Comment: Many commenters strongly encouraged the Secretary to adopt "appendment" rather than "amendment and correction" procedures. They argued that the term "correction" implies a deletion of information and that the proposed rule would have allowed covered entities to remove portions of the record at their discretion. Commenters indicated that appendment rather than correction procedures will ensure the integrity of the medical record and allow subsequent health care providers access to the original information as well as the appended information. They also indicated appendment procedures will protect both individuals and covered entities since medical records are sometimes needed for litigation or other legal proceedings.
Response: We agree with commenters' concerns about the term "correction." We have revised the rule and deleted "correction" from this provision in order to clarify that covered entities are not required by this rule to delete any information from the designated record set. We do not intend to alter medical record retention laws or current practice, except to require covered entities to append information as requested to ensure that a record is accurate and complete. If a covered entity prefers to comply with this provision by deleting the erroneous information, and applicable record retention laws allow such deletion, the entity may do so. For example, an individual may inform the entity that someone else's X-rays are in the individual's medical record. If the entity agrees that the X-ray is inaccurately filed, the entity may choose to so indicate and note where in the record the correct X-ray can be found. Alternatively, the entity may choose to remove the X-ray from the record and replace it with the correct X-ray, if applicable law allows the entity to do so. We intend the term "amendment" to encompass either action.
We believe this approach is consistent with well-established privacy principles, with other law, and with industry standards and ethical guidelines. The July 1977 Report of the Privacy Protection Study Commission recommended that health care providers and other organizations that maintain medical-record information have procedures for individuals to correct or amend the information. 28 The Privacy Act (5 U.S.C. 552a) requires government agencies to permit individuals to request amendment of any record the individual believes is not accurate, relevant, timely, or complete. In its report "Best Principles for Health Privacy," the Health Privacy Working Group recommended, "An individual should have the right to supplement his or her own medical record. Supplementation should not be implied to mean 'deletion' or 'alteration' of the medical record." 29 The National Association of Insurance Commissioners' Health Information Privacy Model Act establishes the right of an individual who is the subject of protected health information to amend protected health information to correct any inaccuracies. The National Conference of Commissioners on Uniform State Laws' Uniform Health Care Information Act states, "Because accurate health-care information is not only important to the delivery of health care, but for patient applications for life, disability and health insurance, employment, and a great many other issues that might be involved in civil litigation, this Act allows a patient to request an amendment in his record."
Some states also establish a right for individuals to amend health information about them. For example, Hawaii law (HRS section 323C-12) states, "An individual or the individual's authorized representative may request in writing that a health care provider that generated certain health care information append additional information to the record in order to improve the accuracy or completeness of the information; provided that appending this information does not erase or obliterate any of the original information." Montana law (MCA section 50-16-543) states, "For purposes of accuracy or completeness, a patient may request in writing that a health care provider correct or amend its record of the patient's health care information to which he has access." Connecticut, Georgia, and Maine provide individuals a right to request correction, amendment, or deletion of recorded personal information about them maintained by an insurance institution. Many other states have similar provisions.
Industry and standard-setting organizations have also developed policies for amendment of health information. The National Committee for Quality Assurance and the Joint Commission on Accreditation of Healthcare Organizations issued recommendations stating, "The opportunity for patients to review their records will enable them to correct any errors and may provide them with a better understanding of their health status and treatment. Amending records does not erase the original information. It inserts the correct information with a notation about the date the correct information was available and any explanation about the reason for the error." 30 Standards of the American Society for Testing and Materials state, "An individual has a right to amend by adding information to his or her record or database to correct inaccurate information in his or her patient record and in secondary records and databases which contain patient identifiable health information." 31 We build on this well-established principle in this final rule.
Comment: Some commenters supported the proposal to allow individuals to request amendment for as long as the covered provider or plan maintains the information. A few argued that the provision should be time-limited, e.g., that covered entities should not have to amend protected health information that is more than two years old. Other comments suggested that the provision should only be applied to protected health information created after the compliance date of the regulation.
Response: The purpose of this provision is to create a mechanism whereby individuals can ensure that information about them is as accurate as possible as it travels through the health care system and is used to make decisions, including treatment decisions, about them. To achieve this result, individuals must have the ability to request amendment for as long as the information used to make decisions about them exists. We therefore retain the proposed approach. For these reasons, we also require covered entities to address requests for amendment of all protected health information within designated record sets, including information created or obtained prior to the compliance date, for as long as the entity maintains the information.
Comment: A few commenters were concerned that the proposal implied that the individual is in control of and may personally change the medical record. These commenters opposed such an approach.
