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mHealth Summit

Mobile Apps and More: Harnessing Technology’s Power for Patient Care and Public Health
Remarks by Margaret A. Hamburg, MD
Commissioner of Food and Drugs
mHealth Summit
Gaylord National Convention Center, National Harbor, MD
December 11, 2013

Good morning. Thank you Steve [Lieber] for the generous introduction, and for inviting me to be with you today. It sounds like this has been a very exciting and productive summit.

I have to say that when I first received your invitation to speak here, my initial response was, “do they really want me?” I am not what you would call your most tech-savvy person. I regularly am forced to turn to others, quite often my kids, for support on something as easy as adding an app to my I-phone, which I only got two weeks ago. My first one! So I’m definitely what you could call a “late adopter.” And I’m still of the world where I consider “friend” to be a noun, not a verb.

But I recognize that the world is transforming in dramatic ways, and it is incumbent on all of us to adapt and change….and importantly to seize the opportunities that these advances in science and technology can offer to improve access to information, quality of life, and of course, our health.

I was reflecting on this a few months ago when I spoke to a group of FDA employees at an event focused on the impact and future of scientific computing. Although we have some of the most state of the art computers and other high-tech tools available to us, I decided to start by giving a little historical perspective on some of the exciting approaches we were discussing.

Certainly, the FDA, since its inception, has understood the value of using scientific computation. Our scientists and reviewers rely on the best available science for their important work and they have been struggling for years to find the best ways to manage, analyze and process all of the data we must examine.

To demonstrate this, our historians pulled out for me to show [and unfortunately I couldn’t bring it here today], what was called a “Calculating Instrument.” It was, FDA’s “first computer,” used by the predecessor of FDA, The Bureau of Chemistry, in the early 1900s.

Essentially, it was an enormously elaborate and clunky cylindrical slide rule that was designed to assist in the number crunching they were doing on the data that even then was rapidly accumulating. For those of you in the audience even know what a slide rule is, I am not sure that you would even have recognized this.

They also pulled out for me another, even older piece of equipment, from 1887, called an arithmometer, which performed long multiplication and division. As I told my colleagues, for those of you who may get frustrated when the internet is running a bit slow, or when it takes a bit longer than usual for your computer to complete the analysis of a data set, just remember how far we’ve come.

And today, through my work as FDA Commissioner, I have the distinct honor—and responsibility—to help shape a range of policies and programs that can encourage and advance next generation technologies; technologies and innovative approaches that can offer new and better diagnosis and treatments for both routine conditions and some of the most challenging diseases before us… and overall, support the promise of better care for patients.

To me, this is the ultimate benefit of any scientific or medical development – how it helps to improve the care and treatment of patients…and better yet, to prevent disease in the first place.

As a physician who has spent the better part of my career focused on questions of public health and medical care, I certainly appreciate the enormous opportunities offered by new scientific developments and technological advances, including in mHealth.

But I want to say at the outset of my remarks, that I strongly believe our focus can’t be just be on, as the author Michael Lewis termed it, the latest “New, New Thing” – no matter how jazzy those technological developments may be.

To me, innovation is not just something that is new, but it is something new that makes a meaningful, positive difference in people’s lives.

So, as I discuss with you today some of these remarkable advances and FDA’s approach to regulating them, including our recent guidance on mobile apps, I want to encourage you to keep in mind the impacts these developments can have on individual patients and the health of the public. As the philosopher Martin Fischer once said, “The patient does not care about your science; what he wants to know is, can you cure him?”

Now this may sound a little strange coming at an event like this one celebrating technological and scientific achievement. But it is completely consistent to spotlight advances in science and technology even as we maintain a focus on the patients those advances serve. And I was pleased to see a session at this conference on mHealth’s role in patient engagement.

My guess is that most of you understand this even better than I that it is not an either/or choice. mHealth is really about getting it right so that it can really be used. The best and most important technological developments in medical science must involve and support the broader goal of helping people and patients. FDA recognizes the importance of facilitating new medical technologies that will improve medical care, promote the health of the public and promote innovation.

Certainly this paradigm was central to our recently finalized guidance on mobile medical apps. There is little question that the widespread use of mobile technologies is opening up new and innovative pathways to improve health and health care delivery. In fact, today in health care, as in so many other areas of life, it increasingly seems that if there is a need, there will be an app for it.

And this is no passing fad. Estimates are that by 2015, 500 million smartphone users across the globe will be using a health care app. By 2018, half of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications. (Frankly I’m not sure which is more remarkable, the number of people who will have downloaded the apps or the fact that we will have 3.4 billion smartphone and tablet users.)

But we know that mobile apps have the potential to provide enormous benefit to consumers, health care professionals and patients.

Whether it is assistance in gaining timely access to useful and important medical information, or promoting better management of health and wellness, or connecting patients and medical professionals with a tool that might otherwise not be available -- even including diagnoses of potentially life-threatening conditions outside of traditional health care settings – mobile apps offer the opportunity for more informed behavior and better care.

Of course, as with many subjects in science and medicine, using generalities to speak about health care apps can be a bit dangerous, given the wide variety that exist.

