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Committed to our community and the future of health care |
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| The U.S. Health Insurance Portability and Accountability Act of 1996 (HIPAA) was enacted to help protect the privacy and security of health care information. Under HIPAA, certain healthcare groups, called “covered entities,” are regulated as to how they handle personal and identifiable health information, called “protected health information” or PHI.
The HIPAA Privacy Rule limits the release of PHI without a patient’s knowledge and consent. PHI must also be more carefully secured and handled under HIPAA security requirements.
A covered entity is any health care provider or business that electronically transmits health information in connection with transactions related to the U.S. Department of Health and Human Services (DHHS). Personal health information that has been de-identified (removal of all personal identifiers) can be used or disclosed without restriction or further patient consent under HIPAA.
The Privacy Rule does not apply to all research and researchers; research physicians who are also health care providers and who are covered entities, however, must comply with HIPAA.
Novara Clinical Research is not a covered entity; however, the security and confidentiality of your personal health information is very important to us, and many of the groups with whom we work are considered covered entities. For this reason, we require your written authorization for release of any health information about you or on your behalf. Specifically, all of our consent forms will request your authorization for the use of your health information, and will describe the research uses and disclosures of your PHI and your rights as a research subject in that clinical trial.
The following is an example of language you would see in a consent form to describe how your personal health information would be used and disclosed in a research study, as required under the HIPAA Privacy Rule: |
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The study doctor will get your personal and medical information. For example:
- Past and present medical records,
- Research records,
- Records about phone calls made as part of the research,
- Records about your study visits, study tests, or other procedures.
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The study doctor and the study staff. |
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- The sponsor of the research,
- The U.S. Food and Drug Administration (FDA),
- Department of Health and Human Services (DHHS) agencies,
- Governmental agencies in other countries,
- Governmental agencies to whom certain diseases (reportable diseases) must be reported, and
- An institutional review board with oversight for the study.
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- To do the research,
- To study the results, and
- To make sure that the research was done right.
If the results of this study are made public, information that identifies you will not be used. |
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Then you will not be able to be in the research study. |
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Yes, but only after the research is over. |
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Yes, but this permission will not stop automatically.
You may withdraw or take away your permission to use and disclose your health information at any time by sending written notice to the study doctor. If you withdraw your permission, you will not be able to stay in a study.
When you withdraw your permission, no new health information identifying you will be gathered after that date. Information that has already been gathered may still be used and given to others. |
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There is a risk that your information will be given to others without your permission. |
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| Additional information about HIPAA and how the Privacy Rule relates to research can be found on the following websites-
General information regarding HIPAA can be obtained at the following
website: http://www.hhs.gov/ocr/hipaa/
Specific information regarding HIPAA as it pertains to research is available on the following
website: http://privacyruleandresearch.nih.gov/
Information regarding HIPAA and research participants is available at:
http://privacyruleandresearch.nih.gov/hippaprivacy/HIPAA.pdf |
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