| Before the advent of the electronic medical record, the majority of people assumed their medical information was private and confidential. In today's world, many more people have access to medical information for various reasons---primary care, medical research, health insurance claims, court cases, etc. This greater access and sharing of information allows greater risk of lapses in confidentiality.;This thesis explored the federal legal protection of medical health information as it relates to medical health research by means of examining various laws and congressional acts, and guideline, and how these apply to confidential medical information. Court cases were also examindd to reveal how lapses in confidentially do occur, and the effects of these lapses on the individual.;This thesis also looked at who holds medical health information, and for what purposes it is held. As the medical industry continues to expand, more and more information is released to third, or fourth, parties for various reasons. The more information is released to additional parties; the chances for lapses in confidentiality increase exponentially.;Identifiability and consent are also explored in this thesis. Identifiability refers to the ability to recognize a health study participant based on the health data itself. Consent refers to the authorization for the collection and use of personal health information. These two aspects are difficult to standardize and monitor. However, each should be thoroughly considered before any research begins.;Further, the role of Institutional Review Boards (IRBs) in relation to medical research is explored. An IRB is the group responsible for ensuring that proposed research complies with the federal government's regulations to protect human subjects in research. Although an IRB monitors medical research sponsored by the federal government, it has no role in non-federal sponsored medical research. While some medical research organizations apply the same standards to both federal and non-federal research, they are not required to do so. Many medical research organizations apply different rules and standards applied to federal and non-federal research.;Analysis of the information revealed that the laws on the books are open to wide interpretation and various lever of enforcement. There is no one overall guiding principle for the protection of health information used for medical research. The federal government provides loose guidelines to protect confidential information, however, these guidelines are interpreted, applied, and enforced differently by each state.;In order to better protect the confidentiality of medical information as it is used for research, a number of steps should be taken. Accountability needs to be ensured. Consents need to be truly informed, specific, and voluntary. Individuals need to be educated about policies, practices, rights, and responsibilities. Technology should be invoked as a solution for protecting medical information. Medical research needs to be guided. Finally, legislation should provide equally high levels of confidentiality protection for all personally identifiable health information. |
