Implement a security management process to prevent, detect, contain, and correct security violations
The foundation of HIPAA Security Rule compliance is a formal security management process. Organizations must conduct a thorough risk analysis to identify vulnerabilities that could expose ePHI, implement a risk management program to reduce those risks to a reasonable level, apply sanctions against workforce members who violate policies, and regularly review information system activity such as audit logs and access reports. Without this foundation, all other safeguards lack the direction and oversight needed to be effective.
Implementation steps
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Conduct a thorough risk analysis
Perform a documented risk analysis that identifies all ePHI your organization creates, receives, maintains, or transmits; all threats and vulnerabilities that could affect the confidentiality, integrity, or availability of that ePHI; the current controls in place; and the likelihood and impact of each threat exploiting each vulnerability. This is the required first step and must be repeated whenever significant changes occur.
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Implement a risk management program
Based on the risk analysis, implement security measures that reduce identified risks to a reasonable and appropriate level. Document your risk management decisions, including why specific controls were selected or accepted. Prioritize high-likelihood, high-impact risks. Review and update the risk management program on an ongoing basis as your environment and threat landscape changes.
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Establish and apply a sanction policy
Create a written sanction policy that specifies the consequences for workforce members who fail to comply with security policies and procedures. Sanctions should be proportional to the severity of the violation. Document sanctions that are applied. The existence of a sanction policy, combined with workforce training on it, deters non-compliance.
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Implement information system activity review
Establish procedures to regularly review records of information system activity such as audit logs, access reports, and security incident tracking reports. Frequency should be based on risk: systems with higher access to ePHI should be reviewed more often. Assign responsibility for reviews and document findings.
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Evidence required
Risk analysis documentation
A current, documented risk analysis covering ePHI, threats, vulnerabilities, likelihood, and impact.
- - Risk analysis spreadsheet or report
- - Risk register with threat/vulnerability/likelihood/impact columns
Risk management plan
Documentation of how identified risks are being addressed and by when.
- - Risk management plan or roadmap
- - Remediation tracking tickets
Sanction policy
Written policy specifying consequences for security policy violations.
- - Sanction policy document
- - HR policy referencing security sanctions
Activity review records
Evidence that information system activity is being reviewed regularly.
- - Log review reports
- - Audit log review schedule and sign-off records
Related controls
Designate a security official responsible for developing and implementing security policies and procedures
Assigned Security Responsibility
Implement procedures to ensure workforce members have appropriate access to ePHI and prevent unauthorized access
Workforce Security
Implement policies and procedures for authorizing access to ePHI
Information Access Management
Implement a security awareness and training program for all workforce members
Security Awareness and Training