Uncharted Territory: The FDA and Mobile Medical Applications

The Food and Drug Administration was created in 1938. It has protected consumers from unsafe food, cosmetics, medicines, and medical devices. In the 21st century, the agency must now contend with the role of mobile technology in medicine. The FDA is still determining its regulatory scope in this field, but there are a few decisions it has made that impact life science companies.

What Does the FDA Say about Mobile Medical Applications?

In September 2013, the FDA released a document detailing the agency’s philosophy on mobile medical applications. The introduction to the document states that it does not bind the FDA to any particular decision. Because the document (referred to as “guidance”) isn’t binding, the FDA is still free to hand down a binding decision later on. The agency updated this guidance in February 2015.

At this point in time, the FDA intends to oversee mobile apps which are medical devices and whose functionality could pose a risk to patient safety. In the guidance, the FDA cites the example of an app used to interpret radiological images. The smaller screen size of a smartphone or tablet coupled with the lower contrast ratio and uncontrolled ambient lighting makes it a poor choice to run an app that would interpret an X-ray.

The FDA’s Approach in the Future

The guidance also contains a section on the FDA’s future regulatory intentions. It declares that it will exercise enforcement discretion for certain mobile apps. These mobile apps include those that help patients self-manage their disease or conditions without providing specific treatment; give patients tools to organize and track their health information; enable patients to access information related to their condition and its treatment; assist patients in communicating or documenting potential medical conditions to healthcare providers; automating some tasks for healthcare providers; allowing patients to interact with electronic healthcare record systems; and transfer, store, convert, format and display medical device data.

Why will the FDA only exercise enforcement discretion towards these apps as opposed to full regulatory oversight? Some might be considered mobile medical apps, while others might not. For those that are mobile medical apps, the FDA does not believe they pose a high risk to patients.

Life Science Firms, Mobile Medical Apps, and the FDA

Technology’s progress has yielded many life-saving innovations. Mobile technologies can fall into that category. The FDA’s leadership understands that mobile technologies offer enormous promise. They also pose a threat to patients if they don’t work properly.

Progress always moves faster than government agencies, which are left to regulate as best they can to protect the public. The FDA is still developing guidelines about the safe usage of mobile technologies in the medical field.
Where does this leave life science companies? They must seize the opportunities mobile technologies present. At the same time, they cannot risk running afoul of the FDA. The FDA recommends that during this time of uncertainty regarding regulations, life science companies consult with the agency to ensure that they protect patients. Consultation also provides these firms with the unique chance to shape the FDA’s future regulatory oversight.