Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FierceHealthIT, in “FDA Finalizes Guidance on Medical Device Data Systems,” by Susan D. Hall.
Following is an excerpt:
At that time, Attorney Brad Thompson, of Epstein Becker Green, who serves as general counsel for both the mHealth Regulatory Coalition and the CDS Coalition, said the guidance was consistent with the notion that the FDA is getting out of broad health IT management, passing those duties off to the ONC. …
“The implications are profound, both for MDDS-type software, but also for what it suggests about the future for health information technology generally,” he wrote. “FDA is quite earnestly working to ensure that it uses the lightest regulatory touch appropriate for software. It’s exciting, because it means that innovation in this space can truly flourish.”