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Before HIPAA, no national
standard existed for the protection of a person’s medical information. The
Privacy Rule establishes a minimum level (“floor”) of protection
nationwide. HIPAA does not preempt existing laws but allows the application
of more stringent state laws.
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Seeks to protect the privacy
of individually identifiable health information while ensuring that
researchers continue to have access to medical information necessary to
conduct research
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Before the Privacy Rule,
protection of human subjects in research focused primarily on assuring that
the research project was performed ethically and that the human subjects
participated on the basis of informed consent.
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Common Rule and FDA
Regulations – supplemented by Privacy Rule
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