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Individuals have a right to receive an accounting of certain disclosures of PHI made by a health care component or by researchers who are part of a health care component in the 6 years prior to the date on which the accounting is requested. The individual may also request an accounting for a time period of up to 6 years.

ACCOUNTINGS OF DISCLOSURES MADE FOR RESEARCH PURPOSES
Researchers who are in a covered health care component must account for disclosures made for purposes other than the original research purpose for which they obtained the PHI. Accountings are required for:

1. PHI disclosed to another researcher who has obtained a IRB waiver or alteration of the individual authorization requirements;
2. PHI disclosed to another researcher for an activity preparatory to research;
3. PHI disclosed to another researcher as allowed for research using individual health information of decedents; and
4. Disclosures made as required by law.

The researcher need not include in the accounting disclosures that occurred prior to April 14, 2003.

ACCOUNTINGS SUSPENDED BY LAW ENFORCEMENT AND HEALTH OVERSIGHT OFFICIALS
Upon request by a health oversight agency or law enforcement official the accounting of the disclosures made to the agency or official will be suspended for the time period specified in the request. The request must state that the accounting would be reasonably likely to impede the agency's activities and must specify the time period of the suspension. The request must be documented and the accounting for the disclosures must be renewed at the end of the specified time period. If the initial statement by the agency or official is oral, the temporary suspension may not exceed 30 days, unless a written statement is submitted by the agency or official within 30 days of the oral request.

TIME PERIOD FOR ACTION
Generally, researchers must act on an individual's request for an accounting within 60 days from receipt of the request. The time for action on a request may be extended for an additional 30 days if the researcher is unable to take action within the original time period for action. To extend the time period for action, a written statement of the reasons for the delay must be provided to the individual within the 60 days from receipt of the request. One extension of the time period for action is allowed per request.

FEE
The first accounting during any 12-month time period must be provided without charge. A reasonable, cost-based fee may be charged for subsequent requests during any one 12-month time period. In situations where a fee would be imposed, the individual will be informed in advance of the fee and given an opportunity to withdraw or modify the request.

CONTENT OF RESEARCH ACCOUNTING
In response to a request for an accounting of disclosures, a researcher must provide a written report of disclosures requiring accounting that were made by the researcher in the 6 years prior to the request, or during a shorter time period if requested by the individual.

Research involving less than 50 subjects
If less than 50 subjects were involved, the accounting must include:

1. Date of disclosure;
2. Name of the recipient, and address if known;
3. Brief description of the PHI disclosed; and
4. Brief statement of the purpose of the disclosure that reasonably informs the individual of the basis for disclosure, or a copy of the request for the disclosure.

If multiples disclosures of PHI are made to the same person or entity for a single research purpose during the accounting period, the following must be provided:

1. The standard accounting information for the first disclosure during the accounting period;
2. The frequency, periodicity, or number of disclosures; and
3. The date of the last disclosure.

Research Involving more than 50 subjects If 50 or more research subjects were involved, the following information must be provided for each protocol or activity for which PHI of the individual may have been released:

1. The name of the protocol or other research activity;
2. A plain language description of the protocol or other research activity, including the research purpose and the criteria for selecting the records ;
3. Brief description of the type of PHI disclosed;
4. Date or time period during which the disclosures occurred or may have occurred, including at a minimum, the last date of disclosure;
5. Name, address and phone number of the entity that sponsored the research and the principal investigator to which the information was disclosed; and
6. A statement that the PHI may or may not have been disclosed for the particular protocol or other research activity.

Contact Information Requirement
If it is reasonably likely that the PHI of the individual was disclosed for a particular protocol or research activity, the person who disclosed the PHI must assist the individual in contacting the person responsible for the protocol or activity.