A legislative showdown is brewing between Congress and the U.S. Food and Drug Administration over the right balance between promoting innovation in a fledgling mobile health industry and protecting patient safety. 2014 could be the year that several laws are passed with significant implications for health I.T., according to a HIMSS14 panel discussion on congressional affairs.
"You have the FDA rule that came out in 2013 which basically said they will regulate mobile apps as a medical device if they see fit. So, that is a cause for some concern," said Mitchell Vakerics, Legislative Counsel for Congresswoman Renee Ellmers (R-N.C.), who sits on the House Energy and Commerce Committee where she serves on the Health, Communications and Technology Subcommittee.
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