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Is The FDA Holding Back Innovation?

In today’s modern age, technology has been advancing global industries to a point where innovations are happening faster than ever before. With the interconnectivity and shared knowledge of the Internet, new tech inventions, and digital access to people around the world, we’re seeing a much faster growth rate when it comes to constant discoveries being made to help our lives become easier. The healthcare industry is no exception, and for good reason. No matter how much technological advancement occurs in society, a person’s health should remain the most valuable commodity, and these days people are looking for more valuable and cost-effective methods to monitor their health.

Yet even with all the evolution that could be taking place in healthcare, there’s still something keeping it from moving forward. The current approval processes of the Food and Drug Administration (FDA) appear to be slowing down the ability to make healthcare more wireless and accessible by delaying approval on mobile medical apps. Although the FDA’s approval process on drugs and healthcare has held firm for many years, given how quickly technology is advancing, it may be time to review the process timelines and figure out how to make exceptions—and new policies—regarding healthcare’s wireless tech revolution.

Mobile medical apps: stalled innovations?

It goes without saying that the FDA protects consumers in a number of ways. If it weren’t for their rigorous testing, research, and regulations, there would be many faulty—even dangerous—pharmaceuticals on the market. Yet as well as this process has worked in the past, it hasn’t quite caught up to the current changing industry when it comes to innovative healthcare practices—namely, wireless technology.

According to the updated 2015 list by the FDA, there are a number of mobile applications that are currently regulated as medical apps. Many of these are designed to use technology to mimic medical devices, such as mobile apps that measure heartbeat like an electrocardiograph, or ones that electronically amplify the sounds of internal organs, thus acting like a stethoscope. The justification behind it is simple: Because mobile tech has the potential to fail or give an inaccurate result, it needs to be properly reviewed and regulated. (The actual machines, however, have been developed over many years and are considered the baseline standard for medical measurement.) Yet while these products are stalled in review, technology continues to improve, and many patients and medical professionals feel stuck in the past. It could be that these new mobile medical apps can deliver just as accurate results as their mechanical counterparts.

A recent opinion piece at FreedomWorks argues that FDA regulations are holding back what could be a revolution in the healthcare tech sector:

Regulations cannot keep up with an innovative market. It is not just 3-D printers that are changing the health market, but innovations from nanobots to wireless telemetry and organ creation to drugs tailored to a patient’s specific DNA. How regulators are able to adjust to these innovations and allow them to improve health care is a growing concern.

Regulation protects the status quo and hinders or prevents innovation, the health care market is too important to be controlled by cronyism. New technology often comes from unexpected places and from people that had previously not been major players in the market. However, this is only possible when the cost of regulation is low.

Through our proposed Open Outcomes Based Regulation (OOBR), mobile medical apps would be continuously collecting and evaluating data while they’re on the market—with the added bonus of money saved by eliminating pre-market studies. Given that app updates can be pushed digitally at the touch of a button, it could be easy to improve data and function while on the go. In order to keep up with rapidly changing technology, apps and wireless devices need to be equally quick and adaptive to change, and tying up tech with pre-market review and FDA approval processes may not be the best way to go.

The case for “general health” monitors

Fortunately, an example of a step forward comes with the FDA’s motion on fitness trackers. Digital Journal reports that over the next few years, wearable tech for monitoring one’s health will see a huge increase in sales and popularity. These fitness tracking devices will allow individuals to measure their levels of activity, track their heart rates, and adjust their physical lifestyles to improve their overall health.

Although these monitors could fall under the umbrella of healthcare technology that might get tied up in FDA review delays, there’s good news: in 2015, the FDA has made the ruling that it won’t regulate wearable tech—specifically the kind that tracks “general wellness” and is backed by common science. Explains Popular Science: “For example, most experts agree that being active contributes to better overall health, so devices that help you track how active you are — step counters, heart rate measurements, and so on — are kosher.” Not necessarily endorsed by the FDA, mind you, but still a positive move. (Additionally, mobile apps that encourage exercise, track physical activity, or enable an individual to log dietary habits have been placed under enforcement discretion by the FDA—see the full list of app examples here.)

The only concern that the FDA appears to have is if a wearable fitness device makes definite claims that it will cure obesity or prevent certain health problems from occurring. That falls under shady legal territory, as a company cannot definitively say that their wearable tech will improve or cure medical conditions. But for the time being, the FDA seems to be content with letting consumers take their physical health tracking into their own hands. (Popular Science adds that this would change if wearable tech were ever to incorporate an ingestible component, as that would involve standard drug approval and research processes, but until fitness trackers come bundled with packs of vitamins, this possible regulation might be a long time coming.)


When it comes to reviewing products that may affect the health of consumers, the FDA has always taken a “better safe than sorry” approach to testing—including months of market research, case studies, and data collection. However, by making an exception when it comes to fitness trackers, the FDA is showing that it might just be willing to adapt to the swiftly-evolving future of healthcare tech. The progression of technology won’t wait for a review process, and it needs to be quick and easily adapted to whatever situation may arise. Once it’s treated differently than its obsolete predecessors, wireless tech will undoubtedly make leaps and bounds in improving healthcare for people across the world.

How should the FDA be regulating wireless tech in the healthcare sector? Should there be new policies in place, or are you satisfied with the current review process? Let us know what you think in the comments.

About The Author
Robert McCray
Robert McCray
Robert B. McCray is the President & CEO of the Wireless-Life Sciences Alliance, Chairman of Alliance Healthcare Foundation, Special Adviser to TripleTree LLC, Member of Midmark Corporation Board of Directors, Member of Board of Directors of CONNECT and an active adviser to several companies. Rob leverages over 25 years of experience as a business owner, senior operating executive, and legal and transactional adviser to private and public companies. Rob has served as President, COO and an early investor in Digital On-Demand, Inc., a retail services technology company that operates under the brandname RedDotNet in chains including Barnes & Noble, Circuit City, Best Buy, Blockbuster and Fred Meyer.