FDA Regulating Smartphone Apps

fda medical smartphone app regulation

According to the Pew Research Center, more than half of all Americans own a smartphone and along with smartphones come thousands of different apps. Typically, people use their apps to listen to music, read the news or get directions to their destination. However, the Food and Drug Administration (FDA) got involved once individuals started developing health and wellness apps. For example, there are apps that measure the electrical activity of the brain, that take an individual’s blood pressure and that store and transfer patient medical records. In June of 2012, Congress passed a bill allowing the FDA to regulate medical apps on smartphones because the apps could pose a risk to a user’s safety if they were to not function as intended.

On September 23, 2013 the FDA issued guidance on its regulatory strategy for health and wellness apps for smartphones and other wireless devices. Senior Policy Advisor at the FDA, Bakul Patel, said it was important for the FDA to weigh the benefits of the innovation the apps bring to the industry and balance it against patient safety risk.

There are three categories of apps that the FDA is regulating, which include, those that connect to and control another regulated device, those that display, transfer, store, or convert patient-specific medical device data from a connected device and those that transform a mobile platform into a regulated medical device. The FDA has currently cleared around 100 mobile medical applications and the review process has taken 67 days on average to complete. The FDA does not intend to regulate apps that pose minimal risk to patients and consumer, such as those that help smartphone users organize and track their health information or count calories.

If we allow our smartphones to manage every other aspect of our lives, is the next logical step to have smartphones help improve health and healthcare delivery? It is the clear direction the healthcare industry seems to be taking with there already being around 200 mobile health apps which have been co-branded with healthcare organizations.

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