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How the HIPAA privacy rule affects UNT researchers

The arrival of the HIPAA Privacy Rule in April will restrict, but not eliminate, researchers' access to patient health data needed to conduct research at UNT. This column answers some basic questions about the new rule.

What is the privacy rule?

The privacy rule is a regulation issued by the U.S. Department of Health and Human Services to implement privacy protections included in the Health Insurance Portability and Accountability Act (HIPAA). The deadline by which UNT must be compliant with the privacy rule is April 14, 2003.

Who is covered by the privacy rule?

The privacy rule directly applies to three categories of health care entities called "covered entities." The covered entities are health plans, health care clearinghouses and health care providers. Researchers are not directly regulated unless they treat patients or work within the covered entities. However, many researchers rely on covered entities to provide them with health information needed to conduct their research. The privacy rule limits the disclosure and use of individually identifiable health information, which is generally defined as information relating to the physical or mental health or condition of an individual, the provision of health care to an individual, and payment for such care.

After HIPAA, how can UNT researchers access health information to conduct research?

The following are the primary options available:

  1. Use of a written authorization signed by the patient
  2. Removal of 18 personal identifiers, including address and Social Security number, from an individual's health information as specified by the privacy rule
  3. Use of a "limited data set," which includes some of the 18 personal identifiers, such as date of birth or zip code, but which still protects the privacy of the individual by removing most identifiers
  4. Conducting of preparatory work for a research project with visual review only
  5. Use of health information of deceased persons
  6. Use of an approved waiver of authorization to access necessary data and records under certain circumstances by the UNT Institutional Review Board

How can I learn more about the privacy rule?

If your research involves the use of such health information, contact me at bherndon@unt.edu to obtain more detailed information.

Boyd Herndon is the research compliance coordinator in the Office of Research Services.

   

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