Federal Regulation of Mobile Medical Apps Used as Devices

by Holly Shoemaker

In July 2011, the Food and Drug Administration (FDA) sought input from consumers, medical professionals and app developers on a proposed oversight approach that would put into place guidelines to follow when developing and using certain mobile medical apps. The FDA stressed that the agency only wants to focus on apps that could harm patient care if used incorrectly. The FDA also stated that it did not intend to monitor items like medical journal apps or apps used to track information related to health and wellness.

The FDA’s narrow definition of “mobile medical apps” supports these statements. In this case, the FDA wants to maintain its oversight ability on what it already overseas – regulated medical devices and accessory medical ones. Those include:

·      Apps that transform into regulated medical devices – This applies to any smartphone, iPad, etc… that can be used just like a medical device. For example, if a cardiologist turns a smartphone into an electrocardiogram (ECG or EKG) to detect a heart attack, the FDA wants some regulations in place.

·      Apps used as accessory medical devices – This applies to any device that allows a health care professional to view a medical image such as a magnetic resonance imaging (MRI) or X-ray to help diagnosis a patient.

Final Thoughts

The FDA already regulates certain medical devices. It seems logical that the agency wants to maintain some control over the above types of medical apps. If used incorrectly, patient care could become compromised and patients may receive misdiagnoses. If the FDA did not take this step, it would fail to do its job and open itself up to lawsuits. If the FDA keeps its focus on oversight of apps used a regulated medical devices, that should not infringe on the rights of patients to find medical information or the ability of developers to design and market apps that pertain to healthcare.