HIPAA's Privacy Regulations: Increased Privacy Comes at a Cost

Deeb Salem, MD


September 24, 2003

In This Article

Impact on Clinical Research

A less-often mentioned (but equally important) aspect of the HIPAA privacy rules is their effect on clinical research. Until recently, the Federal Policy for Protection of Human Research Subjects (the "Common Rule") was the only major regulatory framework for federally sponsored research using human subjects. Briefly, the rule mandates that institutional review boards (IRBs) protect participant confidentiality.

HIPAA's regulations imposed complex new rules that could slow the progress of clinical research at some institutions. Kulynych and Korn[5] articulated 1 reason why such a delay could occur. "It becomes a daunting task for covered entities to create "de-identified" data sets that may be disclosed without patient authorization or further legal restriction. This particularly acute for health research...." The authors also state that "to complicate matters further, the Rule is ambiguous about the status of IRBs...and thus, it is uncertain whether the covered component of an institution may share PHI [protected health information] with an IRB for purposes of reviewing a research protocol. . . . As a result, AHCs [academic health centers] have spent hundreds of faculty hours on HIPAA implementation plans and committees and untold thousands of dollars on legal and consultant services."[5] The authors conclude that HIPAA is "a significant hindrance to health research."

Califf and Muhlbaier[6] estimated that a research center "could require adapting to greater than 100 different interpretations of HIPAA," but conclude that they are "optimistic that we will find our way out from under the current oppressive burden of HIPAA."


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