FDA Seeks to Standardize Regulation of Mobile Medical Apps

Stethoscope on cellphone
Stethoscope on cellphone
Appropriate and standardized regulation of mobile medical applications may enable faster adoption and integration of these technology platforms in the health care environment

Appropriate and standardized regulation by the US Food and Drug Administration (FDA) of mobile medical applications may enable faster adoption and integration of these technology platforms in the health care environment, according to a viewpoint article by FDA researchers in JAMA.1 Efficient regulation of medical apps, as argued by the FDA, may lie in customizing regulation efforts to apps’ benefits and risks.

Integration of mobile medical apps into healthcare systems has been increasing, mostly in response to the overwhelming development of medical software designed to overcome the siloed nature of health care and improve patient-centered data collection. Concerns regarding whether these apps are safe or effective have resulted in greater governmental scrutiny, particularly by the FDA. Many healthcare professionals question whether the FDA should play a wider role in regulating and approving medical apps prior to use within large-scale health systems.

A guidance document released by the FDA in February 2015 states that not all medical apps are required to undergo agency regulation.2 Only those “that are intended to treat, diagnose, cure, mitigate, or prevent disease or other conditions as medical devices” are subject to the FDA regulation process. The current regulatory framework relies on a risk-based approach, ensuring that approved devices are not only effective, but also safe for the intended consumer/patient. Collection of data such as adverse events and clinical efficacy prior to a premarket FDA submission are necessary for some low- as well as medium- and high-risk apps and devices.

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The long-standing FDA regulatory framework of medical devices may not be fully applicable to today’s medical apps, however, and rigid adherence to these rules may result in stifled innovation and access to apps that are highly effective for their intended audience. A working group comprised of regulators led by the agency has been established to create new framework policies for mobile software apps, policies which are designed to meet the needs of both patients and clinicians.

In addition to improving safety, improved FDA regulation of medical apps “could encourage greater integration of apps with electronic health records, potentially allowing clinicians and patients to better manage complex health conditions based on near real-time feedback loops documenting patients’ feeling or function.”


  1. Shuren J, Patel B, Gottlieb S. FDA Regulation of mobile medical apps. JAMA. 2018;320(4):337-338.
  2. US Food and Drug Administration. Mobile Medical Applications: Guidance for Industry and Food and Drug Administration Staff. https://www.fda.gov/downloads/MedicalDevices /DeviceRegulationandGuidance /GuidanceDocuments/UCM263366.pdf. Published February 9, 2015. Accessed August 22, 2018.

This article originally appeared on Medical Bag