Medical Device Cyber-Security

PROJECT SUMMARY The Food and Drug AdministrationFDAhas identified cyber security of medical devices as a high priorityand has taken steps to work with medical device manufactures to address this growing concernNokomis proposes to develop an embeddedor standalone device to analyze unintended Radio FrequencyRFemissions to determine changes in device functionality between normally operating medical devices from those under cyber attackThe proposed noninvasive analysis device would allow medical professionalsand patientsto rapidly identify cyber attacks in operating devices in a matter of minutesincreasing the ability to address critical system breaches before harm can be doneThe noninvasive RF measurement approach is a significant advantage over any other current mitigation techniqueas it relies only on the deviations from normal operational states to identify potential problemsMinimally trained medical professionalsas well as patients with devices at homewould be enabled to use the embedded or standalone device and potentially identify device risks prior to device failureNokomisproposed monitoring device would enable rapid analysis of a widespread array of medical devices for functional capabilities in a noninvasiveand easy to usesystem that would provide many benefits to patients and medical professionalsThe proposed device will utilize unintended RF emissions that are casually related to electronic functionality on medical devices to distinguish abnormal operating conditionsUsing Nokomisultra sensitive sensorthe deviation in spectral content can be automatically detected to allow an alarm for the user to take action to mitigate damage from a cyber attackThe proposed research in Phase I will focus onAimcharacterizing a specific medical device in normal operational mode as well as in an altered state under cyber attackDifferences in spectral content will be used to create detection algorithmsAimthat will be tested in a benchtop prototype system to demonstrate cyber attack detection capabilitiesAimSuccessful results from this program will advance the mission of the agency to assure the safety of medical devices to protect the security of human patients that require medical care PROJECT NARRATIVE The proposal aims to develop a device that can be used to quickly and accurately identify cyberattacks on medical devices in real time with a noninvasive deviceCurrent state of the art technology does not allow for detection of cyber attacksas they occurrather they largely rely on identifying them after device failure or mitigation techniques prior to reported attacksNokomis has demonstrated expertise in Radio FrequencyRFsensing of electronic devices and correlating the spectral content to device operation using the Hiawatha sensor in a portable measurement deviceThe proposed effort builds on that expertise that will result in a rapid portable analytic device with the capability of identifying changes in device operational modesThe impact of this device would be substantial for the ability to actively monitor for cyber attacks in medical devices