Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Health-Care Apps for Smartphones Pit FDA Against Tech Industry."
Following is an excerpt:
While the FDA currently regulates certain medical software, the agency wants to update its thinking now that smartphones have juiced the apps market.
A year ago, the agency proposed policing only a subset of those apps: ones that use supplemental attachments to transform a mobile platform into a medical device (such as AliveCor's EKG app) and others that act as accessories to an already regulated medical device (such as MIM Software's app). ?...
Some in the tech industry do not perceive a threat. They say they've been expecting the FDA to regulate some apps and are eager for the agency to reveal which ones.
A group called the mHealth Regulatory Coalition — which represents established firms such as Qualcomm as well as start-up software developers — was formed in 2010 to deal with mobile health care regulatory issues. Its leaders argue that uncertainty breeds anxiety and drives away potential investors.
"We started telling the FDA that they're going to stifle innovation if they don't start clarifying where the lines will be drawn," said Bradley Thompson, the group's general counsel. Other technology groups — including the West Wireless Health Institute and the Application Developers Alliance — have taken a similar position.
