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HIPAA Compliance in Clinical Trials

Because this article has no abstract, we have provided an extract of the first 100 words of the full text.

The federal Medical Privacy Rule, authorized by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), limits how covered physicians may use and disclose protected health information (PHI) for any purpose.

The Privacy Rule is complex, especially as applied to research. Academic medical centers (AMCs) have detailed policies and procedures in place to ensure that faculty research meets the rule's requirements. By comparison, community physicians who are unaffiliated with AMCs may have fewer compliance resources.

In this article, I summarize key aspects of Privacy Rule research compliance for readers who are familiar with the rule's basic concepts. This summary . . . [Click for More]