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Continua Health Alliance Commends the FCC and FDA for Working to Streamline the Wireless Medical Technology Review Process

Tue, 08/03/2010 - 6:33am
BEAVERTON, Ore.--(BUSINESS WIRE) -- Continua Health Alliance applauds the FCC and the FDA for the timely decision to host a public session to gain a better understanding of the convergence of communications technologies and medical devices, the future of wireless health technologies, and the challenges both organizations face.

On Monday, July 26, 2010, and Tuesday, July 27, 2010, the FCC and the FDA held the groundbreaking session titled “Converged Communications and Health Care Devices Impact on Regulation” to enhance coordination between the two agencies for future devices and applications, and to clarify and delineate the respective areas of expertise and jurisdiction between them.

The principles outlined by FCC Chairman Julius Genachowski and FDA Commissioner Margaret Hamburg and validated in the Memorandum of Understanding between the two agencies are an impressive launch for the federal government in its effort to integrate mobile and wired technologies for more efficient and improved care:

•Innovation in broadband and wireless-enabled medical devices holds significant promise for enhancing health and reducing the costs of healthcare for all Americans. Examples include wireless sensors that remotely monitor heart rhythm and portable glucose monitoring systems. All Americans should be afforded the opportunity to benefit from medical technology advances with improved broadband and wireless technology.

•Developing and integrating wireless and broadband communications technology with medical devices and applications requires cooperation by both agencies to ensure that such devices operate in a safe, reliable and secure manner.

•It is important for the federal government to provide leadership and encourage innovation and investment in new healthcare technologies that enable healthcare consumers, healthcare providers, and other healthcare professionals to access the highest quality care.

•The American public - including industry, healthcare providers, healthcare consumers, and other interested 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 healthcare consumers.

“Collaboration among federal agencies is key to ensuring that connected e-Care solutions can be efficiently deployed in a safe and effective manner,” stated Rick Cnossen, president and board chair, Continua Health Alliance.

Continua Health Alliance executive director Chuck Parker, in his concluding statement at the conference, called for the FCC and FDA to expand the inter-agency cooperation to include CMS (the Centers for Medicare and Medicaid), as the role of reimbursement for these technologies is critical to adoption.

“We look forward to working with the FCC and the FDA on certifications that can lead to better adoption by CMS and national Payers in round two of this essential re-evaluation of accurate, safe, and cost-effective healthcare,” said Parker.

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