Once a patient has been admitted to a hospital, they will be checked on by the nursing staff every four hours (even during the night). With nursing teams being overworked and understaffed, manual checks of patient vital signs and manual data entry may lead to errors and omissions. Corsano’s CardioWatch eliminates the need for manual data entry by syncing patient vital sign data directly into the EHR system via Device Hub. In addition, Corsano’s CardioWatch enables a much more peaceful and comfortable experience for patients. Patients can move around freely as well as sleep through the night without interruptions, which has been proven to lead to faster healing. All this whilst having the reassurance that the physician is making the best possible treatment decisions based on Corsano’s CardioWatch clinically validated cardiac vitals and core body temperature data.
Continuous and reliable data collection is a major challenge in the medical field. Wearable medical devices promise convenient, efficient and long-term clinical trials based on the continuous capturing of biomarkers during every-day life of trial participants. The Real World Data can help to overcome challenges like the increasing burden of chronic diseases with personalized treatments and objective outcomes. Automation reduces patient burden, facilitates decentralized study setups and allows complying with increasing regulatory demands in an economically viable way.
Architecture for device data collection, storage and processing
In collaboration with partner Leitwert, Corsano offers platform consisting of a network of Bluetooth gateways communicating via the hospital’s secure Wi-Fi network, a server application (Device Hub) and associated databases. Already existing access points or low-cost hardware can be used to run the gateway software. This will enable linking of devices with standard hospital IT infrastructure worldwide. The platform can be extended to an out-patient monitoring solution to close the gap between in-house treatments and follow-up patient monitoring. With an open API they are integrated with the hospital’s EHR system.
The infrastructure enables automated patient monitoring using wearable biosensors for data acquisition. The platform consists of a network of Bluetooth gateways, which link devices (i.e. Corsano CardioWatch 287) with the server application (Device Hub) and associated databases based on a network of gateways, servers and databases. The connection is through the secure hospital Wi-Fi network and Bluetooth Low Energy (BLE) available through access points throughout the facility. Once the data is stored in the secure hospital databases (DB) it can be accessed by authorized personnel. Additionally, it is possible to integrate third-party analytics tools via application programming interface (API), creating an ecosystem for data analytics services while preserving the privacy of patients’ data. Importantly, while the current setup is specific to Leitwert, IT infrastructure provider Cisco is in the process to enable standard Cisco access points to connect to devices such as the Corsano 287 Bracelet.
The system maintains an immutable audit trail and provides configurable workflows to comply with application specific regulatory requirements like GCP, HIPAA, FDA 21 CFR Part11 or ISO 13485.