The House Energy and Commerce Committee’s recent questions to FDA are seeking much-needed clarification of the agency’s policy of regulating certain mobile medical apps as medical devices. I’m very pleased to see the FDA responding to attempts to clarify the “gray area” of the guidance it issued in July 2011. Following three days of hearings last week on rules for these products – including the impact of FDA oversight and the potential for new taxes – I hope the FDA will take the following patient safety issues into consideration:
- All mobile medical device apps interfacing with patient data need careful regulation – Traditionally, the FDA has focused on regulating hardware devices, but companies producing software-only medical device apps – such as AirStrip – or even websites need to be regulated as well. Today, many websites or apps have “crept” into FDA-regulated territory without scrutiny by adding features or functionality that position them as clinical decision support systems. For example, a website where vital signs, demographic data or physiological observations are used to power a decision flowchart that guides diagnoses can easily extend out to a mobile platform. That, in essence, creates a medical device that’s conducting clinical support, and should be regulated.
- Look closely at the performance of mobile device platforms – The performance of devices and the network on which it resides is integral to the proper functioning of any device, and when it comes to patient data, this is even more critical. The FDA needs to require that performance-based devices, those whose proper functioning is time-dependent, have been tested in real-use environments to ensure that the device won’t be degraded because of network function or overloading of the mobile device platform in which it resides. For example, an app on an Android phone that has 20 other apps running in the background could degrade the device to the point where it’s not providing effective diagnostic characteristics. I’d like to see the FDA require the validation of not just the app, but also ensure the platforms on which the software is deployed are sound.
- “Accessories” to primary devices should also be evaluated – Currently, software “accessories” (as the FDA terms them) to primary devices do not require separate clearance by FDA. Not only could the network go down, but the mobile medical device itself could be overloaded or failing in other ways. The FDA needs to also consider these accessories and potential failure points to ensure that manufacturers have addressed those issues in their testing.
We have been submitting our solutions to the FDA since 2006, when we became the first company to demonstrate substantial equivalence when sharing diagnostic-quality data in a mobile environment. The industry is greatly benefiting from mobile applications, but not all applications are created equal in terms of risk. Given the number of apps claiming to exchange or display patient data, the FDA should include many more medical device apps under its jurisdiction.