«Patients will now have yet another treatment option, one that does not require injections, monitoring lab work, or
special authorization by their insurance company; provided they have adequate coverage to begin with.
In the final rule, we eliminate the
special rules for this category of information and, instead, require covered entities to obtain an
authorization for the use or disclosure of protected health information the covered entity creates for the purpose of research that includes treatment of individuals, except as otherwise permitted
by § 164.512 (i).
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The agreement still needs approval
by Special Master Vincent McKusick, who was appointed
by the U.S. Supreme Court to hear the dispute, but his
authorization is expected promptly.