Bradley Merrill Thompson Quoted in “Mobile Health Group Urges Lawmakers to Be Cautious on Regulating New Health IT”Bloomberg BNA's Medical Devices Law & Industry Report January 7, 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 "Mobile Health Group Urges Lawmakers to Be Cautious on Regulating New Health IT."
Following is an excerpt:
The mHealth Regulatory Coalition, a mobile health technology advocacy group, is calling for federal lawmakers to slow down on new legislation for health information technologies, including mobile medical applications and other mobile technologies, until three federal agencies issue a much-awaited health IT report.
The group, which counts medical device manufacturers and medical app developers as well as health-care providers among its members, hopes it can convince lawmakers to take a "wait and see" approach to regulating health IT, at least for the first few months of 2014, Bradley Merrill Thompson, general counsel for the mHealth Regulatory Coalition and an attorney with Epstein Becker & Green PC, in Washington, told Bloomberg BNA Jan. 3.
"There is substantial interest in mobile health generally right now and what the federal government's role will be," he said. "Our great fear is that Congress will do something for the sake of getting something done instead of getting it right." ?...
Thompson said legislation like the SOFTWARE Act shouldn't be considered until the FDA, the FCC and the ONC issue their report. He said fragmented or piecemeal approaches will only confuse technology developers instead of promoting real safety efforts.
Thompson said the mobile app industry needs a comprehensive solution. However, what that solution is, he said, is unclear.
"This is complicated stuff and right now we don't have all the data we need to understand it," he said. "We need to start collecting that data."
Thompson cited the European Union's approach to regulating low-risk medical technology as an example of useful surveillance of health technologies.