Magazine article Clinical Psychiatry News

FDA Outlines Intentions for Regulating Medical Apps

Magazine article Clinical Psychiatry News

FDA Outlines Intentions for Regulating Medical Apps

Article excerpt

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 in September 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.

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. …

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