On Wednesday, Congress approved a bill that allows the Food and Drug Administraion to regulate medical applications on smartphones.
In a rare moment of bipartisanship within a particularly divided Congress, the bill “reauthorizes and reforms key FDA programs to ensure the continuation of various FDA initiatives and the creation of new ones to facilitate the review and approval of life-saving and life-improving drugs and medical devices,” according to a statement posted on the House Energy and Commerce Committee website.
After the vote, House Energy and Commerce Chairman Fred Upton said in a speech on the House floor, “Mr. Speaker, this is, this is a jobs bill, and it’s a medical innovation bill. And as we put this package together our goal was to improve the predictability, consistency, transparency and efficiency of FDA regulation.”
A particular portion of the bill concerning smartphones states that within 18 months of its enactment, the secretary of Health and Human Services is to post “a report that contains a proposed strategy and recommendations on an appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications, that promotes innovation, protects patient safety, and avoids regulatory duplication” on the websites of the FDA, Federal Communications Commission and the Office of the National Coordinator for Health Information Technology.
On Wednesday morning, concern was voiced at a press briefing at the American Enterprise Institute over this particular portion of the bill.
The pace of government bureaucracy is continually outpaced by the rapid innovation of the market within the technology sector, and there has been much debate in Washington as to whether government can keep up with the pace of innovation while seeking to fulfill its mandate to protect its citizens.
Joel White of Health IT Now, a healthcare technology coalition that promotes the rapid deployment of health information technology, challenged the idea that the futuristic technologies, like mind-controlled prosthetic limbs that are currently in development, could be properly dealt with under the current bureaucratic system. The role of the FDA in regulating medical technologies, however, was not called into question, but rather how it would go about doing so.
“Regulators need to be thinking about, ‘Does the structure fit anymore, or are we trying to jam a square peg into a round hole?” White said.
Jon Potter, president of the Applications Developers Alliance, echoed White’s concerns. Potter made mention of how regulatory uncertainty deters investors from putting money towards the development of these technologies.
“If the law requires FDA to regulate apps, and the law requires the FDA to say that the iPhone is a medical device because they have an app store that has a health category, then we have a challenge, and we’ve gotta figure that one out,” Potter said.
This article was updated after publication.