Almost 40 years ago, few could have imagined how modern technology would change the way we live. Ground-breaking advancements have changed the way we do business, communicate with one another, and feed the world.One rapidly-growing field is low-risk health information technology (health IT). These products, which pose little threat to human health, range from electronic health records and scheduling software to mobile wellness applications. Yet, they can greatly improve our quality of life.
Pioneers of low-risk health IT are engineering technologies that improve care, empower consumers with information, and save lives. Thanks to a $1.99 mobile app, an American basketball coach was able to download a refresher course on how to properly administer CPR. Thankfully, he was able to perform the procedure on a player who collapsed in practice the very next day.
In 2012, the Departments of Defense and Veterans Affairs partnered to release a free Apple and Android smartphone app called the Post-Traumatic Stress Disorder (PTSD) Coach. The app provides useful and reliable information on the disorder and its treatments. Since the app’s launch, it has been downloaded more than 100,000 times in 74 countries.
Yet, many of the current regulations governing these fields haven’t been appropriately updated to reflect modern developments. We need updated rules to help foster continued progress and ensure we stay competitive.
The current, overly broad definition of a medical device – written in 1976 – gives the Food and Drug Administration authority to regulate a wide range of health information technologies entering the marketplace.
The FDA claims it has discretion to regulate things like mobile wellness apps with the same rules it uses to review complex, invasive medical machines.
This defies common sense.
As a result, many of the products posing little risk to human health fall victim to a long, costly regulatory process. This stalls progress and unnecessarily burdens inventors and entrepreneurs.
To address this problem, I teamed up with Sen. Angus King (I-Maine) to introduce a bill that provides needed regulatory changes. Our legislation, the PROTECT Act of 2014, provides the industry certainty to promote innovation and encourage job creation all while protecting patient safety.
The PROTECT Act offers a more specific, risk-based framework for the FDA by drawing a line between low-risk and high-risk technologies. Our bill enables the FDA to focus its attention on devices that pose the greatest risk to human health. The agency’s work to protect people is important, and our bill makes sure that this oversight continues for dangerous medical devices.
Importantly, our legislation also cuts unnecessary red tape.
Whenever I meet with business owners across Nebraska, I hear time and again that uncertainty, partly due to overregulation, remains an ongoing challenge. Lingering uncertainty holds back business expansion and prevents owners from hiring.
Health IT is a thriving sector of our economy. It is full of enormous growth potential with opportunities for job creation. For example, the mobile health and mobile application market is expected to exceed $26 billion by 2017, and the mobile application economy is responsible for half a million new American jobs.
Congress should be working to help, not hinder, these successful job creators with pro-growth policies. The PROTECT Act provides regulatory certainty and gets government out of the way where it is not needed. Anyone with ambition and a dream should have a shot. Our legislation makes sure they do. We all benefit from more jobs, new technology and innovative forms of healthcare.
I’m so pleased to work with Sen. King and Sen. Marco Rubio (R-FL) – an original cosponsor of our bipartisan bill – to remove bureaucratic hurdles stifling economic growth.