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 "Challenges Abound in Creating Regulatory Framework for Mobile Medical Apps, Health IT."
Following is an excerpt:
FDA plans to release guidance for mobile medical apps ahead of a larger regulatory framework on health information technology, according to an agency official. ...
Earlier this year, there was a push by some in the Senate to hold off finalizing the mobile medical guidance until FDA, along with other agencies, issued a formal report on the federal regulatory framework of health information technologies, including mobile health apps. ...
However, the FDA Safety and Innovation Act (FDASIA) passed this summer — while still requiring within 18 months a formal regulatory framework from FDA, the Federal Communications Commission and the HHS Office of the National Coordinator for Health Information Technology (ONC) — allows FDA to finalize a mobile medical apps guidance before then. ...
Brad Thompson, an attorney with Epstein Becker & Green, said the policy issues of regulating health IT are complex because they must balance the need to empower creative people to innovate against the need to protect public health.
Mobile health and health IT may attract innovators who are new to FDA, adding to the complexities. "You have all these people from California who have never been in the device industry before — they're in the IT business — looking at this for the first time," Thompson noted. The technologies also may be particularly hard for FDA to regulate because the state of the art moves so fast "it's like hitting a moving target," he said.
Thompson added that at various industry meetings he has heard feedback from Silicon Valley-types that "'FDA shouldn't regulate us because we're innovators,'" he explained. "I've got to tell you, I've been in the device industry 27 years, and I take a little offense at that," he said, "because it suggests that device people are not innovative, [that] it's okay to regulate medical device people because they just plod along, but these other people innovate."
Nevertheless, "I do very definitely understand the difficulty of defining through regulations or guidance an area that has really not yet jelled. Because it has not yet jelled, it is very difficult to write a policy that doesn't have unintended consequences."
