Table 2.
App store requirements for developers of health apps that do not apply to non-health applications.
| Requirement | Apple App Store30 | Google Play Store31 |
|---|---|---|
| Market authorisation document required alongside submission to app store for approval | ✓ |
✘ Not requested- there is a general requirement that apps are compliant with applicable laws and regulations. |
| Manufacturer must disclose, with their submission, the data and methodology used to support the accuracy of claims that relate to health measurements |
✓ Apple states that they will reject apps for which they cannot validate the level of accuracy, or the methodology used to support these claims. |
✘ Not requested. There is a statement that apps must not have misleading health claims, that contradict existing medical consensus, or can cause harm to users. |
| Functionality in the app to remind users to consult with a doctor in addition to their use of the app before they make medical decisions.a,b | ✓ | ✘ |
| Additional requirements on the types of organisations who can make drug dosage calculator apps available, verified at the time of submission.b | ✓ | ✘ |
| Apps that make unsupported claims (in the app or in the app store metadata) regarding physiological measurements without dedicated sensors for claimed medical purposes will not be approved.c |
✓ Excludes functionalities of measurement through inbuilt smartphone sensors, such as measuring blood pressure, body temperature, blood glucose levels, blood oxygen levels or internal imaging. |
✓ Requires: (i) this use case be only provided through interaction with dedicated and specifically designed smartphone sensors; (ii) the apps must contain disclaimers in the app store metadata stating that they are not intended for medical use and that they are only designed for general fitness and wellness purposes and are not a medical device; and, (iii) must properly disclose the compatible hardware model/device model. |
a,b these are not specific EU requirements for app stores; c This app functionality is a focus area of US FDA enforcement activity16.