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FDA to begin scrutinizing health related apps

Health app technology can assist with medical procedures, improve patient health, and it is potentially lucrative. For these reasons, companies like Google are investing heavily in this segment of the health market.

Most mobile health apps do not require regulation or sanctioning (unless they are issued by an official body). This leads to variable quality and various degrees of accuracy — just as any ‘web doctor’ service will be as good or as bad as the people behind it.

There is a secondary concern with health apps. This relates to the data that is collected, including its security, what it is used for, and whether the data is ever sold on to a third party.

Health apps also cover a wide spectrum of ‘application.’ This includes information about prescription drugs; checking weight; measuring vital health signs and so on. Due to the broad range QMed reports that the U.S. Food and Drug Administration (FDA) is considering its responsibilities (and those of app providers like Google and Apple) in relation to laying down basic requirements for apps marketed for health purposes.

It is likely the FDA will produce a guidance document for the development, marketing and use of such apps. Currently, health apps, which are not connected to any external equipment, are not classified as medical devices.

Apple already has some guidance in place which states: “Medical apps that could provide inaccurate data or information, or that could be used for diagnosing or treating patients may be reviewed with greater scrutiny.”

Such issues are important, given that health apps represent one of the fastest growing sectors, according to industry analysis firm PwC. PwC data suggests that health app adoption doubled between 2013 and 2015.

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Written By

Dr. Tim Sandle is Digital Journal's Editor-at-Large for science news. Tim specializes in science, technology, environmental, business, and health journalism. He is additionally a practising microbiologist; and an author. He is also interested in history, politics and current affairs.

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