At-Home COVID-19 Monitoring and Triaging Platform
This grant will be primarily used to achieve full regulatory compliance of our “”At-home COVID-19 monitoring and triaging platform”” based on Think Biosolution’s (lead applicant) clinically proven novel COVID-19 early warning scores. This platform will specifically address the challenge that COVID-19 hubs in hospitals have to allocate critical resources such as nurses to do a daily phone-based check-up of at-home COVID-19 positive patients.
The platform uses a CE-Marked finger-based pulse oximeter to monitor patients’ blood oxygen saturation and heart rate levels up to six times a day. This vital sign is then used to derive a COVID-19 early warning score (CEWS) that can be used by clinicians to decide which at-home COVID-19 patients need immediate hospitalisation. A COVID-19 hub in a hospital with 170 COVID-19 beds will be able to monitor 1,000 COVID positive patients remotely using our platform.
The grant will be specifically used to achieve (1) develop a software verification plan (compliant with IEC 62304) and a software risk analysis plan (compliant with ISO 14971) (2) develop the app and clinical dashboard for COVID-19 early warning score based triaging (3) add clinical pathway recommendation UI to the app and clinical dashboard (4) achieve IEC 62304 and ISO 14971 certifications (5) test integration with partner telehealth company’s infrastructure (6) test integration in a hospital setting with Health Innovation Hub Ireland, HSE, Ireland.