Why Are These Guidelines Necessary?

Both Google and Apple are uncomfortable with mobile phones being used as medical devices and do not allow applications that claim to provide medical device features on their market places.

Wellness and health guidance applications are generally acceptable. Specifically, applications that make claims that the phone can produce medical device results will have difficulty being accepted.

It is important that you do not make feature claims as part of your application description or screens that could be easily interpreted as being able to replace or behave like a medical device results.

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When Submitting Your App:

• Do NOT expect to use the app store submission copy as a platform for marketing your app to the end-user. The app store is primarily a distribution tool not a marketing and sales tool.

• Therefore less is more – do NOT promote any specific wellness measurement “features” on your app-store submission copy (such as blood-pressure, CVD risks, metabolic risks etc.). Only say something like “ ….. to increase awareness of your general wellness”

• Whenever possible, reinforce that the submitted app is NOT intended nor promoted for use as a medical device

• Ensure that USA/CAN market users are excluded from (directly) accessing Blood Pressure results. Apps in these markets can consider displaying the results in terms of risk categories rather than numeric values, and state that these are only estimations. E.g. Estimated Hypertension Risk.

• REQUIRED: a (short form) medical disclaimer is always prominently visible BOTH on the app itself and the app-store copy content

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Short Form Disclaimer Message

The AHI (short form) medical disclaimer (2 options):             

For Investigational Use Only.
‍These numbers are only estimates and are not a substitute for the judgment of a health care professional. They are intended to improve awareness of general wellness”.

For Investigational Use Only. [Your App Name] is not a substitute for the clinical judgment of a health care professional. [Your App Name] is intended to improve your awareness of general wellness. [Your App Name] does not diagnose, treat, mitigate or prevent any disease, symptom, disorder or abnormal physical state. Consult with a health care professional or emergency services if you believe you may have a medical issue.

• We suggest the disclaimer is shown on every measurement results screen
• We recommend a separate disclaimer screen presented during the user onboarding UX

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Long Form Disclaimer Message

Optional long form medical disclaimer to be hyperlinked in the app itself 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 STRESS 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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Regarding Smartphone Device Camera:

• You should stress that the submitted app simply uses the device camera “ …. for its intended purpose”
• The device camera is used only to generate a 30-second “selfie” video
• The 30-second “selfie” video is acquired by the device camera while operating within its “ … designed function”

The device camera is NOT used by our tech as a sensor for providing a health measurement - such as performing PPG sensing by placing your finger entirely over the camera lens. This is NOT what we are doing  

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Additional Details for AHI FaceScan SDK:

Only if requested by the review team …. then you should explain that:

• The SDK converts the 30-second “selfie” video into highly compressed binary payloads (blobs)
• These compressed payloads are securely transmitted by the app (off device) to a remote cloud service where they are individually processed by computational models
• The results of the processed payloads are returned by our API to the app for display and/or storage only

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