The convergence of healthcare and wireless technologies is also creating the need for a convergence of regulation. The U.S. Food and Drug Administration and the Federal Communications Commission tried to address that reality through a joint promise to cooperate in bringing clarity to emerging regulatory issues that cross the traditional domains of the two agencies during two days of jointly held public meetings to explore potential obstacles to the emergence of new wireless healthcare devices and applications.

“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 two 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 two-days of public meetings held in Washington, D.C. brought together representatives from healthcare, technology, government, academia, and the venture capital world to discuss ways to ensure the safety and reliability of wireless broadband-enabled medical devices while increasing their availability to consumers and healthcare providers.

The proliferation of smartphones, inexpensive monitors, and the ubiquity of wireless networks is sparking a revolution in healthcare leading to new ways for patients to take a greater role in their own health and wellness, allowing doctors to provide remote monitoring of patients and get earlier detection on evolving problems, and providing cost savings and new forms of delivery. But some fear that uncertainty about the regulatory landscape could impede development of new technologies and discourage investment at a time when the industry is beginning to take shape.

“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,” said Joseph Smith, chief medical and science officer for the West Wireless Health Institute, who spoke on a panel on the importance of venture capital and investment during the two-day meeting. “While the venture capital community has been historically adept at finding and advancing solutions to unmet clinical needs, we must address what may be the most significant unmet need in health care – affordability.”

Venture investors welcomed the initiative between the two regulatory agencies to work together to help bring clarity about the regulatory pathway companies developing devices will face.

“As an area of investment, this arena is challenging, due in no small part to the regulatory uncertainty,” said Jim Glasheen, general partner of Technology Partners. “With that in mind, I am enthusiastically supportive that the FCC is working together with the FDA in taking a first-step towards putting in place a pro-investment / pro-innovation policy.”