Food and Drug Administration Safety Innovation Act (FDASIA)
See the following -
CDC on EHR Errors: Enough's Enough
Evan Schuman | Healthcare IT News | July 6, 2014
The Centers for Disease Control and Prevention does not routinely get involved in telling hospitals how to run operations, but with increasing reports of EHR deployment problems, the Atlanta-based operation now sees the need to act.
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Feds Release FDASIA Workgroup Report On Health IT Governance
Diana Manos | Government HealthIT | April 3, 2014
A widely anticipated report from the U.S. Food and Drug Administration and other agencies may finally clear the air on how healthcare IT – and mHealth in particular – will be regulated.
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mHealth Oversight Suggestions Nearing End Of The Beginning
Anthony Brino | Government Health IT | July 19, 2013
The long and winding road to federal regulation or oversight of mHealth still has some ground to cover, but a key Food and Drug Administration Safety Innovation Act sub-workgroup has tentative suggestions that are about three organizational layers removed from the FDA. Read More »
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