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A mobile medical application, according to the FDA draft guidance issued for comment in July, "is a mobile app that meets the definition of 'device' in section 201(h) of the Federal Food, Drug and Cosmetic Act and either is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."

Register or login for access to this item and much more

All Health Data Management content is archived after seven days.

Community members receive:
  • All recent and archived articles
  • Conference offers and updates
  • A full menu of enewsletter options
  • Web seminars, white papers, ebooks

Don't have an account? Register for Free Unlimited Access