FDA to Release Mobile Health Application Guidance

FDA to Release Mobile Health App Guidance by Oct, 1, 2013Final Mobile Health Guide Expected by Oct. 1

Last week the Committee on Energy and Commerce (E&C) concluded three days of hearings discussing the role of technology in healthcare, and specifically mobile health applications. The hearings resulted in part from a letter sent by committee leaders on March 1, 2013 to FDA Commissioner Margaret Hamburg seeking more information on possible FDA regulation of smartphones, tablets, and mobile apps.  The Hearings were broken down as follows:

  • On Tuesday the technology subcommittee discussed how consumers use existing health and fitness apps
  • On Wednesday the health subcommittee examined how health care practitioners and patients use health apps for diagnoses
  • On Thursday the oversight and investigation subcommittee heard from the FDA and HHS officials including Dr. Farzad Mostashari, National Coordinator of Health Information Technology.

In testimony provided by the Food and Drug Administration (FDA), statement was made of plans to issue final guidance about how the FDA will regulate medical mobile health apps. Christy Foreman, director of the office of device evaluation in the FDA’s Center for Devices and Radiological Health, said the FDA is finalizing the guidance and expects to release it before the end of the government’s fiscal year (October 1, 2013).

The FDA first issued draft guidance in 2011 but a final release has since been delayed. Some mobile health apps have received FDA clearance in recent years but the vast majority currently on the market have had no federal oversight.

Foreman made her prepared marks for testifying available, saying:

The widespread adoption and use of mobile technologies is opening new and innovative ways to improve health and health care delivery. Mobile applications(mobile apps)—software programs that run on smartphones and other mobile communications devices—can help consumers manage their own health and wellness, promote healthy living, and gain access to useful information when and where they need it. Not surprisingly, these tools are being adopted almost as quickly as they can be developed…

FDA believes it is important to adopt a balanced, approach to mobile medical apps that supports continued innovation, assuring appropriate patient protections. We also recognize that mobile health application developers and manufacturers need a clear, predictable, and reasonable understanding of the Agency’s expectations…

FDA recognizes the importance of implementing a balanced, transparent approach that fosters the development of health IT solutions and innovative products like mobile medical apps, while ensuring appropriate patient protections. Like traditional medical devices, mobile medical apps may in some cases present significant health risks to patients. FDA seeks to strike the right balance by providing a risk-based, focused approach to the oversight of a small subset of mobile medical apps that present a potential risk to patients if they do not work as intended. Consistent with this balanced approach, FDA would not regulate the sale or general consumer use of smartphones or tablets…

Foreman also wrote about the FDA’s position on regulation of mobile health technology on the FDA.gov blog.  Read her Keeping Up With Mobile App Innovation.