Mobile healthcare, telemedicine, telehealth, BYOD

Policy News

Mobile Health Applications Lack Oversight from Experts

By Vera Gruessner

- The development and utilization of mobile health applications seems to lack oversight from either federal agencies or public health experts. For instance, research published in the Obstetrics & Gynecology journal shows that very few women’s reproductive mobile health applications were studied and approved by reproductive health experts. Sufficient evaluation of these particular mobile health apps is missing.

Mobile Health Applications

Additionally, more than one-third of these mobile health applications lack reviews by consumers, according to an infographic. The results of the study show that only 12 percent of apps had health expert involvement during the design process and 22 percent had mediocre functionality due to an error. Through better descriptions, increased labeling, and categorization, these mobile health applications for tracking women’s reproductive cycle could help consumers find a needed tool more quickly.

According to the Journal of the American Medical Association, one of the most challenging aspects of mobile health development is that design and release of medical apps is moving much faster than the approval and oversight of this market.

“The literature is not keeping up with the products on the market,” stated Dr. Joyce Lee, an Associate Professor of Pediatrics at the University of Michigan Medical School.

Additionally, very few mobile health applications and devices have been tested in clinical trials. There is also a large influx of mobile health tools in the market right now and many consumers are unaware of which ones are truly beneficial to their care and which will possibly impede or confuse their efforts toward improved health and wellness.

A health policy brief released by the Robert Wood Johnson Foundation states that mHealth developers will be looking toward the Food and Drug Administration (FDA) to provide necessary guidance in designing mobile health applications for years to come.

“The influx of applications pose challenges to the federal agencies responsible for regulating health-related products. This is particularly true for the Food and Drug Administration (FDA),” the brief states. “The agency must ensure that certain mobile health apps—specifically those considered to be medical devices—are demonstratively safe and that the apps do as the companies who make them claim.”

Guidance from the FDA has stated that it plans “to apply its regulatory oversight to only those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.”

This could be a problem for the ongoing influx of mobile health applications within this field, as there is clearly a lack of oversight when it comes to developing and designing these tools. In the case of women’s reproductive health apps, it could be problematic if the tools are inaccurate and make it more difficult for women to become pregnant. Even with fitness trackers, if there are functionalities that provide the wrong information, consumers may not be taking part in enough exercise to combat their particular medical conditions.

Through increased vigilance, regulation, and oversight by both federal agencies and public health experts, mobile health applications could become even more useful toward improving wellness across the nation.


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