As the Food and Drug Administration considers regulation of "mobile medical applications," the American Medical Informatics Association is making available a presentation it gave to the agency on how it should approach oversight of mobile clinical decision support systems.
A mobile medical application, according to the FDA draft guidance issued for comment in July, "is a mobile app that meets the definition of 'device' in section 201(h) of the Federal Food, Drug and Cosmetic Act and either is used as an accessory to a regulated medical device or transforms a mobile platform into a regulated device."
AMIA, in a public workshop FDA hosted on Sept. 12-13, cautioned the agency not to focus narrowly on clinical decision support, nor to consider mobile apps in isolation from other delivery methods or contexts.
"CDS are likely elements in all clinical systems, whether implemented on mobile platforms or on tethered workstations," according to AMIA's presentation. "Their safe and effective use will be dependent on the quality of the associated HIT environment, regardless of whether it is running on a mobile device or in a mainframe setting. There still is a need for development and dissemination of best practices for HIT design and implementation, and these will have a major effect on the quality of CDS implementations as well."
The complete presentation, including AMIA's response to specific questions the FDA included in its draft guidance, is available here.
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