The Food and Drug Administration and the Federal Communications Commission signed a memo of understanding this week committing the agencies to coordinated oversight of medical devices in view of the rapid convergence of network and healthcare technologies.
The coming deluge of wireless medical devices may well be transformative for medical care, officials noted Monday and Tuesday in announcing the partnership at an unprecedented joint FDA-FCC meeting on the subject.
From a "smart band aid" that would continuously communicate a patient's vital signs to systems that would allow specialty care from thousands of miles away, there's hope that such devices will boost quality and cut costs.
But many challenges obscure that vision, officials said, including how to properly allocate electromagnetic spectrum and how to protect privacy and security reliably in a wireless world, according to agency officials.
FDA and FCC quickly arranged the meeting, in part to listen to industry after FCC released the first national broadband plan in March, said FCC chairman Julius Genachowski.
But meeting participants touched on dozens of problems that are intertwined with and go well beyond regulation.
When something goes wrong, most hospitals don't have the expertise to know whether there has been electromagnetic interference between devices, said a number of speakers.
"One of the first things that we collectively need to do is set aside our personal, consumer perception that much of this technology is plug-and-play (and) doesn't need the expertise of on ongoing systems integrator, said Jim McCoy, chief technology officer of InnerWireless, which provides in-building wireless to the healthcare market.
Kevin Fu, a University of Massachusetts computer science faculty member, told the audience, "We have come to learn there really are no secure systems. There are just systems that have not been broken yet."
"It's about quantifying and just understanding the weaknesses," he added. "Because every system has a weakness."
Several speakers warned that patient monitoring devices could end up just giving doctors reams of raw data. They urged that the systems should turn the data into usable information.
Julius Knapp, chief of the FCC's Office of Engineering and Technology, said that although people tend to focus on devices in facilities, "what is changing is the ability to actually monitor people wherever they are."
