Mobile Apps and How They Affect the Medical Device Industry

Mobile health applications, also known as mHealth applications, have been a big topic in 2013. The concept is new, but the FDA has already made plans to accommodate for their existence. Below are the facts and figures circling around the medical device industry.

What are the numbers?

Medical App Numbers

New mHealth apps, ranging from health care Q&A stations to medicine alert programs, have steadily increased throughout the year, but have yet to be fully embraced by consumers. The U.S. iTunes store has approximately 43,000 healthcare apps available. Of those 43,000, the IMS Institute for Healthcare Informatics says only 16,275 are patient-facing apps with “genuine” health content. And among the 16,275, most have limited consumer use, as more than half have fewer than 500 downloads. In fact, five apps account for 15 percent of all mHealth downloads.

However, Allied Market Research has high hopes for the mHealth market, predicting that it will reach $58.8 billion globally by 2020. In 2012, the market was valued at $6.7 billion. The same study expects mobile health applications to bring in $8.3 billion by the end of 2013.

What does the FDA think about mHealth applications?

When any new medical device enters the market, the FDA obviously needs to get involved. According to its website, “The FDA encourages the development of mobile medical apps that improve health care and provide consumers and health care professionals with valuable health information. The FDA also has a public health responsibility to oversee the safety and effectiveness of medical devices – including mobile medical apps.” The administration has already taken steps to help monitor mHealth apps by determining which fall under the category of a medical device and which don’t require FDA registration.

Which applications will be monitored by the FDA?

FDA Monitored Apps

There are a number of mobile apps that the FDA does not plan to regulate because they are not considered medical devices or don’t pose significant risk to users. The applications monitored require oversight because they pose risk to patients.

So far, the FDA has required registration for all apps using sensors connected to ECG equipment, apps using sensors to amplify sounds from electronic stethoscopes and apps that measure physiological parameters used in diagnoses. Applications used to alter infusion pump settings or functions and those that calibrate cochlear implants and hearing aids will also be monitored.

In addition, the FDA will monitor:

  • Apps that connect users to nursing stations in order to display medical device data to mobile platforms.
  • Apps that connect to bedside monitors and transferring patient data to doctors or nurses.
  • Apps that connect to perinatal monitoring equipment to enable remote labor monitoring.

Here is a list with examples of which applications require FDA registration and those that don’t.

How will mHealth apps affect the medical device industry?

These applications have already stuck their feet in the door, but their acceptance around the industry is mixed. Some fear that these applications may give dangerous medical advice, where others see their potential to provide valuable information and resources to the public. Now that the FDA has labeled some as medical devices and has jurisdiction over those that are considered risky, mHealth applications can advance in a safe and innovative matter. Mobile health apps are definitely a trend to follow in the years to come.

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