Developers of health and medical apps will now have strict rules to abide by with Apple's new App Store Guidelines that establish a high bar for any app aimed at health and wellness.
Previous iterations of the guidelines already laid out the proper protocol for human research subjects and avoiding physical harm, but the new rules carry much more detailed and specific language, ranging from privacy protection to warnings about inaccurate data that could potentially cause physical harm. With a whole section on physical harm (previously a short line in the rules) Apple’s new guidelines aren’t letting anything slide.
“If your app behaves in a way that risks physical harm, we may reject it,” the guidelines state, and go on to describe in detail possible pitfalls. Apple is also snuffing out any marijuana related apps and those that encourage people to place their iPhones under a mattress or pillow while charging, such as sleep-tracking apps.
Potential issues include medical apps that could provide inaccurate data or information, or those that could be used in diagnosing or treating patients. If the app has received FDA clearance, the developers must submit a link to the documentation. Previously allowable apps, such as the super popular Instant Blood Pressure app, were subsequently shown to be inaccurate, and wouldn’t make the cut under today’s guidelines. Apple is also cracking down on drug dosage apps, which it has been enforcing the past year already.
“Drug dosage calculators must come from the drug manufacturer, a hospital, university, health insurance company, or other approved entity, or receive approval by the FDA or one of its international counterparts,” the guidelines state. “Given the potential harm to patients, we need to be sure that the app will be supported and updated over the long term.”
With the hundreds of thousands of health and medical apps, it's tough for regulators to keep up. The FDA recently released new guidelines and the FTC also offered up tools to help developers of health apps, but they still aren't the de facto gatekeeper of the app store, like Apple is. While the FDA’s guidelines seek to clarify the regulatory process and encourage device and app makers to share data with patients, the App Store rules could potentially curb problematic apps faster and right at the source. The screening guidelines can stop questionable apps from even getting to the market -- at least on iOS -- and puts additional pressure on developers to also make their policies, information and selves more available.
As Dr. Iltifat Husain of iMedical Apps, who broke the news, wrote, “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.”
Apple did not respond to request for comment.