1 Prepared Remarks of FCC Chairman Julius Genachowski FCC/FDA Joint Meeting on Wireless Medical Technology “Enabling the Convergence of Communications and Medical Systems” Washington, D.C. July 26, 2010 Thank you, Julie, for kicking things off for this unprecedented event. Thank you, Commissioner Peggy Hamburg for your partnership and for joining us. Thank you Aneesh Chopra, our country’s first Chief Technology Officer, focused on every day on harnessing technology for the benefit of our future. Thanks to the terrific teams at the FDA and the FCC for assembling such an impressive program, in particular Julie Knapp, Phoebe Yang, Kerry McDermott, Bruce Romano, Dr. Mohit Kaushal, and Rashmi Doshi on our team and Dr. Jeff Shuren and Bakul Patel at FDA. And thank you all for coming. Hopefully, we got some of you out of your Monday morning staff meetings. Everyone in this room understands the importance of bringing new innovation and technology to health care in the 21st century. By doing so, we can improve the quality of health care, lower costs, and improve access. Some of our greatest health care achievements were the result of government and private industry coming together. The human genome project, for example, catalyzed the multibillion-dollar U.S. biotech industry, and fostered the development of new medical applications and treatments. Breakthroughs such as this will only happen if government works closely with the relevant industries to create conditions that encourage the development of cutting-edge, life-saving devices; that unleash innovation and catalyze investment, improving health care, even saving lives, and creating jobs as well. That is why we are here today. The FCC has been focused on seizing the opportunities of broadband technology to drive economic growth and improve the quality of Americans’ lives. In March, we released America’s first National Broadband Plan. The Plan is a bold strategy to promote private investment and build a world-class broadband infrastructure to bring the benefits of high-speed Internet to all Americans. 2 Today, we bring one of its key recommendations to life. In developing our health care recommendations, our Broadband team conducted extensive outreach across the health care community. It became clear that there would be enormous benefit from the FCC and FDA working together to unleash broadband innovation for health care, particularly wireless. To do so, the Plan recommends that the agencies clarify the requirements and improve the efficiency of the approval process for converged communications and health care devices. We start to make that happen today in what we hope and expect will be an important long-term collaboration. Seizing the opportunities of health IT is a key part of the new landmark health reform law, and it is a key part of the Broadband Plan, because the promise is so great. As we saw this morning, broadband enables remote diagnostics and health care – it can allow patients in the most isolated parts of America to receive care from the very best specialists thousands of miles away. Broadband enables remote medical monitoring – wireless devices can help diabetes patients track their glucose levels, or heart disease patients monitor cardiovascular data. Broadband can enable access to electronic health records wherever the patient may be and save our nation more than $500 billion over the next 15 years. The health strategy of the FCC’s Broadband Plan has three key components: connectivity, spectrum policy, and regulatory clarity for investors and innovators. Let’s start with connectivity. Up to 30 percent of rural clinics don’t have adequate broadband technology. They can’t offer remote video care, for example, or easily access or exchange MRIs, x-rays or other electronic health records. Two weeks ago, the FCC moved forward with a major initiative to deliver broadband connectivity in a significant way to clinics and hospitals that now have no or inadequate service. On spectrum – our airwaves – the Broadband Plan calls for freeing up 500 MHz of spectrum and other steps to seize the opportunity of the wireless broadband revolution. The innovation this can unleash is vital in general for our economy and national competitiveness. And Health care is a powerful vertical application of the opportunity. 3 Smart spectrum policy, including unlocking more spectrum, can pave the way to a new generation of wireless medical devices. For example, as we saw, wireless band-aid-like sensors will be able to monitor a patient’s vital signs, detect the onset of a patient “crash,” and transmit health data to caregivers in time for treatment. We will see and hear about many more such examples today of devices that can help manage and treat a wide variety of diseases, while reducing costs and improving quality of life. Innovations are being developed by companies both big and small. In short, smart spectrum policy is a key enabler to smart health care. But connectivity and spectrum will only get us so far. We also need to provide more certainty and clarity to the innovators and investors who will develop and launch the next generation of health-related communications technologies. That is one of the core reasons the FCC and FDA came together to host this meeting. 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. It’s vitally important that we work together on issues where wireless meets medical. Today, we take the first major step toward implementing the Broadband Plan’s recommendation on this topic. We have brought together the patient and provider communities, the wireless, technology, and health industries, relevant agencies, and other stakeholders to help us better understand emerging wireless medical technologies and trends, their potential benefits, potential risks, and challenges from various stakeholder perspectives. This workshop will help the FCC and the FDA develop answers to key questions, such as how to improve our processes to accelerate innovation and investment while ensuring that patients are protected. It will also help make sure we are asking all of the key questions to accomplish these goals. Recognizing the importance of the opportunity, I am pleased to be joining Commissioner Hamburg in announcing an unprecedented FCC-FDA partnership. This includes a Memorandum of Understanding to improve information exchange between our agencies and streamline collaboration, as we work to unleash the benefits of broadband for health care. 4 We are also releasing a joint statement of principles on wireless health that will guide our work as we tackle this important topic. To briefly summarize the key principles: we recognize that all Americans stand to benefit from broadband-enabled wireless health solutions; that we must unleash innovation while assuring patient safety; and, that we must partner effectively to do so. This joint initiative reflects a shared commitment on behalf of the FCC and FDA. 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. Our staffs have done great work already to help ensure that communications-related medical innovations can swiftly and safely be brought to market. I applaud their efforts, and look forward to ongoing success toward these important goals. With that, it is my pleasure to turn it over to Commissioner Peggy Hamburg. Dr. Hamburg is an internationally recognized medical and public health expert with an unusually impressive and diverse set of experiences. Dr. Hamburg has brought new energy to FDA and its mission of promoting and protecting public health.