Medical Software and FDA Regulation

May 29th, 2012

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. . . .

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.

From WSJ.