Mobile Health Apps That Are Not Considered Medical Devices by the FDA

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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 and on apps that cause Smartphones or other mobile platforms to impact the functionality or performance of traditional medical devices." [Learn more about these mobile medical apps regulated by the (FDA)] 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.

All in all, the agency oversees only a small portion of apps. Some experts have questioned this limited regulatory approach. In Maryland Law Review, Natalie Bilbrough compared the situation to that of dietary supplements. In the early 1990s, following a number of deaths related to supplements, the FDA proposed stricter regulation of dietary supplements. However, they did not succeed and a less stringent regulatory framework persisted.

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 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.

    It is important for consumers to trust their apps and many expect that the FDA should protect us from faulty or inaccurate medical apps. Others, however, argue that innovation and discovery should not be curbed.

    Mobile digital health is a quickly developing market, so many experts suggest close cooperation between different parties to ensure patient safety. The Institute of Medicine also cautions about the over-reliance on apps, especially in people with limited health literacy. Sometimes, being your own advocate and critically examining any app you use can be the best approach.

    Sources:

    Barton A. The regulation of mobile health applications. BMC Medicine. 2012;10(1):46-49.

    Bilbrough N. The FDA, Congress, and mobile health apps: Lessons from DSHEA and the regulation of dietary supplements. Maryland Law Review. 2015;74(4):921-968.

    King J. Building a Mobile Medical App and Understanding FDA Regulatory Requirements. Biomedical Instrumentation & Technology.2015;49(2):99-104.

    U.S. Food and Drug Administration. What does FDA regulate? Accessed on November 14, 2017.

    U.S. Food and Drug Administration. Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff. Accessed on November 14, 2017.

    U.S. Food and Drug Administration. Examples of MMAs that are NOT medical devices. Accessed on November 14, 2017.

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