Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, was quoted in an article titled "FDASIA Hearing Spurs Debate Over Role of Congress in Health IT Legislation Health Care Technology."
Following is an excerpt:
The health information technology developer community is divided on whether Congress should pass new legislation for regulating the health IT products, industry representatives said during a three-day hearing on the Department of Health and Human Services's proposed strategy for overseeing health IT.
Some industry representatives urged the Food and Drug Administration to issue guidance clarifying what health IT tools it will regulate as medical devices, while others said only Congress could provide such clarity.
"What we need right now is clear guidance from the FDA that lays out the rules," attorney Bradley Merrill Thompson, with Epstein Becker & Green PC in Washington, told Bloomberg BNA May 16, after the May 13-15 workshop ended. "Legislation would only be written at a high level and subject to interpretation by the FDA. An entrepreneur sitting in California wants to be able to pick up a document and know for sure if their particular set of software is going to be regulated." ?...
Thompson agreed the FDA should issue guidance. He said the agency needs to define CDS software and outline the FDA's role as a regulator of software.
Such guidance, Thompson said, would go a long way to clarifying the agency's role in regulating health IT overall.
