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Activating Standardization Bodies Around Medical Apps

Author(s): Michael J. Ackerman

The accuracy and safety of the information provided by medical and health related apps are of concern to medical and healthcare professionals. In the United States medical and certain health related devices are regulated for safety and accuracy by the U.S. Food and Drug Administration (FDA). Wireless devices, like smart phones, are regulated by the US Federal Communications Commission (FCC). Until now, the approval process was limited to complete devices. An FDA regulated medical device can contain software but the regulatory approval process involves the complete device, not each of its components separately. But what about apps? Apps are software which may turn an otherwise non-medical or non-healthcare device into a medical or healthcare device. Do you regulate the software? It only has value when running on a device. Should you regulate the combination of device and software? It seems that every day a new smart phone is introduced and new apps become available. Do you have to test every combination? This paper will discuss the approach being taken in the United States by the government as well as by private industry.


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