Response: We do not give individuals the right to alter their medical records. Individuals may request amendment, but they have no authority to determine the final outcome of the request and may not make actual changes to the medical record. The covered entity must review the individual's request and make appropriate decisions. We have clarified this intent in § 164.526(a)(1) by stating that individuals have a right to have a covered entity amend protected health information and in § 164.526(b)(2) by stating that covered entities must act on an individual's request for amendment.
Comment: Some comments argued that there is no free-text field in some current transaction formats that would accommodate the extra text required to comply with the amendment provisions (e.g., sending statements of disagreement along with all future disclosures of the information at issue). Commenters argued that this provision will burden the efficient transmission of information, contrary to HIPAA requirements.
Response: We believe that most amendments can be incorporated into the standard transactions as corrections of erroneous data. We agree that some of the standard transactions cannot currently accommodate additional material such as statements of disagreement and rebuttals to such statements. To accommodate these rare situations, we modify the requirements in § 164.526(d)(iii). The provision now states that if a standard transaction does not permit the inclusion of the additional material required by this section, the covered entity may separately transmit the additional material to the recipient of the standard transaction. Commenters interested in modifying the standard transactions to allow the incorporation of additional materials may also bring the issue up for resolution through the process established by the Transactions Rule and described in its preamble.
Comment: The NPRM proposed to allow amendment of protected health information in designated record sets. Some commenters supported the concept of a designated record set and stated that it appropriately limits the type of information available for amendment to information directly related to treatment. Other commenters were concerned about the burden this provision will create due to the volume of information that will be available for amendment. They were primarily concerned with the potential for frivolous, minor, or technical requests. They argued that for purposes of amendment, this definition should be limited to information used to make medical or treatment decisions about the individual. A few commenters requested clarification that individuals do not have a right to seek amendment unless there is verifiable information to support their claim or they can otherwise convince the entity that the information is inaccurate or incomplete.
Response: We believe that the same information available for inspection should also be subject to requests for amendment, because the purpose of these provisions is the same: to give consumers access to and the chance to correct errors in information that may be used to make decisions that affect their interests. We thus retain use of the "designated record set" in this provision. However, we share commenters' concerns about the potential for minor or technical requests. To address this concern, we have clarified that covered entities may deny a request for amendment if the request is not in writing and does not articulate a reason to support the request, as long as the covered entity informs the individual of these requirements in advance.
Comment: Many commenters noted the potentially negative impact of the proposal to allow covered entities to deny a request for amendment if the covered entity did not create the information at issue. Some commenters pointed out that the originator of the information may no longer exist or the individual may not know who created the information in question. Other commenters supported the proposal that only the originator of the information is responsible for amendments to it. They argued that any extension of this provision requiring covered entities to amend information they have not created is administratively and financially burdensome.
Response: In light of the comments, we modify the rule to require the holder of the information to consider a request for amendment if the individual requesting amendment provides a reasonable basis to believe that the originator of the information is no longer available to act on a request. For example, if a request indicates that the information at issue was created by a hospital that has closed, and the request is not denied on other grounds, then the entity must amend the information. This provision is necessary to preserve an individual's right to amend protected health information about them in certain circumstances.
Comment: Some commenters stated that the written contract between a covered entity and its business associate should stipulate that the business associate is required to amend protected health information in accordance with the amendment provisions. Otherwise, these commenters argued, there would be a gap in the individual's right to have erroneous information corrected, because the covered entity could deny a request for amendment of information created by a business associate.
Response: We agree that information created by the covered entity or by the covered entity's business associates should be subject to amendment. This requirement is consistent with the requirement to make information created by a business associate available for inspection and copying. We have revised the rule to require covered entities to specify in the business associate contract that the business associate will make protected health information available for amendment and will incorporate amendments accordingly. (See § 164.504(e).)
Comment: One commenter argued that covered entities should be required to presume information must be corrected where an individual informs the entity that an adjudicative process has made a finding of medical identity theft.
Response: Identity theft is one of many reasons why protected health information may be inaccurate, and is one of many subjects that may result in an adjudicative process relevant to the accuracy of protective health information. We believe that this provision accommodates this situation without a special provision for identity theft.
Comment: Some commenters asserted that the proposed rule's requirement that action must be taken on individuals' requests within 60 days of the receipt of the request was unreasonable and burdensome. A few commenters proposed up to three 30-day extensions for "extraordinary" (as defined by the entity) requests.
Response: We agree that 60 days will not always be a sufficient amount of time to adequately respond to these requests. Therefore, we have revised this provision to allow covered entities the option of a 30-day extension to deal with requests that require additional response time. However, we expect that 60 days will be adequate for most cases.
Comment: One commenter questioned whether a covered entity could appropriately respond to a request by amending the record, without indicating whether it believes the information at issue is accurate and complete.
