Enterprise Mobility & Connected Devices Blog

Can the FDA Regulate Mobile Device/ Applications Without Stiffling Innovation and R&D Spend?

The increasing number of smartphones and media tablets deployed to the health care environments, has resulted in an influx of mobile apps targeted for patients and health care professionals. While the success of Apple's iPad is the main driver for tablet deployments in the industry, multiple mobile OSes for smartphones and tablets have also flooded the market. Based on our end-user study that we fielded in 2011, 36.9% of health care respondents stated that their organization has evaluated and decided to deploy media tablets, with an additional 42.3% planning to evaluate. As a result of the rapid mobile device proliferation occuring in the health care industry, the U.S. Food and Drug Administration (FDA) has recently proposed a draft guidance to regulate mobile medical apps. With this proposal, the FDA sought to solicit input on some of the mobile medical apps that may represent a potential risk to patient health in case they do not work as intended.

While the general consensus is that the FDA should be regulating some of the mobile medical apps that are specifically designed and used for diagnosis and clinical treatment purposes; the gray areas that have been identified in the proposal could cause potential disruptions in the industry. The agency encourages the technological advancements and further development of mobile medical apps that can provide health care professionals with highly valuable patient information. Hence, some of the mobile medical apps related to medical devices have already been cleared by the agency prior to the proposal. However, it remains to be seen whether the FDA can actually keep up with the latest developments in mobile technology and ensure patient safety without stiffling innovation and R&D spend.

More information on the impact of the FDA on mobile developments can be found in our Research Note that will be published in the next couple of days. In the meantime, please click here to access our most recent QuickCast  - Taking the Pulse of Mobility in Health Care.


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