As technology is growing beyond measure, the perks of smart phones and mobile apps continue to increase. Though at first the precision and accuracy of the in-phone mechanics was questioned, mobile apps are now being developed by doctors and pharmaceutical companies to calculate burn areas percentages and measure fluids. While this may seem impressive, the question still lies as to whether or not these mobile medical applications are up to par with actual medical equipment. Up until now, these devices have been primarily used with store-bought or doctor-approved attachments. For instance, the FDA announced that a heart rate application should have an attachable strap mechanism to be in coordination with their regulations. Today, that is no longer the case.
So, does this mean that doctors and people who are required to regulate bodily functions due to disease or illness will be left trusting unreliable devices? Or are these mobile apps actually as useful and well-functioning as the usual medical devices you might find in a doctor’s office? And if a mobile app CAN be classified as a medical device, where is the threshold? The FDA has declared some mobile apps do classify as low-risk medical devices. These may be used to transfer information from a medical device, provide a conversion formula, or give specific clients specific recommendations rather than a list of possibilities. The FDA also noted that apps used for BMI calculators, trending algorithms, and medication reminders would also be acceptable as low-risk medical devices.
Some of the mobile apps that will not be regulated by the FDA are those used to browse and research medical information. For instance, an application that simulates a medical textbook can be used as a medical device to find information regarding treatment and diagnosis of diseases, as well as those that simply provide general wellness information.
There is also concern growing regarding the amount of privacy these applications will allow. As of right now, there isn’t any word as to how much these applications will grant, but from the apps the FDA is classifying as medical devices, there shouldn’t be too many problems with keeping things confidential. Not only do the apps not carry vital information, but it would be rare that a third party could get a hold of the information as most necessary information regarding health would be transferred directly from doctor to patient and vice versa.
The FDA is expected to speak again before the end of 2012 regarding further regulation and classification of mobile apps as medical devices.