The Federal Communications Commission and the U.S. Food and Drug Administration have joined forces to help advance innovation and investment in wireless-enabled telehealth devices, which can improve the quality of a patient's health and reduce healthcare costs.
FDA commissioner Margaret Hamburg and FCC chairman Julius Genachowski signed a joint statement of principles and memorandum of understanding at the start of a two-day conference, which began on Monday, to showcase a broad range of cutting-edge wireless medical devices as well as discuss issues affecting the telehealth industry.
The joint statement declared that healthcare providers, patients, and other stakeholders "should have clear regulatory pathways, processes, and standards to bring broadband and wireless-enabled medical devices to market. 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."
"Today's action will promote investment and innovation in health technologies, help realize potential cost savings, and deliver real health benefits to the American people," Genachowski said in his address to the conference in Washington, D.C.
Genachowski also said innovators and investors need more certainty and clarity as they develop and launch the next generation of telehealth devices such as wireless sensors that remotely monitor heart rhythm and portable glucose monitoring systems. He added that the partnership is a major step in implementing the FCC's National Broadband Plan, released in March, which outlined the ways in which wireless technology could advance the quality of healthcare.
Irene Berlinsky, senior research analyst covering multiplay services at IDC, observed that by partnering with the FDA, the FCC is signaling its commitment to the larger societal goal of increasing access to healthcare that the Broadband Plan means to address.
"A partnership between the FCC and the FDA is a surprising but logical outgrowth of the FCC's interest in telemedicine and telehealth," Berlinsky said. "Its National Broadband Plan singled out healthcare as one of the sectors with the potential to benefit most from expanding broadband access to rural and underserved areas."
Berlinsky added that the partnership shows that the government recognizes that an integrated approach is required to adequately regulate the medical device market. She also said she will take a wait and see attitude regarding whether the partnership will in fact advance investment and innovation in the telehealth sector.
"It remains to be seen how this partnership affects the regulatory burden wireless health devices will bear. The FCC and the FDA collaboration is meant to streamline the review process for new devices. Nonetheless, it is possible that involving two agencies may in some cases slow the time to market for new devices," Berlinsky said.
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Autor(en)/Author(s): Nicole Lewis
Quelle/Source: Information Week, 27.07.2010
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