Noona

By Varian Medical Systems Belgium

Noona is a cloud-based mobile service designed to capture patient-reported outcomes in Oncology. We connect cancer clinics with patients online to improve patients’ quality of life, treatment outcomes and improve clinic efficiency.

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 ES FR IT NL
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General description
Additional info
Media
Financing

General description (provided by company)

Main purpose

Noona allows patient to stay connected with their cancer care team during their treatment, recovery and post-treatment care, which can lead to improved outcomes and longer survivability.
Noona is designed to support the everyday work of nurses and physicians in cancer care, helping to increase clinical efficiency and reduce workloads through comprehensive communication tools.
Noona is a cloud-based patient-reported outcomes (PRO) solution from Varian that captures structured, real-time symptom information and helps the care team identify patients in need of urgent care based on symptom severity.

Target audience

Cancer patients and caretakers

Approach

Patients can access Noona from any mobile device or computer connected to the internet. With Noona they can report their symptoms real-time, securely message their care team and receive relevant communication from the clinic.
Built-in algorithms will flag those patients whose condition requires attention from the care team and notify the patient in case a severe condition has been reported.

Connectivity to sensors and platforms

Not applicable

Financing and pricing model

Noona is free of charge for the patients or their caregivers whose clinics are using Noona.
Subscription based pricing model for the clinic.

Pathology

Cancer

Functions

Alerts & Notifications Data Sharing Health Tracking Personal Health Record Remote Clinical Monitoring

Users

Teen 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 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 BSI Group The Netherlands 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 29/10/2025 Certificate valid till 31/12/2028 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: 02885 Product identification code at FAMHP: 9

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

https://ascopubs.org/doi/full/10.1200/JCO.2015.63.0830

User instructions

Upon request

Components of the application

Native appWeb applicationMedical deviceClient-server

Complaints handling

Via e-mail: support@varian.comVia telephone: 0800 90 323

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 )