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 "Digital Health Regulation Debate Continues at mHealth Summit."
Following is an excerpt:
Federal officials took pains at this year's mHealth Summit in Washington, D.C., to describe their excitement for the digital health field and their plans to minimize the "touch" of federal regulation. But it was also clear at the meeting that a significant component of the health information technology space still looks skeptically at FDA and its long-term intentions.
The right approach to regulating mobile health and other health information technology tools remains open to significant debate, and that was on display last week at the 2013 mHealth Summit in Washington, D.C.
Bradley Merrill Thompson, who heads the mHealth Regulatory Coalition, specifically said that further guidance was necessary for clinical decision support, wellness and accessories during the Dec. 9 panel.
Thompson, in particular, raised unique concerns triggered by device interoperability that might require statutory change from Congress to address the issue.
"I don't really think right now there are clear lines as to what your obligations are post-market when a system crashes and 20 different vendors are part of that system. It may be no one's fault; it may be an interoperability issue where the blame doesn't fall on one issue," Thompson said. "I think there are system-level issues, and I do think that would be a productive place for statutory change. I don't think the existing statute contemplated or answered the question."
