Plateforme Maela By Medtronic Belgium

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

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Languages

DE EN ES FR IT NL

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General description

Additional info

Media

Financing

General description (provided by company)

Main purpose

Maela is a digital solution for patient engagement and monitoring. The solution is designed to deploy configurable and content rich digital protocols (e.g. colorectal, bariatric, spine, AFS, thoracic surgery) for hospitals to engage patients in their own care and monitor their health status.

Target audience

Maela is available for patients on prescription of their caregivers for patient engagement, education, and remote monitoring for a variety of therapies (e.g. colorectal, bariatric, spine, AFS, thoracic surgery).

Approach

Keeping patients at home while engaged in their care pathway by engaging them through a multi-channel platform (web, mobile, SMS) that allows patients to register symptoms, enter vital-sign measurements, and receive relevant educational content and guidance at different stages of their treatment. In addition, patients can communicate with their care team via secure in-app messaging, share letters and lab results, and report on completed activities and tasks.

Connectivity to sensors and platforms

No connectivity to sensors in the current version. Support will be added in the second release.

Financing and pricing model

Patients can use the app for free. Caregivers pay license fees for the use of the Maela platform.

Pathology

Brain / Nerves Cancer Chest / Lung Gastrointestinal Heart / Blood Vessels Kidney / Genito-urinary Other Pain Rehabilitation

Functions

Alerts & Notifications Automated Guidance Health Tracking Personal Health Record Remote Clinical Monitoring Treatment Support

Users

Child Teen Men Women Elderly

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 )

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 Eurofins 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 12/09/2024 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: 00355 Product identification code at FAMHP: 605184

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 app is intended for use by patients with a compatible consumer mobile device. With the app patients can follow their to do list, answer questionnaires, report on completion of the tasks and activities that are pushed to them and acknowledge reminders. Additionally, patients have access to a library of content and can also message the care team and request to be called.

Components of the application

Native appWeb applicationMedical device

Complaints handling

Via e-mail: contact@maela.frVia telephone: +33 09 62 51 92 05

Media

Financing

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