HIPAA transition: challenges of a multisite medical records validation study of maternally linked birth records.

Numerous researchers have expressed concern over the impacts on medical records availability of the newly effective Medical Information Privacy rule, as authorized by the Health Insurance Portability and Accountability Act (HIPAA). The increased costs associated with compliance with the rule, and the increased potential for financial liability, raises the possibility that hospitals may be less likely to participate in such research, resulting in a decrease of the validity of multisite studies designed to represent an entire population. Our multisite medical record validation study, designed to assess the accuracy of maternally linked birth records, provides an overview of a number of HIPAA implementation challenges. We found that the new HIPAA rule presents new challenges for those who rely on the release of medical record information for epidemiologic research. At the very minimum, increased compliance costs associated with human subjects protection and increased administrative burden for researchers would seem to be inevitable as medical institutions address the requirements of the new HIPAA rule by instituting more complex and thus more cumbersome procedures. Researchers should anticipate increased costs and plan accordingly when budgeting for human subjects review processes.