Mobile Medical Applications
Summary
On July 19, the FDA released a set of proposed guidelines on the regulation of certain mobile medical applications. Under the draft regulations, only a small number of the apps available on the market would be covered by the draft guidelines. At present, the FDA is seeking to regulate only apps that meet certain criteria. One-third of respondents indicated that the position taken by the FDA puts too much regulation in place. With regard to specific use of apps in the healthcare community, respondents were most likely to report that their organization had developed apps for clinicians. These apps were most likely used to look up information, such as information on clinical guidelines or view patient information. With regard to consumer use, respondents were more likely to develop apps that allowed consumers to get medical information (i.e. identify a rash) or to be able to transmit information to clinicians.
Regulation of Mobile Medical Applications by FDA
While one-third of respondents believe that the level of regulation put forth by the FDA is excessive, more than 40 percent believe that this level of regulation is appropriate. Only six percent believe that additional regulation is necessary.
Audiences for Which an App Has Been Developed
Nearly half of respondents noted that their organization has not developed an app for clinicians, patients or consumers. The audience for which companies were most likely to have developed an app is physicians, followed by non-physician clinicians.
Areas in Which Clinicians Use Apps
Approximately two-thirds of respondents noted that clinicians at their organization use apps to look up information, such as information on clinical guidelines. Half of respondents reported that clinicians use an app to view patient information. Respondents were least likely to note that they refer patients to use apps for health-related purposes.
Areas in Which Organization Manufactures Apps for Consumers
More than half of the respondents in this sample noted that their organization did not manufacture apps for consumers. Those that did were most likely to develop apps that allowed consumers to get medical information (i.e. identify a rash) or to be able to transmit information to clinicians. Each was identified by approximately 20 percent of respondents.
Areas in Which Policy Guides App Use
Twenty-percent of respondents reported that their healthcare organization does not have a policy in place at this time that guides the use of apps. Respondents were most likely to report that their policy dictates use of apps by clinicians to view patient data. They were least likely to report that their policy establishes guidelines surrounding the use of apps by consumers.
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