FDA: we won’t regulate most apps
pharmafile | September 24, 2013 | News story | Medical Communications, Sales and Marketing | FDA, apps, iphone
In a move that will have software developers the world over breathing a sigh of relief, the FDA has decided it will not regulate the majority of health-related apps.
The US regulator has come up with its final guidance on apps more than two years after producing draft rules on its role in this burgeoning sphere of medical technology.
The upshot is that the only ones now coming under its jurisdiction fall into two groups: those which are used with an FDA-regulated medical device or apps which transform a mobile platform into such a device.
The first group might include, for example, an app allowing a doctor to make a diagnosis by viewing a medical image from a picture archiving and communication system on a smartphone or tablet.
The second could include an app which turns a phone into an electrocardiography machine to detect abnormal heart rhythms, or to show whether a patient is having a heart attack.
This means that the vast majority of medical apps – which focus on areas such as lifestyle, diet and health management issues – will be ignored because they ‘pose minimal risk to consumers’, the FDA says.
The regulator has also reiterated it will not have anything to do with the sale of mobile devices or with the way app distributors such as iTunes or Google Play conduct their business.
“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “The FDA’s tailored policy protects patients while encouraging innovation,” he added.
It means that those apps which are reviewed by the FDA will have to meet the same standards on risk/benefit and so on to which other medical devices currently have to conform.
The draft standards of 2011 had pointed towards such ‘enforcement discretion’. Shuren added: “We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly.”
The FDA has given the green light to around 100 medical apps in the last decade – about 40 of which were in the last two years, a rate of increase demonstrating the increasing importance of apps in the health sphere.
The first FDA-cleared smartphone app to reach the iPhone App Store was the Airstrip OB, which debuted in 2009 and allows obstetricians to remotely monitor mother and baby during delivery.
Adam Hill
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