Which Mobile Health Apps are not Considered Medical Devices by the FDA?

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[This is part three of a three part series. Read part one and part two if you haven't already done so.]

The U.S. Food and Drug Administration (FDA) regulates "mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended." [Learn more about these mobile medical apps regulated by the (FDA) in part one of the series.] The FDA also chooses not to enforce regulatory requirements for apps that the agency deems low risk to patients, even if they would be considered medical devices (part two of the series).

This final article in the series will describe mobile health (mHealth) apps that are not regulated by the FDA because they are not considered medical devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act. That is, the apps are not “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.” Although the apps appear to be low risk (i.e. their malfunction would not directly cause patient harm), the reason they are not regulated is because they are not medical devices.

Apps for general patient education

Mobile apps in this category house or allow patients to access information relevant to their health condition for the purposes of education, raising awareness, and supporting patient-centered care. Examples include:

  • Apps that function as a portal for clinicians to distribute educational materials to patients about their disease and/or treatment
  • Apps that suggest important questions that patients should ask their health care provider
  • Apps that help the patient find nearby health care providers and facilities
  • Apps that inform the patient about specific clinical trials or other resources relevant to their condition
  • Apps that compare costs of drugs at local pharmacies

    Apps that provide electronic access to medical reference materials

    These apps may have general text search functions, but they do not directly facilitate a clinician’s assessment of a specific patient. Examples include medical dictionaries, textbooks, or collections of scientific literature.

    Apps that function as tools for medical education or training

    These apps are more dynamic or interactive than static medical references, but they are not tailored to a specific patient. Apps in this category might provide quizzes, training videos, interactive graphics, or educational games for medical professionals and students.

    Apps that automate general administrative operations in a health care setting

    These apps are somewhat removed from the processes of diagnosing, treating, or preventing disease, but may can play an important role in the day-to-day workflow of a health care facility. Examples include apps that facilitate billing, claims processing, and appointment scheduling.

    General purpose apps used in health care settings

    Examples include apps that record audio, facilitate note-taking, or allow individuals to communicate electronically. They were not designed specifically designed for medical use, but patients or health care providers may choose to use them in health care settings.

    Sources:

    U.S. Food and Drug Administration. What does FDA regulate? Accessed on July 30, 2014.

    U.S. Food and Drug Administration. Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. Accessed on July 30, 2014.

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