Guideline 1.4.1 Physical Harm: the rejection health, fitness and nutrition apps get — and the 2027 medical device deadline

Guideline 1.4 opens: “If your app behaves in a way that risks physical harm, we may reject it.” 1.4.1 says 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”, and sets three requirements:

The guideline names what's off-limits outright: “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.” Its text hasn't changed in any of Apple's guideline updates since 2024.

Note the scope: “recommendations, calculations, references, wellness reports”. A calorie target, a macro split, a sleep score or a “metabolic age” all count. The citations have to be in the app, linked, and easy to find — next to the number they support, not buried in a policy page.

It isn't always enough to cite. A nutrition app for dietitians was rejected in October 2024 for lacking “appropriate citations for health and medical recommendations” despite citing the USDA, NIH, WHO and EFSA; the developer said App Review kept sending the same automated response. When that happens, ask App Review exactly which screen they mean, or book an App Review consultation through Apple's Meet with Apple sessions.

In an April 2025 rejection, App Review was specific: “Revise the app's description to include a disclaimer reminding users to seek a doctor's advice in addition to using this app and before making any medical decisions.” That's the App Store description, not only the privacy policy or a screen inside the app.

We checked the eight apps Apple's search API returned for “calorie tracker” in the US on October 9, 2026. All eight list Health & Fitness as their primary category. Only two put a no-medical-advice line in their App Store description: Cal AI (“NOTE: We do not offer medical advice”) and MyNetDiary (“MyNetDiary does not provide medical advice”). The others may show a disclaimer inside the app, which we didn't check — but the description is where App Review has asked for it.

[App name] is for general wellness and information only. It does not
provide medical advice, diagnosis or treatment. Always check with a
doctor or qualified healthcare professional before making medical
decisions or starting a new diet or exercise programme.

• Sensor-only measurements. Blood pressure, glucose, oxygen or temperature “using only the sensors on the device” is explicitly not permitted. Neither is a camera-based reading presented as a medical measurement.
• Connected medical hardware. A 2022 rejection asked for regulatory clearance for the hardware, a report or peer-reviewed study showing it works as described, and storefronts limited to regions where it's cleared — or a jurisdiction statement in the description.
• AI health answers. AI chat or analysis apps that discuss symptoms have been rejected under 1.4.1 even with AI disclaimers on every reply. Frame AI output as general information, link sources, and avoid anything that reads as a diagnosis.
• Calorie and nutrition estimates. Photo-based calorie estimates are estimates. Say so, show how they're produced, and don't call them precise or clinical.

For diagnostic or treatment claims, Apple's App Review help lists the evidence it expects: “Regulatory clearance for each country or region where the app is available, such as FDA, CE, or CFDA documentation, or a supporting test report or peer-reviewed study.” Attach it in App Review Information before you submit.

On March 26, 2026 Apple announced that the App Store “will now display whether an app is a regulated medical device on its product page in the European Economic Area (EEA), United Kingdom, or United States.” You must declare a status if your app's primary or secondary category is Health & Fitness or Medical, or if your age rating questionnaire says it contains frequent medical or treatment information.

For new apps it's required now. Most indie fitness, nutrition and habit apps will answer No. The setting is in App Store Connect under App Information › App Store Regulations & Permits › Declare Regulated Medical Device, and only the Account Holder or an Admin can change it (App Store Connect Help).

1. 01

   Find the screen they flagged

   1.4.1 messages often say where — “we found medical information in the Home Screen” — and may attach a screenshot. Start there, then check every screen that shows a health number.

2. 02

   Add linked citations next to each claim

   Formula or source on the same screen, linking to the primary source, plus a sources page reachable from results.

3. 03

   Add the disclaimer to the description

   And show it in the app where people see recommendations.

4. 04

   Remove or prove accuracy claims

   Drop words like “accurate”, “clinical” or “diagnose” unless you can attach validation or regulatory documents.

5. 05

   Declare medical device status

   If your category is Health & Fitness or Medical, set it in App Information while you're there.

Hello App Review team,

Thank you for the feedback on Guideline 1.4.1.

In build [number]:
- Every recommendation now shows its source, with links, on the same
  screen ([Home > Daily target > "How we calculate this"]).
- A Sources page lists all references: [Settings > Sources].
- We removed the words "[accurate/clinical]" from [screen] and the
  description.

The App Store description now includes a reminder to consult a doctor
before making medical decisions.

Thank you,
[Name]