Implantable and wearable medical devices (IWMDs) are widely used for the monitoring and therapy of an increasing range of medical conditions. Improvements in medical devices, enabled by advances in low-power processors, more complex firmware, and wireless connectivity, have greatly improved therapeutic outcomes and patients quality-of-life. However, security attacks, malfunctions and sometimes user errors have raised great concerns regarding the safety of IWMDs. In this work, we present a HW/SW (Hardware/Software) framework for improving the safety of IWMDs, wherein a set of safety rules and a rule check mechanism are used to monitor both the extrinsic state (the patients physiological parameters sensed by the IWMD) and the internal state of the IWMD (I/O activities of the microcontroller) to infer unsafe operations that may be triggered by user errors, software bugs, or security attacks. We discuss how this approach can be realized in the context of a artificial pancreas with wireless connectivity and implement a prototype to demonstrate its effectiveness in improving safety at modest overheads.
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