Guideline 1.4.1 - Safety - Physical Harm

Question

rmehla31 OP

Created Jun ’22

Replies 6

Boosts 1

Views 5.3k

Participants 8

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.

Boost

Answer 1

ronitvasoya OP

Feb ’23

Guideline 1.4.1 - Safety - Physical Harm

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
Restrict the salable storefronts you select in App Store Connect to the regions where you have obtained regulatory clearance for the medical hardware used by your app. Otherwise, you must provide a jurisdiction statement in your app description declaring where the medical hardware has regulatory clearance to be used.

I have faced same issue. your app is approved by app store team?

2

Answer 2

MarinoSch OP

Feb ’23

We're having the same issue. But no possibility to offer a peer reviewed study...

2

Answer 3

briupding OP

May ’23

老哥，你好！想问一下，后面你的app审核通过了吗？他主要是需要什么文件，看你CE等证书都有了（我这边还在申请CE）还被拒。

1

Answer 4

KatP_ OP

Nov ’23

Hello, we are experiencing the same issue with our mobile app. Could you please let me know if you have already resolved this issue and, if so, how? Thank you.

1

Answer 5

palvarezs OP

Aug ’24

Hi @rmehla31 , i'm having the same issue with my app, and we are also using the Glucometer Accu-Chek Instant.

What did you do to solve the problem?

1

Answer 6

rintronic OP

Sep ’24

Hello, we have encounter the same, every time we try to upload a new version to the App Store.

The "Reviewer" if there is really one, doe not read or does not understand all the documentation we have provided as:

FDA, EU (Europe) and Anvisa Clearances and Certifications.
Letters from Hospital or medical institutions.
Reduce the number of countries.
Mentioning that the app might be used only for the Users or Patients associated with a particular Institution.
Etc.

Nothing is enough for Apple and its Reviewers, so we just uploaded a new bundle version with a distribution list for "0" "Zero" countries, maybe knowing that nobody will be able to download it, then Apple or its reviewers might consider it or approve it.

Also, we have not found any where on any documentation that using an iPhone, watch or a MacBook, or any APple's product, the User can not make a misguided decision and have a "Physical Harm 1.4.1", ahh, but if it is made by Apple and approved by its own reviewers then is is correct.

We have spent a lot of time developing these Apps and Remote Patient Monitoring Systems, but now we feel that we must move to other Platforms as the WebApps or any other distribution form without a Store, which forces developers to comply with non sense and endless requirements, and that the reviewers deny all documentations, certifications, documents, etc., provided, no end to the story, just time to move to WebApps.

Good luck to all of you.

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