Recent, widespread dissemination of smartphones and improvements in wireless network coverage have created an opportunity for people to take a more active role in maintaining their health. It also permits physicians to remotely monitor patients and detect evolving health issues quickly and cheaply.
One potential impediment to such progress would be an overbearing regulatory environment which could slow innovation and discourage investment at a critical juncture in the evolution of the technologies.
To their credit, the Food and Drug Administration and the Federal Communications Commission have recognized this risk. Recently, the 2 agencies held a joint summit in which they tried to address the matter. During the summit, they agreed to cooperate on matters that cross their traditional domains, while focusing on ways to assure the safety and reliability of wireless medical devices and increase their availability to providers and consumers of health care.
“The American public–including industry, providers, patients, and other interested stakeholders–should have clear regulatory pathways, processes, and standards to bring broadband and wireless-enabled medical devices to market,” the agencies said in a joint statement. “This includes clarity regarding each agency’s scope of authority with respect to these devices, predictability regarding regulatory pathways, and streamlining the application process, as appropriate, to facilitate innovation while protecting patients.”
The summit was attended by leaders from healthcare, technology, academia, and the venture capital sector.
“The relationship between FDA approval and FCC certification of wireless-enabled medical devices must be further delineated and expedited to overcome hurdles to innovation identified by both agencies,” Joseph Smith, the chief science officer for the West Wireless Health Institute said at the conference.
Venture capitalists welcomed the initiative. “As an area of investment, this arena is challenging, due to the regulatory uncertainty,” said Jim Glasheen, a general partner at Technology Partners. “I am enthusiastically supportive that the FCC is working together with the FDA in taking a first-step towards a pro-investment/pro-innovation policy.”