The impact of privacy regulations on clinical research.

The enactment of the Health Insurance Portability and Accountability Act (HIPAA) has garnered significant attention in the health care sector. This legislation represents a major effort to address patient confidentiality and privacy. In general, HIPAA has three goals: first, to create a framework in which protected health information may flow; second, to make it difficult for this information to escape outside the system, and finally, to give patients more control over their medical records and to inform them about how their medical information is used. The effects of HIPAA will impact virtually every aspect of health care. Pharmaceutical manufacturers and biotechnology companies conducting clinical trials or research involving treatment in a covered entity need to be aware of the additional duties that HIPAA imposes on collaborators. This article offers a brief overview of HIPAA privacy rules and the ways in which HIPAA regulations may create obstacles for clinical research efforts, along with initial observations on how research organizations may limit these obstacles.