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 “Nationwide ‘Roadshow’ to Educate mHealth App Developers About FDA Regulations.”
Following is an excerpt:
The MMA Roadshow’s first event took place today at the University of Illinois at Chicago. Other workshops, scheduled over the next few months, will be hosted at Johns Hopkins University, University of California-San Diego, Stanford University, University of Texas at Austin and the Massachusetts Institute of Technology.
“FDA recently published its final guidance on mobile medical apps, and while helpful, the guidance leads to more questions. This workshop will focus on answering those questions for app developers in or close to FDA regulated territory,” states the MMA Roadshow landing page on the mHealth Regulatory Coalition website. “We will dive deeply into the regulatory issues associated with bringing new mobile apps into the healthcare space.” ?…
“It’s really all about innovation and regulation, and showing that they can be compatible,” Bradley Merrill Thompson, the mHealth Regulatory Coalition’s general counsel and the chairman of the steering committee for the MMA Roadshow program, told FierceMobileHealthcare. “We need innovation. Patients need innovation. Our economy needs innovation. But, we also need product safety and we need discipline. And, these are not mutually exclusive. What’s so exciting is that there are so many people, many of them from the IT industry with no healthcare background, now innovating in healthcare. So, we want to reach out to those people to help them.”