Digital Health In Brief
This article was originally published in The Gray Sheet
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FDA needs new regulations to establish product classifications for mobile health accessories and software applications that do not fall within existing agency rules, a mobile health industry group urged in a draft proposal document issued Sept. 29.
The medical device and software industries voiced support last week for a July 19 FDA draft guidance that helps clarify the types of mobile software applications that would face FDA regulation.
FDA and Federal Communications Commission officials gave updates last week on guidances and rulemakings they hope will advance the field of wireless health care.