Comment: Numerous commenters questioned the methodology used to estimate the systems compliance cost and stated that the ensuing cost estimates were grossly understated. Some stated that the regulation will impose significant information technology costs to comply with requirement to account for disclosures, additional costs for hiring new personnel to develop privacy policies, and higher costs for training personnel.
Response: Significant comments were received regarding the cost of systems compliance. In response, the Department retained the assistance of consultants with extensive expertise in health care information technology. We have relied on their work to revise our estimates, as described below. The analysis does not include "systems compliance" as a cost item, per se. Rather, in the final analysis we organized estimates around the major policy provisions so the public could more clearly see the costs associated with them. To the extent that the policy might require systems changes (and a number of them do), we have incorporated those costs in the provision's estimate.
Comment: Items explicitly identified by commenters as significantly adding to systems compliance costs include tracking disclosures of protected health information and patient authorizations; restricting access to the data; accommodating minimum disclosure provisions; installing notices and disclaimers; creating de-identified data; tracking uses of protected health information by business partners; tracking amendments and corrections; increased systems capacity; and annual systems maintenance. The commenters noted that some of the aforementioned items are acknowledged in the proposed rule as future costs to covered entities, but several others are singularly ignored.
Response: The Department recognizes the validity of much of this criticism. Unfortunately, other than general criticism, commenters provided no specific data or methodological information which might be used to improve the estimates. Therefore, the Department retained consultants with extensive expertise in these areas to assess the proposed regulation, which helped the Department refine its policies and cost estimates.
In addition, it is important to note that the other HIPAA administrative simplification regulations will require systems changes. As explained generally in the cost analysis for the electronic Transactions rule, it is assumed that providers and vendors will undertake systems changes for these regulations collectively, thereby minimizing the cost of changes.