Can the practice deny the request to amend the record?
The request can be denied for one of the following reasons:

• The record was not created by the practice, unless the individual provides a reasonable basis to believe that the originator of the protected health information (PHI) is no longer available to act on the request. 
• The information is not a part of the designated record set. 
• It would not be available under inspection § 164.524. 
• It is accurate and complete. 

Is there any time limitation for response to a request to amend a record?
The practice must act on an individual’s request for an amendment no later than 60 days after the request is received.

Are there requirements if a request to amend a record is approved?

• The practice must make the appropriate amendment to the protected health information (PHI) or record that is the subject of the request for amendment by identifying the records in the designated data set that are affected by the amendment and appending or otherwise providing a link to the location of the amendment. 
• The practice must inform the individual that the amendment was accepted and obtain the individual’s identification of and agreement to notify the relevant persons. 
• The practice must make reasonable efforts to inform and provide the amendment to appropriate persons within a reasonable time.
• Persons, including business associates, who the practice knows have the affected PHI and who may have relied on that information or could foreseeably rely on that information, or have been identified by the individual as needing the amendment, must receive the amendment. 

What happens next if the request to amend the record is denied by the practice?

• The practice must provide the individual with a timely, written denial. 
• The denial must be in plain language and contain the following: 
  • The basis for the denial. 
  • The individual’s right to submit a written statement disagreeing with the statement of denial and how they can file a statement. 
  • A statement that if the individual does not submit a statement of disagreement, the individual may request that the practice provide the individual’s request for amendment and the denial with any future disclosures of the protected health information (PHI) that is the subject of the amendment. 
  • A description of how the individual may complain to the practice per the complaint procedures or to the Secretary of Health and Human Services. The description must include name, title, and phone number of the contact person or office designated. 
• The practice must permit the individual to submit a written statement disagreeing with the denial of all or part of the requested amendment and the basis of the disagreement. The practice may reasonably limit the length of a statement of disagreement. 
• The practice has the right to prepare a written rebuttal to the individual’s statement of disagreement. When a rebuttal statement is prepared, a copy must be made available to the individual. 
• Record keeping requirements stipulate linking the request for amendment, denial, statement of disagreement, and rebuttal, if any, to the designated record set.