Wireless/Mobile Apps

AMIA offers guidance to FDA on regulation of mobile medical apps

This week, the American Medical Informatics Association delivered a presentation during an FDA workshop advising the agency on how to approach oversight of mobile clinical decision support systems, Health Data Management reports. FDA’s workshop aimed to spark conversation about the agency’s recent draft guidance on the regulation of mobile medical applications. During its presentation, AMIA recommended that FDA not focus solely on clinical decision support systems or consider mobile health apps independently of other delivery systems. The presentation stated that clinical decision support programs “are likely elements in all clinical systems, whether implemented on mobile platforms or on tethered workstations.” It added, “Their safe and effective use will be dependent on the quality of the associated [health IT] environment, regardless of whether it is running on a mobile device or in a main frame setting.” AMIA also called for the development of best practices in health IT design and deployment, which could “have a major effect on the quality of [clinical decision support] implementations”.

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