Abstract
We give a practical example of transferring High Level Software Separation and Risk Analysis Techniques initially developed for measuring instruments in Legal Metrology, into the medical device domain. The concepts are used to separate medically sensitive, and hence regulated software, from the dynamic, unregulated software parts. In that way, the highly valuable patient data are securely separated from potential security threats, ensuring greater IT protection of the medical device and hence the patient data. Concretely, virtualization with the Xen hypervisor has been implemented, to show how IT security for Windows software can be enhanced by separating software parts and restricting access to hardware. The knowledge gained is presented as an experience report and compares the concept with the already known software separation mechanisms for Legal Metrology. Additionally, an experimental test was done, to analyze how a second graphics card, which is forwarded to the medically relevant software parts through PCI passthrough, can significantly improve performance.
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