OCR Publishes HIPAA/HITECH Act Privacy and Security Compliance Audit Protocol

July 9, 2012.  Late in June, the Office for Civil Rights (OCR) of the Department of Health and Human Services (HHS) published its HIPAA/HITECH Act Privacy and Security Compliance Audit Protocol.  Here is OCR’s description of the program, which outlines 77 audit procedures for the HIPAA Security Rule and 88 audit procedures for the HIPAA Privacy and HITECH Act Breach Notification Rules:

“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 [protected health information], (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.”

The OCR Audit Protocol Web site link highlighted above outlines each of the audit procedures that starts with the phrase “inquire of management,” and permits keyword search. As an example, we identify below the first audit procedure under the Security Rule, whose key activity is:  conduct risk assessment:

Section: 45 CFR 164.308

Established Performance Criteria:  45 CFR 164.308(a)(1).  Security Management Process (45 CFR 164.308(a)(1)(ii)(a)–Conduct an accurate and thorough assessment of the potential risks and vulnerabilities to the confidentiality, integrity, and availability of electronic protected health information held by the covered entity.

Key Activity:  Conduct Risk Assessment

Audit Procedures:  Inquire of management as to whether formal or informal policies or practices exist to conduct an accurate assessment of potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI [electronic PHI].  Obtain and review relevant documentation and evaluate the content relative to the specified criteria for an assessment of potential risks and vulnerabilities of ePHI.  Evidence of covered entity risk assessment process or methodology considers the elements in the criteria and [whether the it] has been updated or maintained to reflect changes in the covered entity’s environment. Determine if the covered entity risk assessment has been conducted on a periodic basis.  Determine if the covered entity has identified all systems that contain, process, or transmit ePHI.

Implementation Specification:  Required.

HIPAA.com recommends that covered entities pay close attention to the wording of OCR’s audit procedures as they pertain to their documented and implemented policies and procedures for successfully passing a compliance audit and avoiding potentially costly and time consuming OCR enforcement action.