Bradley Merrill Thompson, a Member of the Firm in the Healthcare and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "mHealth Congress: Some Mobile Apps Unduly Burdened by Regulation."
Following is an excerpt:
Institutions responsible for regulating mobile health (mHealth) products are hustling to keep up with the pace of technological innovation. ?...
The FDA issued a draft guidance for mobile medical applications and a request for comments in July 2011 to form specific regulations that may be finalized later this year, but the guidance is in need of clarification, according to co-panelist Brad Merrill Thompson, JD, the general counsel to the mHealth Regulatory Commission. ?...
Thompson recognized the FDA's concern with safety risks and agrees that mHealth tools should be regulated, but he said regulators should weigh potential tools' health benefits against the costs their developers will incur should their products require FDA approval. ?...
"It all comes down to how you promote your product," said Thompson, illustrating his point by telling of the debate that occurred when he asked a Columbia University law class whether or not a tongue depressor was a medical device. "There are certain lines you can't cross without dealing with the FDA."
