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Abstract
HIPAA, the Health Insurance Portability and Accountability
Act, is a federal law passed by US Congress in 1996
that requires the establishment of national standards
for electronic transactions, privacy and security of
healthcare information. This white paper highlights
the impact of HIPAA on clinical research activities,
how the HIPAA Privacy rule works in the course of conducting
research, the HIPAA requirements from Business Associate
perspective, transition provisions, and penalties for
non-compliance and key monitoring agencies for HIPAA
compliance.
The HIPAA Administrative Simplification-mandated regulations
of DHHS do not apply directly to life science organizations
(LSOs). Nevertheless, HIPAA’s privacy and security
regulations will have a significant impact on the conduct
of clinical trials by LSOs. The HIPAA Privacy Rule establishes
the conditions under which protected health information
(PHI) may be used or disclosed by covered entities for
research purposes. Research is defined in the Privacy
Rule as, “a systematic investigation, including
research development, testing, and evaluation, designed
to develop or contribute to generali zable knowledge.
To know more about Wipro in HealthScience, go to www.wipro.com/healthscience
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