FCC and FDA Bring Wireless Devices to the Forefront

At a public meeting at FCC's headquarters on Monday, Chairman Julius Genachowski and FDA Commissioner Margaret Hamburg announced a landmark agreement to start a substantive conversation about the role of wireless communications in health care. With U.S. CTO Aneesh Chopra presiding, the two leaders signed a Memorandum of Understanding and a Joint Statement of Principles highlighting the importance of nurturing mobile health innovation.

In his opening remarks, Genachowski summarized:

"All Americans stand to benefit from broadband-enabled wireless health solutions... Today's action will promote investment and innovation in health technologies, help realize potential cost savings, and deliver real health benefits to the American people."

Following the introductory comments, representatives from the health care industry, wireless technology groups, relevant agencies, and other stakeholderes gathered in a series of panels to share their perspectives on wireless health. Throughout the day, two conclusions were made clear:

1. Wireless and mobile health technologies will profoundly impact every corner of the health care industry:

In the nearby exhibitors' rooms, 25 mHealth innovators displayed an impressive showcase of wireless health technologies. Watch the FCC and FDA leaders tour the exhibits below (or on YouTube here):

 

 

Most of these exhibits demonstrated how mobile wireless technologies can improve patient monitoring and communication -- devices which monitor glucose levels 24/7 and send SMS warnings to diabetic patients, for example. But as Drexel University biomedical engineer Elliot Sloane explained, implementing wireless technology into health care will have far-reaching effects on the entire ecoystem.

For example, social networks could be incorporated into hospitals and nursing homes, allowing "P2P" -- patient-to-patient -- communication. Wireless entertainment systems in health care facilities could enhance the patient and family experience. On-call doctors would be more readily available if they could conduct procedures wirelessly from their homes. And the wireless transmission of patient information between and within hospitals would bring efficiency and transparency to an oudated system. No area of health care stands to lose from this technology.

2. Still, the vast potential of this emerging space is matched by the numerous challenges confronting it:

Panelists representing the wireless health industry expressed several challenges facing wireless and mobile health technologies. By far the biggest concern was mentioned by DexCom's CTO Jorge Valdes, who said that FCC and FDA regulation needs to be more "flexible and intelligent." Too often, he continued, the rate of mobile innovation exceeds the time consumed by the approval process of the FDA and FCC. By the time a wireless monitoring device is finally approved, the mobile phone for which it was made is already discontinued or obsolete. Additionally, regulations regarding spectrum allocations to the wireless health community need to be reviewed often in order to ensure network interoperability and international function.

Another concern among the panelists was what Intel's Bonnie Norman called "the human factor." It is critically important that these new wireless innovations conform to the patients' lifestyles, not vice-versa. Devices can't be cumbersome of finnicky. They must have "mobility and adaptability" in order to accommodate the lifestyles of athletes, young veterans, and students. The challenge is particularly salient among young patients, echoed another panelist, who "fully expect their solution to integrate completely with their smart phone. They don't want to carry around another device."

The final issue worth mentioning was again raised by Bonnie Norman. IT and network infrastructure must be able to reliably and securely keep up to pace with wireless health solutions. It's one thing to experience the occasional dropped call on your iPhone, she said, but when your mother's life is on the line, you can't afford for her device's emergency signal to be lost by the network. And the IT systems in the health care industry must be able to synthesize and make accessible the "tsunami of data" which flow from full-time wireless monitoring and communications.

It's clear to me, as it was to the panelists, that a conversation about wireless health technologies is long-overdue. The new FCC-FDA partnership should pave the way for a new era of wireless health innovation, making good on Dr. Hamburg's declaration that "the convergence of communications technology and medical technology could change the face of medicine forever."