Hello
Our app has been rejected from the app store because of 1.4 Physical Harm https://developer.apple.com/app-store/review/guidelines/#safety
This app is used by the users from Kenya (Only registered users). Users can log their health based self-assessment data like blood pressure, glucose level, temperature, body weight, BMI with medical hardware devices and that will be shared with specialist (Physician or Clinical) to do the diagnosis and advice subscription accordingly.
Problem: We have the above features from earlier versions but with the new version update our app got rejected from app store stated that we have violated the app stores' guidelines (1.4.1 Physical Harm - Safety)
Your app connects to external medical hardware to provide medical services. However, to be compliant with App Store Review Guideline 1.4.1, you must:
-
Provide documentation from the appropriate regulatory organization demonstrating regulatory clearance for the medical hardware used by your app
-
Provide documentation of a report or peer-reviewed study that demonstrates your app’s use of medical hardware works as described
Our app's features: AccuCheck-Instant Glucometer: CE0088 This product fulfils the requirements of the European Directive 98/79/EC on in vitro diagnostic medical devices.
b) FORA-DigitalThermometer-IR21b: CE Mark for compliance with European Directive integration over Bluetooth
c) FORA-OximeterPO200: CE0123 and IEC 61000-4-3 Compliant integration over Bluetooth
d) FORA-Weighing Machine-W310b: IEC/EN 61010-1, IEC/EN 61326, EN 301 489-17, EN 300 328 Compliant integration over Bluetooth
e) OmronBPMachine-HEM -9210T: EC & EN Compliance integration over Bluetooth
Please anyone help us to resolve this issue.