Apps can range in both sophistication and medical significance, from something as basic as a tool to help individuals maintain a certain bodyweight, to a smartphone that becomes an otoscope, the instrument doctors use to look into an ear, to apps that allow smartphones to produce electrocardiograms (EKGs), measure glucose levels and more.

Not surprisingly, the differences in the potential risks that different apps present are just as varied. While many carry little or no danger to patients, there is a small portion that can pose a significant peril if they don’t operate correctly or accurately, or are relied on inappropriately.

The policy FDA issued was developed after an extensive period of public engagement, including input from industry, patient and consumer groups, health care professionals, mobile app developers and bloggers, technical and professional associations, and others, including other government agencies. It is designed to provide clarity to developers and manufacturers about which mobile apps are the focus of FDA oversight, and which are not, and to provide a clear, predictable, and reasonable understanding of the Agency’s expectations.

At its core, our guidance is focused on risk and functionality.

For example, an electrocardiography device that measures heart rhythms to help doctors diagnose patients is the same machine, no matter whether it is a foot wide and sits in a doctor’s office or is the size of a credit card and resides in your phone. The risk to patients and practitioners is essentially the same. That device needs to be safe and effective, and work in a way that is reliable, reproducible and does what it claims to do.

The FDA guidance makes clear that if a mobile app is intended to transform a mobile platform into a medical device, or is an accessory to a medical device, for example, an app that acts as a remote control for such a device, we would continue to regulate that kind of technology if it is on a mobile platform. The focus is on the functionality, not the specific platform.Our goal is to promote innovation and protect patient safety through a pragmatic, narrowly-tailored approach.

This balanced approach means that our regulatory focus is primarily on a small group of mobile apps that present a greater risk to patients if they do not work as intended. For many mobile apps that may otherwise be regulated but are less risky, we intend to exercise our enforcement discretion.

For example, we do not intend to focus our regulatory oversight on apps that help patients self-manage their diseases or conditions without providing specific treatment suggestions; that enable patients or practitioners to interact with Personal Health Records or Electronic Health Record systems; that use a camera or video conferencing to supplement a patient’s oral discussion with his or her health care practitioner; or that conduct simple calculations such as body mass index or provide alerts to patients to take medications.

And a fundamental goal is to make sure that the best available science and technology is harnessed for the benefit of consumers and patients.

We are in the midst of a remarkable period of scientific innovation, with achievements offering the potential for us to transform our ability to prevent, diagnose and treat disease. I’m sure this is one audience that I don’t have to explain how quickly these changes are happening – how just a few years ago what might have been termed science fiction, is today … just plain science.

Much of this progress is occurring in the IT sector, but it is by no means confined there. But it is striking how often it is the combination of advaces in the lifesciences combined with It capabilities that are really producing key breakthroughs. For example, advances in sequencing the human genome and greater understanding of the underlying mechanisms of disease, combined with increasingly powerful computers and other technologies, are making it possible to tailor medical treatments to the specific characteristics, needs, and preferences of individual patients, an area known as “personalized medicine,” or more and more termed “precision medicine.”

And the prospects for this field are astounding, representing a somewhat different angle on the notion of a more individualized approach to treatment as offered by mobile medical apps.

Consider, for example, that many cancer drugs today are increasingly used with a diagnostic device that can help doctors determine whether a patient will respond to the drug based on the genetic characteristics of the patient’s tumor. Or that progress in regenerative medicine and stem cell therapy using a patient’s own cells could lead to the replacement or regeneration of the patient’s missing or damaged tissues. Or that just this year, a 3-D printer was used to create a bioresorbable tracheal splint for treating a critically ill infant.

In each of these instances, the ability to match the treatment to the specific needs and often genetic makeup of the patient allowed for treatments that were simply not previously available because the technology did not yet exist.

FDA’s regulatory role in these emerging areas is developing as well, sometimes even as the technologies themselves are taking shape. But our responsibility remains the same -- to ensure the safety and effectiveness of medical products.

We know there will be new challenges that arise with new technological developments, and the increasing commercial opportunities and applications.

Each of the new medical products we approve and usher to the market involves a balancing of risks and benefits, which is based on study and evaluation of hard data and the best available science. It is a huge responsibility that FDA is charged with, nowhere more so than when dealing with unfolding technologies that offer enormous potential -- but also may present real risks for people and their health.

But whether it involves a mobile medical app, advances in sequencing the human genome, applications of nanotechnology, or the development of some other state-of-the-art medical device — FDA is committed to uphold our responsibility to ensure the safety and effectiveness of medical products, while helping these scientific achievements reach their full potential by building a pathway for continued innovation.

We will do so knowing that these technologies by themselves must be part of a foundation of basic medical care by doctors and other providers focusing on individual patients … and also part of a system that serves the overall needs of public health.

It was Benjamin Franklin, a somewhat cynical guy, who said, “He's the best physician that knows the worthlessness of the most medicines.” It’s a truism to note that medical science has come a long way since Franklin’s time. But his point, I believe, was that medicine alone, without the proper context, thought and appropriate care, will fall short.

It is up to all of us to work to ensure that these new technologies have real value to the people who will use them, and that they are used effectively and appropriately to address their needs.

These are exciting times. Whole new realms of possibility stretch out before us. New opportunities emerge every day.

Let us work together to harness the power of science and technology to improve patient care and public health. We can make a lasting difference.

Thank you.

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