Should the FDA regulate medical apps?

Smart phones, iPads, iPhones--all are becoming regularly used tools among doctors. A station in Myrtle Beach, SC, for example, recently reported on Dr. Claudio Palma, who has an iPad hooked up to the operating room's wifi signal to zoom in on herniated discs. And the A2Z of Dermatology app is used to help classify skin conditions. But even as these apps become a regular feature of doctors' diagnostic tool kits, the FDA must wrestle with how (and whether) it can regulate these devices, an article in Scientific American points out.

Nearly 1,500 smart phone applications for healthcare professionals are available for download--along with many more for patients. Just yesterday, UBM Medica said it has launched an iPhone application for SearchMedica, the medical professional's search engine. The handy app will allow access the most recent, relevant, and authoritative information in any of eleven specialty channels and also target searches to journal articles, evidence-based content, guidelines, trials, or patient information.

Although many apps may be helpful, the FDA is now weighing how to ensure patient safety with their increased popularity, as they are technically medical devices. By 2012, 81 percent of physicians will have a smart phone, according to a report from Manhattan Research.

Currently, there are no clear federal mandates in place to guarantee the quality and accuracy of apps. The FDA is considering various degrees of oversight of so-called health information technology. This regulation could be mild, focusing on postmarket safety via an electronic registry, according to CDRH Director Jeff Shuren. However, the agency could apply its traditional regulatory framework, through which manufacturers would be required to meet the same requirements as other devices--including risk-based premarket review.

An FDA spokesperson declined to comment on whether there are concrete plans to regulate medical smart phone apps and when new policies might be instituted, saying the agency's role in these applications and other health information technology is evolving, according to Scientific American.

Most currently available apps are simply a way to make it so reference tomes can be accessible on handheld devices, so FDA approval should be unnecessary, says Adam Wilcox, professor of medical informatics at Columbia University. "If the FDA is going to regulate referential information, are they going to monitor the textbooks from which the information is coming from?" he asks.

- see the UBM release
- get the Scientific American story here
- Check out the report on Dr. Palma

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