Apple App Store Now Requires Medical Device Disclosures for Health Apps in US UK and Europe
New policy forces health apps to declare whether they are regulated medical devices
The new requirement targets apps that make health-related claims or provide diagnostic, monitoring, or treatment functionality. Developers must now disclose their regulatory status, making it easier for users to distinguish between regulated medical devices and general wellness apps.
The policy reflects growing regulatory attention on digital health tools, which have proliferated across app stores without consistent oversight. The distinction matters because regulated medical devices must meet safety and efficacy standards that general apps do not.
Analysis
Why This Matters
Health apps that claim to diagnose or monitor conditions have been operating in a regulatory grey zone. Requiring disclosure helps users make informed decisions and may push unregulated apps to seek proper certification.
Background
The FDA, UK MHRA, and EU MDR have all been tightening their approach to software as a medical device, but enforcement has lagged behind the pace of app development.
What to Watch
Whether Google follows with a similar Play Store policy, and whether the disclosure requirement leads to a wave of app removals.