Food and Drug Administration involve PHI and are therefore subject to HIPAA regulations. For example, sponsored clinical trails that submit data to the U.S. Also, studies that create new medical information because a health care service is being performed as part of research, such as diagnosing a health condition or a new drug or device for treating a health condition, create PHI that will be entered into the medical record. However, HIPAA only affects research that uses, creates, or discloses PHI that will be entered in to the medical record or will be used for healthcare services, such as treatment, payment or operations.įor example, PHI is used in research 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.
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