Airview[TM]

By Resmed

AirView™ - enabling efficient and secure access to your patients’ therapy, anywhere at any time. AirView is ResMed’s secure, cloud-based, patient screening, diagnosis and therapy management solution for both sleep and respiratory patients. It allows timely remote access to home sleep tests as well as to sleep and respiratory care therapy and device information. You can securely share information and collaborate to help optimise patient therapy outcomes.

Level 2

I submitted a reimbursement request to NIHDI, which is eligible.

Downloads

Download for web

Languages

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General description
Additional info
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General description (provided by company)

Main purpose

Screening and management of patients suffering from Sleep disorderd breathing or respiratory failure.

Target audience

AirView is a tool destined to healthcare professionals and healthcare institutions.

Approach

AirView makes it possible to remotely monitor ResMed screening and treatment devices.
The information sent can be of several types:
- Technical data of connected devices
- Clinical data results from the use of connected devices
This information can then be complemented by the healthcare professional via the user interface with personal information about the patients.

The data processing performed has the following purposes:
- Allow the caregiver to remotely follow patients with ResMed devices and that the data is accessible via the internet
- Develop indicators based on use and quality of treatment
- Ensure monitoring and maintenance of the system
- Provide user support

Connectivity to sensors and platforms

AirView is compatible with the connectable screening and therapy devices from ResMed.

Financing and pricing model

The costs for hosting, data transmission, updates and the development of new functionalities are covered by a monthly subscription per connected device and these are covered by the healthcare professional providing therapeutic follow-up of the patient.

Pathology

Chest / Lung Sleep

Functions

Alerts & Notifications Data Sharing Remote Clinical Monitoring Treatment Support

Users

Clinicians

Additional info

Compliance to M2 criteria

Reimbursement request

Submission date

30-08-2021

Evaluation date

21-02-2022

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 TÜV SÜD 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 13/09/2022 Certificate valid till 12/09/2027 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: 71902 Product identification code at FAMHP: 504373

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

Reference publication

Airview is an evolution of an existing solution (ResScan) allowing remote access to saved data in the internal memory of our treatment devices. Previously these were only accessible by a direct download of the device.

User instructions

After the creation of a user account and installing a security certificate on the computer of preference, the user must connect online to the "ResMed AirView" website available at the following address: https://airview.resmed.eu /

Components of the application

Web applicationWearable / SensorClient-server

Complaints handling

Via e-mail: support.airview@ResMed.eu

Media

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