The document summarizes key audit procedures for ensuring HIPAA compliance in healthcare organizations. It outlines requirements for conducting risk assessments, acquiring secure IT systems, reviewing system activity, implementing risk management programs, and assigning security responsibilities. Organizations must identify vulnerabilities, establish security policies and standards, approve procedures on a periodic basis, and clearly define the role of a Security Official responsible for HIPAA security.
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OCR HHS HIPAA HITECH Audit Advisory Template
1. The New Trend in Healthcare IT
Implementation HIPAA
Section Established Performance Criteria Key Activity Audit Procedures Specification Compliance Area
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.
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 has been
updated or maintained to reflect changes in the covered entity's environment.
§164.308(a)(1): Security Management Process §164.308(a)(1)(ii)(a) -
Conduct an accurate and thorough assessment of the potential risks Determine if the covered entity risk assessment has been conducted on a periodic basis.
and vulnerabilities to the confidentiality, integrity, and availability of
§164.308 electronic protected health information held by the covered entity. Conduct Risk Assessment Determine if the covered entity has identified all systems that contain, process, or transmit ePHI. Required Security
§164.308(a)(1)(i): Security Management Process - Although the
HIPAA Security Rule does not require purchasing any particular
technology, additional hardware, software, or services may be
needed to adequately protect information. Considerations for their Inquire of management as to whether formal or informal policy and procedures exist covering the specific features of the
selection should include the following: HIPAA Security Rule information systems §164.306(a) and (b).
-Applicability of the IT solutions to the intended environment;
-The sensitivity of the data; Obtain and review formal or informal policy and procedures and evaluate the content in relation to the specified
-The organization's security policies, procedures, and standards; performance to meet the HIPAA Security Rule §164.306(a) and (b).
and
-Other requirements such as resources available for operation, Acquire IT Systems and Determine if the covered entity's formal or informal policy and procedures have been approved and updated on a periodic
§164.308 maintenance, and training. Services basis. Required Security
Inquire of management as to whether formal or informal policy and procedures exist to review information system activities;
such as audit logs, access reports, and security incident tracking reports.
Obtain and review formal or informal policy and procedures and evaluate the content in relation to specified performance
criteria to determine if an appropriate review process is in place of information system activities.
§164.308(a)(1)(ii)(D): Security Management Process - Implement
procedures to regularly review records of information system Develop and Deploy the Obtain evidence for a sample of instances showing implementation of covered entity review practices
activity, such as audit logs, access reports, and security incident Information System
§164.308 tracking reports. Activity Review Process Determine if the covered entity policy and procedures have been approved and updated on a periodic basis. Required Security
Inquire of management as to whether current security measures are sufficient to reduce risks and vulnerabilities to a
reasonable and appropriate level to comply with § 164.306(a).
Obtain and review security policies and evaluate the content relative to the specified criteria.
§164.308(a)(1): Security Management Process §164.308(a)(1)(ii)(b) -
Implement security measures sufficient to reduce risks and Determine if the security policy has been approved and updated on a periodic basis.
vulnerabilities to a reasonable and appropriate level to comply with § Implement a Risk
§164.308 164.306(a). Management Program Determine if security standards address data moved within the organization and data sent out of the organization. Required Security
Inquire of management as to whether the organization has assigned responsibility for the HIPAA security to a Security Official
to oversee the development, implementation, monitoring, and communication of security policies and procedures.
§164.308(a)(2): Assigned Security Responsibility - the responsibility Obtain and review the assigned Security Official's responsibilities(e.g., job description) and evaluate the content in relation to
for security should be assigned to a specific individual or organization Select a Security Official To the specified criteria.
to provide an organization focus and importance to security, and that Be Assigned Responsibility
§164.308 the assignment be documented. for HIPAA Security Determine if the responsibilities of Security Official have been clearly defined. Required Security
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