The HIPAA Privacy Rule provides federal protections for individually identifiable health information held by covered entities and their business associates and gives patients an array of rights with respect to that information. At the same time, the Privacy Rule is balanced so that it permits the disclosure of health information needed for patient care and other important purposes.
The Security Rule specifies a series of administrative, physical, and technical safeguards for covered entities and their business associates to use to assure the confidentiality, integrity, and availability of electronic protected health information. BIG has completed a HIPAA Risk Assessment using the ISAAC HIPAA tool against our databases, internal procedures and work processes. We strive to keep our security practices aligned with federal requirements and university policies in regards to protecting PHI data.
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. HIPAA regulations allow researchers to access and use PHI when necessary to conduct research. 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.
For example, PHI is used in research studies involving review of existing medical records for research information, such as retrospective chart review. 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. For example, sponsored clinical trails that submit data to the U.S. Food and Drug Administration involve PHI and are therefore subject to HIPAA regulations.
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