Benefits of Unregulated Digital Health Tools Outweigh Risks, FDA Says


Posted January 3, 2019

The benefits of many digital health tools that are not regulated as medical devices outweigh their risks. That’s according to a new report published by the Food and Drug Administration (FDA).

As part of the 21st Century Cures Act, the FDA is mandated to study five kinds of software functions that are excluded from the definition of a medical device—thus exempting them from FDA regulation. Such software:

  • Provides administrative support to a healthcare facility (e.g., software that sends prescriptions from a pharmacy)
  • Helps maintain or encourage a healthy lifestyle (e.g., mindfulness apps)
  • Serves as electronic patient records but does not interpret or analyze these records
  • Transfers, stores, converts formats, or displays data (e.g., displaying clinical laboratory test data)
  • Provides certain types of clinical decision support (e.g., identifying drug interactions)

According to the FDA’s Report on Non-Device Software Functions: Impact to Health and Best Practices – December 2018, unregulated digital health tools improve clinical outcomes, promote physical activity and weight loss, increase behavior that would lead to greater medication adherence, provide evidence of better self-management of chronic conditions, and reduce patient safety events or medication errors.

During its analysis, the FDA did find some examples of potential risks. These included three reports of malfunctioning e-prescription software that may have resulted in a missed dose or the wrong patient receiving the medication, one instance of a software bug in clinical decision support software that could have resulted in an incorrect medication dose calculation, and some incidents where electronic health record usability issues contributed patient harm (comprising 0.03% of events evaluated in the Pennsylvania Patient Safety Authority database).

“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,” said FDA Commissioner Scott Gottlieb in a statement. “Moving forward, the FDA will continue to update this report to ensure the agency is striking the right balance in our approach to digital health.”

To compile its report, the FDA drew upon peer-reviewed literature, adverse event report databases, and public input, well as expert interviews. The 21st Century Cures Act requires the publication of additional reports every two years to continue evaluating the risks and benefits of these non-device software functions. The next report will include research and evidence published after July 31, 2018.

In addition, the FDA said it is planning to provide more detail about its Digital Health Software Precertification Program (Pre-Cert) for technologies that fall under the agency’s regulatory purview in the coming weeks. That program, currently in a pilot phase, is intended to streamline the premarket review of software as a medical device.