With the constant development of new technologies that supplement our lives, applications (often referred to as “Apps”) have become increasingly common, allowing us to accomplish a variety of tasks ranging from purchasing our coffee to finding directions to the nearest hotel or restaurant. It is not surprising, then, that monitoring our health has become easier than ever, with Apps such as Fitbit and MyFitnessPal helping us to regulate everything from calories consumed to steps taken, all from the convenience of our mobile devices. Now, Apps even monitor blood glucose and heart rate for individuals with medical conditions such as diabetes.
Unbeknownst to many, some of these Apps are classified as medical devices by the United States Food and Drug Administration (FDA), meaning they are required to abide by federally-mandated regulations and to submit to continual oversight. In fact, the FDA recently issued a comprehensive document outlining its policies with regard to mobile medical applications (MMA’s), which significantly impacts the legal avenues available to those who suffer injuries or health problems as a result of medical app malfunctions.
First, it is important to note that medical devices are considered “products” under the law, meaning that those injured as a result of defective medical products may pursue claims through product liability litigation. In its report “Mobile Medical Applications: Guidance for Food and Drug Administration Staff,” published on February 9, 2015, the FDA explained that the intended use of a mobile app determines whether or not it can be considered a medical device. Under the law, a medical device is defined as an “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar related article including any component, part or accessory, that is…intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of disease in man.” In other words, if a mobile app meets the criteria of a medical device, or is connected to a medical device, it may be subject to FDA oversight.
The intended use of an app is identified through a variety of communications, including product labels, advertising materials, and information dispensed by app manufacturers or their representatives. Notably, the mobile medical apps that fall within the purview of FDA regulation are those that may present a health risk to the individual using them if they malfunction. As such, general health trackers are unlikely to be considered medical devices in need of monitoring by the FDA. Also, many mobile apps, such as those involving patient or health-care provider education, do not meet the criteria of medical devices.
Ultimately, malfunctioning mobile medical apps such as blood glucose monitors may lead to catastrophic health consequences for patients who rely on them, providing grounds for product liability lawsuits against MMA manufacturers and even health-care providers in medical malpractice cases. This realm of litigation is largely uncharted territory, with the potential to evolve significantly over time. However, the application of underlying themes throughout personal injury law may apply, including those surrounding product failure to warn, design defects, or failure to perform intended use.
At Fronzuto Law Group, we dedicate the entirety of our practice to personal injury victims with cases involving product liability and medical malpractice in order to provide the most contemporary and compelling representation. With such a focused concentration, we have achieved millions of dollars in verdicts and settlements on behalf of victims and their families. If you or someone you love has suffered an injury as a result of a defective product or the negligence of a medical professional, contact our offices anytime at 973-435-4551for a cost-free consultation.
For additional information related to this issue, access the following article: Uncharted Territory: Mobile Medical Apps and Product Liability Collide
