Modified Accounting System

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FAU-C A system of accounting that can be utilized only in research studies that involve more than fifty records, where the covered entity must provide the individuals with just the following information: 

  • The name of the protocol or other research activity; 
  • Plain language description of the research protocol or activity including the purpose of the research, and criteria for selecting particular records; 
  • A brief description of the type of protected health information that was disclosed; 
  • The date or period of time during which such disclosures occurred, or may have occurred, including the date of the last such disclosure during the accounting period; 
  • The name, address, and telephone number of the entity that sponsored the research and of the researcher to whom the information was disclosed; and 
  • A statement that the protected health information of the individual may or may not have been disclosed for a particular protocol or other research activity.