To provide individuals with an accounting for disclosures, does a covered entity have to document each medical record that may be accessed by a public health authority in the course of surveillance activities that involve all patient records?
The Privacy Rule does not require a notation in each medical record that has been accessed by public health authorities, as long as the information required under the Privacy Rule is included in the accounting for disclosures. Where, as with many public health disclosures, access to an entire universe of records is involved, tracking disclosures can be accomplished without the need for documentation in each record. This flexibility in the manner of documentation facilitates complying with the accounting requirement.
By way of background, a covered entity may disclose protected health information (PHI) without the patient’s authorization to a public health authority that is legally permitted to collect or receive such information for public health surveillance or related activities (45 CFR 164.512(b)(1)). A covered entity is also required by the Privacy Rule to account to the patient for such disclosures of PHI, if the patient asks (45 CFR 164.528). Further, under the Privacy Rule, making a set of records available for review by a third party constitutes a “disclosure” of the PHI in the entire set of records, regardless of whether the third party actually reviews any particular record. See 45 CFR 164.501, for the definition of disclosure. Thus, mere access by a third party, such as a public health authority, to PHI is a disclosure and subject to an accounting for disclosures.
Public health surveillance activities often involve a retrospective review by a public health authority of a universe of patient records to identify reportable events. When a reportable case is identified, the specific data items pertinent to the public health surveillance activity are extracted and reported to the public health authority.
For example, retrospective review of the medical charts for all patients treated by a health care provider or all charts of patients treated in the entity’s emergency department may be required to identify cases of new or previously unknown infectious agents, clinical conditions associated with the use or abuse of illicit or prescription drugs, or adverse events or reactions associated with pharmaceuticals or medical devices. In these cases, as noted above, all records to which access was provided to the public health authority are deemed to have been disclosed under the Privacy Rule. Because of the universal nature of the access provided, the documentation required for the disclosure can be easily maintained. The covered entity need only document the identity (and address if known) of the public health authority to which access was provided, a description of the records and PHI subject to access, the purpose for the disclosure, and when access was provided. This documentation need not be noted in each record. It would be sufficient, for instance, for the covered entity to maintain a separate notation of such disclosures, applicable to all records so accessed. Then, if an individual requests an accounting, the covered entity need only determine whether the individual’s records were among the universe of records to which the public health authority was granted access. All individuals whose records were accessed in this fashion would receive the same accounting for the disclosure.
For example, if on August 1, 2003, a hospital began providing a public health authority ongoing access to the medical charts of all patients treated in its emergency department to identify reportable cases and extract relevant information required for a particular surveillance activity, it would be sufficient, under §164.528(b)(2), for the accounting to include the following:
- the identity, and address, if known, of the public health authority;
- a statement that the public health authority had access to medical charts for patients treated in the emergency department
- the date (or approximate range of dates) when the individual’s record was subject to access (e.g., access provided within a week of treatment in ER on [fill in date of individual visit]); and
- a statement of the purpose of the access (e.g., identify the particular public health surveillance activity).
The same basic statement could then be provided in response to a request for an accounting by any individual who was seen in the emergency department of the hospital on or after August 1, 2003.
Date Created: 08/28/2003