HopeCare

HopeCare is the OEM version of HCAlert. HCAlert is a software classified as a Class IIb medical device, certified according to EU MDR 2017/745 and UK 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 that receives data from different health monitoring device providers and creates alerts for the user to draw attention to critical situations. The server is a centralized computer database managed by a predefined entity that receives, stores, and manages the platform data, along 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 authorized users (doctors and nurses) through the HopeCare website or the Android mobile application. Information can be collected from other devices (such as mobile applications on wearable devices), laboratory measurements, or entered by patients themselves or healthcare professionals. This data is securely transferred to the central database, where it is analyzed using a scoring system – HCAlert. After analyzing the entered data, alerts are generated for nurses and doctors, who then analyze them. The system does not provide continuous real-time monitoring.

Data must be entered or synchronized according to the initial configuration setting, unless the responsible healthcare professional has made another decision to change the monitoring frequency for an individual patient. Devices from other manufacturers (not included in the manual list of devices) are not compatible with the system. The algorithm is based on a scoring system where a color score is assigned to each measurement, stratifying its risk:

• Gray – no measurement; No definition
• Dark green (no risk) – normal
• Light green (low to medium risk) – mild
• Yellow (medium to high risk) – important
• Orange (high risk) – very important
• Red (very high risk) – emergency.

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

Target population: It is intended for adult patients at home, aged 18 years and older, who may suffer from at least one chronic disease and other clinical conditions that may require continuous monitoring, under the guidance of an authorized medical professional or clinical personnel trained in its proper use.

Contraindication: HCAlert is not intended for pregnant women and critically ill patients, as the baseline physiological parameters are different in these populations. Unless requested by a physician and the protocol is developed with baseline physiological parameters for these populations.

Precautions: In people suffering from psychiatric disorders (especially psychotic illnesses and dementia) along with the aforementioned chronic diseases, the use of HCAlert and devices synchronized with the HCAlert software should be done by caregivers or personnel trained for this purpose.

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