Press Release

Embargoed Until Contact

December 05, 2013

Sue Ducat
Director of Communications
(301) 841-9962


mHealth and FDA Guidance


Bethesda, MD --A new Health Policy Brief from Health Affairs and the Robert Wood Johnson Foundation explores the promise and challenges surrounding Mobile Health, or mHealth: the use of smartphones, tablets, and other mobile and wireless devices in public health. Mobile Health provides consumers greater personal control over their health care, and can help physicians provide day-to-day medical care in regions where access to care is often not widely available. The benefits of Mobile Health can also create problems for regulatory agencies tasked with ensuring that these devices are both safe and effective. Guidance is needed for companies making and selling mHealth apps so that they know when regulations apply and how to comply when introducing new products into the health care market.


Topics covered in this brief include:


  • What's the background? There are two types of mHealth apps: those used by consumers to make appointments and track their own health status; and health care-operated apps, used by clinicians, for a variety of functions, from making electronic medical records accessible to monitoring patients' vital signs. While consumer apps will not be regulated by the Food and Drug Administration (FDA), that agency will regulate apps classified as medical devices if they pose some potential risk to consumers. As technology rapidly evolves, the potential transformation of smartphones and tablets into medical devices underscores the need for more regulatory oversight.

  • What's the debate? In September 2013 the FDA issued final guidance on mobile medical apps. This issue has provoked considerable debate. The mHealth Regulatory Coalition, which represents industry stakeholders, pushed for more rapid and more clearly defined guidance, while another group led by Athena Health, pressed the FDA to withhold formal guidance until a congressionally mandated health IT framework is submitted in January 2014. To date, there are no formal laws or regulations governing the use of mHealth apps.

  • What's next? The FDA's report outlining a broad framework for health IT regulations must be submitted to Congress by January 2014. If the agency follows an FDA workgroup's final recommendations, the framework will emphasize innovation, patient safety, and efficient regulation. These recommendations are also likely to help the FDA to form guidance for clinical decision support application software and provide details omitted from its September guidance.
About Health Affairs

Health Affairs is the leading journal at the intersection of health, health care, and policy. Published by Project HOPE, the peer-reviewed journal appears each month in print, with additional Web First papers published periodically and health policy briefs published twice monthly at Read daily perspectives on Health Affairs Blog. Download weekly Narrative Matters podcasts on iTunes.