HIPAA and the Privacy Rule: What Clinical Investigators Need to Know

In addition to obtaining Informed Consent prior to enrolling subjects in clinical trials, Investigators are now required to obtain written permission from these individuals to use and/or disclose their protected health information for research purposes. This relatively new requirement is a provision of HIPAA entitled Standards for Privacy of Individually Identifiable Health Information or, as it is more commonly known, the Privacy Rule. Physicians involved in clinical research need to be aware of the Privacy Rule, what it intends to accomplish, who is required to comply, exceptions to the Rule, enforcement and penalties for non-compliance. This article summarizes key features and provides practical suggestion for incorporating these requirements into the conduct of studies that are planned, on-going or completed.