Should the FDA regulate mobile medical apps?

What are higher risk medical apps?

Let me be clear: I am not suggesting that the government regulates low risk apps that do things like count calories. Indeed, most so-called health and wellness apps would never be regulated.

Instead, we should look at two higher risk categories of “mobile medical apps,” the phrase the FDA has coined for the higher risk apps it proposes to regulate. The first includes those apps that accessorize a traditional medical device—for example, an iPad app through which a doctor can help directly manage a patient’s implanted pacemaker or defibrillator to control heart rhythms. The second category includes apps that work on a standalone basis, not tethered to a medical device. An example in this category is an app used by radiologists to view medical images on a tablet that might include algorithms to analyze the images for potential cancerous lesions. The risks in both cases seem relatively clear.

Why regulate them?

Here is the main point: we and the rest of the developed world decided to regulate products such as these long ago. This is not a new question. Ever since the Medical Device Amendments of 1976, Congress has regulatory obligations on such products designed to make sure that each product that rolls off the assembly line is safe and effective and meets certain quality standards. Why did Congress do that? At least two …