Sikkerhed i medicinske apparater
Oversat titel
Security in medical devices
Forfatter
Jakobsen, Ulrik Møller
Semester
4. semester
Udgivelsesår
2017
Antal sider
46
Resumé
Denne masterafhandling undersøger sikkerheden i medicinske apparater med fokus på ICD-pacemakere med trådløse funktioner og hjemmemonitorering. Ud fra forfatterens egne erfaringer som ICD-bruger formuleres spørgsmålet om, hvor sikre disse enheder er, hvilke angrebsveje der findes, og hvordan cybersikkerhed kan afvejes mod patientsikkerhed. Metodisk anvendes Three Pillars of Software Security og FIT-modellen (fortrolighed, integritet, tilgængelighed) til at gennemføre en risikovurdering af en indopereret ICD, herunder en gennemgang af konkrete angrebsvektorer som ændring af indstillinger via trådløst interface, reverse engineering af transmitter, deaktivering med magnet, batteridræning, opsnapning af data, tyveri af udstyr og radiobølgeangreb. Afhandlingen gennemgår desuden mulige sikkerhedsmekanismer (bl.a. kryptering, nøgleopbevaring, biometrik, auditing og anomaly detection) set i lyset af patientsikkerhed, og sammenligner FDA’s anbefalinger for cybersikkerhed i medicinsk udstyr med Three Pillars-tilgangen. Analysen indikerer, at mange angreb er teknisk mulige, men at der ikke er rapporteret faktiske angreb, og den fremhæver, at patientsikkerhed er det primære designhensyn. Forfatteren anbefaler FDA’s retningslinjer som særlig relevante for trådløse medicinske enheder og ICD’er, mens nye sikkerhedsmekanismer synes lovende, men endnu ikke er på markedet. Overordnet bidrager afhandlingen til en bedre forståelse af udvikleres designvalg og kompromiser mellem høj sikkerhed og ufravigelig patientsikkerhed.
This master’s thesis examines security in medical devices with a focus on wireless ICD pacemakers and home monitoring. Drawing on the author’s experience as an ICD user, it asks how secure these devices are, what attack vectors exist, and how to balance cybersecurity with patient safety. Methodologically, it applies the Three Pillars of Software Security and the FIT model (confidentiality, integrity, availability) to perform a risk assessment of an implanted ICD, covering specific attack vectors such as changing settings via the wireless interface, reverse engineering the transmitter, magnet-based deactivation, battery draining, data interception, equipment theft, and radio-frequency attacks. The thesis also reviews potential security mechanisms (including encryption, key storage, biometrics, auditing, and anomaly detection) through the lens of patient safety, and compares FDA cybersecurity guidance for medical devices with the Three Pillars approach. The analysis indicates that many attacks are technically feasible but that no actual attacks have been reported, and it emphasizes patient safety as the foremost design priority. The author recommends FDA guidance as especially pertinent for wireless medical devices and ICDs, while noting that several promising mechanisms are not yet on the market. Overall, the work clarifies the trade-offs developers face between strong security and uncompromised patient safety.
[Dette resumé er genereret med hjælp fra AI direkte fra projektet (PDF)]