There's a medical app for that—or not

Even the most ideologically opposed politicians agree: Health care is choking on paperwork, and medicine is prone to errors of handwriting, lost information and guesswork. That's why the promotion of health information technology is one of the only demilitarized zones in Washington—consistently attracting bipartisan support since the Bush administration began funding ways to standardize and computerize health-care records a decade ago.

Despite such broad political support—plus that of health insurers, providers, drug companies and patient groups—the Food and Drug Administration (FDA) unfortunately has rushed in to play bureaucratic spoiler just as this new engine of innovation was leaving the station.

The FDA wants to regulate software used to support the decisions made by patients and health-care providers in the same way it regulates the software embedded in medical hardware such as X-ray machines and infusion pumps. But existing regulations don't fit the new kinds of apps that developers are making, such as portable health records and programs that let doctors and patients keep track of data on iPads. Some 62% of physicians are now using tablets at the point of patient care.

As health-care providers computerize how they take care of us, we're computerizing how we take care of ourselves—and how we connect back to our doctors. There are apps for managing our prescriptions, tracking blood sugar, and monitoring pacemakers or pregnancies. These tools are critical to breaking the chokehold that paperwork, waiting rooms and endless process have on medicine.

Like all apps that have revolutionized the way we interact with our physical world, mobile health apps are the creatures of an innovation juggernaut. Now this culture of innovation is threatened by government bureaucracy.

Are mobile apps for monitoring blood sugar and the like "medical devices," as the FDA wants to classify them? Of course not. They're programs for managing your own care, not for doctoring yourself.

A handful of mobile apps read data streams transmitted by medical devices implanted in patients, but one that tracks your pacemaker or blood sugar isn't the same as software embedded in medical devices that are cut into your body and then generate data. In its regulatory grab, the FDA is pretending not to be able to tell the difference.

The result could be the worst regulatory mismatch possible. An FDA process that takes years cannot possibly be applied to technologies that run on our phones or iPads and get updated on a regular basis.

Sens. Michael Bennet (D., Colo.) and Orrin Hatch (R., Utah) have introduced an amendment that puts a moratorium on the FDA's power grab while Congress studies how to build a modern regulatory framework suited to these new software tools. There's good reason why apps that support doctor and patient decisions might merely need to meet certain specifications (regarding ease of use, for example, or reproducibility of performance) to earn government approval, rather than undergo the time-consuming and costly premarket clearance that the FDA demands for other kinds of products.

The Bennet-Hatch amendment—which a bipartisan group of senators is trying to insert into a bill expected to pass Congress this week (the Prescription Drug User Fee Act, which helps fund the FDA's operations)—asks for the different government agencies that already have a stake in this software technology to work together on developing proposals for regulating these new tools. Yet FDA staff is lobbying against the proposal.

The FDA's approach to health-information technology risks snuffing out activity at a critical frontier of health care. Poor, slow regulation would encourage programmers to move on, leaving health care to roil away for yet another generation, fragmented, disconnected and choking on paperwork.

The process already exists for safeguarding the public for computers in health care. It's not FDA premarket review but the health information technology certification program, established under President George W. Bush and still working fine under the Obama Health and Human Services Department. The government sets the standards and an independent nonprofit ensures that apps meet those standards. It's a regulatory process as nimble as the breakout industry it's meant to monitor.

That is where and how these apps should be regulated. The Bennet-Hatch bill would give Congress time to consider these and similar options rather than let the FDA muscle into a space where it's ill-suited to be.

Dr. Gottlieb, a former deputy commissioner of the FDA who has advised health-technology firms, and Mr. Kleinke, who has helped launch several health-information companies, are resident fellows at the American Enterprise Institute.




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About the Author


  • Scott Gottlieb, M.D., a practicing physician, has served in various capacities at the Food and Drug Administration, including senior adviser for medical technology; director of medical policy development; and, most recently, deputy commissioner for medical and scientific affairs. Dr. Gottlieb has also served as a senior policy adviser at the Centers for Medicare & Medicaid Services. 

    Click here to read Scott’s Medical Innovation blog.

    Follow Scott Gottlieb on Twitter.

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  • J. D. Kleinke, an expert on health care business strategy and entrepreneurship, was instrumental in the creation of four health care information organizations. He has also advised established and start-up companies on health care business, product and technology strategy. Mr. Kleinke writes on the business of health care, health insurance and benefits as well as about doctors and the culture of medicine. His books include Bleeding Edge: The Business of Health Care in the New Century (Jones & Bartlett Learning, 1998), Oxymorons: The Myth of a U.S. Health Care System (Jossey-Bass, 2001), and Catching Babies (Fourth Chapter Books, 2011). At AEI, he is studying the interplay between health policy, health care market dynamics and health venture formation; the influence of information technology and medical technology on the overall health economy; and the impact of medical culture on health care organizations, markets and public health.

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