Feb 18 2014
They've helped coaches perform CPR on breathless athletes. They remind pharmacists in sub-Saharan Africa to order more retroviral drugs for HIV patients, and their pocket-sized storage capacity dwarfs bulky filing cabinets. Smart phones have revolutionized the way we live and their capabilities appear restricted only by the limits of our imaginations.
Technology has changed the way Nebraskans and Mainers stay in touch, do business, and feed the world. The best ideas have always come from a couple of guys working out of a garage, or a young woman with a breakout business model. That's the genius of America.
As the gatekeeper for new health information technologies trying to enter the marketplace, the Food and Drug Administration is tasked with keeping Americans safe. The FDA's work is important, but its processes are often painstakingly slow and based on outdated assumptions. This halting regulatory pace, along with a lack of bureaucratic incentives to embrace disruptive technological change, has often held back progress.
The FDA's regulatory footprint is growing beyond its statutory shoe size. The overreach comes in various forms, including sub-regulatory proceedings and selective regulation. Companies — including those who have already invested and deployed their technology — are left on uncertain footing given the FDA's regulatory discretion.
Such heavy-handed moves have caused legitimate concern that the FDA could slow down the development of low-risk health technology, including mobile-wellness applications and electronic health records.
Today's statutory definition of a medical device — one written almost four decades ago — gives the FDA jurisdiction over nearly "any instrumentality" used in the diagnosis or treatment of a patient. This overly broad, dated definition is bad news for health IT innovation. Forty years ago, a personal computer was a pipedream, an apple was strictly a fruit, and "software" was a mink coat.
Rather than constraining creativity with obsolete parameters, our laws should reflect our generation. It isn't hard to figure out that smart phone apps shouldn't be subject to the same oversight as MRI machines. Regulating low-risk health technology the same as complex medical devices is like regulating 787 Dreamliner jets under rules predating the Wright Brothers.
Misguided regulation leads to fewer innovators and frustrated developers who turn away from exploring health technology to other, more hassle-free fields. Low-risk health IT deserves a modern regulatory regime — one that promotes innovation, supports jobs growth, and protects patient safety.
We believe Congress must act and codify the common sense that you can't regulate new technology with old rules. We've offered a bipartisan proposal that says if people can develop mobile apps to keep neighbors out of the hospital, improve lives, or lower costs, we should get government out of the way and spread the knowledge. The regulatory timeline for dangerous devices should not be the same for low-risk software that gets released every 60 days, has major updates every month, and sees regular changes each week. Having an approval process that takes longer than the shelf life of the average device operating system stifles innovation and opportunity.
From assisting nurses with scheduling or tracking emerging malaria epidemics, mobile health can dramatically lower costs, empower individuals, and transform the way we deliver care.
Moreover, our plan protects American jobs in a key growth sector of our economy. The mobile health and mobile application market is expected to exceed $26 billion by 2017, while the U.S. mobile apps economy is responsible for nearly half a million new American jobs. A report from Health Data Management anticipates 23% annual growth in this jobs sector over the next five years.
The FDA notes on its own website that 500 million smart phone users worldwide will be using health apps by 2015. It's clear the future should be bright for health IT. That's good news for entrepreneurs, and even better news for doctors and patients. But regulating every new product as a traditional medical device — subjecting it to an approval process that takes years and costs millions — prevents emerging technology from entering the marketplace in the first place.
Congress should send the message to startup innovators that they don't need costly corporate counsels and hired guns on K Street to navigate the FDA and open the right political doors. All anyone should need is a good idea and a dream.
Regulating a health care field ripe with innovation under an arcane, one-size-fits-all framework defies reason — even for Washington. Until Congress clarifies the FDA's oversight role, we'll continue to live in a world where health IT is monitored with rules written before the advent of the VCR.
U.S. Sens. Deb Fischer, R-Neb., and Angus King, I-Maine.