Apple just released updated App Store Review Guidelines, and there are tremendous implications for the medical and health apps in the iOS App Store.
The changes they are announcing contain the most stringent language I have ever seen Apple use for the health and medical categories of apps. Frankly — these are a long time coming. The FDA recently updated guidelines on health apps, but this is definitely a bigger deal as Apple is the gateway for these apps.
In the past Apple has let slip dangerous health apps, such as Instant Blood Pressure — an application that promised to measure your blood pressure simply by using your iPhone’s camera and microphone. These apps often became the most downloaded health apps available, and studies showed how inaccurate they were. Apps such as Instant Blood Pressure would not get through the screening and review process under Apple’s new guidelines.
The following are highlights from Apple’s new guidelines to developers:
- If your app has potential to cause any physical harm, Apple could reject it.
- If your app provides inaccurate data or information that could be used to diagnose or treat patients, your app will get increased scrutiny.
- Drug dosage calculating apps have to come from the drug manufacturer, a hospital, university, health insurance company, or other approved entity. This means individual developers can not make a medical app with drug dosages by themselves (Apple has actually been enforcing this for the past year already).
- No more Marijuana related apps
- Apps that encourage people to place their iPhones under a mattress or pillow while charging (such as those that monitor sleep) will no longer be allowed.
This is a much bigger deal than FDA guidance on regulation. There is no way the FDA can regulate the hundreds of thousands of health and medical apps, and the updates made to them. The screening process is what has to change — and it seems like Apple is finally stepping up to the plate to do this.
I’m interested to see more details from their review policy as well. For example, if a Physician creates a medical reference app, will Apple require they include references to the information they provide within the app if the app helps with “diagnosing or treating patients”? Having more detailed guidance on topics such as this would help developers tremendously. As a physician who cares for patients daily though, I’m happy to see apps such as Instant Blood Pressure and several others will no longer be allowed to prey on patients.