Accounting for Disclosure Requirements Summary of Changes Included in the Proposed Rule 76 Federal Register May 31, 2011

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1 Accounting for Disclosure Requirements Summary of Changes Included in the 76 Federal Register May 31, 2011 Current Rule Right to an Accounting; Content Generally An individual has a right under to an accounting of certain disclosures of PHI about the individual, regardless of where such information is located. Business Associates CEs are required to include in BA agreements the requirement that the BA will make available the information required to provide an accounting of disclosures in accordance with Section (b)(1) currently provides that the accounting must include disclosures to or by business associates of the covered entity without regard to whether such information is maintained within a designated record set. Time Period CEs and BAs must account for disclosures made within the six-year period prior to the request. Types of Disclosures Subject to Accounting All disclosures are generally subject to the accounting requirement, except for certain disclosures (see below). Generally An individual s right to obtain an accounting of disclosures is limited to an accounting of disclosures of PHI about the individual from a designated record set. Designated record sets include the medical and health care payment records maintained by or for a CE, and other records used by or for the CE to make decisions about individuals. Records that contain PHI but are used for other purposes, such as a hospital s peer review files, would not be subject to the accounting requirement. Business Associates The CE must include accounting information for all disclosures by the CE s BAs that create, receive, maintain, or transmit designated record set information. Time Period CEs and BAs must account for disclosures made within the three-year period prior to the request. Types of Disclosures Subject to Accounting HHS explicitly lists the types of disclosures that are subject to the accounting requirement: Non-permitted disclosures unless the individual has received notification of the impermissible disclosure pursuant to Disclosures for public health activities as provided in (b), except disclosures to report child abuse or neglect pursuant to (b)(1)(ii) For judicial and administrative proceedings as provided in (e) Disclosures for law enforcement purposes as provided in (f) Disclosures to avert a serious threat to health or safety as provided in (j) Disclosures for military and veterans activities, the Department of State s medical suitability

2 determinations, and government programs providing public benefits as provided in (k)(1), (4), and (6) Disclosures for workers compensation as provided in (l) Types of Disclosures Not Subject to Accounting All disclosures are generally subject to the accounting requirement, except for disclosures: To carry out treatment, payment, and health care operations as provided in To individuals of PHI about them as provided in Incident to a use or disclosure otherwise permitted or required by this subpart, as provided in Pursuant to an authorization as provided in For the facility s directory or to persons involved in the individual s care or other notification purposes as provided in For national security or intelligence purposes as provided in (k)(2) To correctional institutions or law enforcement officials as provided in (k)(5) As part of a limited data set in accordance with (e) That occurred prior to the compliance date for the CE Impermissible Disclosures The disclosure accounting must include disclosures that are impermissible under the Privacy Rule. Patient Safety Work Product Research Disclosures For disclosures made for research purposes, a CE may provide a list of research protocols rather than specific information about each disclosure. Accordingly, an individual who requests an accounting of disclosures Types of Disclosures Not Subject to Accounting HHS explicitly lists the types of disclosures that are subject to the accounting requirement, rather than the exceptions (see above). Despite this change in regulatory approach, these the types of disclosures not subject to the accounting requirement under the current rule, continue to be excluded from the accounting requirement under the Proposed Rule, except that to the extent such disclosures are made through an electronic designated record set information, such disclosures will be recorded and available to the individual in an access report under proposed (b). Impermissible Disclosures The disclosure accounting must include disclosures that are impermissible under the Privacy Rule, but HHS proposes to exempt from the accounting requirement impermissible disclosures for which the CE (directly or through a BA) has provided the individual a breach notice. Patient Safety Work Product A CE would exclude from its accounting any information that meets the definition of patient safety work product under 42 C.F.R Part 3. Research Disclosures HHS is considering eliminating the requirements for CEs to provide an accounting of disclosures made for research purposes, including through a protocol listing. Rather, the individual would continue to receive notice

