Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled “FDA Role, Safety Oversight Addressed in Health IT Framework Comments.”
Following is an excerpt:
There is no shortage of chatter on possible approaches to health information technology regulation. Adding to the discussion now is written commentary streaming into the HHS Office of the National Coordinator for Health IT.
The ONC, along with FDA and the Federal Communications Commission, requested public comment in May, due Aug. 31, to inform a broad proposal for a health IT regulatory framework, including mobile medical apps, due to Congress next year under the FDA Safety and Innovation Act.
Meanwhile, Bradley Thompson, a lawyer from Epstein Becker Green, continues his push for FDA to issue the final mobile apps guidance, since he says it will clarify the regulatory environment and spell out a policy where most apps are not expected to be actively regulated by FDA. Thompson oversees the mHealth Regulatory Coalition, a group of app makers, device firms, software companies and health care provider organizations, among others, that have worked closely with FDA on the mobile app issue.
In his comments to ONC, Thompson says FDA needs to engage in outreach, in part, by “creation of useful guidance.”
Thompson also argues that FDA needs make efforts “in proactively educating developers, perhaps through more user-friendly, Web-based information but also face-to-face educational programs.”