Self-care monitoring web-based application software

Risk Class

Class IIb

Product Type

Single Device Product

ARTG Category

General

Start Date

August 02, 2023

Effective Date

August 02, 2023

Name

Freyr Australia Pty Ltd

Name

Huma Therapeutics Limited

Country

United Kingdom

Address

13th Floor Millbank Tower, 21-24 Millbank, London, SW1P 4QP

The Huma platform is a modular Software as a Medical Device (SaMD) which may utilise compatible devices and software to obtain data collated via a mobile app or web app and delivered to the clinician via a web portal or web app where it may be viewed to drive clinical management. It is intended to be used for the physiological and non-physiological intermittent or spot-check monitoring of all condition patients in professional healthcare facilities, such as clinics, hospitals or skilled nursing facilities, or in the patient’s home setting. It is intended for the monitoring of patients by trained healthcare professionals. The Huma platform comprises a number of different modules and functionalities that can be selected by the customer for configuration of care plans which can be further personalised for the patients. Clinical information collected from these modules is displayed on a clinician web portal and patient app with the addition of flagging out of range datasets, trend visualisation, goal setting and communication channels between clinicians and patients. The data displayed on the mobile app, web portal or web app can be labelled, flagged and triaged for the purposes of monitoring disease or deterioration, improvement and 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, diagnosis, disease monitoring and prognostication. The Huma platform can be used for adult and paediatric populations with functionality to accommodate data entry by caregivers and guardians.