![]() ![]() This website focuses on the Privacy Rule, which has special regulations that particularly affect clinical research. The second and third parts concern security and privacy, and protect the confidentiality and integrity of health information. The first, the "Administrative Simplification" provisions, include national standards for transactions of electronic patient health, administrative and financial data between health care providers and health plans. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that was intended to improve the efficiency and effectiveness of the health care system. Who should I contact if I have questions?.Notification of Privacy Practices (NPP).Research Arising from Health Care Operations Activities.Special considerations for Research Databases.Special Considerations for Multi-site Research.What is a Business Associate Agreement and when do I need to have one?.What do I need to know about a subject's ability to revoke authorization?.How does the Privacy Rule affect patient recruitment?. ![]() Research when Authorization is not obtained.Research when Authorization is obtained.Does the study involve Protected Health Information?.Privacy in Research Flowchart (see also printable version).How do Investigators access Protected Health Information in compliance with the Privacy Rule?.How does the Privacy Rule affect research?.What types of research are subject to the Privacy Rule?.What kinds of information does the Privacy Rule Protect?.General Information about the Privacy Rule
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