Mobile healthcare, telemedicine, telehealth, BYOD

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Why Mobile Health Applications Require FDA Regulation

By Vera Gruessner

- If a medical device like a pacemaker was to be installed through surgery and hadn’t been thoroughly vetted by the proper agency, what patient would ever allow their doctor to go through with the surgery? It’s likely no such patient exists and healthcare advocates expect all medical devices to undergo the relevant approval process before being marketed to healthcare providers.

Mobile Health Tools

If so, why do consumers continually download and utilize mobile health applications that haven’t undergone due inspection by the Food and Drug Administration (FDA)? Current policies on tracking the safety and benefits of mHealth applications are lackluster in the United States.

The Baltimore Business Journal also considers the reasoning behind why consumers don’t expect more oversight over mobile health applications while no one would ever take any prescribed medications that haven’t been properly vetted by the FDA.

The Journal mentioned that many mobile health applications “lack evidence to back up their claims of improving users’ health.”

“People should have full disclosure over what the app can do,” Dr. Douglas Mogul, a pediatric gastroenterologist at Johns Hopkins, told the news source. “If it’s going to make a claim about health that should be supported.”

Essentially, drugs and medical devices have a significant amount of regulations in the healthcare market via the FDA but mobile health applications do not have the same standards of authorization.

There are some apps that the FDA has more regulation over such as those that are portable devices capable of measuring blood oxygen levels. Mogul continued by explaining that medical institutions and healthcare providers could lead to more effective mobile health applications being out on the market if they test their usability regardless of state or federal regulations.

Consumers would benefit more greatly from using mobile health applications that were developed by medical experts, a healthcare-based society, or at least an institution that created the product with the assistance of medical doctors, according to Mogul.

“From wearable sensors to simple tracking apps, more and more consumers are choosing to use technology to monitor their health and motivate them to engage in health-promoting activities,” the FDA Voice blog reported. “These products, which may count steps, calculate burned calories, or record heart rates and sleep cycles, all have the goal of helping individuals to live a healthy lifestyle.”

“The FDA seeks to advance public health by promoting innovation and development in this area by continually adapting our regulatory approach to technological advances to meet the needs of patients and consumers.”

The New England Journal of Medicine reports that the mobile health market has a variety of barriers for the FDA to overcome, as the agency has mostly focused on whether medical devices are safe and effective among patients. Mobile health applications, however, are on a different platform when it comes to patient safety, as they usually don’t pose nearly as much harm.

Nonetheless, the effectiveness of mobile health applications is vital for consumers to understand, as many may rely on these tools to track their overall health and wellness. Both members of Congress and industry stakeholders have been concerned that an excess of FDA regulation over mobile health applications could impact the market negatively and put a dent into the ongoing innovations within the mHealth space.

The New England Journal of Medicine article goes on to speak on the importance of having regulation over mobile health applications, as the amount of apps and diversification of devices leads consumers and patients to be confused as to the tools’ utility and effectiveness.

Legislation and regulation from the FDA would bring more information on the public health benefits and potential risks of mobile devices and applications. Through FDA regulation, mobile health applications will be able to more strongly support access to healthcare, reduce medical errors, boost patient outcomes, and reduce healthcare costs.


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