FDA Now Regulating Mobile Medical & Nursing Apps

In recent years, mobile medical and nursing apps have gained favor from providers and patients alike. The apps are available on a variety of mobile devices and make healthcare more streamlined and easier to understand. With apps to track steps and calories, check heart rates and glucose levels, and monitor chronic health conditions, it’s clear that reliance on the apps will only keep growing.

However, with all of the benefits that are clearly available with the spread of these apps, there are some undeniable downsides. Like with any new trend, development, or invention, not enough time has passed to properly research the effectiveness of the apps and correct any problems. Because the apps are still relatively new, we’re only just starting to identify problems that could arise. These problems are more than simple IT issues. Instead, apps can manipulate data, give incorrect calculations, or improperly manage patient health information.

For example, according to a 2012 report, the pharmaceutical company Pfizer discovered that an app designed to help manage inflammatory diseases was giving wrong information to patients. As a result, Pfizer asked doctors to get rid of the app from devices and review any information and data that they received from the app, as it could be incorrect.

To help reduce the negative impact of improperly working apps, the FDA (Food and Drug Administration) released a guide for how to manage mobile apps. The Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff stipulates the regulation of medical apps that are designed to turn regular mobile devices like phones and tablets into a medical device. This includes apps that manage pacemakers, apps that analyze medical images, or apps that can transform a regular smartphone to act as an ECG machine. These are the types of apps that can cause the most damage if used incorrectly or if they experience some sort of malfunction.

On the other hand, the FDA will remain silent regarding apps that are intended for educational or informational purposes. Medical apps that give advice for managing conditions or that offer helpful tips to patients will generally not result in major issues if something goes wrong. Apps deal with scheduling and health records will not be regulated either.

Some members of the medical field may feel that FDA involvement in medical apps will stifle technological growth in healthcare. However, regulation does not necessarily mean “removal” of the apps. Instead, app users can rest assured that the apps are properly managed so as to avoid any future issues. With the FDA stamp of approval, the app is legitimized, and users can be certain that it will function according to plan. Like vitamins and supplements on the shelves, apps without FDA approval are lest trustworthy and reliable. It doesn’t indicate that they are “bad”, but they aren’t vouched for by the government agency.

FDA regulation will not only ensure safety but will also encourage innovation in the way of medical and nursing mobile apps. In 2013, CBS News revealed some amazing apps that were on the way:

“One app that has been released on the market is SprioSmart. It uses a smartphone’s microphone to take lung measurements of breath capacity. This could help people with asthma, chronic obstructive pulmonary disease and cystic fibrosis check their stats, especially because home testing systems called spirometers can cost up to a few thousand dollars. Researchers at Seattle Children’s and the University of Washington are seeking FDA approval for the app.

Another app and device can reportedly turn a smartphone into a handheld biosensor so people can test their food for allergens. The device, which was developed at the University of Illinois at Urbana-Champaign, uses lenses and filters on a cradle mirror to detect toxins, bacteria, spot water contamination and identify allergens. The smartphone then processes the information. The additional device contains about $200 of optical parts, but may do tests as well as a $50,000 laboratory device can.”

In the few years since these apps have been revealed, there have been quite a few more apps available to patients and healthcare workers. Ranging from fetus growth trackers to period trackers to asthma regulation, mobile apps certainly seem like the way of the future. And with the current FDA involvement in the creation and supervision of said apps, nurses can be sure that these apps will be helpful to them and to their patients.