Starting immediately, Apple requires certain apps on the App Store to disclose whether they qualify as regulated medical devices in the United States, United Kingdom, and the European Economic Area. This new policy targets apps categorized under Health & Fitness or Medical, or those flagged for frequent medical or treatment references in their app ratings.
Developers submitting new apps must declare their product’s medical device status and provide associated regulatory details, such as safety information and contact data, directly within App Store Connect. The deadline to comply for existing apps is set for early 2027. After this grace period, apps without proper disclosures will no longer receive update approvals from Apple, effectively enforcing transparency around medical app regulation.
This shift aligns with rising scrutiny over health-related digital products as governments across major markets tighten regulations. By making regulatory status visible upfront, Apple aims to boost user trust and safety for health apps, which often handle sensitive data or influence medical decisions. Notably, Apple’s policy only covers apps that are officially classified as medical devices or regularly deal with treatment information, so casual fitness apps without regulated medical claims are unaffected.
App Store medical device disclosure requirements for developers
Developers will need to adjust their App Store Connect listings to include detailed medical device compliance information, increasing administrative overhead but signaling Apple’s intent to keep healthcare app standards stringent. This move also nudges app makers toward regulatory compliance, which can involve approvals from bodies like the FDA in the US or CE marking in Europe.
Impact of Apple’s policy on healthcare apps in the US, UK, and Europe
With the deadline looming, healthcare app creators should prioritize reviewing their status and preparing to meet Apple’s disclosure requirements. This update demonstrates how Apple’s gatekeeping role is evolving beyond just content curation to include regulatory enforcement, a trend likely to continue as digital health technologies grow.