While Health Canada is moving ahead with licensing of health IT software as medical devices, the Federal Drug Administration (FDA) in the US is contemplating possible regulation of smartphone applications that monitor vital signs. The FDA appears to moving cautiously. According to an article in eWeek.com, “the FDA plans to seek public input before issuing a final document”. FDA spokesperson Dick Thompson notes that “Some mobile applications are very similar to traditional software applications that the FDA has already classified or regulated, but we believe that further clarifications on mobile applications would be helpful.”
Given the confusion surrounding the Health Canada regulations regarding licensing of health IT software, I wonder if they also apply to smartphone applications?