Human Subjects 

The Privacy Rule, or Standards for the Privacy of Individually Identifiable Health Information, issued by the U.S. Department of Health and Human Services implements the Health Insurance Portability and Accountability Act of 1996. It establishes a set of national standards for the protection of certain health information.

The standards address the use and disclosure of individuals’ health information – called protected health information – by organizations subject to the Privacy Rule (referred to as “covered entities”) for various purposes, including research. It also sets standards for individuals’ privacy rights to gain access to, be informed of, and control how their health information is used.

The Privacy Rule applies to health plans, health care clearinghouses, and any health care provider that electronically transmits health information in connection with certain transactions, which include claims, benefit eligibility inquiries, referral authorization requests, or other transactions for which DHHS has established standards under the HIPAA Transactions Rule.

It is important to note that many research organizations that handle individually identifiable health information do not have to comply with the Privacy Rule because they are not considered covered entities. The Privacy Rule will not directly regulate researchers who are engaged in research within such organizations, even though they may gather, generate, access, and share personal health information. For instance, entities that sponsor health research or create and/or maintain health information databases may not themselves be covered entities, and thus may not directly be subject to the Privacy Rule. However, researchers may rely on covered entities for research support or as sources of individually identifiable health information to be included in research repositories or research databases. The Privacy Rule may affect such independent researchers, as it will affect their relationships with covered entities.

As of April 14, 2003, NSHE, a hybrid covered entity, designated its health care components as follows:

UNLV

  • Dental School and any associated clinics
  • Student Health Center & Pharmacy
  • Student Wellness
  • Center for Individual & Family Counseling
  • Center for Health Information Analysis
  • National Supercomputing Institute

Extensive information about HIPPA is available from the U.S. Department of Health and Human Services. The American Psychological Association also maintains a list of useful FAQs.