The Department of Health and Human Services (DHHS) issued the HIPAA "Privacy Rule," on August 14, 2002 (http://www.hhs.gov/ocr/ ). This federal regulation governs the protection of individually identifiable health information. The Rule was enacted to increase the privacy and confidentiality of health information on identified individuals, and to regulate known and unanticipated risks to privacy that may accompany the use and disclosure of such information.
HIPAA applies to all of the CHTN institutions that supply tissues and patient information to you as an investigator and all CHTN divisions must follow their institutional policies. The Privacy Rule does not apply to specimens per se, but does apply to some of the health information that may be provided with the specimen. The CHTN has always protected the identity of patients from whom specimens are obtained. However, the Privacy Rule imposes new requirements on the use of information associated with the specimens. In order to meet the requirements of the Privacy Rule for providing specimens with associated data, the CHTN implemented a Data Use Agreement. The Data Use Agreement will permit you to receive tissue and associated patient information from any division of the CHTN from which such data is available. Because the CHTN Western Division, based at Vanderbilt University, only supplies anonymized, de-identified patient information, they are not listed in the agreement.
Investigators who require patient information beyond that routinely provided or clinical outcome data must inform the CHTN at the time that tissues are requested. This is necessary because of CHTN operating procedures and local IRB requirements for protecting human subjects and patient privacy and confidentiality. As a result of HIPAA regulations, some Divisions may apply more stringent requirements for obtaining such information. Similarly, local requirements for protecting patient privacy and confidentiality may limit the ability of some CHTN divisions to obtain copies of pathology reports for samples previously shipped.