In the United States, the Health Insurance Portability and Accountability Act (better known as HIPAA) is a first-time enactment into law (effective April 14, 2003) of nationwide privacy and security standards developed by the Department of Health and Human Services and designed to protect individuals' medical records and other identifiable health information (on paper, in computers, or communicated orally).
The HIPAA privacy rule establishes standards to protect the confidentiality of individually identifiable health information, granting new rights to individuals regarding protected health information about them and mandating compliance from health care providers, health plans, and health care clearinghouses. The HIPAA security rule sets standards for the security of protected health information that is collected, maintained, used, or transmitted electronically, requiring that measures be taken to secure this information while in the custody of entities ‘covered’ by HIPAA (health care plans, providers, or clearinghouses) as well as while in transit between covered entities and from covered entities to others. HIPAA's impact on research is related to the privacy and security regulations governing protected health information (PHI) and all procedures necessary to assure compliance with these federally mandated regulations.
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