Food and Drug Administration involve PHI and are therefore subject to HIPAA regulations. For example, sponsored clinical trials that submit data to the U.S. Also, PHI is created in studies that produce new medical information in the course of the research, such as diagnosing a health condition or evaluating a new drug or health device, and that information will be entered into the medical record. However, HIPAA applies only to research that uses, creates, or discloses PHI that enters the medical record or is used for healthcare services, such as treatment, payment, or operations.įor example, PHI is used in studies involving review of existing medical records for research information, such as retrospective chart review.
HIPAA regulations allow researchers to access and use PHI when necessary to conduct research.
Protected health information (PHI) is any information in the medical record or designated record set that can be used to identify an individual and that was created, used, or disclosed in the course of providing a health care service such as diagnosis or treatment. The privacy provisions of HIPAA found in the Privacy Rule apply to health information created or maintained by health care providers who engage in certain electronic transactions, health plans, and health care clearinghouses. The intention of HIPAA is to protect patients from inappropriate disclosures of "Protected Health Information" (PHI) that can cause harm to a person's insurability, employability, etc. HIPAA is the acronym for the Health Insurance Portability and Accountability Act of 1996.
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