The lack of such a rule increases clinical risks to patients and costs an estimated $16 billion a year in inefficiencies in the medical supply chain, said the Advancing Patient Safety Coalition, which represents the AMA, AHA, the American Academy of Orthopaedic Surgeons, American Nurses Association, AARP, APIC, Premier and other groups.
OMB review is one of the final steps before publication of the rule, which was mandated in 2007. The FDA sent the proposed rule to ONC on July 11.
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