FDA Report Says Unregulated Digital Health Tools' Benefits Outweigh Risks

A report by the U.S. Food and Drug Administration (FDA) found that the benefits of digital health tools that are not regulated by the agency outweigh the risks.

FDA Commissioner Scott Gottlieb, M.D., said that there are many digital health products that people are using to track their wellness and health information that are not regulated by the agency. The report touches on tools such as e-prescribing software and mindfulness apps.

The FDA looked at information about the non-device software functions and how the functions impact patient safety.

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“In general, the FDA’s analysis found more benefits than risks to patient safety and health from the use of these digital products,” the FDA said in a release.

The report focused on five types of software functions that are required by Congress: administrative support of a healthcare facility, like e-prescribing software; products that encourage or maintain a healthy lifestyle, like mindfulness apps; certain types of electronic health records (EHRs); certain types of software that transfer, stores or display clinical laboratory tests or other device data and results; and certain types of clinical decision support software, like those that identify drug interactions.

Findings of each function were analyzed in three categories: impact to patient safety, benefits and risks to health and best practices to promote safety, education and competency.

The FDA analysis found a positive association between using e-prescription refills and a change in HIV viral load status. According to the report, another study found that the implementation of store and forward teledermatology within an existing EHR system “improved access to care by decreasing wait time to evaluation, decreased treatment time for skin diseases and increased the percentage of patients referred to a dermatologist.”

There were no direct effects on patient safety when it came to software whose function was to maintain a healthy lifestyle, the FDA found.

One study found that the use of mindfulness smartphone applications was associated with an increase in self-reported mindfulness and an upward trend in positive effects. There was also evidence from a study that suggested a significant increase in activity when people used a daily activity tracker to monitor physical activity. The study reflected a 73 percent increase in steps per day.

Outside experts recommended users be educated on the difference between a health product and a medical device.

Another study found a 30 percent decrease in reported events related to medication errors through the use of EHRs.

Most of the software functions had little to no patient risks, but the FDA and experts still urged patients and consumers to educate themselves on the software and devices they are using.

“While we believe that the benefits of these products generally outweigh the risks to patients, we still encourage consumers and healthcare providers who use these technologies to stay informed about the benefits and risks of these and any digital health products they are considering using or recommending for their patients,” Gottlieb said.

The FDA will continue to update its “Report on Non-Device Software Functions: Impact to Health and Best Practices” every two years.

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