Head To Head

Should the FDA regulate mobile medical apps?

BMJ 2013; 347 doi: http://dx.doi.org/10.1136/bmj.f5211 (Published 29 August 2013) Cite this as: BMJ 2013;347:f5211
  1. Bradley Merrill Thompson, attorney1,
  2. Ira Brodsky, consultant 2
  1. 1Epstein Becker & Green, 1227 25th Street, NW, Washington, DC 20037, USA
  2. 2Datacomm Research, St Louis, MO, USA
  1. Correspondence to: B M Thompson bthompson{at}ebglaw.com, I Brodsky ibrodsky{at}datacommresearch.com

Bradley Merrill Thompson says regulation of certain medical apps is essential for patient safety, but Ira Brodsky believes unfettered development could see the reinvention of healthcare

Yes—Bradley Merrill Thompson

How could a diehard Republican attorney like me who gets hired by companies to oppose over-regulation by the US Food and Drug Administration actually favor regulation and not get fired by his clients? The answer is simple: by using cold, hard logic—instead of ideology—to examine the case for regulating higher risk 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 …

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