It seems like a new app for allergy or asthma hits the market almost daily. Some simply alert patients to pollen levels and air quality in the patient’s geographic area or provide information for those with food allergies. However, some have more medical uses. For example, in the asthma area, there are many apps that allow patients to track their symptoms and medication use. Some include sensors that can be attached to the patient’s inhaler to track usage and send alerts to the physician’s office. Others sync with peak-flow meters to measure lung function.
Allergists should be aware that the vast majority of these apps are unregulated and are not required to meet any specific quality standards. Although the Federal Trade Commission (FTC) will investigate if it appears that an app is being used in consumer fraud, the FTC cannot police the many thousands of health apps. This makes it difficult for physicians to know how to advise patients that ask them to recommend apps to help them monitor their allergies or asthma. In our July 9 article we reported on Xcertia, a company formed by the AMA and other organizations to develop guidelines to guide consumer and clinicians’ health app choices.
This week we want to make you aware of the Federal Drug Administration’s (FDA) role in the evolving world of mobile health apps and its new “software as medical device” (SaMD) program. As you know, before a medical device can be marketed in the United States, it must go through an FDA approval process. The FDA has struggled with how to regulate the thousands of mobile health apps that are constantly being revised and updated. Recently passed federal legislation precludes the FDA from regulating health and wellness apps, but apps used for medical purposes and involving medical devices are required to have FDA approval.
The rapidly evolving nature of digital medicine has caused the FDA to rethink its traditional approach of regulating one device at a time. Instead of separate approval of each app, the FDA has launched a pilot precertification program that would approve certain companies rather than approving the apps. If the companies can meet FDA criteria – such as having a culture of quality and organizational excellence – they can qualify for precertification which will entitle them to a streamlined review process. The FDA is working with nine of the biggest health technology companies, including Apple, Johnson & Johnson, Fitbit, and Samsung, to develop the pilot program which is scheduled to go live in 2019.
Although most of the allergy and asthma apps in circulation would probably be considered health and wellness apps and not subject to FDA regulations, those that connect to hardware medical devices would likely be considered SaMD and subject to FDA regulation.