Officials at the Food and Drug Administration have no plans to regulate mobile applications that let consumers compare their symptoms to a list of medical conditions, link patients to a portal with their own health information, or allow patients to measure and track their own vital signs.
But the agency has identified a limited scope of mobile medical apps that it intends to regulate because they function as medical devices and pose a potential safety risk if they malfunction. For instance, a mobile app that uses either internal or external sensors to create an electronic stethoscope would be regulated as a medical device.
The FDA issued a 43-page guidance document on Sept. 23 outlining its regulatory approach and listing examples of what will be regulated, what probably won’t be regulated, and what is not considered a medical app.
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The FDA has identified a limited scope of mobile medical apps that it intends to regulate because they function as medical devices and pose a potential safety risk if they malfunction.
In general, the FDA plans to regulate mobile apps that act as an extension of a medical device by displaying, storing, analyzing, or transmitting patient-specific medical data. Also, the agency will regulate apps that transform a mobile platform into a device, such as the attachment of electrocardiographic (ECG) electrodes to a mobile platform to measure, store, or display ECG signals.
Mobile apps will be regulated if they perform patient-specific diagnoses or make treatment recommendations. This type of app might use patient data to calculate a drug dosage or create a dosage plan for radiation therapy.
The agency does not plan to regulate apps that help patients self-manage their health conditions, provide tools for patients to track their health information, automate simple tasks for providers, or allow patients and providers to interact with a personal health record or an electronic health record.
"Although many mobile apps pertain to health, of which many may be medical devices, we are only continuing our oversight for a very small subset of those mobile apps that are medical devices," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said during a press briefing. "We believe this approach will promote innovation, while protecting patient safety, by focusing on those mobile apps that pose greater risk to patients."
But even if an app is deemed a mobile medical app by the FDA, the agency does not intend to regulate apps that pose minimal risks to consumers. For instance, a mobile app that prompts consumers to enter which herbs or drugs they would like to take concurrently and provides drug interaction information could be considered a medical device, according to the guidance document. But because it poses a low risk to the public, the agency does not intend to regulate it at this time.
The FDA first issued draft guidance on mobile medical apps in July 2011. This final guidance document represents the agency’s current thinking on the topic, but it is not binding on either the agency or the public.
"Regulating mobile apps is nothing new for us," Dr. Shuren said. Over the past 15 years, the FDA has cleared more than 75 apps, with about 20 of those receiving approval in the past year.
The guidance also makes clear that physicians who create mobile medical apps, or who customize a medical app for their own professional use, are not subject to regulation as long as they aren’t promoting it for general use by others. Even if the physician allows the app to be used by others in a group practice, he or she is still not considered a manufacturer under the FDA guidance.
The guidance does not apply to clinical decision support software. That software will be addressed as part of a larger health information technology regulatory framework that the FDA is working on in collaboration with the Office of the National Coordinator for Health Information Technology.
mschneider@frontlinemedcom.com
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