The first comprehensive Federal protection for the privacy of personal health information. The Privacy Rule regulates the way certain health care groups, organizations, or businesses, called covered entities under the Rule, handle the individually identifiable health information known as…
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A healthy volunteer is a person with no known significant health problems who participates in clinical research to test a new drug, device, or intervention.
A living individual about whom an investigator conducting research obtains:
data through intervention or interaction with the individual, or identifiable private information.Intervention includes both physical procedures by which data are gathered and manipulations of the…