FDA Seeks Regulation of Mobile Medical Apps

Published September 27, 2011

Mobile applications, commonly referred to as “apps,” can be enjoyed with just the touch of a screen and are often effortless to download. However, the Food and Drug Administration’s (FDA) current thinkingmight change all that for a specific subset of mobile apps.

On July 21, the FDA issued its “Draft Guidance for Industry and Food and Drug Administration Staff – Mobile Medical Applications,” targeting certain types of mobile applications for regulation as medical devices or accessories. The Draft Guidance asserts this subset of mobile apps meets the statutory definition of a medical device because of their implementation as accessories to a previously regulated medical device or because they enable the transformation of a mobile platform into a regulated medical device.

“The FDA’s desire to regulate medical-related apps for smartphones would significantly delay or stop deployment of innovative programs that would help people with health problems,” said Carl Gipson, director of small business, technology and telecommunications policy for the Washington Policy Center, a small-government, free-market think tank. “We’ve seen an incredible increase in the productivity of smartphones and mobile computing, and this step could hinder development of new technologies or programs that will keep people healthy or help with any health-related issues.

“The federal government is not regulating mobile apps dealing with maps, restaurant reviews, shopping, stock quotes, news, or anything else, so why does the FDA think it is wise to do so in this instance?” Gipson added.

Apps a ‘Device’?
The FDA is seeking public comment on whether and how it can provide clarity on mobile medical apps.

Manufacturers of apps that may meet the description of a mobile medical app must now evaluate their product to determine whether it falls under the parameters the FDA has set forth. The Draft Guidance provides lists for mobile apps the FDA will seek to regulate and those it will not regulate. FDA will not seek to regulate apps that:

•    are electronic copies of medical textbooks, teaching aids, or reference materials;
•    are solely used to log, record, track, evaluate, or make decisions or suggestions related to developing or maintaining general health and wellness, but do not treat or diagnose specific, identifiable health conditions;
•    only automate general office operations;
•    are generic aids, much like a magnifying glass, recording audio, note-taking, etc, but are not commercially marketed; or
•    function as an electronic health record system or personal health record system.

Many Uses Regulated
FDA will seek to regulate mobile apps as medical devices if the app:
•    connects to a medical device for purposes of controlling the device or displaying, storing, analyzing, or transmitting patient-specific medical device data (for example, inflates a blood pressure cuff or controls the delivery of insulin or signals an insulin pump);
•    transforms a mobile platform into a medical device by using attachments, display screens, or sensors or by including functionalities that are similar to medical devices currently regulated (for example, attachment of electrocardiograph electrodes to a mobile platform to measure, store, and display ECG signals); or
•    allows the user to input patient-specific information and from the aid of formulae or processing algorithms, produces a patient-specific result, diagnosis, or treatment recommendation.

The definition of a “mobile medical app” is further clarified by stating, “When the intended use of a mobile app is for the diagnosis of disease or other conditions, or the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or any function of the body of man, the mobile app is a device.”

Censoring Medical Information
Dr. John Dunn, an emergency room physician at Fort Hood, Texas, says computerized medical devices have operating systems and mobile medical apps cannot alter those systems.

“If a medical device has a computerized operating system, any app that you buy is nothing more than a digital, electronic method for using it. It’s kind of like an operating manual,” Dr. Dunn said.

“The FDA doesn’t have any business getting involved in trying to censor medical information just because they say that it’s going to be used to influence how people use medical devices,” said Dunn.

Alyssa Carducci ([email protected]) writes from Tampa, Florida.