App was rejected 1.4: Safety - Physical Harm

Question

Created Jun ’20

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Our app has been rejected from the app store because of 1.4 Physical Harm https://developer.apple.com/app-store/review/guidelines/#safety

App Description:

This app is used by users from the USA (Only registered users). Users can log their health based self-assessment data like Vital, Symptoms, OTC medications, Diet, and Physician activities. and our app will deliver these data into the user's care team (Physician or clinician).

Problem:

We have the above features from 2018 itself. But recently we have integrated some of the FDA approved medical devices within our application to transmit the data from the medical devices to our application over the Bluetooth protocol. Since then our app got rejected from app store stated that we have violated the app stores' guidelines (1.4.1 Physical Harm - Safety)

"1.4.1 Medical apps that could provide inaccurate data or information, or that could be used for diagnosing or treating patients may be reviewed with greater scrutiny."

Our app's features:

FDA approved Blood Pressure Monitor Device integration over Bluetooth
FDA approved Weight Scale Device integration over Bluetooth
FDA approved Pulse Oximeter Device integration over Bluetooth
FDA approved Blood Glucometer integration over Bluetooth

Please anyone help us to resolve this issue.

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Answer 1

PBK OP

Jun ’20

Actually section 1.4.1 goes on from there with a set of requirements. Do you satisfy those requirements?

1.4.1 Medical apps that could provide inaccurate data or information, or that could be used for diagnosing or treating patients may be reviewed with greater scrutiny.

Apps must clearly disclose data and methodology to support accuracy claims relating to health measurements, and if the level of accuracy or methodology cannot be validated, we will reject your app. For example, apps that claim to take x-rays, measure blood pressure, body temperature, blood glucose levels, or blood oxygen levels using only the sensors on the device are not permitted.
Apps should remind users to check with a doctor in addition to using the app and before making medical decisions.

If your medical app has received regulatory clearance, please submit a link to that documentation with your app.

1

Answer 2

KMT OP

Jun ’20

Did you appeal?

If so, what did you say?

How many times?

How many rejections?

What did each rejection say?

Were you told to make changes to meta data and not re-submit another build?

Were you told to resubmit?

** Note these are simply questions to learn more details about what’s transpired to this point, not suggestions on what you should do next.

-=-

1

Answer 3

manoharbonala OP

Aug ’20

Is it approved by app store team?. We also have the same situation now.If it is approved please share with us.

0

Answer 4

Vishwa689 OP

Aug ’21

Did anyone get approval for the Application? and which documents you had to provide for it?

0

Answer 5

theatulverma OP

Jan ’22

Any response from their team? Did your app get an approval?

0