Which Mobile Health Apps Does the FDA Regulate?

Oversight for the safety and effectiveness of mobile health apps

Health care professionals using tablet
Ron Levine/Digital Vision/Getty Images.

[This is part one of a three part series.]

The U.S. Food and Drug Administration (FDA) is charged with protecting public health by regulating and evaluating the safety and effectiveness of health-related products. The FDA regulates items such as:

  • Foods
  • Drugs
  • Tobacco
  • Biologics (e.g. vaccines, blood products)
  • Cosmetics
  • Veterinary products
  • Medical devices (e.g. heart pacemakers, dental devices)
  • Electronic products that emit radiation (e.g. x-ray machines, microwave ovens)

    The FDA’s jurisdiction over medical devices gives it jurisdiction over many mHealth technologies that would qualify as devices. But what about mobile health (mHealth) apps? The rapid proliferation of apps presents a challenge to the FDA. Furthermore, there is concern that FDA oversight threatens to stifle innovation and growth in the multibillion dollar mHealth market. The potential for mHealth to transform health care would be greatly stunted.  

    Yet the concern driving efforts to regulate mHealth is that the field is a wild frontier where millions of users are exposed to unsafe or inaccurate mHealth apps. It is not feasible for an individual health care professional or patient to systematically evaluate the safety and effectiveness of mHealth apps.

    An example of an unsafe medical app came to light in 2011 when the Pfizer pharmaceutical corporation warned that its Rheumatology Calculator app was generating inaccurate scores for evaluating disease activity in patients with rheumatoid arthritis.

    Pfizer removed the app from online stores and urged physicians to delete the app and review any calculations made with the app. However, physicians unaware of the recall may still be using the app and may be making treatment decisions based on inaccurate information.

    In 2013, the FDA issued a nonbinding guidance statement describing how mHealth oversight is applied.

    (Note that the FDA approved some mobile health apps prior to releasing the guidance statement). The document states that the FDA focuses regulatory efforts on "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." The FDA defines these apps as “mobile medical apps.” There are three broad categories of mobile medical apps that fall under agency’s oversight.

    Apps that function as an accessory to a regulated medical device

    The first category includes mobile apps that control medical devices or display, store, analyze, or transmit patient-specific data from medical devices. These apps are considered accessories to (or extensions of) the medical device. Examples include:

    • App that controls inflation and deflation of a blood pressure cuff
    • App that controls the delivery of insulin on an insulin pump
    • App that displays patient-specific medical device data such as EEG (brain waveforms) or medical images

    Apps that transform the mobile platform into a regulated medical device

    The second type of regulated apps are those that essentially transform the mobile platform (commonly a smartphone or tablet) into a regulated medical device through sensors, attachments, or displays.

    Examples include:

    • App that connects to a blood glucose strip reader to transform the phone or tablet into a glucose meter
    • App that connects to electrocardiograph (ECG) electrodes to display, analyze, or store ECG signals on the phone or tablet. The AliveCor Heart Monitor received FDA approval in February 2014.
    • App that connect to sensors to transform the phone or tablet into an electronic stethoscope
    • App that uses the built-in accelerometer in the phone or tablet to monitor sleep apnea or other medical disorders (but not simply to measure physical activity)
    • App that displays x-ray or other radiology images for diagnostic purposes, thereby transforming the phone or tablet into a class II Picture Archiving and Communications System

      Apps that function as medical software

      Lastly, the FDA regulates mobile apps that function as a regulated medical device (software) by conducting sophisticated analyses of patient-specific data to provide patient-specific diagnoses or treatment recommendations. Examples include:

      • App that uses patient-specific parameters to calculate dosage or create a dosage plan for radiation therapy
      • Computer Aided Detection software
      • Image processing software

      Not all mHealth apps fit the FDA definition of mobile medical apps, and thus would not fall under the agency’s review.

      On the horizon

      Just as mHealth continues to evolve, so must the regulatory framework. The challenge is to simultaneously promote innovation, protect the public from unsafe or ineffective mHealth technology, and promote confidence in approved apps. Key issues include postmarketing surveillance, evaluating app updates, and providing the FDA with adequate resources to adapt and implement regulatory policies as mHealth expands in scope and complexity.

      Several initiatives and bills have proposed alternative regulatory frameworks for mHealth apps, such as an approach based more on risk presented to the patient. Dedicated federal groups may be created to regulate mHealth apps. Other thought leaders believe that the best strategy would not rely solely on the FDA, but would also involve unbiased, third party groups to serve as app review organizations.

      [Learn about how the FDA addresses low-risk medical apps in part two of this three part series.]


      AliveCor Receives FDA Over-the-Counter Clearance For Its Heart Monitor. Accessed on July 30, 2014.

      Cortez NG et al. FDA regulation of mobile health technologies. New England Journal of Medicine 2014;371(4):372-9.

      Powell AC et al. In search of a few good apps. Journal of The American Medical Association 2014;311(18):1851-2.

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

      Pfizer UK. Dear Doctor letter: “Pfizer Rheumatology Calculator” iPhone/Android application — important information. Accessed on July 30, 2014.

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

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