Security Integration in Medical Device Design: Extension of an Automated Bio-Medical Engineering Design Methodology

This paper describes an automated solution for improving the design methodology of bio-medical applications on embedded platform devices with security and privacy guarantees. Besides typical design parameters, the need for security and privacy guarantees at the communication, software and hardware layers further extend the design space. Security and privacy features require expertise in evaluating and deploying solutions which are often specific to the individual application scenario. This makes these concerns hard to take into account in a typical hardware-software design process. We discuss how an existing design workflow can be extended to support the early detection of security and privacy issues, the selection of appropriate countermeasures and their effective integration. We consider the application scenario of continuous heart monitoring and analysis, through employing a Holter device. The design space exploration enacted by our methodology allows solving the conflicting requirements posed by security, software optimization, and hardware architectural parameters, in order to fine tune the overall system design and optimize the desired system metrics. We provide an experimental analysis of the proposed approach, showing a 3X decrease in design time, as well as demonstrating that quality assurance constraints are met.