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Human Research Protection Program (RPP) HIPAA and Research at Brown Version Date: 12/03/2018 I.HIPAA and Research at Brown A. The Health Insurance Portability and Accountability Act of 1996 (HIPAA)
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HIPAA and research forms are required by individuals and organizations involved in healthcare and medical research.
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Healthcare providers, researchers, patients, and study participants are some examples of who may need these forms.
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HIPAA (Health Insurance Portability and Accountability Act) is a U.S. law designed to provide privacy standards to protect patients' medical records and other health information. Research at refers to regulatory requirements related to conducting research under HIPAA regulations, ensuring that protected health information (PHI) is handled properly during research activities.
Entities that handle protected health information, such as healthcare providers, health plans, and healthcare clearinghouses, are required to file under HIPAA. Researchers that utilize PHI for their studies must also comply with HIPAA regulations and file appropriate documentation related to their research activities.
To fill out HIPAA and research-related documentation, researchers must identify the relevant forms, accurately provide information about the study, ensure compliance with privacy requirements, obtain necessary consents, and submit the forms to the designated institutional review board (IRB) or regulatory body.
The purpose of HIPAA is to ensure patient privacy and security regarding health information. In research, HIPAA regulations aim to protect patients while allowing for the necessary use of their health data for studies that may contribute to medical knowledge and public health.
Information that must be reported includes the nature of the research, type of data being collected, how PHI will be used and safeguarded, participant consent, and IRB approval or exemption status.
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