Comunicare

By Comunicare Solutions

Comunicare is a digital care companion that enables a better communication between patients and caregivers. It provides personalized information, self-management tools, and patient reported outcomes.

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

Downloads

Download for IOS
Download for Android

Languages

DE EN FR NL
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General description
Additional info
Media
Financing

General description (provided by company)

Main purpose

Comunicare is a digital care companion that enables a better communication between patients and caregivers. The purpose is to provide personalized information, self-management tools, and patient reported outcomes.

Target audience

Comunicare is available to patients on the prescription of their caregivers for chonic disease management (cancer, heart failure, copd, multiple myeloma, etc.)

Approach

Comunicare enforces patient empowerment, literacy, therapeutic adherence and self-efficacy. The information made available to patients is created and validated by medical experts and is adaptable for each healthcare organization.
Smart algorithms are used to deliver personalized information about the pathology and its therapy; intelligent notifications helps patients to report their outcomes (physiological parameters, symptoms, questions about quality of life), manually or using validated medical devices.
A dashboard is available to caregivers to manage patient data, take action on alerts and initiate teleconsultation.

Connectivity to sensors and platforms

Comunicare provides connectivity to validated bluetooth medical devices such as oximeters, thermometers, scales and blood pressure monitor.
Comunicare also connect to health data hubs such as Brusafe+ (Abrumet) and RSW (Réseau Santé Wallon)

Financing and pricing model

Comunicare is free for patients
Subscription and integration services for healthcare organizations

Pathology

Brain / Nerves Cancer Chest / Lung Diabetes Gastrointestinal Heart / Blood Vessels Kidney / Genito-urinary Mental Health Other Pain Pregnancy Rehabilitation Skin Treatment adherence

Functions

Alerts & Notifications Automated Guidance Data Sharing Diagnostics Environmental Data Health Tracking Online Appointments Online Prescriptions Personal Health Record Remote Clinical Monitoring Treatment Support

Users

Everyone

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 )

This app temporarily, until October 1, 2024, still carries the old M2 label because the requested ICT criteria were met. For now, no reimbursement request has been submitted for this app so it would no longer fall under level M2 in the new model.

Compliance to M2 criteria

Reimbursement request

Self declaration to 6 ICT criteria

Criterion 1: GDPR app category

1 (no processing of personal data) 2 (processing of personal data) 3 (processing of sensitive personal data)

Criterion 2: Identification of the user in need of care

through his/her Social Security Identification Number (SSIN) (obliged for applications of GDPR app category 2 or 3, see above) other

Criterion 3: App user authentication

not applicable (only for app category 1) via FAS level 400 (FAS = Federal Authentication Service, More info) company own authentication system fulfilling the M2 requirements (self-declared)

Criterion 4: Verification of therapeutic relationship and informed consent

not applicable via eHealth platform user and access management system IAM (More info) via company own database fulfilling the M2 requirements (self-declared)

Criterion 5: Applied interoperability standards

KMEHR (More info) HL7 CDA (More info) HL7 FHIR (More info) SNOMED-CT (More info) Other

Criterion 6: GDPR compliance

comply with the principles of (stated in article 5 of the GDPR)
  • lawfulness, fairness and transparency
  • purpose limitation
  • data minimisation
  • accuracy
  • storage limitation
  • integrity and confidentiality
 honour the rights of the data subject (as mentioned in Chapter III of GDPR) comply with the special provision on the processing of sensitive personal data (obliged for applications of GDPR app category 3, see above) carried out a data protection impact assessment (according to articles 35 and 36 of GDPR)

Extra: Secured Messaging

not applicable via eHealth platform’s eHealth Box (More info)

Compliance to M1 criteria

CE certification

Download document Granted by DQS Medizinprodukte 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 14/05/2019 Certificate valid till 31/12/2028 Class type of medical device (More info): 1
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: 71828 Product identification code at FAMHP: 11

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 is available for download on Apple and Google stores. After registration by the caregivers, the patient receives a personal code to access the application. The instruction for use is available at the startup of the application and in the help menu.

Components of the application

Native appMedical deviceClient-server

Complaints handling

Via e-mail: support@comunicare.be

Media

Screenshot6

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 )