Bradley Merrill Thompson Quoted in “Digital Health Dilemma: Regulators Struggle to Keep Pace with Health-Care Technology Innovation”Government Technology January 13, 2015
Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in Government Technology, in “Digital Health Dilemma: Regulators Struggle to Keep Pace with Health-Care Technology Innovation,” by David Raths.
Following is an excerpt:
A fundamental tension has developed between the FDA on one hand and software companies and some members of Congress on the other, explained Bradley Merrill Thompson, general counsel of the mHealth Regulatory Coalition. “Members of Congress want to lock the definitions and process in, and FDA is saying we don’t know enough to draw those lines with enough certainty that a year from now we won’t need to revisit them,” he said. “FDA is saying you need to leave us flexibility about what causes harm and allow us to be flexible in how we apply the rules. Innovators are saying we don’t know whether our product will be regulated or not and investors need to know. There has to be some compromise between those positions.”