3 may receive a list of research protocols with information about each protocol, including contact information, rather than specific information about disclosures for research. through the notice of privacy practices that PHI may be used or disclosed for research, and the CE would only be able to disclose the individual s PHI for research under limited circumstances (such as based on the individual s authorization or an IRB/ Privacy Board finding that the research poses no more than a minimal risk to the individual s privacy). Disclosures of limited data sets for research purposes and disclosures for research purposes pursuant to an individual s authorization are currently exempt from the accounting requirements and would not be impacted by the. Content of the Disclosure An accounting of disclosures must include: The date of each disclosure For multiple disclosures of PHI to the same person or entity for the same purpose, the accounting for subsequent disclosures may provide the frequency, periodicity, or number of disclosures during the accounting period, and the date of the last disclosure The name of the entity or person and (if known) address of the recipient An accounting of disclosures must include: The date of disclosure may be descriptive, rather than an actual date (e.g., "within 15 days of discharge ). If the actual date of disclosure is not known, the accounting may include an approximate date or period of time for each disclosure. At a minimum, the approximate date must include a month and year or a description of when the disclosure occurred from which an individual can readily determine the month and year of the disclosure. For multiple disclosures of PHI to the same person or entity for the same purpose, the accounting would require only the approximate period of time during which the disclosures were made. The name of the entity or natural person who received the PHI and, if known, his or her address, unless providing the name of the recipient would itself represent a disclosure of PHI about another individual. Brief description of the PHI disclosed Brief statement of the purpose of the disclosure Brief description of the type of PHI disclosed Brief description of the purpose of the disclosure. HHS intends to make clear that only a minimum description is required if it reasonably informs the individual of the purpose.. HHS proposes to retain the language indicating that a copy of a written request may be substituted for a description of the purpose of the disclosure.

4 Requests for Accounting; Response Format and Deadlines Written Request Limited Accounting Response Deadline Permissible time period to respond to request for accounting: 60 days. The response may be delayed upon the request of law enforcement or for a health oversight investigation. Form and Format Fees The CE must provide the first accounting to an individual in any 12-month period without charge. The CE may impose a reasonable, cost-based fee for each subsequent request for an accounting by the same individual within the 12- month period, provided that the CE informs the individual in advance of the fee and provides the individual with an opportunity to withdraw or modify the request for a subsequent accounting in order to avoid or reduce the fee. Written Request The CE may require individuals to make requests for an accounting in writing provided that it informs individuals of such a requirement. Limited Accounting Individuals must have the option of limiting the accounting to a particular time period, type of disclosure, or recipient. Response Deadline Permissible time period to respond to request for accounting: 30 days. The response may be delayed upon the request of law enforcement. A provision allowing a delay for health investigations is no longer necessary because HHS is proposing that such disclosures would be exempt from the accounting requirements. Form and Format CEs must provide individuals with the accounting in the form and format requested by the individual if readily producible (e.g., an electronic copy of the accounting). Fees The CE must provide the first accounting to an individual in any 12-month period without charge and inform the individual at the time of the request that there may be a fee for each subsequent request for an accounting by the individual within the 12-month period. The CE may impose a reasonable, cost-based fee for each subsequent request for an accounting by the same individual within the 12- month period, provided that the CE informs the individual of the fee at the time of the subsequent request and provides the individual with an opportunity to withdraw or modify the request for a subsequent accounting in order to avoid or reduce the fee. Documentation A CE must: Maintain the information necessary to generate an accounting of disclosures for six years. Retain a copy of any accounting that was A CE must: Maintain the documentation necessary to generate an accounting of disclosures for three years (rather than for the six-year retention period that is set forth at 45 CFR (j))

5 provided to an individual for six years from the date the accounting was provided. Document the designation of the persons or offices responsible for receiving and processing accounting requests. In the case of the designation of who is responsible for handling accounting requests, the CE must retain the designation for six years from the date when it was last in effect. No change No change

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