FCC, FDA Partner to Address Health Technologies Using Spectrum

WASHINGTON, July 26, 2010 – To plug it in and keep it beating, these two agencies must keep on meeting was the general theme of a panel discussion Monday convened by the Federal Communications Commission and Food and Drug Administration to address the current state of wireless health, and the lessons learned in those fields.

The FCC is responsible for overseeing the efficient use of airwaves, and the FDA is responsible for the safety and efficacy of medical devices. The FCC said the meeting was held in part to move forward on recommendations made in the FCC’s National Broadband Plan that was released in March.

“I think that the world is moving way faster than many of our folks are aware of,” said panelist Bernie Liebler of AdvaMed, an association of advanced medical technology providers. “We need both agencies to pay a lot of attention.”

Panelists commented on the evolution of the regulation of the telephone system and agreed that lessons could be learned when considering regulation of this facet of the healthcare industry.

Charles Farlow of medical device manufacturer Medtronic gave the example of his company’s Telemetry System that more than 500,000 patients have registered to use.

Farlow said regulators must keep in mind that when a patient has a medical device implanted in the body – like those patients using the Medtronic network – they may have it for decades, and the spectrum the devices use must be there for the duration of their operability.

Panelists agreed that regulation was important for safety, but that it should not stifle innovation in this exciting new field.

Elliot Sloane, a professor at Drexel University’s School of Biomedical Engineering, said the current CIA model – Confidentiality, Integrity and Availability – for healthcare must also have an “S” for safety.

Sloane suggested creating federally funded testing facilities, like the one he is starting at Drexel, for new devices created for the industry.

Safety wasn’t the only issue though. Many panelists reiterated the importance of consistency, not only between agencies, but over time.

Bonnie Norman of Intel urged regulators to not get lost in the technology itself, but look at its purpose and the problem it is trying to solve.

Norman said technologies must be safe so that a patient does not have to wonder, for example, whether or not their device’s urgent text message seeking help was received by a care provider.

The balance between innovation and safety was at the crux of every argument.