FCC to Consider Two mHealth Orders, Wants the Technology a Routine by 2017, Genachowski Says

The FCC plans to consider two orders this year designed to encourage mHealth technologies, Chairman Julius Genachowski said Monday at an event hosted by the Information Technology and Innovation Foundation. One will streamline the FCC’s experimental licensing rules to encourage the creation of wireless health device “test beds” to permit easier testing of mHealth technologies, he said. The other will “comprehensively reform and modernize” the Rural Health Care Program to permit networks of hospital and health care facilities to jointly apply for RHC funds to boost broadband capacity and enable electronic health records. The commission will also recruit a permanent Health Care Director to be a central point of contact to external groups on all health-related issues, he said.

These were recommendations offered by the mHealth Task Force in its report released Monday (http://xrl.us/bnq874). Genachowski wants mHealth technology to become a “routine medical best practice” within five years, he said, another task force recommendation. He will direct the International Bureau to work with its counterparts in other countries to encourage them to make spectrum available for Medical Body Area Networks, he said. The bureau has had discussions with E.U. telecom regulators, and communications ministers in Mexico and Israel, but now the commission is “formalizing” this as an International Bureau project to try to achieve the goal of “internationally harmonized spectrum” for “medically safe cross-border patient travel,” he said.

MHealth may not be “what people think of when they think of the FCC,” but the National Broadband Plan directs the commission to “seize the opportunities of these new technologies,” Genachowski said. He’s directed staff to review all the recommendations made by the task force, and the commission will continue to work with the Food and Drug Administration to ensure communications-related medical innovations can be “safely and swiftly” brought to market, he said. “The tides here are so strong” that eventually society will figure out how to implement medical wireless technologies, he said. “It’s up to us how quickly” that happens, and whether the U.S. will be the first country in the world to figure it out, he said.

As part of the RHC modernization order, the commission plans to collect “richer data” on broadband and telehealth applications from program participants that will enable more targeted support for telemedicine, an FCC spokesman said. He said the commission also plans to develop and execute a health care stakeholder “outreach plan” to inform them of FCC opportunities and procedures. The orders are the latest in a series of FCC actions to further development of medical wireless technologies. In 2010, the FCC entered into a partnership with the FDA to streamline bringing communications-related medical devices to market. In 2011 it adopted rules that would allow “medical micropower networks” to enable wireless medical devices to restore functions to paralyzed limbs. Earlier this year, the commission allocated spectrum for MBANs, making the U.S. the first country to dedicate spectrum for this usage (CD May 18 p9).

The task force set out five goals for the commission. They include increasing collaboration with other agencies; linking programs to expand broadband access for healthcare; and continuing efforts to ensure reliability, interoperability and radio frequency safety. Radio interference becomes a major issue if there are thousands of mobile devices hooked up to patients, said Julian Goldman, medical director of biomedical engineering at Partners Healthcare System, a leading task force participant. Hopefully the “wireless test bed plan” will help with that, he said.

ITIF has been concerned that because devices like the iPad can run health apps, the government would end up regulating them, said President Rob Atkinson. Robert Jarrin, senior director-government affairs for Qualcomm, said the FDA’s statutory definition of a medical device is “as clear as mud” when it comes to health apps and related accessories. The burden is on the maker of an “obvious” medical device to ask for FDA approval, he said. But “it gets murky” when the late, former Apple CEO Steve Jobs stands on stage, holds an iPad displaying a medical wave form and says the iPad can be used for such applications, Jarrin said. It would be useful to have a “clean distinction” between unregulated apps and regulated devices, but that’s not always possible, Goldman said. If a blood pressure app has transmission problems, it could have “real repercussions” on patient safety, he said, advising regulators to think of the entire system on an end-to-end basis.