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Comarch HomeHealth 2.0

By Comarch AG - Belgian Branch

Comarch HomeHealth is designed for remote medical care. The mobile application is a product providing telemedical services available from the patient's home. Thanks to the possibility of cooperation with various devices, the application enables reception, transmission and presentation of medical data in text and visual form, as well as reception of results of questionnaires filled in by the patient. The application has been designed to collect and partially information about the health condition of patients.

Level 3 plus

I am a CE-certified medical device
I am safely connected
I have proven my social-economic evidence and get reimbursed by NIHDI

Languages

DE EN FR IT NL
General description
Additional info
Media
Financing

General description (provided by company)

Main purpose

Comarch HomeHealth 2.0 provides remote medical care to connect patients who needs monitoring with healthcare providers. It has a positive impact on healthcare facilities organization, therapies efficiency and patients’ quality of life because it allows to:
-avoid useless hospitalizations
-perform a personalized monitoring of patients in real-time
-improve diagnostic and patient’s adherence
-ease the access to medical data for patients and healthcare providers
-improve the sense of safety of patients

Target audience

Comarch HomeHealth 2.0 is intended for patients and healthcare professionals. More specifically, it targets adults with chronic diseases, elderly people, patients after hospitalization or during diagnosis process as well as nurses, doctors and caregivers who examine these patients.

Approach

The app records the historical results of the measurements and questionnaires so that the user can present them to his or her doctor during the visit in order to make the best possible diagnosis and treatment. The patient's personal data (name, surname, id, address, contact, medical history, individually determined measurement standard ranges and all measurement results) are stored in a telemedicine platform. These data are necessary for the provision of a medical service such as 24-hour medical monitoring provided by medical personnel and appropriate intervention in cases of emergency. For example, the application performs automatic data analysis based on the configuration of patient's medical parameters thresholds sent from the Telemedicine platform. When extreme values (thresholds) are exceeded, Comarch HomeHealth sends information to the platform, which analyzes the measurement once again. An alert about exceeding the norm is immediately displayed to the doctor and enables immediate reaction through a video consultation.

Connectivity to sensors and platforms

All sensors are connected with the Comarch HomeHealth 2.0 application via Bluetooth technology. Measurements that can be made by connected devices are:

- Body composition (body fat level, bone mass, muscle mass, water content, BMI, etc.)

- Body weight

- Blood pressure

- blood glucose levels

- heart rate

- ECG signal

- O2 saturation

- Body temperature

- spirometry

In addition, Comarch HomeHealth is connected with a Telemedicine platform, Comarch e-Care, via internet. The platform enables to store and analyze patients' data while connecting them with the medical staff.

Financing and pricing model

The key part of the HomeHealth solution is communication with the telemedicine platform operated by the Client. The fee charged for the platform depends on the duration of the cooperation and number of devices. We offer the HomeHealth solution as an integral part with a dedicated tablet and integrated medical sensors. Such a solution may be purchased or leased by the Client. The price depends on the number and type of sensors and the lease time.

The HomeHealth app can also be downloaded on the Google Store (soon also on the App Store) on mobile device and then license fee is charged. In this case it is also possible to purchase or lease integrated medical sensors.

Pathology

Cancer Chest / Lung Diabetes Healthy Living Heart / Blood Vessels Kidney / Genito-urinary Pregnancy Treatment adherence

Functions

Alerts & Notifications Automated Guidance Data Sharing Environmental Data Goal Setting & Gamification Health Tracking Online Appointments Remote Clinical Monitoring Treatment Support

Users

Men Women Elderly Clinicians

Additional info

Compliance to M3 criteria

This application has completed levels M1 and M2 of the pyramid, and the company declares to meet the criteria for mobile medical applications that NIHDI has set within the following specific care process:

Telemonitoring and therapy guidance in chronic heart failure ( More info: NL, FR )

Compliance to M1 criteria

CE certification

Download document Granted by TUV Rheinland Assessed and certified meeting the requirements of:
Medical Device Directive: MDD 93/42/EEC (old regulation) Medical Device Regulation: MDR 2017/745 (new regulation) In Vitro Diagnostic Directive: 98/79/EC (old regulation) In Vitro Diagnostic Regulation: IVDR 2017/746 (new regulation)
Certificate granted on 20/07/2023 Certificate valid till 17/07/2027 Class type of medical device (More info): 2A
ISO Standards:
ISO 13485 Quality Management Systems for Medical Devices (on company level) ISO 14155 Clinical Investigations of Medical Devices in Human Subjects ISO 14971 Risk Management of Medical Devices ISO 27000 series: Information Security Management Systems ISO 62304 Medical Device Software Lifecycle Processes ISO 62366 Application of Usability Engineering to Medical Devices

FAMHP registration and notification

Company registration number at FAMHP: 74238 Product identification code at FAMHP: 905258

General Data Protection Regulation (More info)

Company declares explicitly to be compliant with GDPR rules Company declares that the data are stored in EU only

The app is only available through prescription

User instructions

The application guides the user step-by-step and thus, in itself, contains a user manual. Each test or survey shows intuitively what the next step the patient should take and how to use the measuring device. The application has been designed to be easy to use also for the elderly.

Components of the application

Native app

Media

Screenshot6 Screenshot2 Screenshot3

Financing

This application has completed levels M1 and M2 of the pyramid, and the company declares to meet the criteria for mobile medical applications that NIHDI has set within the following specific care process:

Telemonitoring and therapy guidance in chronic heart failure ( More info: NL, FR )