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Margaret A. Hamburg, M.D., Commissioner of Food and Drugs - Remarks at the FDA/FCC Public Workshop: Enabling the Convergence of Communications and Medical Systems

Remarks as Delivered of Margaret A. Hamburg, M.D.
Commissioner of Food and Drugs
at the
FDA/FCC Public Workshop: Enabling the Convergence of Communications and Medical Systems
July 26, 2010

Good morning — it’s a pleasure to stand here with you, Chairman Genachowski. And it’s great to see such a terrific turnout … and so much support for our collective cause. I want to echo the thanks of the Chairman to all those who helped organize what will be a great two days. We just had the opportunity to walk through the display area and see some of the products. I must say: we saw some amazing stuff … and so much enthusiasm and great ideas.

It is exciting and encouraging because we are all here for the same reasons.

We are here because we recognize the tremendous potential of wireless-enabled medical devices combined with the power of broadband to improve healthcare for all Americans. We are here because we believe in the promise of innovation if we remove barriers and unleash investment while assuring patient safety. And, above all, we are here because we know we need a strong partnership — an effective collaboration — between the FCC and the FDA to shift the paradigm … and, in doing so, potentially change the face of medicine forever.

And that’s exactly what the convergence of communications technology and medical devices can offer us. When these two fields come together, we get such things as portable glucose monitoring systems, new technology pacemakers, remote vital sign monitors — in other words, we get a broad range of innovative devices that can reduce costs, bolster quality and benefit both patients and providers by making healthcare data and information immediately accessible for patient care and by monitoring the performance of patients and medical devices. And with this cutting-edge technology, we can finally transition from facility-centered care to patient-centered care, in which patients can be monitored — even diagnosed and treated — in any setting … at the hospital, in the workplace or even at home.

But we are also here because we have faced, and will continue to face, some challenges along the way. 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. And we must improve the efficiency of regulatory processes in areas where FDA’s jurisdiction and the jurisdiction of the FCC overlaps.

This meeting is an opportunity to hear about the challenges that everyone in this room — from investor to innovator to user — struggles with everyday. And, of course, these are challenges both of our agencies must understand and help address … which only underscores the importance of our working together.

As Chairman Genachowski has already explained, this partnership between our agencies — this exchange of information and sharing of expertise — has its roots in the National Broadband Plan released by the FCC in March … a plan that commits our agencies to clarifying and streamlining, as appropriate, the regulatory requirements and the approval process for converged communications and health care devices.

So today, we will release a Joint Statement of Principles and sign a Memorandum of Understanding that enhances efforts to: share information, improve the efficiency of our regulatory processes, promote efficient use of tools for product analysis and risk identification, and build infrastructure and processes that meet common needs for evaluating the safety and efficacy of broadband and wireless enabled medical devices.

I hope this meeting can be a forum for an open exchange of ideas. I know I speak for myself and Chairman Genachowski when I say that we want to hear the opinions of the innovators, investors, healthcare providers and patients here today. We want you to speak freely about your concerns over regulatory requirements and potential barriers and challenges.

We will use your input to enhance coordination between our agencies and to identify new ways to improve our regulatory processes to better support innovations while maintaining safety and effectiveness. And we will work within our respective regulatory frameworks to assess issues of reliability and efficacy for converged communications technology and medical devices.

Most importantly, will keep all of you — and the public — informed of our progress. And, in the coming months, the FDA will issue draft guidance informed by what we hear at this meeting on how we will approach mobile apps that are truly medical devices … how we can facilitate innovation while assuring safety and effectiveness. This guidance will be part of a public process that will include a public comment period.

In other words, today is just the start. This meeting represents a promising beginning of what I hope will be a long and valuable partnership between our agencies. Today, we will begin to examine key issues and begin to determine the best path forward for both our agencies, a path that keeps in mind our fundamental missions.

At the FDA, for example, we view every issue through the lens of public health, because, as many of you know, the fundamental mission of our agency is to promote and protect the public health. And we are dedicated to fulfilling both parts of that mission … promotion through discovery and innovation and protection through the delivery of safe and effective products for consumers. Our ultimate goal is a balanced approach … an approach that meets the unique challenges of the 21st century while prioritizing health and well-being above all else.

I know it’s a tall order, but it’s what the American people demand — and it’s what we must deliver. I look forward to working with Chairman Genachowski and the FCC as we make good on this promise — and I want to thank Chairman Genachowski and his staff for hosting today’s workshop and for your leadership and commitment to our shared goal.

Thank you all for coming today and for participating in what I hope will be a productive and continuing dialogue.