Mobile healthcare, telemedicine, telehealth, BYOD

Policy News

Poor Regulatory Framework Challenges Mobile Health Industry

By Vera Gruessner

- The mobile health industry has undergone profound transformations over the last decade, as it continues to forge a new path for the medical industry and play a role in reforming the regulatory landscape. While there have been a multitude of successes throughout the mobile health industry, there have also been several challenges that healthcare providers and lawmakers continue to address.

Mobile Health Applications

The American Enterprise Institute (AEI) states that the Food and Drug Administration (FDA) is not taking part in defining what mobile health apps should be regulated, which agencies or experts should be handling the regulations, and how to enforce the correct actions.

This type of inaction could lead to a delay in the product coming to market. These challenges need to be overcome by including more regulation and oversight from the FDA and other regulatory agencies throughout the country.

However, the FDA can assist the mobile health industry in making headway in patient care, better outcomes, and more data capabilities by developing a more cohesive regulatory process and promoting innovation within this particular field.

There are a wide variety of medical uses that mobile health applications sustain such as asthma detectors, glucose monitoring tools, and even portable stethoscopes, according to AEI. The publication also mentions that nearly 80 percent of smartphone users are interested in portable health devices. The mobile health industry could also potentially lower the skyrocketing costs of healthcare.

“Imagine you suffer from high blood pressure and are required to take medicine twice a day. As you prepare to take your medication, you grab a small electronic device and swallow it alongside your pills,” the AEI stated.

“Powered by your stomach fluids, this sensor tracks the effects of the pill on your body and relays it to your iPad, where the information is presented to you in an accessible form. The information is seamlessly transmitted to your doctor’s computer, through which you can easily review it during your next visit. While this invention may have belonged in a futuristic novel a decade ago, it is now a reality thanks to the incredible advances made in mobile health over the last five years.”

In 2012, the Federal Communications Commissions (FCC) loosened its licensing rules to offer simpler testing of mobile health devices. The Office of the National Coordinator for Health IT (ONC) has also helped the mobile health industry by magnifying the assistance from other regulatory agencies.

The FDA is set to review a number of mobile health products and applications in 2015, according to a pwc report. At this point in time, the FDA has approved more than 100 mobile health products over the last decade.

The mobile health industry offers a variety of complex apps and devices that can monitor a range of different symptoms and conditions including glucose levels, heart rate, or blood pressure. Mobile health developers will need to know whether their products need regulatory review and may need to work with the FDA to receive approval before bringing certain devices or applications to market.

One of the key aspects of tools that the FDA looks at before deciding to approve a product or not is whether the applications’ “functionality could pose a risk to a patient’s safety if the mobile app were to not work as intended.”

The government agency is also expected to publish more information on which devices and applications will need to be reviewed and obtain approval before making it to market in the mobile health industry. While the FDA approval process is costly, regulatory approval may make a product more trusted, which is useful for creating strong and sustainable revenue models.

The challenges within the mobile health industry often stem from a lack of a regulatory framework but currently federal agencies are working on addressing these problems and ensuring a stronger future for mobile health applications and devices. The transforming market has shown past successes and is poised to take on more accomplishments.


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