FDA Issues Guidance on Mobile Medical Apps

In a long awaited move by federal regulators, the FDA has issued final guidance on medical applications used on smartphones and other mobile devices. The official guidance comes nearly two years after draft guidance was proposed to regulate mobile medical apps. 

The FDA guidance outlines how the agency plans to regulate mobile apps used to provide medical care or information that would traditionally have been provided by a medical device.

Mobile medical apps are software programs that run on mobile phones or tablets and meet the definition of a medical device, are an accessory to a regulated medical device, or change a mobile phone into a regulated device.

The FDA has identified mobile apps that fall under this definition of a mobile medical app under section 201(h) of the Federal Food, Drug, and Cosmetics Act. It has determined that these programs could pose a potential risk to public health.

Mobile medical apps that will be subject to oversight will include apps that will function as an extension of medical devices, connect to or control medical devices. This will include apps like those which measure blood pressure and control the inflation or deflation of the blood pressure cuff.

Other regulated apps include those that control the delivery of medication, recommend treatment or diagnosis, or perform a patient specific analysis.

Apps that will not be strictly regulated will be health related apps that allow patients to manage their own care without offering specific treatment. These apps may provide tools to track or organize health information, to document or communicate medical conditions to healthcare providers, or to allow patients to interact with their own Electronic Health Record system.

These may include apps that calculate BMI or NIH Stroke Scale or offer reference information which informs patients of drug interactions or allergy information.

Each new mobile medical app must be cleared by the FDA before being allowed on the market. The FDA plans to apply special focus on mobile medical apps whose “functionality could pose risk to patients safety” if the app didn’t function correctly.

The FDA said it plans to assess medical apps with the same standards used to assess other medical devices. However, the agency does not plan to regulate the sale of apps through distributors, such as iTunes or the Google Play store.

They have also said they will refrain from regulating basic personal wellness apps, such as pedometers or hear-rate monitors, which pose no risk to users.

Medical Mobile App Use On The Rise

The market for mobile health apps is expected to reach $26 billion by 2017, according to Research2Guidance research firm. Currently there are nearly 100,000 mobile health apps on the market, apps which potentially may help or harm consumers.

Some apps are specifically targeted to assist in health and wellness management. Others are used as tools for healthcare providers to improve the delivery of patient care.

Federal officials estimate 1,000 new medical apps are sold each month for cellphones and more than 500 million smartphone users worldwide will use health care apps by 2015. A growing market which the FDA clearly hopes to keep in check.

In comparison, over the past decade the FDA has cleared approximately 100 mobile medical apps for use, with 40 of those apps cleared within the last two years. The approximate review time for app clearance is takes roughly 67 days.