FDA Medical App Guidance Regulates Some Apps, Ignores Others

The FDA’s regulation of medical mobile apps will apply only to apps deemed as “medical devices,” and those in which a malfunction would compromise patient health or safety, a guidance from the federal agency states.

The guidance, issued September 25, 2013, clarifies the types of apps that will be subject to FDA scrutiny, as well as the parties considered responsible for the apps.

Generally, the FDA intends to scrutinize apps based on the app’s intended use, although it also provides exemptions for certain cases. In particular, apps used as an accessory to a typical medical device and apps that transform mobile devices into medical devices would be subject to FDA oversight if they intend to diagnose, cure, treat, mitigate, or prevent disease. Defining factors for such apps include whether malfunctions would compromise patient safety, as well as their advertising, labeling, or marketing materials.

Examples of apps subject to FDA regulation include those providing electrocardiograph or stethoscope capabilities, those used for diagnostic hearing examinations, apps used to measure blood glucose levels, and those used to control medically implanted devices, such as insulin pumps.

The FDA guidance suggests that manufacturers of mobile apps meeting the definition of medical devices follow the existing Quality System regulation for medical devices and initiate corrections to the app quickly. In addition, requirements for medical devices, including control specifications and premarket approval, may apply to certain medical apps, the guidance states.

Contrary to earlier concerns, iTunes’ App Store, Google Play, and BlackBerry App World will not be deemed app manufacturers. Instead, the FDA considers the entities to be app distributors and will not hold them responsible under its guidance. In addition, software developers who are not directly involved in creating the app concept, and are instead employed solely for code creation, would be exempt from FDA scrutiny. Nor would apps created for use solely in a professional practice and apps used specifically for research purposes be subject to FDA scrutiny, providing the apps are not promoted for use outside the practice or outside the research.

Apps designed as medical calculators, medical textbooks, translation services, routine office management aids, note-taking or dictation assistants, or medical exam reviewers are exempt from FDA regulation entirely.

The FDA intends to exercise enforcement discretion with other apps, including those designed for aiding patient self-management; organizing or tracking health information; providing condition information; or documenting, showing, or communicating medical conditions to medical providers. Although apps provide disease diagnosis, treatment, or prevention, they present a lower risk of public harm, the guidance notes.

Medical apps that record blood pressure or blood glucose data and medication adherence apps would fall under the FDA’s enforcement discretion regulation, the guidance states.

University of Arkansas for Medical Sciences College of Pharmacy Professors Lindsey Dayer, PharmD, Seth Heldenbrand, PharmD, and Paul Gubbins, PharmD, conducted a study on medical adherence applications, which was covered in the July edition of Pharmacy Times. Their position, explained in a letter to the editor appearing in the July/August issue of the Journal of the American Pharmacists Association that was e-mailed to Pharmacy Times, supports the possibility of regulating medication adherence apps.

“We believe that apps designated as ‘mobile medical apps’ or those that are designed as decision-making apps should have oversight and that regular app updates are important, especially for these types of apps,” the researchers said. “We also agree that adherence apps should undergo some review process prior to being marketed; currently, however, there [are] no criteria in place for these types of apps.

“Pharmacists need to be aware of this when helping patients select an app for adherence,” the statement continued. “We also believe that pharmacists should be prepared to educate and counsel patients over other types of mobile medical apps. . . We need to accept this new kind of technology and be aware of the many ways in which it can improve patient care.”