A smart phone that can perform an electrocardiogram (ECG)—measuring the electrical activity of a person’s heart to determine whether he is having a heart attack—is in my opinion an extremely smart phone. That is just one example of how mobile medical applications are transforming healthcare.

As the Food and Drug Administration (FDA) testified last week before Congress, we have no intention of stifling innovation in this exciting and rapidly growing field. The fact is, only a fraction of mobile apps would require FDA review. However, when a mobile app is doing the job of a medical device that requires FDA clearance or approval, it’s only logical that both should be governed by the same rules. These are the small percentage of mobile apps that pose a risk of serious illness or death to patients. With these considerations in mind, FDA in coming weeks will be issuing a final guidance document that will help companies determine whether their product will require FDA clearance or approval.

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