Smartphones and tablets are quickly becoming the ubiquitous tool for both personal and business activities. The convenience of the platforms, their mobility, and their ability to tie into the Internet means not only is the adoption rate of these devices outpacing the adoption of standard PCs worldwide, but they present a growing opportunity for mobile application developers.

The healthcare industry is no exception to this rule. In the last several years, there has been an increase in the number of healthcare related apps available for every major smartphone and tablet platform. These apps range from electronic health record access portals, to x-ray imaging apps and glucose meters, to some that claim they can cure acne. The government has taken notice of these apps and the risks they pose to consumers. Two such apps that claimed to be a cure for acne were removed from the market and their developers fined more than $14,000.

Since then, the FDA has released a Guidance for Industry titled “Mobile Medical Applications,” or MMAs. This guidance aims to define the who, how and why of the regulatory requirements for the developers of these applications. In so doing, the FDA defined a new group of products and entities that now fall under the FDA’s regulatory requirements. The FDA based this regulation on the existing definition of a Medical Device under 21 U.S.C. § 201(h), specifically those devices “intended for use in the diagnosis, treatment, cure, mitigation or prevention of a disease or condition in man or other animals.”

Any MMA that operates such that it causes the devices it is installed upon to fit within this definition, or which interfaces with an existing medical device, will now be regulated by the FDA, and the creators will be required to follow the same regulatory requirements as any manufacturer of traditional medical devices. This includes entity and facility registrations the likes of which such creators have likely never encountered.

There are, however, exceptions because the FDA has taken a risk-based approach to what apps it will regulate. Thus, the FDA has stated that it will exercise “enforcement discretion” and not regulate apps that are low risk (examples including coaching apps, fitness trackers and targeted reference manuals and WebMD-style encyclopedias). However, it should be noted that the FDA is not bound to continue this enforcement discretion and may regulate these apps in the future.

The FDA specifically stated it will look to advertising and marketing materials, as well as the statements of the MMA creator and its agents, to determine whether an app is an MMA. The Guidance documents provide a particularly good example: on one hand, an app that uses the camera and camera flash and is marketed as a lighted magnifier will not be regulated. However, the exact same app, using precisely the same code, would be covered by the new definition if it were to be marketed as a smartphone ophthalmoscope.

In creating these new rules, the FDA defined a new class of entity that has never before been subject to FDA oversight: Mobile Medical App Manufacturers. These are companies that are responsible for the development of the software and any hardware accessories with which it interacts.

A good example is an app that interfaces with a glucose meter. The creator of the app, the meter, as well as any companies that later repackage or rebadge those products, now fall under the definition of an MMA Manufacturer. There are many exceptions, however. The phone manufacturers (Samsung, Apple, HTC, LG), the creators of the phones’ operating systems (Microsoft, Apple, Google), as well as any companies that provide infrastructure, severs, hosting services and other background support, are exempt from the definition of an MMA Manufacturer.

For those companies whose app is now regulated by the FDA, there are a complex series of determinations and registrations that must be completed. We recommend such companies seek the advice of an attorney who is competent in classifying medical devices, as well as understanding the various registration requirements that will have to be fulfilled. In addition, many MMA Manufacturers will be required to comply with pre-market notification and/or testing requirements, specific labelling and marketing regulations, as well as ongoing duties to report corrections, incidents and other voluntary (and involuntary) reporting requirements.

These newly regulated companies are at high risk of finding themselves in violation of these regulations. As software companies, they are not used to dealing with the FDA and its specific requirements. Many companies, in fact, might not even realize their product is now regulated by the FDA. Failing to adhere to the FDA’s regulatory requirements carries a wide range of possible repercussions. The federal government has already shown it is willing to not only remove offending apps from the various app stores, but to fine the creators as well.

For more information, please see the Husch Blackwell webinar from April 29, 2014, available HERE.