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RESILIENCE PRO

By Resilience

Resilience is a solution dedicated to remote monitoring and support for oncology patients. The Resilience mobile application accompanies people affected by cancer on a daily basis in order to help them cope with the side effects caused by their treatments and improve their quality of life. The remote monitoring platform proposed by Resilience, a class IIa medical device, enables healthcare professionals to better understand and follow their patients remotely in order to improve their care.

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

EN FR NL
General description
Additional info
Media
Financing

General description (provided by company)

Main purpose

Resilience is a solution dedicated to remote monitoring and support for oncology patients.

The Resilience mobile application accompanies people affected by cancer on a daily basis in order to help them cope with the side effects caused by their treatments and improve their quality of life.

The remote monitoring platform proposed by Resilience, a class IIa medical device, enables healthcare professionals to better understand and follow their patients remotely in order to improve their care.

Target audience

Resilience improves patient follow-up in oncology care.

Resilience's remote monitoring platform is a class IIa medical device that allows healthcare professionals to better understand and follow their patients remotely in order to improve their care. Resilience is available in French, Dutch and English and is intended for all people affected by cancer or in remission.

Approach

Resilience is developing a digital solution dedicated to the remote monitoring and support of people affected by cancer, as well as those who care for them. The company has major objectives to pursue its mission:

- To have a clinical impact on patients. Improving the quality of life of patients and their overall survival is Resilience's main objective. We want to enable them to live better and longer thanks to a more adapted, human and personalized support.

- Making the health care system more efficient. To universalize medical excellence in oncology so that every patient can benefit from it is Resilience's raison d'être, which is enshrined in its statutes as a company with a mission. We want to optimize care and make care paths more fluid. A more efficient healthcare system means more patients treated and better care provided.

The development of the Resilience telemonitoring platform is based on scientific studies that have proven the effectiveness of telemonitoring in oncology. Its clinical and organizational impacts, particularly on patients' overall survival and quality of life, have been demonstrated.

Connectivity to sensors and platforms

Connectivity to hospital information systems.

Financing and pricing model

Upon prescription by the oncologist

Adoption abroad

In France, Resilience PRO is marketed since 2021, and it is listed under article L.165-52 of the Social Security Code (CSS) thus being a health technology reimbursed under the French health system since October 2023.

Pathology

Cancer

Functions

Alerts & Notifications Health Tracking 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 of cancer patients ( More info: EN, NL, FR )

Compliance to M2 criteria

Reimbursement request

Submission date

24-05-2024

Evaluation date

01-10-2024

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 G-MED 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 22/02/2024 Certificate valid till 16/11/2028 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: 73718 Product identification code at FAMHP: 918021

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

Convinced that a better informed, understood and monitored patient is a better cared patient, Resilience offers a digital solution dedicated to remote monitoring and support of patients in oncology through two synergistic products.

A remote monitoring platform for healthcare professionals.

- The remote monitoring platform proposed by Resilience is a class IIa medical device that allows healthcare professionals to better understand and follow their patients remotely in order to improve their care.
- Real-time data collection, via an e-PRO (Patient Reported Outcomes) system, and an alert system allow the care team to detect and predict relapses, toxicities or complications encountered by patients, to proactively adapt management and to improve coordination of the care pathway.
- The development of the Resilience telemonitoring platform is based on reference scientific studies that have proven the effectiveness of telemonitoring in oncology. Its clinical and organizational impacts, notably on patients' overall survival and quality of life, have been demonstrated.
- Resilience's medical device can be indicated for all cancers, all phases and all treatments.

The mobile application for people affected by cancer

- The mobile application accompanies people affected by cancer to help them better cope with the side effects caused by their treatments and improve their quality of life.
- Patients can measure and track their symptoms, then through a personalized library of articles, videos and podcasts, each person can find concrete answers to their concerns and better understand them. The application also offers digital support programs (meditation, yoga, CBT, discussion groups, etc.) to help alleviate side effects and improve daily life. Thanks to these keys to understanding and calming down, patients can become actors in their own care.
- Co-constructed with the Gustave Roussy Institute (Europe's leading cancer center and the world's third largest cancer hospital), the Resilience application is a safe place to find the right information. It provides patients with reliable information, developed and validated by a team of multidisciplinary physicians.
- The application is intended for all people affected by cancer or in remission.

Components of the application

Native appWeb applicationMedical device

Complaints handling

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