In Reply: Dr Tilden speculates that HIPAA Privacy Rule regulations make epidemiologic research more burdensome due to malalignment with the IRB process. First principles suggest that the initial step in resolving the problem that the HIPAA Privacy Rule may impose on research is to assess the problem's scope and degree. In the study survey, more than two-thirds of epidemiologist respondents reported that the Privacy Rule has made research substantially more difficult by adding cost and delay to study completion. More than half identified a “most affected” protocol. Moreover, the Privacy Rule was felt to have a more negative than positive influence on human subjects' protection. Thus, epidemiologists indicated that the scope of the problem is broad and the degree serious.
Ness RB. Health Research and the HIPAA Privacy Rule—Reply. JAMA. 2008;299(11):1259-1260. doi:10.1001/jama.299.11.1260-a