This section generally applies to End-users and Customers.
Our products fall into two main categories: hospital devices and homecare devices. Hospital devices are generally multi-user devices that do not collect any identifiable information and we do not know who is using the devices. These devices collect anonymised operational device usage data only. Homecare devices generally relate to single-user owned medical devices that can be used in the home and may collect End-user health information which is stored on the device. Some of our homecare devices may support therapy monitoring. In addition to our devices, we may also provide complementary Mobile Applications to support your therapy and device use. Depending on the set up of your homecare device, we may be able to identify you as a device user.
Our products are provided to End-users by Healthcare Providers, homecare providers or sleep laboratories (collectively known as “Healthcare Providers”).
2.1 What we collect
Hospital and Homecare devices. Our devices may log operating data such as End-user temperatures, air flows and device alarms. Operating data is not collected by, or shared with, us. Operating data is usually only recorded on the device unless you choose share it (e.g. via Bluetooth or USB or you connect your homecare device to InfoSmart WebTM). Performance and diagnostic device information may be collected to support effective device monitoring and support, including performance metrics, usage, sensor measurements, firmware update status. This may be collected and used by your Healthcare Provider to support administration of the device. Limited performance and diagnostic information may also be shared with us to support these activities and product improvement (e.g. firmware updates). Information shared with us is anonymised and managed securely. Our devices have varying capabilities and options. You should refer to your device manual, technical manual, user instructions or product guides for more specific information.
Hospital devices. Our hospital devices generally collect anonymised health information regarding device performance and treatment relating to multiple individuals and do not record identifiable personal information.
Homecare devices. Our monitored homecare devices generally collect health information from End-users while they are using their device at home. They record health and medical information relating to the efficacy of an End-user’s therapy which may be shared with an authorised Healthcare Provider. Some homecare devices may have the ability to collect optional additional personal information about End-users, such as lifestyle information, with your explicit consent on the device.
If you are an End-user, we may collect your personal information to assist you to use your monitored homecare device. Your Healthcare Provider will assist you to register your device on our InfoSmart WebTM web-based software platform (refer below to Part II, section 3). The information we collect during the registration process may include your name, contact details, date of birth, phone number, email address, login details, IP address, your device’s serial number, personalised settings and the date your device was set up. This information will be linked with the health information collected by the monitored homecare device. After your device is registered for use with InfoSmart WebTM, and if you agree with your Healthcare Provider, data relating to the usage of your device and the efficacy of your therapy will be collected and stored. This data may include health information, such as times and dates of use of your monitored homecare device, personalised settings, details of mask leak and other sleep therapy information, including your sleep hours and your Apnoea Hypopnea Index, or information relating to your high-flow nasal oxygen therapy.
If your Healthcare Provider uses the InfoSmart WebTM platform, you may download and use F&P Mobile Applications to support your End-user access and access to your therapy information, therapy efficacy and device usage, for example F&P SleepstyleTM. For further information about Mobile Applications, refer below to Part II, section 9. If necessary, we may request that you provide us with your identity, contact or F&P product information, serial number of your device and details of your mask when you download some of our Mobile Applications to verify your access to information or use of services.
2.2 Why we need to collect it
Hospital devices. We may collect anonymised health information relating to our hospital devices for diagnostic purposes to support the provision of medical therapies and to support device and product improvements e.g. firmware updates. The information collected by our hospital devices is only kept on the device itself for a limited period before being automatically deleted on each device. We only collect limited anonymised operational device performance monitoring and maintenance data, and this only occurs if a connectable device is connected using our Device Manager software application. This is controlled by your Healthcare Provider.
Homecare devices We may collect your personal information gathered from your use of a monitored homecare device to ensure the efficacy of your device and support the therapy treatment you requested from your Healthcare Provider. This is controlled by your Healthcare Provider. We may collect and process information for the purpose of providing your Healthcare Provider with the InfoSmart WebTM platform, providing you with our Mobile Applications, and any other relevant information or services.
Where applicable, your Healthcare Provider will collect your consent or provide you with a privacy notice regarding your use of our devices. If you are an End-user and have concerns regarding your privacy, you should consult your Healthcare Provider in the first instance as to how and why your personal information is being processed.
Any collection of additional personal information about End-users, such as lifestyle information, is optional and only obtained with your explicit consent on the device.
2.3 How we collect and use it
Hospital devices. Information may be generated and collected by our hospital devices for performance and diagnostic purposes. The anonymised information collected by hospital devices is automatically deleted within a short period of time, typically within 2-3 days. Depending on the hospital device you use, information from the hospital device may be shared via Bluetooth, a secure USB device (the process is password protected) or internet connectivity. Therapy information may be collected by Healthcare Providers to support your therapy. Diagnostic performance data generated by the hospital device may be used by Healthcare Providers for medical device administration and management. We only collect limited anonymised operational device performance monitoring and maintenance data, and this only occurs if a connectable device is connected using our Device Manager software application.
Homecare devices. End-user information from monitored homecare devices is collected by the homecare device and through your interactions with your Healthcare Provider, which they may record through InfoSmart WebTM. Depending on which homecare device you use, information from your homecare device may be shared via Bluetooth, a secure USB device (the process is password protected) or internet connectivity. Your information is stored and managed by F&P Healthcare and may be securely shared with your Healthcare Provider to access and use. Diagnostic performance data generated by the homecare device may be used by Healthcare Providers for medical device administration and management. Some homecare devices may have the ability to collect optional additional personal information about End-users, such as lifestyle information, with your explicit consent on the device itself. The information will only be used for the purposes specified in the on-device consent.
Hospital and Homecare devices. Some of our devices may be able to record performance and diagnostic data generated during their use. This data may be collected by, or shared with, F&P Healthcare to (1) further support your Healthcare Provider’s administrative purposes or (2) support our product and service improvement and support. Performance and diagnostic data that we collect for these purposes is either anonymised or de-identified according to our policies to support privacy by design.
2.4 What we share
Hospital devices. The information recorded on our hospital devices is used and shared by Customers to effectively treat End-users. Healthcare Providers may provide details of hospital devices and their diagnostic information to us alongside identifiable personal information for post market monitoring, product support and complaint management. For more information on how we collect post market monitoring information, please see the Customer Care section of this statement.
Homecare devices. If you are an End-user using one of our monitored homecare devices, we will collect, process and manage your personal information as instructed and authorised by your Healthcare Provider. In some cases, we may also share information with your insurers, if required by your insurer to enable payments to be made for the use of your device and/or authorised by you. All insurer authorisation requests are vetted and follow an identification process before an insurer of a Healthcare Provider is approved through InfoSmart WebTM.
We do not sell your personal information to any third parties.