NRPM: Standards for Privacy of Individually Identifiable Health Information. 13. Rights and procedures with respect to an accounting of disclosures. (§ 164.515)

11/03/1999

In this proposed rule, we propose that individuals have a right to receive an accounting of all instances where protected health information about them is disclosed by a covered entity for purposes other than treatment, payment, and health care operations, subject to certain time-limited exceptions for disclosures to law enforcement and oversight agencies as discussed below. Providing such an accounting would allow individuals to understand how their health information is shared beyond the basic purposes of treatment, payment and health care operations.

We considered whether to require covered entities to account for all disclosures, including those for treatment, payment and health care operations. We rejected this approach because it would be burdensome and because it would not focus on the disclosures of most interest to individuals. Upon entering the health care system, individuals are generally aware that their information would be used and shared for the purpose of treatment, payment and health care operations. They have the greatest interest in an accounting of circumstances where the information was disclosed for other purposes that are less easy to anticipate. For example, an individual might not anticipate that his or her information would be shared with a university for a research project, or would be requested by a law enforcement agency.

We are not proposing that covered entities include uses and disclosures for treatment, payment and health care operations in the accounting. We believe that it is appropriate for covered entities to monitor all uses and disclosures for treatment, payment and health care operations, and they would be required to do so for electronically maintained information by the Security Standard. However, we do not believe that covered entities should be required to provide an accounting of the uses and disclosures for treatment payment and health care operations.

This proposed rule would not specify a particular form or format for the accounting. In order to satisfy the accounting requirement, a covered entity could elect to maintain a systematic log of disclosures or it could elect to rely upon detailed record keeping that would permit the entity to readily reconstruct the history when it receives a request from an individual. We would require that covered entities be able to respond to a request for accounting within a reasonable time period. In developing the form or format of the accounting, covered entities should adopt policies and procedures that would permit them to respond to requests within the 30-day time period in this proposed rule.

We also considered whether or not the disclosure history should be a formal document that is constantly maintained or whether we should give more flexibility to entities in this regard. We decided that since our ultimate goal is that individuals have access to a disclosure history of their records upon request, it would be reasonable to require only that they be able to do this. We are not prescribing how they fulfill the requirement. We also believe that it is less burdensome to require that they be able to create a disclosure history than to require that they have a specific format for maintaining a disclosure history.

We are proposing that the accounting include all disclosures for purposes other than treatment, payment, and health care operations, subject to certain exceptions for disclosures to law enforcement and oversight agencies, discussed below. This would also include disclosures that are authorized by the individual. The accounting would include the date of each disclosure; the name and address of the organization or person who received the protected health information; and a brief description of the information disclosed. For all disclosures that are authorized by the individual, we are proposing that the covered entity maintain a copy of the authorization form and make it available to the individual with the accounting.

We considered whether the accounting of disclosures should include the name of the person who authorized the disclosure of information. The proposed Security Standard would require covered entities to have an audit mechanism in place to monitor access by employees. We concluded that it would be unnecessary and inappropriate to require the covered entity to include this additional information in the accounting. If the individual identifies an improper disclosure by an entity, he or she should hold the entity – not the employee of the entity – accountable. It is the responsibility of the entity to train its workforce about its policies and procedures for the disclosure of protected health information and to impose sanctions if such policies and procedures are violated.