Data Security And Patient Privacy - Canary CanarE System Instructions For Use Manual

9.

Data Security and Patient Privacy

All communication between the CanarE and the Clinic Base Station employs a unique
communication protocol, with each CanarE having a unique Radio ID that is assigned to it in
manufacturing. A Clinic Base Station can communicate with only one CanarE at a time using
this Radio ID.
The communication between the Clinic Base Station and CanarE device is also encrypted with
the unique encryption key assigned during the manufacture of the CanarE. In addition,
communication integrity as well as data integrity checks are applied on the data received at both
ends.
The Canary Medical Cloud Platform is designed for assuring HIPAA compliance. When the
Clinic App is set up, a secure connection is established between the Clinic App and the Canary
Cloud and is in effect for all communication thereafter. The Clinic Base Station decrypts
messages and data from the CanarE, adds the serial number of the CanarE package, and then
encrypts the unprocessed data before transmitting that data to the Cloud. The communication
and data are checked for integrity by the Cloud application before it is processed.
Patients must consent to the CanarE data collection, storage, analysis, and sharing their
CanarE and basic personal and health data with an HCP(s) they designate to provide their
healthcare. As such, data will be identifiable to their healthcare provider and authorized
administrators of the Canary Medical CanarE System. The patient will have the right to be
forgotten and can turn off device data collection after a minimum required time for data
generation. If the patient does not wish to consent, they can receive the standard of care.
Each HCP user is assigned a unique username and will be prompted to enter a password at
initial login. The unique username and password are needed for logging into their account
thereafter and for accessing the Clinic App.
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CanarE System