Standards for Privacy of Individually Identifiable Health Information. Final Privacy Rule Preamble.. Scope of the Regulation


Comment: Numerous commenters noted the potential cost and burden of keeping track in medical records of information which had been transmitted electronically, which would be subject to the rule, as opposed to information that had only been maintained in paper form.

Response: This argument was found to have considerable merit and was one of the reasons that the Department concluded that the final regulation should apply to all medical records maintained by covered entities, including information that had never been transmitted electronically. The costs analysis below reflects the change in scope.