Bradley Merrill Thompson Quoted in “Are Smartphones the Best Medicine?”The Hill June 17, 2014
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 "Are Smartphones the Best Medicine?"
Following is an excerpt:
The explosion of medical devices and apps that integrate with smartphones has the potential to transform the healthcare system by allowing doctors to collect information about patients in real-time.
The marketing research firm Research2Guidance projects the global business in "mHealth" technology will grow 61 percent from 2013 to rake in $26 billion in revenues by 2017. …
Bradley Merrill Thompson, an attorney with Epstein, Becker and Green and an expert in the medical device industry, said the FDA's guidance was "extremely" well received by developers but still left a lot of unanswered questions.
In particular, Thompson said the guidance has left a "gray zone" that has created uncertainty about medical devices and apps that are made for low-risk use but could be used for high-risk purposes. …
Thompson says the overwhelming number of stakeholders would prefer to see the agencies regulate the devices and apps instead of having Congress step in and legislate.
"The reason I want to work with the FDA is because the questions that I have are very detailed and Congress is not capable of rendering that kind of detail," he said. "All Congress can do is high-level legislation, and high-level legislation isn't where the problem is." …
Thompson said the mHealth industry is mostly waiting on the sidelines to see how things play out in Congress, but warned legislation could hinder the emerging business.
"Right now no one knows enough about this area to be able to craft legislation," he said. "Frankly what the issues are today will be different from what the issues are tomorrow because the technology is moving so quickly that freezing it in legislation would be very problematic."