YARMOUTH, Me. – Apple made headlines recently when it announced that it will tighten up guidelines for health apps on its App Store, but it’s business as usual for many app developers.
The guidelines “contain the most stringent language I have ever seen Apple use for the health and medical category of apps,” said Dr. Iltifat Husain of iMedicalApps in a statement. “Frankly, these are a long time coming.
Apple made the changes after studies showed how inaccurate many of the App Store’s most downloaded health apps actually were.
Some app developers said the guidelines were always tight.
“This isn’t really going to change how we develop our health apps,” said Jonathan Roger, project portfolio manager for AndPlus, a Boston-area mobile app and software developer.
Among the changes: increased scrutiny of apps that could provide inaccurate data or information that could be used for diagnosing or treating patients; and apps that calculate drug dosages need to come from a hospital, drug manufacturer, health insurance company or university, or have approval from the U.S. Food and Drug Administration.
“Given the potential harm to patients, we need to be sure the app will be supported and updated over the long term,” Apple’s guidelines state.
Of the thousands of mobile health apps released every year, the FDA only regulates a select group.
“While many mobile apps carry minimal risk, those that can pose a greater risk to patients will require FDA review,” according to the agency’s guidelines. Those guidelines state that the FDA will focus on apps that meet the regulatory definition of “device,” and that are intended to be used as an accessory to a regulated medical device or transform a mobile platform into a regulated medical device.
“We’ll have to wait to see how vigorously Apple enforces the new guidelines,” said Keith Barritt, an attorney with Fish & Richardson P.C. in Washington, D.C. “The new guidelines give Apple discretion to reject medical apps, but do not mandate FDA clearance and are thus still a bit vague. If the rejection rate ticks up significantly, app developers will no doubt be more inclined to seek FDA clearance.”
Roger said that while the updated guidelines won’t really change the way AndPlus develops its apps, there may be an added benefit.
“Providing a bit more documentation on these apps will probably help patients feel better,” he said.