Self-care monitoring web-based application software

Intended purpose

The Huma Ig platform is a software as a medical device (SaMD) which utilises software and, to obtain health data collated via a mobile or a web app for patients on immunoglobulin therapies. The data collected may be shared with healthcare professionals to drive clinical management or be used for the physiological and non-physiological intermittent or spot-check monitoring of patients in professional healthcare facilities, such as clinics, hospitals or skilled nursing facilities, or in the patient’s home setting. The Huma Ig app comprises modules and functionalities that are tailored to support patients on immunoglobulin therapies and help them navigate the complex, region-specific care pathways and treatment administration processes. Clinical information collected can be displayed on a clinician web portal and patient app with the addition, trend visualisation, goal setting and communication channels between clinicians and patients. The data displayed on the mobile or web app and the web portal can be labelled, flagged and triaged for the purposes of monitoring disease, its’ deterioration or improvement, to support clinical decision making and to encourage self management of disease by the patients. The platform may also provide data analytics, risk scores and static algorithms that may assist in the assessment of risk prediction, disease monitoring, prognostication and treatment dosage titration. The Huma Ig platform can be used for adult and paediatric populations with functionality to accommodate data entry by caregivers and guardians. The Huma Ig platform is not intended for use in high-acuity environments, such as ICU or operating rooms.