With an ever-increasing store of health information being developed and collected, consumers need protection. The advancing science of gene therapy poses new challenges to protect the privacy of confidential health information. If gene therapy is to be beneficial in helping to treat and prevent a host of diseases and health conditions, consumers must be assured that their valuable information is protected so that it cannot be used against them in a discriminatory manner (i.e., denial of health insurance or termination from employment). Further, consumers should be fully informed as to how their confidential medical records are to be used-who will have access to them, how will they be distributed. And more importantly, consumers should knowingly consent (opt in) to allow their medical records, which include sensitive genetic information, to be used by outside entities and researchers.