FCC, FDA Partner on Wireless Health IT

In an effort to unlock the potential of new wireless health devices and streamline the regulations governing their deployment, the FCC and FDA have joined forces in a formal partnership.

The Federal Communications Commission and Food and Drug Administration have joined forces in an effort to promote the development and deployment of wireless technologies to improve health care and lower costs while also taking care to protect patients' safety.

Through the partnership, the agencies aim to streamline the approval process and regulatory requirements for wireless health IT device makers, spurring innovation and investment in an emerging sector of the medical industry.

Wireless health applications offer the potential to provide remote consults with specialists from distant medical centers, delivering a level of care beyond the reach for many rural Americans.

Similarly, medical monitoring applications can provide remote diagnostic information, such as a crop of smartphone apps that can check glucose levels in diabetics.

"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," FDA Commissioner Margaret Hamburg said in a statement. "Working alongside the FCC, we can improve the efficiency of regulatory processes in areas where our jurisdictions overlap."

The agencies developed a set of operating principles (PDF available here) and a memorandum of understanding (PDF) clarifying that the agreement is limited to areas that come under the regulatory purview of both the FCC and FDA.

Under the agreement, each agency will establish a liaison officer who will be responsible for sharing information of mutual interest.

The joint effort on wireless health IT marks the first partnership between the two agencies, and broadly aims to pair the FCC's technical expertise overseeing areas such as spectrum with the FDA's focus on consumer safety.

"The FCC is responsible for overseeing the efficient use of the airwaves, and the FDA is responsible for the safety and efficacy of medical devices," FCC Chairman Julius Genachowski said in a speech at a health IT event announcing the partnership this week. "It's vitally important that we work together on issues where wireless meets medical."

The wireless health IT push builds on a set of recommendations included in the national broadband plan the FCC delivered to Congress in March, and extends the administration's advocacy of tapping advanced technology to overhaul the country's medical system.

In addition to the nearly $20 billion allocated to health IT initiatives in last year's economic stimulus bill, the administration has taken several steps to drive the adoption of electronic health records (EHR) and other similar initiatives.

Earlier this month, the Department of Health and Human Services issued the final set of rules to reward providers for using EHRs with Medicare and Medicaid payment bonuses.

EHRs are widely viewed as a path to reduce manual errors in patients' records and improve the coordination of care, while helping to flag for harmful drug interactions and reduce duplicate or unnecessary tests.

The new rules aim to clarify the certification criteria that vendors' EHR systems will have to meet in order to qualify for the incentives, and provide similar guidelines for doctors and hospitals.

HHS said it could pay out as much as $27 billion in Medicare and Medicaid bonuses to providers that adopt EHR systems that satisfy the requirements for "meaningful use" under the new regulations.

The same week, the FCC announced a major initiative to expand broadband access to doctors and health facilities operating in remote and rural areas. The program would reallocate as much as $400 million annually under the FCC's Universal Service Fund to deliver high-speed connectivity to more than 2,000 rural health-care facilities.

The commission noted that nearly 30 percent of rural clinics receiving federal funding don't have broadband service that's either fast or secure enough to handle health IT applications such as a remote consultation with a specialist or the transmission of data-intensive records like X-rays or MRIs.

Kenneth Corbin is an associate editor at InternetNews.com, the news service of Internet.com, the network for technology professionals.

Tags: wireless, FCC, Health IT, wireless network, FDA

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