Everyone with a smartphone or tablet computer has likely run across one of the tens of thousands of health-related apps that can now be downloaded. Some of the apps work by tracking calories, exercise, monitoring blood pressure or blood sugar and others even exist to diagnose health conditions. Despite the seriousness of the apps, there has been little if any oversight to ensure that the apps on the market are actually helping, rather than harming, consumers.
In a move that surprised some, the FDA appears to be eager to stay on the cutting edge of protecting consumers’ health, announcing this week that it would issue guidelines for healthcare-related apps. The FDA revealed earlier this week its final guidelines for the development of health apps, saying that it would focus its regulatory energies on those apps that, if used improperly, could cause harm to consumers.
The FDA said that it intends to focus on those apps that are used as accessories to already regulated medical devices. For example, the FDA said it would regulate applications that allow doctors to make a diagnosis by viewing information gathered by an app. It would also regulate those apps that transform mobile devices into regulated medical devices, such as apps that turn smartphones or tablets into ECG machines to watch for abnormal heart rhythms or to warn of potential heart attacks.
The FDA announced that for those apps that now fall under this umbrella, it would apply the same regulatory standards that it does to traditional medical devices. The agency will consider the apps on a case-by-case basis and will not require expensive, time-consuming clinical trials if the app resembles a medical device currently on the market.
Some apps have already gotten the agency’s seal of approval. One example includes an app that turns a phone paired with a special case into a portable electrocardiogram machine. Others make a phone double as an ultrasound device or a tool for measuring a person’s glucose levels.
The FDA’s decision to specify the regulatory rules is likely to spur the innovation of additional apps designed to perform medical functions. Experts in the healthcare field say that development of such apps had been slow, in part because of a lack of clarity about how the agency would treat them. With the issue resolved, many believe a flood of new apps and device are likely to hit the market over the coming years. Hopefully with FDA oversight, these apps will all lead to improvements in patient health.
If you or someone you know have been injured by a defective product and you would like to discuss your case with an attorney, please contact the Georgia product liability litigation attorneys at Pope, McGlamry P.C. today to schedule a free consultation.