Who Should Ensure the Quality and Safety of mHealth Technology?

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The massive and growing market for mobile health (mHealth) technology currently operates without much oversight or regulation. Given the potential for defective mHealth apps and devices to compromise patient safety, it is important to consider which organization(s) should be expected to evaluate and regulate mHealth technology.

U.S. Food and Drug Administration (FDA)

The FDA is the de facto choice because the agency has already developed and applied a framework for regulating mHealth products.

[Learn about the FDA framework in part one of a three part series.] This is a logical extension of the agency’s mission to protect public health by regulating and evaluating the safety and effectiveness of health-related products. However, there are concerns that the FDA’s framework could be excessively burdensome for some mHealth technologies while too lenient for others.

It is also not clear that the FDA is equipped to regulate the vast mHealth market. In an editorial in the New England Journal of Medicine, Nathan G. Cortez and colleagues call for additional measures to be taken to help the FDA oversee mHealth apps and devices. Key recommendations include:

  • Legislation to preserve and expand the authority of the FDA to regulate mHealth apps and devices
  • Creation of a center or office within the FDA that is dedicated to mHealth technology
  • Additional funding and technical expertise
  • Creation of a “unique approval pathway and postmarketing surveillance system for mHealth products and other types of medical software”

    Independent app review organizations

    At present time, no single organization is able to adequately regulate mHealth products. Rather than rely on the FDA, another approach would involve multiple unbiased app review organizations, as proposed by Adam C. Powell and colleagues in an editorial in the Journal of The American Medical Association.

    The editorial cites examples of how certification entities in other industries  are protecting people from harm.

    Powell also suggests that the Office of the National Coordinator for Health Information Technology could support the development of mHealth app guidelines and formally commission app review organizations. Other helpful measures would be increased training and funding for research focused on evaluation of mHealth products.

    Mobile platform manufacturers

    Manufacturers of mobile platforms (e.g. iOS, Android) also have a stake in the quality of mHealth apps.

    This movement has already begun. Apple has asked some developers to provide documentation or citations of the scientific evidence underpinning their mHealth apps before they are released onto the marketplace. While these demands are not sufficient for ensuring that an app is safe and effective, it is a starting point. It is not clear whether Apple is willing or able to actually verify the sources submitted by developers.

    Others have called for Google to take the same approach.

    ​404.

    Sources:

    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.

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

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