[{"first_name"=>"Daniel B.", "last_name"=>"Kramer", "scopus_author_id"=>"35750072000"}, {"first_name"=>"Matthew", "last_name"=>"Baker", "scopus_author_id"=>"7403074607"}, {"first_name"=>"Benjamin", "last_name"=>"Ransford", "scopus_author_id"=>"24725598400"}, {"first_name"=>"Andres", "last_name"=>"Molina-Markham", "scopus_author_id"=>"36722006700"}, {"first_name"=>"Quinn", "last_name"=>"Stewart", "scopus_author_id"=>"19036303100"}, {"first_name"=>"Kevin", "last_name"=>"Fu", "scopus_author_id"=>"18434230000"}, {"first_name"=>"Matthew R.", "last_name"=>"Reynolds", "scopus_author_id"=>"34979210800"}], "year"=>2012, "source"=>"PLoS ONE", "identifiers"=>{"scopus"=>"2-s2.0-84864058685", "sgr"=>"84864058685", "issn"=>"19326203", "doi"=>"10.1371/journal.pone.0040200", "pmid"=>"22829874", "isbn"=>"1932-6203", "pui"=>"365285012"}, "id"=>"5d747bf9-64d2-352b-9a19-e1427174712a", "abstract"=>"BACKGROUND: 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.\\n\\nMETHODS: 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.\\n\\nRESULTS: 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.\\n\\nCONCLUSIONS: 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.", "link"=>"http://www.mendeley.com/research/security-privacy-qualities-medical-devices-analysis-fda-postmarket-surveillance", "reader_count"=>69, "reader_count_by_academic_status"=>{"Unspecified"=>2, "Professor > Associate Professor"=>5, "Librarian"=>1, "Student > Doctoral Student"=>9, "Researcher"=>11, "Student > Ph. D. Student"=>7, "Student > Postgraduate"=>7, "Student > Master"=>14, "Other"=>4, "Student > Bachelor"=>8, "Professor"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>2, "Professor > Associate Professor"=>5, "Librarian"=>1, "Student > Doctoral Student"=>9, "Researcher"=>11, "Student > Ph. D. Student"=>7, "Student > Postgraduate"=>7, "Student > Master"=>14, "Other"=>4, "Student > Bachelor"=>8, "Professor"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>5, "Agricultural and Biological Sciences"=>4, "Philosophy"=>1, "Arts and Humanities"=>1, "Computer Science"=>19, "Engineering"=>13, "Nursing and Health Professions"=>1, "Biochemistry, Genetics and Molecular Biology"=>1, "Mathematics"=>1, "Medicine and Dentistry"=>14, "Sports and Recreations"=>1, "Physics and Astronomy"=>1, "Psychology"=>2, "Social Sciences"=>5}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>14}, "Social Sciences"=>{"Social Sciences"=>5}, "Sports and Recreations"=>{"Sports and Recreations"=>1}, "Physics and Astronomy"=>{"Physics and Astronomy"=>1}, "Psychology"=>{"Psychology"=>2}, "Mathematics"=>{"Mathematics"=>1}, "Unspecified"=>{"Unspecified"=>5}, "Arts and Humanities"=>{"Arts and Humanities"=>1}, "Engineering"=>{"Engineering"=>13}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>4}, "Computer Science"=>{"Computer Science"=>19}, "Nursing and Health Professions"=>{"Nursing and Health Professions"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Philosophy"=>{"Philosophy"=>1}}, "reader_count_by_country"=>{"United States"=>4, "South Africa"=>1, "Portugal"=>1}, "group_count"=>7}

Scopus | Further Information

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Relative Metric

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