2016
DOI: 10.2345/0899-8205-50.1.23
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Cybersecurity for Medical Device Manufacturers: Ensuring Safety and Functionality

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Cited by 14 publications
(18 citation statements)
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“…Medical devices, which were traditionally stand-alone systems, are becoming network-integrated within hospital IT systems and are no longer immune to traditional cyber attacks [8]. As of recent, medical device manufacturers are implementing and expanding networked medical devices, while failing to maintain a pace to circumvent the possible cybersecurity threats posed by network integration [9,27]. Many IT experts are concerned that recent trends will convince cybercriminals to target medical devices such as pacemakers or Intensive Care Unit (ICU) respirators [33].…”
Section: Synthesis Of Resultsmentioning
confidence: 99%
See 1 more Smart Citation
“…Medical devices, which were traditionally stand-alone systems, are becoming network-integrated within hospital IT systems and are no longer immune to traditional cyber attacks [8]. As of recent, medical device manufacturers are implementing and expanding networked medical devices, while failing to maintain a pace to circumvent the possible cybersecurity threats posed by network integration [9,27]. Many IT experts are concerned that recent trends will convince cybercriminals to target medical devices such as pacemakers or Intensive Care Unit (ICU) respirators [33].…”
Section: Synthesis Of Resultsmentioning
confidence: 99%
“…Wu et al [9] Introduces the topic of new wireless applications of medical devices left vulnerable to cyber attacks and how safety risk management in manufacturing is being redefined to address growing cybersecurity threats.…”
Section: Synthesis Of Resultsmentioning
confidence: 99%
“…These costs account for about four percent of the loss, reputation damage associated with about eight percent of the loss, and damage to infrastructure, which accounts for about 10 percent of the losses. Other costs include theft of information assets (23 percent), system downtime (25 percent), and end user and IT productivity loss; with the latter accounting for 30 percent of the costs incurred [2][3][4]6]. The figure below provides a summary of these healthcare costs associated with endpoint attacks.…”
Section: Introductionmentioning
confidence: 99%
“…As described in the MDPC (2014) framework, the process of choosing controls is not trivial, especially when there are multiple control options. Wu and Eagles (2016) highlight that cybersecurity controls need to be balanced against usability, which is also articulated in the FDA's guidance (FDA, 2016). An example of the tradeoff is the use of a password to access information on a medical device, which could result in a delay of treatment.…”
Section: Tailored Impactmentioning
confidence: 99%
“…An assurance case is a communication method that organizes information in a systematic and structured way to articulate evidence and critical thinking, and it is traditionally applied to safety assessments (FDA, 2014). Wu and Eagles (2016) provide a template of a cybersecurity assurance case and propose that this assurance case can be used to articulate cybersecurity assessment to outside stakeholders, specifically to regulators, which has also been recommended by the FDA for infusion pump manufacturers.…”
Section: Tailored Impactmentioning
confidence: 99%