The advances of low-power and highly integrated technology provide enormous opportunities for the deployment of implantable medical devices (IMDs) and body area networks (BANs). BANs and IMDs either provide critical clinical information for medical decision-making or directly deliver medical treatment to maintain an individual?s health status. However, failures of these devices, either caused by device faults or malicious attacks, can have negative impact on the user?s health or even cause the loss of life. The significant increase in device complexity has created major challenges in ensuring reliability, safety, and security of these devices. First, researchers from the different domains, specifically engineering and medicine, have developed their respective perspectives, concerns and definitions regarding patient safety, security, and dependability. In fact, the concept of (patient) safety is often compromised by inconsistent use of language. The lack of a consistent understanding of the perspectives with respect to the healthcare and engineering disciplines could be the cause of the rising number of recalls and adverse events of medical devices in recent years, as recorded by the US Food and Drug Administration (FDA). In addition, the consideration of safety and security in the design of these devices is often ignored or overlooked in the design phase due to the limited time-to-market and lack of knowledge of the area of fault tolerant and dependable system design.
This work proposes to consider a new system-resilience design methodology which integrates the multidiscipline perspectives and considers the many dimensions of complexity and design constraints to design a system that continuously prevents, detects, mitigates, or ameliorates hazards and incidents. The intellectual merit of this project is in development of a generalized fault-tolerant model-based technique that applies the principle of "resilience-by-construction" to design of the next generation IMDs and BANs. The main goal is to develop a design methodology that provides the automatic inclusion of safety monitors in any functional design without the designer having to explicitly designate monitors during the design process. To be specific, this design methodology/framework includes: (i) a rigorous safety requirement development environment that enables the close and effective collaboration between engineers, medical professionals, and regulators to identify all the potential safety hazards and develop safety requirements that guide product design; and (ii) a standardized architecture for more resilient BANs and IMDs that enables the designers to concentrate on the development of a functional device and not be concerned about the safety and fault tolerance features. Once the functional architecture is complete, the designer will be able to add standardized hardware and software safety mechanisms based on the specific safety requirements of the device. Both model-based and knowledge-based fault detection and diagnosis methods and the combination of the two will be investigated for design of effective standardized safety mechanisms.
