Some experts believe that government involvement in mobile health will help strengthen the industry, the Wall Street Journal's "Venture Capital Dispatch" reports.
At the Personalized Medicine World Conference in California this week, experts said that FDA -- which is emerging as the dominant agency in mobile health product regulation -- could be undergoing changes that would benefit the mobile health sector (Hay, "Venture Capital Dispatch," Wall Street Journal, 1/30).
For example, Rep. Mike Honda (D-Calif.) in December 2012 introduced a bill (HR 6626) that aims to advance innovation in mobile health and other health care technologies in part by requiring FDA to establish a new office of wireless health technology (iHealthBeat, 12/5/12). Honda's bill includes provisions that would provide loans and prizes to developers of certain wireless health technologies.
Meanwhile, Mavis Yee -- a partner at California law firm Nixon Peabody -- said that FDA has little or no interest in regulating most of the 40,000 or more mobile health applications that currently are available for various devices. Yee said that the agency only is interested in companies that build wireless accessories for existing medical devices or seek to turn phones or tablets into clinical medical devices.
However, Yee added that FDA has yet to issue a final statement on which mobile health products it will regulate.
Other Agencies' Actions
Other federal agencies also have taken steps could help strengthen the mobile health industry, experts say. For example, the:
Federal Communications Commission has approved a band of spectrum for wireless medical devices; and
- Federal Trade Commission has forced mobile app developers that made fraudulent claims related to medical efficacy to remove their products from app marketplaces.
Conference attendees said the involvement of three separate government agencies in mobile health product oversight suggests that the field is expanding quickly ("Venture Capital Dispatch," Wall Street Journal, 1/30).