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Wearables & Consumer Health Technology: evidence guidance

Prepare the evidence for a wearables & consumer health technology entry. This guide covers the product details, reports and use information reviewers need.

Define the measurement

Name the principal output, intended interpretation and reference used to evaluate it. Distinguish a measured signal, an estimated value and a health interpretation presented to the user. Explain whether the function is for health tracking or a diagnostic purpose.

Show performance in relevant conditions

Supply results for the users, activities and wearing conditions that matter to the claim. Report error and limitations alongside averages. Explain excluded or unsuccessful readings and how users recognise a poor signal.

Include the user experience and version

Describe fit, setup, charging, interpretation, accessibility and relevant data handling. Record the sensor, firmware, app and algorithm versions affecting performance. Explain changes since testing. A later device does not automatically inherit evidence because it looks similar.

Evidence checklist

Area Required material Check before submitting
Outputs Quantities, units, intended interpretation and restrictions Signals and inferred health conclusions are distinguished.
Performance Reference, protocol, sample, conditions, results and limitations Error or agreement measures address the actual claim.
Versions Hardware, sensor, firmware, algorithm and app release Every report maps to an identified configuration.
Use Setup, fit, tasks, unsuccessful readings and instructions Relevant user variation and wearing conditions are addressed.
Data Data flows, permissions, updates and security material The description concerns the product supplied.

Explaining measurement limits

A strong average result during seated testing does not establish performance during exercise. Identify the additional support or limit the claim to the assessed condition. Correlation alone may not establish an accuracy claim. Explain exclusions and their effect on results; user satisfaction is not a substitute for measurement evidence.

Map claims to sources

For each principal claim, record its exact wording, report or study, file and page, assessed version, method or population, finding and limitation. Identify the author and relevant relationship with the applicant. Explain how evidence about a different formulation, component or version applies to your product.

Prepare readable files

Supply readable reports, with the original and relevant English passages where needed. Keep private reports separate from proposed public information. Remove personal information not needed for review.

The entry permits up to 20 attachments and 250 MB in total: 25 MB per PDF and 10 MB per image. Video is supplied by link. Contact the awards team if an essential report exceeds these limits.

Return to the category · Use the evidence worksheet · Read the rubric

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