FDA Drafting Guidelines, Seeks Comments on Medical Apps

Staying in shape and being healthy can be a challenge for many people. And with mobile technology use increasing, it is a lot easier for people to track their fitness and stay informed through health apps.

But what if those apps don't work properly?

The federal government wants to prevent that by targeting apps that could harm patients if they don't function correctly. The Food and Drug Administration has released, for comment purposes, proposed regulations on certain medical- and health-related apps that are used on smartphones and mobile computing devices.

The agency said this approach encourages the development of new apps, focuses only on a select group of applications and will not regulate the sale or general consumer use of smartphones or tablets.

The FDA is currently seeking input on this approach; the guidelines are already posted in the Federal Register. Comments can be submitted for 90 days either online or in writing. The agency will update the guidelines based on the feedback it gets.

The use of mobile medical apps on smart phones and tablets is revolutionizing health care delivery, said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health. Our draft approach calls for oversight of only those mobile medical apps that present the greatest risk to patients when they don't work as intended.

Mobile medical applications, or mobile medical apps, today serve a variety of uses. These uses include the ability for one to monitor his or her calorie intake and for allowing doctors to view a patient's radiology images on their mobile communications device.

The FDA's draft guidelines outline a small subset of mobile medical apps that either impact or may impact the performance of currently regulated medical devices. This includes mobile medical apps that:

• Are used as an accessory to medical device already regulated by the FDA. This includes applications that allow a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system on a smartphone or a mobile tablet; or
• Transform a mobile communications device into a regulated medical device by using attachments, sensors or other devices. An example of this is an application that turns a smartphone into an ECG machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
• Allow the user to input patient-specific information and -- using formulae or processing algorithms -- output a patient-specific result, diagnosis, or treatment recommendation to be used in clinical practice or to assist in making clinical decisions. Examples include mobile apps that provide a questionnaire for collecting patient-specific lab results and compute the prognosis of a particular condition or disease, perform calculations that result in an index or score, calculate dosage for a specific medication or radiation treatment, or provide recommendations that aid a clinician in making a diagnosis or selecting a specific treatment for a patient.

Smartphone applications will allow the mobile health industry to reach some 500 million smartphone users by 2015, according to a research2guidance.com study.

FDA Policy Advisor Bakul Patel said some of the new mobile apps are designed to help consumers manage their own health and wellness -- like the National Institutes of Health's LactMed app. This app gives nursing mothers information about the effects of medicines on breast milk and nursing infants. There are also apps geared at helping health-care providers improve patient care such as the Radiation Emergency Medical Management, or REMM, app, which gives health care providers guidance on diagnosing and treating radiation injuries.

The FDA said it has already cleared some of the mobile medical apps used by health-care professionals, such as a smartphone-based ultrasound and an application for iPhones and iPads that allows doctors to view medical images and X-rays.

There are advantages to using medical apps, but consumers and health care professionals should have a balanced awareness of the benefits and risks, Patel said.