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June 27, 2012

OCR Releases HIPAA Privacy and Security Audit Protocol

Having completed an initial 20 HIPAA privacy and security compliance audits since last fall, and with 95 additional audits in the pipeline, OCR has just released its HIPAA privacy and security audit protocol, together with information about the audit pilot program.  As always, information like this is extremely valuable to the regulated community.  Covered entities and business associates should avail themselves of the information contained in the audit protocol and related materials so that they may prepare themselves for the eventuality of an audit or investigation -- whether as part of the current audit plan or otherwise -- and focus their compliance efforts.

(Links updated 06/01/2013)


From the OCR website: 

The OCR HIPAA Audit program analyzes processes, controls, and policies of selected covered entities pursuant to the HITECH Act audit mandate. OCR established a comprehensive audit protocol that contains the requirements to be assessed through these performance audits. The entire audit protocol is organized around modules, representing separate elements of privacy, security, and breach notification. The combination of these multiple requirements may vary based on the type of covered entity selected for review.

  • The audit protocol covers Privacy Rule requirements for (1) notice of privacy practices for PHI, (2) rights to request privacy protection for PHI, (3) access of individuals to PHI, (4) administrative requirements, (5) uses and disclosures of PHI, (6) amendment of PHI, and (7) accounting of disclosures.

  • The protocol covers Security Rule requirements for administrative, physical, and technical safeguards.
  • The protocol covers requirements for the Breach Notification Rule.

OCR reported on the first 20 audits it conducted as well:

OCR Audit Presentation - First 20 Audits

David Harlow
The Harlow Group LLC
Health Care Law and Consulting 



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