4 ways to regulate safety, effectiveness of mobile apps

Throughout the last decade, more than 300,000 healthcare-based, mobile applications have been created for patients to help address specific health issues. However, there’s no way to ensure patients and physicians mobile apps are safe and effective ways to help treat any condition.

In a viewpoint article recently published in JAMA, Brigham and Women’s Hospital and Harvard Medical School physicians David W. Bates, MD, Adam Landman, MD, and David M. Levine, MD, argue the Food and Drug Administration (FDA) should develop regulatory policies that ensure the safety and effectiveness of mobile apps.

“Substantial gaps exist today between what the marketplace is producing in terms of apps and what is needed to make care better,” the authors wrote. “Specific approaches can be taken at the FDA and at federal agencies that support research and encourage redirection.”

The authors suggest the top four issues with mobile applications include: safety, evidence catalogs, interoperability and incentivizing value. Additionally, they suggested the following four major policy solutions to tackle those issues:

  1. Safety of apps must be established so users are protected.
  2. A directory of evidence is needed to allow patients and clinicians to assess which apps work best.
  3. Apps must be able to connect with electronic health records (EHRs) to allow easy, secure transfer of information.
  4. Policies should encourage the market to develop apps that will improve care and value. 

The authors stated a multi-pronged policy approach would not only improve the value of health apps but also provide a more rigorous evaluation of available apps, require the FDA to review the safety, privacy and effectiveness of each app, increase federal support and enhance data exchange.

“The marketplace needs to produce applications that will be helpful to patients and health care organizations, along with the ability to identify them,” the authors concluded. “Apps have enormous potential benefits, but these benefits will not be realized unless these issues are addressed.”