Pam Hepp, shareholder in the firm's healthcare section, comments on the FDA's concerns around fitness monitors and smartwatches being used as medical devices in "Fitness Monitors, Smartwatches Are Not Medical Devices," published in Communications of the ACM.
"The FDA has recognized that it is a very quickly growing area," says Pamela Hepp, an attorney with the Pittsburgh-based law firm Buchanan, Ingersoll & Rooney who specializes in healthcare issues. What the FDA is concerned about, says Hepp, is both how the product will be marketed, and the degree of risk users might face. General health and fitness devices are considered low risk compared to those that may be used for diagnosis or treatment.
To address lower-risk consumer devices, the FDA has been conducting a pilot precertification program for software as a medical device, says Hepp. "They are looking at the manufacturers, rather than on a product-by-product basis. The idea behind it is that the FDA will look at (each manufacturer's) culture and their design criteria. It doesn't spell out specific technology or specific privacy or security measures; they're looking at it more from the organizational standpoint of the entities involved to make sure they have robust measures with respect to product design."