App Store Guideline 1.4.1: Physical Harm and Medical Apps

The guideline text#

Quoted verbatim from Apple's App Review Guidelines, which the page states were last updated June 8, 2026. We checked the text on October 3, 2026. Apple revises the guidelines and sometimes renumbers sub-items, so compare this against the live page before you cite it in a reply to App Review.

1.4 Physical Harm

If your app behaves in a way that risks physical harm, we may reject it. For example:

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.

What it means for a fitness or health app#

• Apple reviews medical apps more closely. This covers apps that "could provide inaccurate data or information" or "could be used for diagnosing or treating patients". The guideline doesn't define "medical app". Our reading is that a fitness app showing health measurements, such as heart rate, recovery scores or readiness scores, should expect the accuracy sentence to be applied to it.
• Accuracy claims need disclosed data and methodology. "Apps must clearly disclose data and methodology to support accuracy claims relating to health measurements". If Apple can't validate the accuracy or the method, the guideline says the app will be rejected.
• Named examples are banned outright. Apps that claim to take x-rays, or to measure blood pressure, body temperature, blood glucose or blood oxygen, "using only the sensors on the device" are not permitted. The list is introduced with "for example", so it isn't complete.
• Remind users to check with a doctor, both alongside using the app and before making medical decisions.
• If you have regulatory clearance, link it in your submission. Whether your app needs clearance at all is a separate question. See does the FDA regulate fitness apps.

What typically triggers it in a fitness app#

These come from the guideline text, not from a log of rejections.

• A camera or sensor-only vital sign. A feature that reads one of the named vitals from the phone's own sensors is the case the guideline describes. For vitals the guideline doesn't name, the general rule still applies: disclose the data and methodology, or expect rejection if Apple can't validate them.
• Marketing that promises more than the method supports. For example, "clinically accurate" or "medical-grade" in the description, with no methodology in the app.
• Health scores with no stated basis. A readiness or stress number that appears without saying what data and method produce it, when the app presents it as a health measurement.
• No doctor reminder where health results are shown.

Two nearby guidelines matter for fitness apps. Guideline 1.1.6 lists "False information and features, including inaccurate device data" as objectionable content and says calling a feature "for entertainment purposes" won't overcome it. Guideline 1.4.5 says: "Apps should not urge customers to participate in activities (like bets, challenges, etc.) or use their devices in a way that risks physical harm to themselves or others."

Checklist before you resubmit#

1. List every health measurement the app claims. Go through the app, the description, screenshots and previews, and note every reading the app says it produces or estimates, and how it produces it.
2. Remove sensor-only claims Apple names as not permitted. Guideline 1.4.1 says apps claiming to take x-rays or to measure blood pressure, body temperature, blood glucose or blood oxygen using only the device's sensors are not permitted. Remove those claims or the feature.
3. Disclose data and methodology for any accuracy claim. For each remaining measurement, say in the app and in your review notes where the value comes from (a paired device, HealthKit, or your own algorithm) and how accurate it is. If you can't validate the accuracy, remove the accuracy claim.
4. Add a check-with-a-doctor reminder. Show a visible reminder, at the point where results appear, to check with a doctor in addition to using the app and before making medical decisions. 1.4.1 asks for it.
5. Attach regulatory clearance if you have it. If the app has received regulatory clearance, include a link to the documentation with your submission.
6. Check challenges and goals for physical-harm risk. If the app runs challenges, streaks or bets, make sure none urges people to do something that risks physical harm. Guideline 1.4.5 bars that.

Related#

• Where the data comes from matters for accuracy. Values read from HealthKit come from whatever source wrote them. See the HealthKit integration guide for how reads work.
• Writing an estimate back into HealthKit raises a separate rule: guideline 5.1.3(ii) bars false or inaccurate data in HealthKit. For all of Apple's health-data rules, see the App Store health data rules overview.

A note on limits#

Apple doesn't publish the accuracy threshold or validation method App Review uses. "Validated" is Apple's judgement, case by case. Whether a medical-device regulator also has a say in your app is a separate legal question. This page is general guidance, not legal or regulatory advice.