Last month, the FDA (Food and Drug Administration) issued final
guidelines regarding mobile health apps regulations. The agency stated that it
would not regulate apps that don’t threaten users if they fail. The mobile apps
that pose a threat are the ones that would ““transform a mobile platform into a
regulated medical device by using attachments, display screens, sensors or
other such methods,” said the FDA. The guidance reinforce their intentions to
not regulate technologies that receive, transmit, store and display data from
medical devices.
The guidelines came a
few weeks after the FDA authorized the first set of mobile health apps,
“including one that allows the remote monitoring of glucose levels in people
with diabetes. The application allows real-time data sharing from a continuous
glucose monitor via an iPhone.” The agency also approved a mobile app that aims
to diagnose head injuries on the battlefield, which was developed by
AnthroTronix for the US Department of Defense with funding from the US Navy
Bureau of Medicine and Surgery and a Rapid Innovation Fund award by the US
Army.
The FDA’s acknowledgment
on this matter represents, not only an achievement for the medical app
industry, but an accomplishment for the healthcare workers and patients. The
two previous examples prove how an app can help the medical industry. In the
United States, more than 60% of the population owns a smartphone. In Brazil,
84% of the population has a mobile phone and about 36% of which have a
smartphone. In the medical profession, this number is even higher. In Brazil
there are some legislative peculiarities that prevent several advances, such as
telemedicine.
References: http://www.empreendersaude.com.br/como-foi-a-evolucao-da-mhealth-nos-ultimos-cinco-anos/
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