Understanding mHealth regulation: FCC and FDA

By Brian Dolan
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Russell Fox, Communications Practice, Mintz LevinBy Russell Fox, Communications Practice, Mintz Levin

Wireless technology has long been a part of medical devices. The recent introduction of more sophisticated wireless phones and the deployment of wireless broadband networks has sparked the development of new "mHealth" (mobile health) applications and services that enable medical professionals to monitor patient data and help patients manage their condition and adhere to a treatment regimen. New applications in the pipeline will empower patients by aiding in early detection and allowing for home-based diagnostic tests.

mHealth raises policy issues within the domain of at least two federal agencies-the Federal Communications Commission (FCC) and Food and Drug Administration (FDA). The FCC has jurisdiction over the use of the electromagnetic spectrum used by cellphones, Wi-Fi routers, and similar devices. It also has jurisdiction over the spectrum used by devices that are attached to or are implanted in patients, measure vital signs or other medical information, and transmit that information wirelessly elsewhere. The FDA has jurisdiction over medical devices and must approve the medical devices before they are made available to the public.

The FCC is currently considering whether to make more spectrum available for certain types of medical devices. The FDA has already determined that some mHealth software (applications) loaded on to cellphones constitutes a medical device, and is now beginning to wrestle with the question of whether the mobile phone itself may become a medical device, requiring regulation by the agency, when it is running these types of applications. In this alert, we provide an overview of the FCC's and FDA's respective roles regarding mHealth and the current mHealth issues before these agencies.

The FCC's Role in Spectrum Management

The FCC acts as a spectrum traffic cop. It decides who can use particular spectrum bands and under what technical conditions. In some cases, spectrum is designated for use on a licensed basis only-cellular companies generally have exclusive use of their spectrum in the geographic area in which they are licensed. Similarly, many types of two-way radios operate on licensed spectrum, and the entities that operate those radios--taxicabs, construction companies--must hold FCC licenses for their use. Some spectrum is designated for shared use-anyone can operate Wi-Fi routers in the spectrum bands designated for their use without an FCC license. The FCC's technical rules establish guidelines for equipment manufacturers so that these "unlicensed" devices can operate together, causing each other a minimum of interference. Those rules group technically compatible devices in the same spectrum bands. Some wireless medical devices operate in these unlicensed bands, sharing the band with a host of other Wi-Fi devices.

In other cases, the FCC designates spectrum bands for unlicensed use, but for particular applications. In these cases, the FCC generally decides that while it is unnecessary to require users to obtain licenses to use a particular band, it should restrict the type of unlicensed users to compatible entities. Based on this rationale, the FCC has created particular spectrum bands for the use of medical technology.