Partner Portal Requirements
FibriCheck is cleared as a medical device in different jurisdictions. When you decide to visualize FibriCheck results in your portal, your application must adhere to the following requirements:
Requirement 1: Show list of measurements
An overview of all measurements for a specific user should be visualized in relation to time and include the following information:
Measurement timestamp
Heart Rate(1)
Heart rhythm with the correct label and color
Reported symptoms and symptom severity
Requirement 2: Show individual measurements
Individual measurements should be visualized with the following information:
Measurement timestamp
Heart rate with the correct label and color
Heart rhythm with the correct label and color
All symptoms and the symptom severity
Reported Activity
Measurement status
FUSDR data registry tag (only for US)
Measurement report
Requirement 3: Updated information after review
It's possible that measurements are reviewed by a FibriCheck technician, after which the measurement result is updated. All measurement information in the overview or at individual measurement level should be updated(2) in line with review updates.
Requirement 4: Summary reports
Summary reports group together a number of measurements and are generated on a weekly or monthly basis and/or at the end of a prescription. All summary reports must be available to the healthcare provider.
Requirement 6: Access to FibriCheck Portal
A redirect to and/or visualization of the user results in the FibriCheck portal must be available in the provider platform. This can be via a context integration or a URL.
Requirement 7: Show user prescription status
The provider platform should clearly show if a user has an active FibriCheck prescription or not.
Requirement 8: Prescription cancellation
The FibriCheck prescription for a user should be cancelled when FibriCheck is no longer listed as active on the provider platform.
(1) Heart rate can be shown without a label or color in the overview. However, if you choose to use a label or color then it needs to be in line with approved labels and colors for heart rate.
(2) This can be the heart rhythm label, color and measurement report.
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