Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Appending Records (Amendment and Correction)


Comment: The proposed rule estimated the cost of amending and correcting patients' records at $75 per instance and $260 million per year for small entities. At least one commenter stated that such requests will rise significantly upon implementation of the regulations and increase in direct proportion to the number of patients served. Another commenter described the more subtle costs associated with record amendment and correction, which would include a case-by-case clinical determination by providers on whether to grant such requests, forwarding the ensuing record changes to business partners, and issuing written statements to patients on the reasons for denials, including a recourse for complaints.

Response: The comments were considered in revising the proposal, and the decision was made to clarify in the final regulation that providers must only append the record (the policy is explained further in the preamble and the regulation text). The provider is now only required to note in the medical record any comments from the patient; they may, but are not required to, correct any errors. This change in policy significantly reduces the cost from the initial proposal estimate.

Comment: Several commenters criticized the proposed rule's lack of justification for assumptions regarding the percentage of patients who request inspection and copying, who also request amendment and correction. Another commenter pointed out that the cost estimate for amendment and correction is dependent on a base assumption that only 1.5 percent of patients will request inspection of their records. As such, if this estimate were too low by just one percentage point, then the estimates for inspection and copying plus the costs for amendment and correction could rise by 67 percent.

Response: Based on information and data received in the public comments, the estimate for the number of people requesting inspection and copying has been revised. No commenter provided specific information on the number of amended record requests that might result, but the Department subsequently engaged in fact-finding and made appropriate adjustments in its estimates. The revisions are explained further below.