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Final medical app guidance issued by FDA
Healthcare IT News: The FDA has issued its final guidance for mobile medical application developers, committing to limited regulation for most health and wellness apps while applying risk-based standards to diagnostic and quasi-medical device apps. The FDA will implement “enforcement discretion,” under the Federal Food, Drug & Cosmetic Act, for the majority of mobile apps “as they pose minimal risk to consumers,” the agency announced in a recent press release. Included are apps helping patients self-manage their disease or conditions “without providing specific treatment or treatment suggestions,” such as for tracking exercise and diet, automating health tasks or communicating with providers via EMRs.
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