Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in POLITICO Morning eHealth, in “Cyber on Stage,” by Darius Tahir.
Following is an excerpt:
Bradley Merrill Thompson, a digital health lawyer at Epstein Becker Green, was pleased, saying the amendment would be particularly helpful for wearable manufacturers. “For a long time [we’ve been] struggling with the old regulatory model that focused on disconnected health. FDA just approved systems, and they approve them on the basis of a singular system where all of the risks and benefits were neatly weighed. But now vendors of wearables produce useful products that can in fact be combined with many different perhaps presently undefined systems, and the risk needs to be evaluated independently from the systems that may eventually be employed.”