Summary: | Health-care delivery in developing countries has many challenges because they do not have enough resources for meeting the healthcare needs and they lack testing lab infras- tructures in communities. It has been proven that Point-Of-Care (POC) testing can be considered as one of the ways to resolve the crisis in healthcare delivery in these com- munities. The POC testing is a mission critical processes in which the patient conduct tests outside of laboratory environment and it needs a secure communication system of architecture support which the research refers as POCT system Almost every ten years there will be a new radio access technology (RAT) is released in the wireless communication system evolution which is primarily driven by the 3GPP standards organisation. It is challenging to develop a predictable communication sys- tem in an environment of frequent changes originated by the 3GPP and the wireless operators. The scalable and expandable network architecture is needed for cost-effective network management, deployment and operation of the POC devices. Security mecha- nisms are necessary to address the specific threats associated with POCT system. Se- curity mechanisms are necessary to address the specific threats associated with POCT system. The POCT system communication must provide secure storage and secure com- munication to maintain patient data privacy and security. The Federal Drug Admin- istration (FDA) reports the leading causes of defects and system failures in medical devices are caused by gaps between the requirements, implementation and testing. The research was conducted, and technical research contributions are made to resolve the issues and challenges related to the POCT system. A communication protocol implemented at the application level, independent of radio access technologies. A new methodology was created by combining Easy Approach to Requirement Specifications (EARS) methodology and Use Case Maps (UCM) model which is a new approach and it addresses the concerns raised by the FDA. Secure cloud architecture was created which is a new way of data storage and security algorithms models were designed to address the security threats in the POCT system. The security algorithms, secure cloud architecture and the communication protocol coexist together to provide Radio access technology Independent Secure and Expandable (RISE) POCT system. These are the contributions to new knowledge that came out of the research. The research was conducted with a team of experts who are the subject matter experts in the areas such as microfluidics, bio-medical, mechanical engineering and medicine.
|