The Federal Communications Commission and the Food and Drug Administration have announced a joint effort to help ensure that the capabilities of broadband use in healthcare and wireless-enabled medical devices are fully realized.
The Federal Communications Commission (FCC) and the Food and Drug Administration (FDA) have announced a joint effort to help ensure that the capabilities of broadband use in healthcare and wireless-enabled medical devices are fully realized.
The agencies issued a joint statement of principles indicating that governmental agencies should ensure the safety, reliability, and security of devices such as wireless sensors that remotely monitor heart rhythm and portable glucose monitoring systems. They also said that the federal government should encourage innovation and investment in such technologies.
Healthcare providers, patients, and others "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," the statement reads.
The FCC is responsible for overseeing airwave usage, and the FDA is responsible for ensuring the safety and efficacy of medical devices.
"Not only will cutting-edge devices improve medical care and reduce health costs, they will catalyze private investment to create jobs and spur economic growth," says FCC Chairman Julius Genachowski.
FDA Commissioner Margaret Hamburg adds, "The benefits that wireless technologies can provide to healthcare are clear, but to harness the full power of those benefits, we must navigate a delicate balance between innovation and safety and effectiveness. Working alongside the FCC, we can improve the efficiency of regulatory processes in areas where our jurisdictions overlap. "
The National Broadband Plan found that the use of communications devices and networks in the provision of healthcare is increasingly transforming medicine by allowing doctors to treat patients anywhere, anytime, while improving quality and reducing costs. These devices increasingly rely on commercial wireless networks to relay information for patient health monitoring and decision support. The plan recommended that the FCC and FDA clarify regulatory requirements and the approval process for converged communications and healthcare devices for the benefit of consumers and healthcare providers.