BeWell Well@Home

By BeWell Innovations

With Well@Home, you can easily stay in touch with your care team wherever you are: fill out questionnaires from the comfort of your home, measure your vital parameters with connected measurement devices, receive the right education at the right time, keep track of your progress with a diary, exchange messages with your caregivers, call into video consultations, and much more.

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
Download for web

Languages

DE EN ES FR NL
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General description
Additional info
Media
Financing

General description (provided by company)

Main purpose

The application allows a detailed follow up of the patient at any moment of his disease cycle. The embedded functionalities allow the healthcare team to have an instant and detailed view of the patients’ daily health situation. The functionalities consist of several integrated modules including a validated and quality of live questionnaires module with PREM/PROM outcomes, a patients’ vital and viral parameter module measuring outcome via medical device connectivity, a medication follow-up module for particular analgesics with validated outcome parameters and a patient information/education module. The modules can be activated separately.

Well@Home allows interoperability with third party applications for several indications/pathologies.

Target audience

Patients & healthcare professionals

Approach

The main purpose of the system is to obtain more and detailed data of the patient which allows the HCP to make a more accurate diagnosis. All the data, whether acquired from telemonitoring, from validated/lifestyle questionnaire, patient education, integrated carepaths, etc., is presented in an easy-to-use interface (screen) to the HCP. It can also be derived as raw data information or as processed data, allowing analysis and obtaining improved insight in the health situation of the patient.

Connectivity to sensors and platforms

Well@Home allows Bluetooth communication with several medical devices, including medical-grade wireless blood pressure device, weight scale, pulse-oximeter, activity tracker, sleep monitor, etc…

Financing and pricing model

License SaaS model

Pathology

Brain / Nerves Cancer Chest / Lung Dental Diabetes Ear / Nose / Throat Eyes Gastrointestinal Healthy Living Heart / Blood Vessels Kidney / Genito-urinary Mental Health Other Pain Pregnancy Rehabilitation Skin Sleep Treatment adherence

Functions

Alerts & Notifications Automated Guidance Data Sharing Diagnostics Goal Setting & Gamification Health Tracking Online Appointments 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: EN, NL, FR ) Telemonitoring of cancer patients ( More info: EN, NL, FR )

Compliance to M2 criteria

Reimbursement request

Submission date

12-02-2025

Evaluation result

Negative Positive

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 Interlek Medical 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 14/10/2016 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: 15391 Product identification code at FAMHP: 505199

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

Reference publication

The Well@Home system has been used by over 25.000 patients who are enrolled via the hospital setting. The platform has also been used for clinical trials and scientific research. Well@Home has been the subject of two dedicated clinical trials, showing beneficial evidence-base results on the use of the Well@Home platform for tracking patients and improving their health and quality of life. In one of the publications the research has shown that the platform can post-surgery significantly impact the decreased use of opioids and generate a quicker recovery period in patient with pectus excavatum (Wildemeersch et al, 2018, https://periop.jmir.org/2018/2/e10996).

User instructions

The system is prescription driven, meaning the physician is in the lead for applying the application and using it for his patients. The application can be accessed on his PC/laptop/tablet as a dashboard using the webbrowser. For the patient an online mobile application is available, allowing to enter data at any place and any time. The patient receives a specific code, ensuring patient data privacy.

The instruction manual is online available within the platform itself.

Components of the application

Native appWeb applicationWearable / SensorMedical device

Complaints handling

Via e-mail: support@bewellinnovations.com

Media

Screenshot1Screenshot2Screenshot3

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: EN, NL, FR ) Telemonitoring of cancer patients ( More info: EN, NL, FR )