Introduction
This section focuses on the legal protection of personal medical information in
the clinical setting and research settings. When this personal medical
information also has public health significance, these laws and regulations
have exceptions that allow the sharing and use of the information to protect
the public health and to maintain vital statistics records. Since most clinical
research depends on the use of the patient's existing medical treatment
records, it is key to understand the legal protections for those records before
introducing the special rules for research. The legal protections for medical
records and the regulations governing their use in research are in the process
of dramatic change. What was once a system of paper records governed by a
mishmash of state laws and very limited overall federal control is moving to an
electronic world regulated by federal law. The key legal change has been
regulations authorized by the
Health Insurance Portability and Accountability
Act HIPAA of 1996 (HIPAA)
.