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 5: 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 6: Show user prescription status

The provider platform should clearly show if a user has an active FibriCheck prescription or not.

Requirement 7: Prescription cancellation

The FibriCheck prescription for a user should be cancelled when FibriCheck is no longer listed as active on the provider platform.

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⁽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.