Response: An amendment need not include a statement by the covered entity as to whether the information is or is not accurate and complete. A covered entity may choose to amend a record even if it believes the information at issue is accurate and complete. If a request for amendment is accepted, the covered entity must notify the individual that the record has been amended. This notification need not include any explanation as to why the request was accepted. A notification of a denied request, however, must contain the basis for the denial.
Comment: A few commenters suggested that when an amendment is made, the date should be noted. Some also suggested that the physician should sign the notation.
Response: We believe such a requirement would create a burden that is not necessary to protect individuals' interests, and so have not accepted this suggestion. We believe that the requirements of § 164.526(c) regarding actions a covered entity must take when accepting a request will provide an adequate record of the amendment. A covered entity may date and sign an amendment at its discretion.
Comment: The NPRM proposed that covered entities, upon accepting a request for amendment, make reasonable efforts to notify those persons the individual identifies, and other persons whom the covered entity knows have received the erroneous or incomplete information and who may have relied, or could foreseeably rely, on such information to the detriment of the individual. Many commenters argued that this notification requirement was too burdensome and should be narrowed. They expressed concern that covered entities would have to notify anyone who might have received the information, even persons identified by the individual with whom the covered entity had no contact. Other commenters also contended that this provision would require covered entities to determine the reliance another entity might place on the information and suggested that particular part of the notification requirements be removed. Another commenter suggested that the notification provision be eliminated entirely, believing that it was unnecessary.
Response: Although there is some associated administrative burden with this provision, we believe it is a necessary requirement to effectively communicate amendments of erroneous or incomplete information to other parties. The negative effects of erroneous or incomplete medical information can be devastating. This requirement allows individuals to exercise some control in determining recipients they consider important to be notified, and requires the covered entity to communicate amendments to other persons that the covered entity knows have the erroneous or incomplete information and may take some action in reliance on the erroneous or incomplete information to the detriment of the individual. We have added language to clarify that the covered entity must obtain the individual's agreement to have the amendment shared with the persons the individual and covered entity identifies. We believe these notification requirements appropriately balance covered entities' burden and individuals' interest in protecting the accuracy of medical information used to make decisions about them. We therefore retain the notification provisions substantially as proposed.
Comment: Some commenters argued against the proposed provision requiring a covered entity that receives a notice of amendment to notify its business associates, "as appropriate," of necessary amendments. Some argued that covered entities should only be required to inform business associates of these changes if the amendment could affect the individual's further treatment, citing the administrative and financial burden of notifying all business associates of changes that may not have a detrimental effect on the patient. Other commenters suggested that covered entities should only be required to inform business associates whom they reasonably know to be in possession of the information.
Response: We agree with commenters that clarification is warranted. Our intent is that covered entities must meet the requirements of this rule with respect to protected health information they maintain, including protected health information maintained on their behalf by their business associates. We clarify this intent by revising the definition of designated record set (see § 164.501) to include records maintained "by or for" a covered entity. Section 164.526(e) requires a covered entity that is informed of an amendment made by another covered entity to incorporate that amendment into designated record sets, whether the designated record set is maintained by the covered entity or for the covered entity by a business associate. If a business associate maintains the record at issue on the covered entity's behalf, the covered entity must fulfill its requirement by informing the business associate of the amendment to the record. The contract with the business associate must require the business associate to incorporate any such amendments. (See § 164.504(e).)
Comment: Some commenters supported the proposal to require covered entities to provide notification of the covered entity's statement of denial and the individual's statement of disagreement in any subsequent disclosures of the information to which the dispute relates. They argued that we should extend this provision to prior recipients of disputed information who have relied on it. These commenters noted an inconsistency in the proposed approach, since notification of accepted amendments is provided to certain previous recipients of erroneous health information and to recipients of future disclosures. They contended there is not a good justification for the different treatment and believed that the notification standard should be the same, regardless of whether the covered entity accepts the request for amendment.
These commenters also recommended that the individual be notified of the covered entity's intention to rebut a statement of disagreement. They suggested requiring covered entities to send a copy of the statement of rebuttal to the individual.
Response: Where a request for amendment is accepted, the covered entity knows that protected health information about the individual is inaccurate or incomplete or the amendment is otherwise warranted; in these circumstances, it is reasonable to ask the covered entity to notify certain previous recipients of the information that reliance on such information could be harmful. Where, however, the request for amendment is denied, the covered entity believes that the relevant information is accurate and complete or the amendment is otherwise unacceptable. In this circumstance, the burden of prior notification outweighs the potential benefits. We therefore do not require notification of prior recipients.
We agree, however, that individuals should know how a covered entity has responded to their requests, and therefore add a requirement that covered entities also provide a copy of any rebuttal statements to the individual.