HopeCare

HopeCare is the OEM version of HCAlert. HCAlert is a Class IIb medical device, certified in accordance with the EU’s MDR 2017/745 and the UK’s MDR 2002. It is an analytical system applied to the telemonitoring of health data included in the HopeCare solution. It is based on a cloud service, which receives data from different suppliers of health monitoring devices and generates alerts for the user to draw attention to critical situations. The server is a centralised computer database managed by a pre-defined entity that receives, stores and manages the platform’s data, together with patient details. The system collects sensitive personal data. Patients must consent to the collection and sharing of data before being registered in the system. Individual patient data can only be accessed by authorised users (doctors and nurses) via the Hope Care website or the iPhone mobile app. Information can be collected from other devices (such as mobile apps for wearable devices), laboratory measurements, or entered by the patients themselves or healthcare professionals. This data is securely transferred to the central database, where it is analysed using a scoring system – HCAlert. Once the entered data has been analysed, alerts are generated for nurses and doctors, who then review them. The system does not provide continuous real-time monitoring.

Data must be entered or synchronised in accordance with the initial configuration settings, unless the responsible healthcare professional has decided otherwise to change the monitoring frequency for an individual patient. Devices from other manufacturers (not included in the manual device list) are not compatible with the system. The algorithm is based on a scoring system in which a colour score is assigned to each measurement, categorising its risk:

• Grey – no measurement; undefined
• Dark green (no risk) – normal
• Light green (low to medium risk) – mild
• Yellow (medium to high risk) – significant • Orange (high risk) – very significant
• Red (very high risk) – emergency.

Intended purpose: HCAlert is intended for health prevention and surveillance purposes, through the long-term remote monitoring of patients’ vital signs and the provision of a telehealth system for medical care. Patients selected to use this technology are those referred by hospitals for the implementation of telemonitoring strategies.

Target population: Intended for adult patients at home, aged over 18, who may suffer from at least one chronic condition and other clinical situations that may require continuous monitoring, under the guidance of a licensed medical professional or clinical staff trained in its proper use.

Contraindications: HCAlert is not intended for pregnant women or critically ill patients, as baseline physiological parameters differ in these populations. Unless the doctor requests it and the protocol is designed with baseline physiological parameters for these populations.

Disclaimer: Use of the device does not replace consulting a doctor or seeking advice from a healthcare professional before making any clinical decisions.

https://ec.europa.eu/tools/eudamed/#/screen/search-device/2af57d7f-2d25-466d-97c1-635ea04bee7c