On July 8, 2010, the Department of Health and Human Services (HHS) published proposed modifications to the Health Insurance Portability and Accountability Act (HIPAA) Privacy, Security and Enforcement Rules (the Proposed Rules) implementing the Health Information Technology for Economic and Clinical Health Act (HITECH) provisions of the American Recovery and Reinvestment Act of 2009.
The purpose of the Proposed Rules is to strengthen the privacy and security of protected health information (PHI) and to clarify the HIPAA rules, but they also contain two key provisions of particular interest to researchers. The adoption of one provision would permit authorizations for future, unspecified research; the other would permit compound authorizations for research-related uses and disclosures of PHI. HHS collaborated with the Office for Human Research Protections (OHRP) to develop the research proposals and will coordinate any changes with the Food and Drug Administration (FDA).
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