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 "Attorneys, FDA Hit the Road to Instruct on Mobile Health Regs."
Following is an excerpt:
Attorneys have joined up with FDA and others on a national "roadshow" to educate mobile app developers on the subtleties of navigating mobile medical app regulations. ...
"The idea is to give innovators support by sharing experience," Bradley Thompson, a lawyer at Epstein Becker & Green and the head of the mHealth Regulatory Coalition, wrote "The Gray Sheet" in an e-mail. ...
The broad participation from industry, trade groups, academia and policymakers reflects a general enthusiasm for the sector, Thompson suggested at the Johns Hopkins stop of the roadshow in Baltimore on Jan. 23.
Thompson felt government is particularly enthusiastic about the mobile health space. "I've never seen the agency as excited as it is now," Thompson concluded, noting his 30 years' experience in the regulatory field. ...
Thompson also hopes the effort can actually help trigger new types of app development by more companies. He pointed out in an email interview that most app developers currently focus on functionalities that don't pose much risk to patients, such as "basic tracking" and "trending" of health data, and, thus, won't attract much or any attention from FDA. But better education could encourage more development in areas of high-risk and high-benefit, Thompson argues.
"[W]ith these greater opportunities come greater risk and the likelihood of FDA regulation. The consortium wants to help traditional medical device companies and IT companies looking to bring their technology to healthcare understand the process for innovating in this regulated space," Thompson said. ...
Thompson, whose group has supported FDA's overall efforts, hopes the roadshow will help demystify FDA and, perhaps, remove some fear.
At the Johns Hopkins meeting, Thompson noted that many people interested in developing apps are pure software developers or entrepreneurs without previous medical experience. "When you say the acronym FDA, some of them will freak out a bit. The purpose today is to demystify a bit of it. The purpose is to make you comfortable if you choose to get into an FDA-regulated space."
