Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Inspection and Copying


Comment: Numerous commenters disagreed with the cost estimates in the NPRM for inspection and copying of patient records, believing that they were too low.

Response: The Department has investigated the potential costs through a careful reading of the comments and subsequent factfinding discussions with a variety of providers. We believe the estimates, explained more fully below, represent a reasonable estimate in the aggregate. It is important to note, however, that this analysis is not measuring the cost of all inspection and copying because a considerable amount of this already occurs. The Department is only measuring the incremental increase likely to occur as a result of this regulation.

Comment: One commenter speculates that, even at a minimum charge of $.50/page, (and not including search and retrieval charges), costs could run as high as $450 million annually.

Response: The $0.50 per page in the proposal represent an average of several data sources. Subsequently, an industry commenter, which provided extensive medical records copying, stated that this was a reasonable average cost. Hence, we retained the number for the final estimate.

Comment: One respondent states that, since the proposed rules give patients the right to inspect and copy their medical records regardless of storage medium, HHS must make a distinction in its cost estimates between records stored electronically and those which must be accessed by manual means, since these costs will differ.

Response: The cost estimates made for regulations are not intended to provide such refined gradations; rather, they are intended to show the overall costs for the regulation as a whole and its major components. For inspections and copying (and virtually all other areas for which estimates are made) estimates are based on averages; particular providers may experience greater or lesser costs than the average cost used in this analysis.

Comment: Several commenters noted that the Department did not appear to include the cost of establishing storage systems, retrieval fees and the cost of searching for records, and that these costs, if included, would significantly increase the Department's estimate.

Response: Currently, providers keep and maintain medical records and often provide copies to other providers and patients. Therefore, much of the cost of maintaining records already exists. Indeed, based on public comments, the Department has concluded that there will be relatively few additional copies requested as the result of this regulation (see below). We have measured and attributed to this regulation the incremental cost, which is the standard for conducting this kind of analysis.

Comment: A federal agency expressed concern over the proposal to allow covered entities to charge a fee for copying personal health information based on reasonable costs. The agency requests personal health information from many covered entities and pays a fee that it establishes. Allowing covered entities to establish the fee, the agency fears, may cost them significantly more than the current amounts they pay and as a result, could adversely affect their program.

Response: The proposal and the final rule establish the right to access and copy records only for individuals, not other entities; the "reasonable fee" is only applicable to the individual's request. The Department's expectation is that other existing practices regarding fees, if any, for the exchange of records not requested by an individual will not be affected by this rule.