At an event hosted by The Information Technology and Innovation Foundation yesterday in Washington, the mHealth Task Force convened by Federal Communications Commission Chairman Julius Genachowski earlier this year released their findings and recommendations.
While the Task Force had a specific focus on the role the FCC should play in eliminating barriers to mHealth innovation, the recommendations were far-reaching and recognized the important role that other federal agencies play in the regulatory oversight of mHealth devices and applications. Specifically, the Task Force urged the FCC to accelerate collaboration with the FDA in order to provide “regulatory clarity” in areas where the two agencies have overlapping jurisdiction, and called on the Secretary of Health and Human Services to exercise the authority granted to her by Congress in the FDA Safety and Innovation Act of 2012 to convene a formal working group of external stakeholders to develop recommendations on issues relevant to the FDA, FCC, and the Office of the National Coordinator for Health Information Technology (ONC).
Chairman Genachowski, who spoke at the event, said the FCC was already working to implement many of the recommendations of the Task Force. Specifically, he said that the agency is taking steps to hire a Health Care Director for the agency who will support the regulatory needs of the health care technology sector and work to identify and remove barriers. Further, the Chairman indicated by year-end the agency will consider orders to reform and make permanent a Rural Health Care Pilot Program that the agency recently completed, which has as a goal the promotion of creating affordable broadband-based solutions to rural health care challenges, as well as an order that will streamline the process for gaining experimental licenses for medical devices leading to the creation of more “wireless test beds.” Finally, Genachowski stated that the FCC has already begun efforts to improve international coordination with the goal of promoting assignments of compatible spectrum for mHealth technologies in foreign countries. While the FCC has made the US the first country in the world to allocate spectrum for purposes of certain implanted wireless medical devices, the Task Force said that it is critical to ensure compatible spectrum allocations in order to avoid unexpected health risks for patients who travel internationally.
The full Findings and Recommendations of the Task Force are available here.