Full article reprinted from "The Gray Sheet"- February 8, 2009
Even as the use of mobile wireless devices for medical applications burgeons, some would-be entrepreneurs and venture capitalists are holding back from entering the field until they get a better handle on the regulatory hurdles involved. Read more....
Mobile Health Device Field Seeks Regulatory Guidance From FDA And FCC
Full article reprinted from "The Gray Sheet"- February 8, 2009
Even as the use of mobile wireless devices for medical applications burgeons, some would-be entrepreneurs and venture capitalists are holding back from entering the field until they get a better handle on the regulatory hurdles involved.
At the mHealth networking conference held Feb. 3-4 in Washington, D.C., proponents of the technology suggested that better clarity from FDA, CMS and the Federal Communications Commission would go a long way in fostering growth.
As the mobile health technology industry develops, questions continue to arise about how the communications networks, devices and software should be monitored by the government, said Mohit Kaushal, digital healthcare director at FCC's Office of Strategic Planning and Policy, Feb. 3.
Questions include what components of a health solution present a risk that should be regulated, what constitutes a medical characteristic of broadband service, and "importantly, who is the proper authority for such regulation?" Kaushal said.
FCC is already engaged in matters involving medical technology. For instance, the agency is currently in the center of a debate between GE Healthcare and the test flight industry over the proposed use of a portion of the radio spectrum for in-development wireless patient monitoring devices (The Gray Sheet' Nov. 9, 2009).
Kaushal noted that FCC has a long history of cooperation with FDA. In the past, for example, the agencies have explored the hazards of radiation exposure.
"Both agencies recognize that as we move into an era of expanded innovation and opportunity for interaction between wireless and health devices, the importance of working together is really heightened," Kaushal said.
The two agencies plan to explore ways to streamline introduction of new mobile health applications on wireless devices "while meeting the really important dual objectives of, first of all, ensuring consumer safety and optimizing the use of radio spectrum."
As part of the National Broadband Plan, a project funded by the American Recovery and Reinvestment Act to maximize public value of wireless spectrum, FCC wants regulation that expands incentives for private sector innovation, Kaushal said. The plan is due out in March.
"Costly and lengthy approval processes will only hold this very exciting area back, and our recommendation is striving to not let that happen," he said.
Federal agencies will also look into the issue of a "viable business model," which Kaushal said "is extremely important for this whole area to flourish."
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