Key Points to Note

• We strongly suggest that short form disclaimers are shown on every measurement results screen
• Optionally, you can attach a hyperlink to a long form disclaimer to provide more details
• A separate disclaimer screen may be presented during the user onboarding process
• Please review the additional guidelines for blood pressure measurement

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Short Form Disclaimer

For investigational use only

[Your app / FaceScan feature name] is not designed for medical diagnosis or to evaluate medical conditions and is not a substitute for the clinical judgement of a health care professional. [Your app / FaceScan feature name] does not diagnose, treat, mitigate, monitor or prevent any disease, symptom, disorder or abnormal physical state. You should always consult a trusted health professional before making decisions about your health.

Expected Fluctuations in Readings

Moment-to-moment fluctuations in your physiology mean that readings could vary to some degree from one measurement to the next. The best estimate of your readings is therefore obtained by averaging several measurements throughout the day and across several days to adequately account for this physiological variation.

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Long Form Disclaimer

Optional long form medical disclaimer to be hyperlinked in the web page behind the short form disclaimer.

Not for Medical Purposes

OUR SERVICES ARE NOT INTENDED FOR MEDICAL PURPOSES. THE SERVICES DO NOT OFFER ANY KIND OF MEDICAL ADVICE AND ARE NOT INTENDED FOR ANY MEDICAL USE OR PURPOSES. OUR SERVICES ARE INTENDED FOR GENERAL WELLNESS ONLY.

THE ESTIMATIVE MEASUREMENTS (“MEASUREMENTS”) PROVIDED TO YOU OF PHYSIOLOGICAL AND PSYCHOLOGICAL STATES INCLUDING HEART RATE AND BLOOD PRESSURE SHOULD NOT BE TREATED AS MEDICAL ADVICE. THE MEASUREMENTS WE PROVIDE TO YOU ARE NOT INTENDED TO BE UTILIZED FOR ANY MEDICAL PURPOSES OR TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE, AILMENT OR INJURY. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, YOU EXPRESSLY AGREE WE ARE NOT PROVIDING ANY MEDICAL ADVICE VIA OUR SERVICES. ALL CONTENT PROVIDED BY OUR SERVICES INCLUDING THE MEASUREMENTS IS NOT INTENDED TO BE AND SHOULD NOT BE USED IN PLACE OF (A) THE ADVICE OF YOUR PHYSICIAN OR OTHER MEDICAL PROFESSIONALS, AND (B) A VISIT, CALL OR CONSULTATION WITH YOUR PHYSICIAN OR OTHER MEDICAL PROFESSIONALS. SHOULD YOU HAVE ANY HEALTH-RELATED QUESTIONS, PLEASE CALL OR SEE YOUR PHYSICIAN OR OTHER HEALTHCARE PROVIDER PROMPTLY. IF YOU HAVE AN EMERGENCY, CALL YOUR PHYSICIAN OR YOUR LOCAL EMERGENCY SERVICES IMMEDIATELY. YOUR USE OF OUR SERVICES DOES NOT CONSTITUTE OR CREATE A DOCTOR-PATIENT, THERAPIST PATIENT OR OTHER HEALTHCARE PROFESSIONAL RELATIONSHIP BETWEEN [Brand/Business Name] AND YOU

Accuracy

THE MEASUREMENTS PROVIDED TO YOU ARE BASED ON INDICATORS AND STANDARDS DEVELOPED BY [Brand/Business Name] ITSELF AND ARE ONLY FOR PERSONAL INFORMATION PURPOSES, WITHOUT ANY REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED. WHILE WE MAKE EVERY EFFORT TO PROVIDE ACCURATE ESTIMATIVE MEASURES, WE MAKE NO WARRANTY AND DISCLAIM ALL RESPONSIBILITY AND LIABILITY FOR ANY ACCURACY, RELIABILITY, AVAILABILITY, SECURITY, COMPLETENESS OR CORRECT USE OF MEASUREMENTS, CONTENT AND ANY OTHER INFORMATION OR RESULTS YOU RECEIVE THROUGH THE SERVICES.

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Additional Guidelines for Blood Pressure Measurement

Blood pressure is a highly volatile reading as it is easily affected by a variety of environmental factors such as whether a person has been recently active or is resting in the wrong position. It is important to take this into account when displaying results and when guiding users to take a scan. Doing so will help to provide more accurate representations of their health.

Suggested Methods to Display Blood Pressure Results

1. Consider using terms like “Estimated blood pressure” to show that you are providing approximations.
2. Consider displaying the risk categories or number ranges in place of exact blood pressure numbers.
3. You can categorize results as 'Hypertension' and 'Hypotension' risks, shifting user focus from fluctuating numbers to understanding associated risks.
4. Consider assessing blood pressure related risks/ranges based on an average of multiple scans (2-3 scans as described in next section) rather than a single reading.

Tips to improve accuracy of blood pressure measurement for users

• Avoid exercise, consuming caffeine or smoking 30mins before measurement
• Rest for at least 5 minutes prior
• Sit in a chair with back supported
• Place both feet on the floor, legs should not be crossed
• Measure blood pressure twice with 1 minute break in between. If the readings vary by 5 points or more, do a third measurement. Use the average of the readings.
• If consistently high readings persist, it's essential to see a healthcare professional. They can provide guidance, perform further evaluations, and, if necessary, recommend treatment.

References:
NIH National Library of Medicine - Blood Pressure Measurement
Harvard Health Publishing - Tips to measure your blood pressure correctly